[Federal Register Volume 85, Number 141 (Wednesday, July 22, 2020)]
[Notices]
[Page 44296]
[FR Doc No: 2020-15863]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL20-34-000]

Constellation Power Source Generation, LLC; Notice of Institution
of Section 206 Proceeding and Refund Effective Date

    On July 16, 2020, the Commission issued an order in Docket No.
EL20-34-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e (2018), instituting an investigation into the continued
justness and reasonableness of Constellation Power Source Generation,
LLC's rate schedule for Reactive Supply and Voltage Control from
Generation or Other Sources Service. Constellation Power Source
Generation, LLC, 172 FERC 61,051 (2020).
    The refund effective date in Docket No. EL20-34-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL20-34-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, 888 First
Street NE, Washington, DC 20426, in accordance with Rule 214 of the
Commission's Rules of Practice and Procedure, 18 CFR 385.214 (2019),
within 21 days of the date of issuance of the order.

    Dated: July 16, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-15863 Filed 7-21-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 150 (Wednesday, August 5, 2015)]
[Notices]
[Pages 46612-46615]
[FR Doc No: 2015-19132]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75566; File No. SR-NYSEArca-2015-42]

Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a
Proposed Rule Change, as Modified by Amendments No. 1 and No. 2, To
List and Trade of Shares of Newfleet Multi-Sector Unconstrained Bond
ETF Under NYSE Arca Equities Rule 8.600

July 30, 2015.

I. Introduction

    On June 5, 2015, NYSE Arca, Inc. (``Exchange'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
section 19(b)(1) of the Securities Exchange Act of 1934 (``Exchange
Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to list
and trade shares (``Shares'') of the Newfleet Multi-Sector
Unconstrained Bond ETF (``Fund''), a series of the ETFis Series Trust I
(``Trust'') under NYSE Arca Equities Rule 8.600, which governs the
listing and trading of Managed Fund Shares. On June 15, 2015, the
Exchange filed Amendment No. 1 to the proposed rule change.\3\ The
Commission published notice of the proposed rule change, as modified by
Amendment No. 1 thereto, in the Federal Register on June 24, 2015.\4\
On July 23, 2015, the Exchange filed Amendment No. 2 to the proposed
rule change.\5\ The Commission received no comments on the proposal.
This

order approves the proposed rule change, as modified by Amendments No.
1 and No. 2.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 to the proposed rule change replaced and
superseded the original filing in its entirety.
    \4\ See Securities Exchange Act Release No. 75247 (June 18,
2015), 80 FR 36372 (``Notice'').
    \5\ Amendment No. 2 clarified that the Adviser expects that,
under normal market conditions, the Fund will seek to invest at
least 75% of its corporate bond assets in issuances that have at
least $100,000,000 par amount outstanding in developed countries or
at least $200,000,000 par amount outstanding in emerging market
countries. Because it only makes this clarification and does not
materially affect the substance of the proposed rule change or raise
unique or novel regulatory issues, Amendment No. 2 to the proposed
rule change does not require notice and comment. The text of
Amendment No. 2 is available at: http://www.sec.gov/comments/sr-nysearca-2015-42/nysearca201542-2.pdf.
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II. The Exchange's Description of the Proposal \6\
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    \6\ The Commission notes that additional information regarding
the Fund, the Trust, and the Shares, including investment
strategies, risks, creation and redemption procedures, fees,
portfolio holdings, disclosure policies, calculation of net asset
value (``NAV''), distributions, and taxes, among other things, can
be found in the Notice and the Registration Statement, as
applicable. See Notice, supra note 3, and Registration Statement,
infra note 7.
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    NYSE Arca proposes to list and trade Shares under NYSE Arca
Equities Rule 8.600, which governs the listing and trading of Managed
Fund Shares on the Exchange. The Shares will be offered by the Trust,
which is registered with the Commission as an investment company.\7\
The investment adviser to the Fund will be Etfis Capital LLC
(``Adviser''), and the sub-adviser to the Fund will be Newfleet Asset
Management LLC (``Sub-Adviser'').\8\ ETF Issuer Solutions Inc. will
serve as the Fund's operational administrator. ETF Distributors LLC
will serve as the distributor, and the Bank of New York Mellon will
serve as the administrator, custodian, transfer agent and fund
accounting agent for the Fund.
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    \7\ The Trust is registered under the Investment Company Act of
1940 (``1940 Act''). The Exchange states that on January 26, 2015,
the Trust filed with the Commission an amendment to its registration
statement on Form N-1A under the Securities Act of 1933 (15 U.S.C.
77a) (``Securities Act'') and under the 1940 Act relating to the
Fund (File Nos. 333-187668 and 811-22819) (``Registration
Statement'').
    \8\ The Adviser and Sub-Adviser are not registered as broker-
dealers, but each is affiliated with one or more broker-dealers and
has implemented and will maintain a fire wall with respect to each
such broker-dealer affiliate regarding access to information
concerning the composition of or changes to the portfolio. In the
event (a) the Adviser or Sub-Adviser become registered broker-
dealers or newly affiliated with a broker-dealer, or (b) any new
adviser or sub-adviser is a registered broker-dealer or becomes
affiliated with a broker-dealer, it will implement a fire wall with
respect to its relevant personnel or its broker-dealer affiliate
regarding access to information concerning the composition of or
changes to the portfolio, and it will be subject to procedures
designed to prevent the use and dissemination of material non-public
information regarding such portfolio.
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    The Fund's investment objective is to provide a high level of
current income and, secondarily, capital appreciation. Under normal
market conditions,\9\ the Sub-Adviser will seek to select securities
using a sector rotation approach and seek to adjust the proportion of
Fund investments in various sectors and sub-sectors in an effort to
obtain higher relative returns.
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    \9\ The term ``under normal market conditions'' includes, but is
not limited to, the absence of extreme volatility or trading halts
in the fixed income markets or the financial markets generally;
operational issues causing dissemination of inaccurate market
information; or force majeure type events such as systems failure,
natural or man-made disaster, act of God, armed conflict, act of
terrorism, riot or labor disruption, or any similar intervening
circumstance. In the absence of normal market conditions, the Fund
may invest 100% of its total assets, without limitation, in cash or
cash equivalents. The Fund may be invested in this manner for
extended periods depending on the Sub-Adviser's assessment of market
conditions.
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A. The Fund's Principal Investments

    Under normal market conditions, at least 80% of the Fund's net
assets will be invested in the fixed income securities identified below
and in U.S. Treasury futures. The Fund may invest across the credit-
rating spectrum, which includes securities rated below investment grade
by a nationally recognized statistical rating organization (``NRSRO''),
and in unrated securities. The Fund has no target duration for its
investment portfolio.
    The Fund may invest in the following fixed income securities:
     Securities issued or guaranteed as to principal and
interest by the U.S. Government, or by its agencies, authorities or
instrumentalities, including, without limitation, collateralized
mortgage obligations (``CMOs''), real estate mortgage investment
conduits, and other pass-through securities;
     non-agency \10\ commercial mortgage-backed securities
(``CMBS''), agency and non-agency residential mortgage-backed
securities (``RMBS''), and other asset-backed securities (``ABS''),
including equipment trust certificates; \11\
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    \10\ ``Non-agency'' securities are financial instruments that
have been issued by an entity that is not a government-sponsored
agency such as the Federal National Mortgage Association, Federal
Home Loan Mortgage Corporation, Federal Home Loan Banks, or the
Government National Mortgage Association.
    \11\ The Fund may invest up to 20% of its net assets in the
aggregate in non-agency CMBS, RMBS, and ABS.
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     Yankee bonds; \12\
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    \12\ Yankee bonds are denominated in U.S. dollars, registered in
accordance with the Securities Act and publicly issued in the U.S.
by foreign banks and corporations.
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     loan assignments, including senior and junior bank loans
(generally with floating rates); \13\
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    \13\ The Fund may invest in loan assignments, including senior
and junior bank loans, rated C or higher by an NRSRO or unrated but
considered to be of comparable quality by the Adviser or Sub-
Adviser. The Fund will not invest in loan assignments that are in
default at time of purchase. The Fund will only invest in U.S.
dollar-denominated loan assignments. In addition, for investment
purposes, a bank loan must have a par amount outstanding of U.S.
$150 million or greater at the time it is originally issued. The
Fund may invest up to 20% of its net assets in junior bank loans.
The Adviser generally will invest in loan assignments, including
bank loans, that it deems highly liquid, with readily available
prices.
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     corporate bonds; \14\ and
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    \14\ The Adviser expects that under normal market conditions,
the Fund will seek to invest at least 75% of its corporate bond
assets in issuances that have at least $100,000,000 par amount
outstanding in developed countries or at least $200,000,000 par
amount outstanding in emerging market countries. See Amendment No.
2, supra note 5.
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     taxable municipal bonds and tax-exempt municipal bonds.
    Generally, the portfolio will include a minimum of 13 non-
affiliated issuers of debt securities, and the Fund will only purchase
performing securities, not distressed debt.\15\
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    \15\ Distressed debt is debt that is currently in default and is
not expected to pay the current coupon.
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    The Fund may invest in U.S. Treasury futures contracts traded on
U.S. futures exchanges to attempt to protect the Fund's current or
intended investments from broad fluctuations in securities prices.

B. The Fund's Non-Principal Investments

    While the Fund, under normal market conditions, will invest at
least 80% of its assets in the fixed income securities and financial
instruments identified above, the Fund may invest its remaining assets
in other assets and financial instruments, as described below.
    The Fund may hold the following exchange-traded equity securities:
Common stocks, preferred stocks, warrants, convertible securities, unit
investment trusts, master limited partnerships, real estate investment
trusts (``REITs''), exchange-traded funds (``ETFs''),\16\ and exchange-
traded notes (``ETNs'').\17\ These equity securities will be traded in
the U.S. on registered exchanges.
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    \16\ The Fund may invest in inverse ETFs, leveraged ETFs and
inverse leveraged ETFs (e.g., 2X or 3X).
    \17\ The Fund will not invest in leveraged ETNs and inverse
leveraged ETNs (e.g., 2X or 3X).
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    To gain exposure to the performance of foreign issuers, the Fund
may also invest in the following types of equity securities: American
Depositary Receipts (``ADRs''); ``ordinary shares'' and ``New York
shares'' (each of which is issued and traded in the U.S.); and Global
Depositary Receipts, European Depositary Receipts, and International
Depositary Receipts, which are traded on foreign exchanges.\18\
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    \18\ The Fund may invest in sponsored or unsponsored ADRs;
however, non-exchange listed ADRs will not exceed 10% of the Fund's
net assets.
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    With respect to its exchange-traded equity securities, the Fund
will normally invest in equity securities that are listed and traded on
a U.S. exchange or in markets that are members of the Intermarket
Surveillance Group (``ISG'')

or parties to a comprehensive surveillance sharing agreement with the
Exchange. In any case, not more than 10% of the net assets of the Fund
in the aggregate invested in exchange-traded equity securities will
consist of equity securities whose principal market is not a member of
ISG or a market with which the Exchange does not have a comprehensive
surveillance sharing agreement.
    The Fund may invest in, to the extent permitted by Section 12(d)(1)
of the 1940 Act and the rules thereunder,\19\ other affiliated and
unaffiliated funds, such as open-end or closed-end management
investment companies (``closed-end funds''), including other ETFs. The
Fund may also invest in the securities of other investment companies in
compliance with Section 12(d)(1)(E), (F) and (G) of the 1940 Act and
the rules thereunder.\20\
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    \19\ 15 U.S.C. 80a-12(d)(1).
    \20\ 15 U.S.C. 80a-12(d)(1)(E),(F) and (G).
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    The Fund may invest in exchange-traded securities of pooled
vehicles that are not investment companies and, thus, not required to
comply with the provisions of the 1940 Act, although such pooled
vehicles would be required to comply with the provisions of other
federal securities laws, such as the Securities Act. These pooled
vehicles typically hold commodities, such as gold or oil; currency; or
other property that is itself not a security.\21\
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    \21\ Exchange-traded pooled investment vehicles include Trust
Issued Receipts (as described in NYSE Arca Equities Rule 8.200);
Commodity-Based Trust Shares (as described in NYSE Arca Equities
Rule 8.201); Currency Trust Shares (as described in NYSE Arca
Equities Rule 8.202); Commodity Index Trust Shares (as described in
NYSE Arca Equities Rule 8.203); and Trust Units (as described in
NYSE Arca Equities Rule 8.500).
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III. Discussion and Commission Findings

    After careful review, the Commission finds that the Exchange's
proposal to list and trade the Shares is consistent with the Exchange
Act and the rules and regulations thereunder applicable to a national
securities exchange.\22\ In particular, the Commission finds that the
proposed rule change, as modified by Amendments No. 1 and No. 2, is
consistent with Section 6(b)(5) of the Exchange Act,\23\ which
requires, among other things, that the Exchange's rules be designed to
promote just and equitable principles of trade, 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. The Commission also finds that the proposal to list and trade
the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii)
of the Exchange Act,\24\ which sets forth the finding of Congress 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.
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    \22\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \23\ 15 U.S.C. 78f(b)(5).
    \24\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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    Quotation and last-sale information for the Shares and the
underlying U.S. exchange-traded equity securities will be available via
the Consolidated Tape Association (``CTA'') high-speed line, and from
the national securities exchange on which they are listed. In addition,
the intraday indicative value or ``IIV'' (which is the Portfolio
Indicative Value, as defined in NYSE Arca Equities Rule 8.600(c)(3))
will be widely disseminated at least every 15 seconds during the Core
Trading Session by one or more major market data vendors.\25\ On each
business day, before commencement of trading in Shares in the Core
Trading Session on the Exchange, the Fund's Web site will publish the
Disclosed Portfolio \26\ that will form the basis for the Fund's
calculation of NAV at the end of the business day.\27\
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    \25\ Currently, it is the Exchange's understanding that several
major market data vendors display or make widely available IIVs
taken from CTA or other data feeds.
    \26\ The term ``Disclosed Portfolio'' is defined in NYSE Arca
Equities Rule 8.600(c)(2).
    \27\ Under accounting procedures followed by the Fund, trades
made on the prior business day (``T'') will be booked and reflected
in NAV on the current business day (``T+1''). Accordingly, the Fund
will be able to disclose at the beginning of the business day the
portfolio that will form the basis for the NAV calculation at the
end of the business day.
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    The NAV for the Shares will be calculated after 4:00 p.m. Eastern
Time each trading day. Information regarding market price and trading
volume of the Shares will be continually available on a real-time basis
throughout the day on brokers' computer screens and other electronic
services. Information regarding the previous day's closing price and
trading volume information for the Shares will be published daily in
the financial section of newspapers. Pricing information regarding each
asset class in which the Fund will invest will generally be available
through nationally recognized data service providers through
subscription agreements. Foreign exchange prices are available from
major market data vendors. Intra-day and closing price information for
Rule 144A fixed income securities and loan assignments will be
available from major market data vendors. Price information for
investment company securities (other than ETFs and exchange-traded
closed end funds) will be available from the investment company's Web
site and from market data vendors. Quotation information from brokers
and dealers or pricing services will be available for unsponsored ADRs;
fixed income securities; bank loans; U.S. Treasury securities; other
obligations issued or guaranteed by U.S. government agencies or
instrumentalities; bank obligations; short-term securities; money
market instruments; ABS; MBS; CMBS; RMBS; CMOs; shares of mutual funds;
corporate debt securities; and convertible securities.
    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 Exchange will obtain a representation from the issuer of
the Shares that the NAV per Share will be calculated daily and that the
NAV and the Disclosed Portfolio will be made available to all market
participants at the same time. Trading in Shares of the Fund will be
halted if the circuit-breaker parameters in NYSE Arca Equities Rule
7.12 have been reached. Trading also may be halted because of market
conditions or for reasons that, in the view of the Exchange, make
trading in the Shares inadvisable.\28\ Trading in the Shares also will
be subject to NYSE Arca Equities Rule 8.600(d)(2)(D), which sets forth
circumstances under which Shares of the Fund may be halted. The
Exchange represents that it has a general policy prohibiting the
distribution of material, non-public information by its employees. The
Adviser and Sub-Adviser are not registered as broker-dealers but are
affiliated with two broker-dealers and have implemented and will
maintain a fire wall with respect to each such broker-dealer
affiliate.\29\
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    \28\ These may include: (1) The extent to which trading is not
occurring in the securities or the financial instruments
constituting the Disclosed Portfolio of the Fund; or (2) whether
other unusual conditions or circumstances detrimental to the
maintenance of a fair and orderly market are present.
    \29\ See supra note 7. The Exchange represents that an
investment adviser to an open-end fund is required to be registered
under the Investment Advisers Act of 1940.

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    Prior to the commencement of trading, the Exchange will inform its
Equity Trading Permit Holders (``ETP Holders'') in an Information
Bulletin (``Bulletin'') of the special characteristics and risks
associated with trading the Shares. The Exchange represents that
trading in the Shares will be subject to the existing trading
surveillances, administered by the Financial Industry Regulatory
Authority (``FINRA'') on behalf of the Exchange, which are designed to
detect violations of Exchange rules and applicable federal securities
laws.\30\
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    \30\ The Exchange states that FINRA surveils trading on the
Exchange pursuant to a regulatory services agreement. The Exchange
is responsible for FINRA's performance under this regulatory
services agreement.
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    The Exchange represents that it deems the Shares 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 also made the following
representations:
    (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) Trading in the Shares will be subject to the existing trading
surveillances, administered by FINRA on behalf of the Exchange, which
are designed to detect violations of Exchange rules and applicable
federal securities laws, and these 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 federal securities
laws applicable to trading on the Exchange.
    (4) FINRA, on behalf of the Exchange, will communicate as needed
regarding trading in the Shares, exchange-traded equity securities and
futures contracts with other markets and other entities that are
members of the ISG, and FINRA, on behalf of the Exchange, may obtain
trading information regarding trading in the Shares, exchange-traded
equity securities and futures contracts from such markets and other
entities. In addition, the Exchange may obtain information regarding
trading in the Shares, exchange-traded equity securities and futures
contracts from markets and other entities that are members of ISG or
with which the Exchange has in place a comprehensive surveillance
sharing agreement.\31\ FINRA, on behalf of the Exchange, is able to
access, as needed, trade information for certain fixed income
securities held by the Fund reported to FINRA's Trade Reporting and
Compliance Engine.
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    \31\ For a list of the current members of ISG, see
www.isgportal.org. The Exchange notes that not all components of the
Disclosed Portfolio for the Fund may trade on markets that are
members of ISG or with which the Exchange has in place a
comprehensive surveillance sharing agreement.
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    (5) Prior to the commencement of trading of the Shares, the
Exchange will inform its ETP Holders in a Bulletin of the special
characteristics and risks associated with trading the Shares. The
Bulletin will discuss the following: (i) The procedures for purchases
and redemptions of Shares in Creation Unit aggregations (and that
Shares are not individually redeemable); (ii) 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; (iii) the risks involved in trading the Shares during the
Opening and Late Trading Sessions (as defined in NYSE Arca Equities
7.34) when an updated IIV or Index value will not be calculated or
publicly disseminated; (iv) how information regarding the IIV, the
Disclosed Portfolio, and the Index value will be disseminated; (v) 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 (vi) trading information.
    (6) For initial and continued listing, the Fund will be in
compliance with Rule 10A-3 under the Exchange Act,\32\ as provided by
NYSE Arca Equities Rule 5.3.
---------------------------------------------------------------------------

    \32\ 17 CFR 240.10A-3.
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    (7) Not more than 20% of the Fund's net assets in the aggregate
will be invested in non-agency CMBS, RMBS, and ABS.
    (8) Not more than 20% of the Fund's net assets will be invested in
junior bank loans.
    (9) The Fund will invest only in U.S. dollar-denominated loan
assignments, and for investment purposes, a bank loan must have a par
amount outstanding of U.S. $150 million or greater at the time it is
originally issued. Furthermore, the Adviser will invest generally in
loan assignments, including bank loans, which it deems to be highly
liquid, with readily available prices.
    (10) The Fund may hold up to an aggregate amount of 15% of its net
assets in illiquid assets (calculated at the time of investment),
including Rule 144A fixed income securities and bank loans that are
deemed illiquid by the Adviser, consistent with Commission guidance.
    (11) A minimum of 100,000 Shares for the Fund will be outstanding
at the commencement of trading on the Exchange.
    This approval order is based on all of the Exchange's
representations, including those set forth above and in the Notice. The
Commission notes that the Fund and the Shares must comply with the
requirements of NYSE Arca Equities Rule 8.600 to be initially and
continuously listed and traded on the Exchange.
    For the foregoing reasons, the Commission finds that the proposed
rule change, as modified by Amendments No. 1 and No. 2, is consistent
with Section 6(b)(5) of the Exchange Act \33\ and Section
11A(a)(1)(C)(iii) of the Exchange Act \34\ and the rules and
regulations thereunder applicable to a national securities exchange.
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    \33\ 15 U.S.C. 78f(b)(5).
    \34\ 15 U.S.C. 78k-1(a)(1)(C)(iii).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\35\ that the proposed rule change (SR-NYSEArca-2015-42),
as modified by Amendments No. 1 and No. 2 thereto, be, and it hereby
is, approved.
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    \35\ 15 U.S.C. 78s(b)(2).
    \36\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\36\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-19132 Filed 8-4-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Proposed Rules]
[Pages 71191-71196]
[FR Doc No: 2021-27137]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2021-N-0310]
RIN 0910-AI32

Medical Devices; Orthopedic Devices; Classification of Spinal
Spheres for Use in Intervertebral Fusion Procedures

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

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is proposing
to classify spinal spheres for use in intervertebral fusion procedures
(an unclassified, preamendments device) into class III for which FDA is
separately proposing to require the filing of a premarket approval
application (PMA). FDA has determined that general controls and special
controls together are insufficient to provide reasonable assurance of
safety and effectiveness for this device. FDA is publishing this
proposed rule based, in part, on the recommendations of the Orthopaedic
and Rehabilitation Devices Panel, regarding the classification of
spinal spheres for use in intervertebral fusion procedures.

DATES: Submit either electronic or written comments on the proposed
rule by March 15, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before March 15, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 15, 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-2021-N-0310 for ``Medical Devices; Orthopedic Devices;
Classification of Spinal Spheres for Use in Intervertebral Fusion
Procedures.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
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FOR FURTHER INFORMATION CONTACT: Constance Soves, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002, 301-
796-6951, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Need for the Regulation
    B. FDA's Current Regulatory Framework
    C. History of This Rulemaking
IV. Legal Authority
V. Description of the Proposed Rule
    A. Device Description
    B. Risks to Health and Public Health Benefits
    C. Proposed Classification and FDA's Findings
VI. Proposed Effective/Compliance Dates
VII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VIII. Analysis of Environmental Impact
IX. Paperwork Reduction Act of 1995
X. Federalism
XI. Consultation and Coordination With Indian Tribal Governments
XII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to classify spinal spheres for use in
intervertebral fusion procedures (spinal spheres), which are
unclassified, preamendments devices, into class III. A spinal sphere is
a prescription device used to provide stabilization of a spinal segment
as an adjunct to fusion. FDA currently regulates these unclassified
devices as devices requiring premarket notification, with the product
code NVR.
    FDA initiated the classification of spinal spheres by consulting
the Orthopaedic and Rehabilitation Devices Panel (the Panel). The Panel
recommended that spinal spheres be classified into class III because
there was a lack of available evidence to determine that general and
special controls are sufficient to provide reasonable assurance of its
safety and effectiveness, and these devices present a potential
unreasonable risk of illness or injury. FDA conducted its own analysis
as described below and agrees with the Panel's recommendation. As such,
FDA proposes to classify spinal spheres into class III. FDA is also
proposing, by proposed order published elsewhere in this issue of the
Federal Register, to require the filing of PMAs for such devices.

B. Summary of the Major Provisions of the Proposed Rule

    This rule proposes to classify spinal spheres into class III. The
proposed rule, if finalized, would establish the identification and
classification for spinal spheres. In addition, FDA proposes that the
use of spinal spheres devices be limited to prescription use.

C. Legal Authority

    The Agency is proposing this classification under the authority of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 301).
Specifically, the relevant authority related to the proposed
classification includes section 513(a) through (d) of the FD&C Act (21
U.S.C. 360c(a) through (d)), regarding device classes, classification,
and panels, and section 515 (21 U.S.C. 360e), regarding PMAs.

D. Costs and Benefits

    This proposed rule, if finalized, would classify spinal spheres for
use in intervertebral fusion procedures (an unclassified, preamendments
device) into class III for which FDA is separately proposing to require
the filing of a premarket approval application. The costs of the rule
include one-time costs associated with reading the proposed rule. FDA
is only able to identify the costs of this proposed rule. We estimate
that the present value of the costs of the rule are between $427 and
$20,480, with a primary estimate of $10,453. Annualizing over a 10-year
period at a discount rate of 3 percent, the costs of this proposed rule
are estimated to be between $29 and $1,377, with a primary estimate of
$703. Annualizing over a 10-year period at a discount rate of 7
percent, the costs of this proposed rule are estimated to be between
$40 and $1,933, with a primary estimate of $987.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

                                                           Table 1--Abbreviations and Acronyms
--------------------------------------------------------------------------------------------------------------------------------------------------------
          Abbreviation or acronym                                                           What it means
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k).....................................  Premarket Notification.
CoCrMo.....................................  cobalt-chromium-molybdenum.
FDA........................................  Food and Drug Administration.
FD&C Act...................................  Federal Food, Drug, and Cosmetic Act.
MAUDE......................................  FDA's Manufacturer and User Facility Device Experience database.
OMB........................................  Office of Management and Budget.
PMA........................................  Premarket Approval Application.
--------------------------------------------------------------------------------------------------------------------------------------------------------

III. Background

A. Need for the Regulation

    Currently, spinal spheres are unclassified devices subject to
premarket notification (510(k)) under section 510(k) of the FD&C Act
(21 U.S.C. 360(k)). Until an unclassified device type has been formally
classified by regulation, marketing of new devices within this device
type requires FDA clearance of a 510(k). As described below, FDA
granted the first clearance for spinal spheres (K051320, September 9,
2005) based on documentation that demonstrated that these devices were
substantially equivalent to devices that were in commercial
distribution prior to passage of the Medical Device Amendments on May
28, 1976. Because the clinical evidence is limited, FDA is proposing to
classify spinal spheres into class III, subject to PMA.

B. FDA's Current Regulatory Framework

    The FD&C Act (21 U.S.C. 301 et seq.), as amended by the Medical
Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295),
established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act established
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness: Class I (general controls), class II (special controls),
and class III (premarket approval).
    Section 513(a)(1) of the FD&C Act defines the three classes of
devices. Class I devices are those devices for which the general
controls of the FD&C Act (controls authorized by or under sections 501,
502, 510, 516, 518, 519, or 520 of the FD&C Act (21 U.S.C. 351, 352,
360, 360f, 360h, 360i, or 360j) or any combination of such sections)
are sufficient to provide reasonable assurance of safety and
effectiveness; or those devices for which insufficient information
exists to determine that general controls are sufficient to provide
reasonable assurance of safety and effectiveness or to establish
special controls to provide such assurance, but because the devices are
not purported or represented to be for a use in supporting or
sustaining human life or for a use which is of substantial importance
in preventing impairment of human health, and do not present a
potential unreasonable risk of illness or injury, are to be regulated
by general controls (section 513(a)(1)(A) of the FD&C Act). Class II
devices are those devices for which general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but for which there is sufficient information to
establish special controls to provide such assurance, including the
promulgation of performance standards, postmarket surveillance, patient

registries, development and dissemination of guidelines,
recommendations, and other appropriate actions the Agency deems
necessary to provide such assurance (section 513(a)(1)(B) of the FD&C
Act). Class III devices are those devices for which insufficient
information exists to determine that general controls (controls
authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 of
the FD&C Act or any combination of such sections) and special controls
would provide a reasonable assurance of safety and effectiveness, and
are purported or represented for a use in supporting or sustaining
human life or for a use which is of substantial importance in
preventing impairment of human health, or present a potential
unreasonable risk of illness or injury (section 513(a)(1)(C) of the
FD&C Act).
    Under section 513(d) of the FD&C Act, FDA refers to devices that
were in commercial distribution before the 1976 amendments as
``preamendments devices.'' FDA classifies these devices after the
Agency: (1) Receives a recommendation from a device classification
panel (an FDA advisory committee); (2) publishes the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) publishes a final regulation
classifying the device (section 513(d)(1) of the FD&C Act). FDA has
classified most preamendments devices under these procedures.
    A person may market a preamendments device that has been classified
into class III through premarket notification procedures without
submission of a PMA until FDA issues a final regulation order under
section 515(b) of the FD&C Act requiring premarket approval. FDA is
also proposing, by proposed order published elsewhere in this issue of
the Federal Register, to require the filing of PMAs for such devices.
    After the enactment of the 1976 amendments, FDA undertook an effort
to identify and classify all preamendments devices in accordance with
section 513(d) of the FD&C Act. As part of this effort, FDA issued a
proposed rule for classification of 77 generic types of orthopedic
devices in the Federal Register of September 4, 1987 (52 FR 33686).
However, spinal spheres were not included in this action and were never
separately classified. FDA initiated the classification of spinal
spheres by holding a panel meeting on December 12, 2013, regarding the
classification of spinal spheres (Ref. 1).

C. History of This Rulemaking

    As described previously, spinal spheres for use in intervertebral
fusion procedures are unclassified, preamendments devices. These
devices have been subject to premarket review through a 510(k)
submission and have been cleared for marketing if FDA considers the
device to be substantially equivalent to a legally marketed predicate
in accordance with section 513(i) of the FD&C Act. To date, FDA has
cleared six spinal sphere devices from four manufacturers. Spinal
sphere devices, however, are no longer used due to the widespread
adoption of intervertebral body fusion devices (``interbody cages'').
Unlike spinal sphere devices, interbody cages generally possess
different features to engage with vertebral endplates, allowing them to
resist migration and subsidence, and features that allow for the
packing of graft material, facilitating bone growth into and through
the device.
    On December 12, 2013, FDA convened the Panel to secure
recommendations regarding the appropriate classification, regulatory
controls, as well as risks to health and benefits of spinal spheres
(Ref. 1). At the meeting, FDA requested the Panel consider whether this
device type fits the statutory definition for a class III device. The
Panel considered the information provided by FDA about spinal spheres,
including results and analysis from a literature search and search of
known adverse events (Ref. 1).
    The Panel unanimously recommended that spinal spheres be classified
into class III, subject to PMA. The Panel believed that classification
in class III is appropriate given that there was a lack of available
evidence to determine that general and special controls are sufficient
to provide reasonable assurance of its safety and effectiveness for use
in intervertebral body fusion procedures. Furthermore, the Panel
unanimously agreed that spinal spheres for use in fusion procedures
present an unreasonable risk of illness or injury to the patients. In
addition to the risks to health identified by FDA that include removal/
revision, pain, and neurologic impairment, the Panel recommended
incorporating all known risks generally associated with spinal
interbody fusion procedures (see Ref. 1, Panel transcript at page 58).
In summary, the Panel unanimously determined that given the lack of
available evidence and unreasonable risk profile of spinal spheres
devices for use in fusion procedures, these devices should be
classified as class III devices which would, after publication of a
final order calling for PMAs, require submission of a PMA and approval
to market the device. FDA agrees with the Panel's recommendation that
there was a lack of available evidence to determine that general and
special controls are sufficient to provide reasonable assurance of its
safety and effectiveness, and that the device presents a potential
unreasonable risk of illness or injury. FDA further agrees with the
Panel's recommendation that spinal sphere devices for use in fusion
procedures be classified into class III subject to PMA.

IV. Legal Authority

    The Agency is proposing this classification under the authority of
the FD&C Act (21 U.S.C. 301). Specifically, the relevant authority
related to the proposed classification includes sections 513(a) through
(d), regarding device classes, classification, and panels; and section
515, regarding PMAs.

V. Description of the Proposed Rule

    We are proposing to amend subpart D of 21 CFR part 888 by adding
Sec.  888.3085 to classify spinal spheres for use in intervertebral
fusion procedures in accordance with section 513(d) of the FD&C Act.
This proposed rule applies to spinal spheres for use in intervertebral
fusion procedures regulated under the product code NVR. This proposed
rule does not apply to spinal spheres intended for use in non-fusion
procedures, which are currently regulated as class III devices subject
to PMA requirements.

A. Device Description

    A spinal sphere for use in intervertebral fusion procedures is a
prescription device that is an implanted, solid, spherical device
manufactured from metallic (e.g., cobalt-chromium-molybdenum (CoCrMo))
or polymeric (e.g., polyetheretherketone) materials. They are intended
to be inserted into the intervertebral disc space of the lumbar spine
following a discectomy in order to maintain disc space height and
provide postoperative stabilization to the affected spinal segment
during fusion procedures. The device is to be used with bone graft
material. FDA currently regulates these unclassified devices as devices
requiring a 510(k) submission under product code NVR.

B. Risks to Health and Public Health Benefits

    In evaluating the risks to health associated with use of spinal
spheres, FDA considered information from the

2013 Orthopaedic and Rehabilitation Panel meeting, the adverse event
reports for spinal spheres in FDA's Manufacturer and User Facility
Device Experience (MAUDE) database, and published scientific
literature, which is discussed in FDA's executive summary for the Panel
meeting (Ref. 1). We also considered adverse event reports and
literature since that time, which is consistent with the prior
information that was analyzed for the Panel meeting.
    FDA's review of the information in the MAUDE database, as presented
to the Panel, resulted in the identification of 21 unique Medical
Device Reports (MDRs) on spinal sphere devices. Of this total, 18 MDRs
were reported as injuries and 3 as malfunctions. Three additional MDRs
have been reported under this product code since the previous review of
the MAUDE database prior to the Panel meeting. One report reflects use
of a spinal sphere device without fusion that was also reported in the
literature as discussed below. One report was regarding devices that
were not spinal spheres, and the remaining report was unclear on the
device that caused the event.
    Additionally, for the purposes of the Panel, FDA conducted a
comprehensive literature review to identify and gather relevant
published information regarding the safety and effectiveness of spinal
sphere devices for use in fusion procedures. However, no references
specifically describing spinal sphere devices for use in fusion
procedures were identified. A contemporary search using the same
parameters yielded a similar result. Of note, one article, a case study
of a patient implanted with a spinal sphere, reflected one of the MDRs
reported above; however, this patient did not undergo spinal fusion in
conjunction with implantation of the device (Ref. 2). Consequently, FDA
concludes there is inadequate information characterizing the safety and
effectiveness of spinal sphere devices when used for fusion procedures.
The 510(k) clearances of these devices were based solely on nonclinical
information and determinations of substantial equivalence to the
preamendments device in accordance with section 513(i) of the FD&C Act,
which, in light of the available information regarding the risks with
no information supporting the benefit of these devices, is inadequate
to support a reasonable assurance of safety and effectiveness for these
devices.
    At the Panel, FDA identified the following risks to health
associated with spinal spheres that could result from device-related
adverse events, including implant breakage during implantation, device
migration and/or subsidence, removal/revision, pain, and neurological
impairment. The Panel agreed with the risks to health and emphasized
that there would likely be a significantly higher risk of revision or
clinical failure as compared to standard intervertebral body fusion
devices. Furthermore, the Panel noted that these risks to health may
arise from mechanical instability associated with placement of a
spherical implant inserted between the parallel vertebral endplates.
Additionally, the Panel acknowledged that the risks to health
identified for intervertebral body fusion devices would also apply to
spinal spheres (Ref. 1). These devices are similar in terms of
materials, placement, and insertion, and therefore spheres would also
carry similar risks as those already identified for intervertebral body
fusion devices. The risks to health associated with use of
intervertebral body fusion devices that contain bone grafting material
identified during their reclassification were infection, adverse tissue
reaction, pain and loss of function, soft tissue injury, vertebral
endplate injury, reoperation, and pseudarthrosis (i.e., non-union) (72
FR 32170, June 12, 2007).
    FDA agrees with the Panel's recommendations to incorporate the
risks to health associated with intervertebral body fusion devices into
the list of risks to health FDA identified as associated with spinal
spheres to more completely capture the risks to health associated with
such devices. FDA notes that the risk of vertebral endplate injury as
described in the risks associated with intervertebral body fusion
devices also encompasses the risk of subsidence; therefore, we are not
listing subsidence as a unique risk to health for spinal spheres. Based
on this information, FDA has identified and proposes the following
risks to health for spinal spheres:
    (1) Reoperation: The need for reoperation could result from a
failed spinal sphere device or component of the device, from nerve root
decompression or adjacent level disease, or from reasons related to any
surgery, e.g., infection or bleeding.
    (2) Pain and loss of function: Some device-related complications
that may cause pain and loss of function include device fracture,
deformation, loosening, or extrusion. The wear of materials, which may
cause osteolysis (dissolution of bone), and component disassembly,
fracture, or failure may also result in pain and loss of function.
    (3) Infection: Infection of the soft tissue, bony tissue, and the
disc space may arise due to implantation of a spinal sphere device.
Material composition or impurities, wear debris, operative time, and
operative environment may compromise the vascular supply to the area or
affect the immune system, which could increase the risk of infection.
Improper sterilization or packaging may also increase the risk of
infection.
    (4) Adverse tissue reaction: The implantation of the spinal sphere
device will elicit a mild inflammatory reaction typical of a normal
foreign body response. Incompatible materials or impurities in the
materials and wear debris may increase the severity of a local tissue
reaction or cause a systemic tissue reaction. If the materials used in
the manufacture of the spinal sphere device are not biocompatible, the
patient could have an adverse tissue reaction.
    (5) Soft tissue injury: Soft tissue injury could include injury to
major blood vessels, viscera, nerve roots, spinal cord, and cauda
equina.
    (6) Vertebral endplate injury: Surgically inserting a device with a
different geometry and modulus of elasticity than bone may lead to
vertebral fracture, sinking of the device into the vertebral endplate
(subsidence), collapse of the local blood supply, and collapse of the
vertebral end plate.
    (7) Pseudarthrosis: Pseudarthrosis (i.e., non-union) signifies
failure of the bony fusion mass and results in persistent instability.
    (8) Implant migration and/or instability: The spinal sphere device
may not adequately stabilize the disc space and may migrate out of its
intended placement as it is a spherical implant inserted between the
parallel vertebral endplates. This may lead to subsequent adverse
clinical sequelae, such as pain or loss of function or pseudarthrosis.
    (9) Implant breakage during insertion: The device may fracture
during implantation, which could result in a mechanical or functional
failure. This may lead to subsequent adverse clinical sequelae, such as
neurologic, vascular, or osseous injury.
    The purported benefit of use of spinal spheres for use in
intervertebral fusion procedures is to provide stabilization of a
spinal segment, as an adjunct to fusion. As described above, however,
FDA is not aware of evidence supporting the stated benefit of spinal
spheres for use in fusion procedures.

C. Proposed Classification and FDA's Findings

    Based on FDA's experience with spinal spheres, the Panel's
recommendations, and other available

information, FDA is proposing to classify spinal spheres for use in
intervertebral fusion procedures into class III. FDA is proposing this
classification because FDA believes that insufficient information
exists to determine that general controls and special controls would
provide reasonable assurance of safety and effectiveness for such
devices and, based upon assessment of benefits and risks, these devices
present a potential unreasonable risk of illness or injury. Elsewhere
in this issue of the Federal Register, FDA is proposing through a
proposed order to require the filing of a PMA under section 515(b) of
the FD&C Act. The proposed order will only be finalized if and when FDA
finalizes this proposed rule classifying spinal spheres in class III.

VI. Proposed Effective/Compliance Dates

    FDA proposes that any final rule, based on this proposed rule,
become effective 30 days after its date of publication in the Federal
Register.
    If this proposed rule and related proposed order to require the
filing of a PMA are finalized, spinal spheres for use in intervertebral
fusion procedures are considered adulterated if a PMA is not filed with
FDA within 30 months after the classification of the device into class
III, and commercial distribution of the product must cease (see section
501(f)(1)(2)(B) of the FD&C Act). However, the product may be
distributed for investigational use only, if the requirements of the
investigational device exemptions regulations in 21 CFR part 812 are
met.

VII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct us to assess all costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety, and other advantages; distributive impacts; and equity). We
believe that this proposed rule is not a significant regulatory action
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because the estimated costs imposed on any affected firm are
very low, we propose to certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $158 million, using the most current (2020) Implicit
Price Deflator for the Gross Domestic Product. This proposed rule would
not result in an expenditure in any year that meets or exceeds this
amount.

B. Summary of Costs and Benefits

    This proposed rule, if finalized would classify spinal spheres for
use in intervertebral fusion procedures (an unclassified, preamendments
device) into class III for which FDA is separately proposing to require
the filing of a PMA.
    The costs of the proposed rule are summarized in table 2; we did
not quantify benefits for this proposed rule. The costs of the rule
include one-time costs associated with reading the proposed rule. The
present value of the costs of the rule are estimated to be between $427
and $20,480, with a primary estimate of $10,453. The annualized value
of the primary estimate of costs over 10 years at a 3 percent discount
rate is approximately $703. The annualized value of the primary
estimate of costs over 10 years at a 7 percent discount rate is
approximately $987.

                Table 2--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
----------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                 ------------------------------------
          Category              Primary       Low        High                  Discount     Period       Notes
                               estimate    estimate    estimate      Year        rate       covered
                                                                    dollars    (percent)    (years)
----------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Monetized $millions/year  ..........  ..........  ..........  ..........           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Quantified..............  ..........  ..........  ..........  ..........           3          10
    Qualitative.............  ..........  ..........  ..........  ..........  ..........
Costs:
    Annualized..............    $0.00099    $0.00004    $0.00193        2019           7          10
    Monetized $millions/year     0.00070     0.00003     0.00138        2019           3          10
    Annualized..............  ..........  ..........  ..........  ..........           7          10
    Quantified..............  ..........  ..........  ..........  ..........           3          10
    Qualitative.............  ..........  ..........  ..........  ..........  ..........          10
Transfers:
    Federal.................  ..........  ..........  ..........  ..........           7          10
    Annualized..............  ..........  ..........  ..........  ..........           3          10
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........          10
                             ------------------------------------------------------------------------
    From/To.................                 From:
                                              To:
----------------------------------------------------------------------------------------------------------------
    Other...................  ..........  ..........  ..........  ..........           7          10
    Annualized..............  ..........  ..........  ..........  ..........           3  ..........
    Monetized $millions/year  ..........  ..........  ..........  ..........  ..........          10
                             ------------------------------------------------------------------------

    From/To.................                 From:
                                              To:
----------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal
     Government: None.
    Small Business: Costs
     would not exceed 0.002
     percent of average
     small firm annual
     revenues.
    Wages: None.
    Growth: None.
----------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of
Impacts that assesses the impacts of the proposed rule. The full
preliminary analysis of economic impacts is available in the docket for
this proposed rule (Ref. 3) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VIII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IX. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no
collection of information. Therefore, clearance by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 is not
required.

X. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
this proposed rule does not contain policies that have substantial
direct effects 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. Accordingly,
we conclude that the rule does not contain policies that have
federalism implications as defined in the Executive order and,
consequently, a federalism summary impact statement is not required.

XI. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13175. We have tentatively
determined that the rule does not contain policies that would 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. The Agency solicits comments from tribal
officials on any potential impact on Indian Tribes from this proposed
action.

XII. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

    1. * Orthopaedic and Rehabilitation Devices Panel--
Classification of Spinal Sphere Devices Meeting, December 12, 2013,
available at https://wayback.archive-it.org/7993/20170405192244/https:/www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.
    2. Lindley, E.M., B. Levy, E.L. Burger, et al., ``Failure of the
Fernstrom Ball in Contemporary Spine Surgery: A Case of History
Repeating Itself.'' Current Orthopaedic Practice, 25(1): 87-91,
2014.
    3. * FDA's full preliminary analysis of economic impacts is
available in the Docket No. FDA-2021-N-0310 for this proposed rule
and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 888

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic
Act, and under authority delegated to the Commissioner of
Food and Drugs, we propose that 21 CFR part 888 be amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  888.3085 to subpart D to read as follows:

Sec.  888.3085  Spinal spheres for use in intervertebral fusion
procedures.

    (a) Identification. A spinal sphere device is an implanted, solid,
spherical, prescription device manufactured from metallic or polymeric
materials. The device is inserted into the intervertebral body space of
the lumbar spine to provide stabilization and to help promote
intervertebral body fusion. The device is to be used with bone graft
material.
    (b) Classification. Class III.

    Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27137 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P