[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71880-71883]
[FR Doc No: 2015-29232]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-76412; File No. SR-NYSEArca-2015-111]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to the
Listing and Trading of Shares of the RiverFront Strategic Income Fund
Under NYSE Arca Equities Rule 8.600

November 10, 2015.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on November 4, 2015, NYSE Arca, Inc. (the ``Exchange'' or
``NYSE Arca'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I and II
below, which Items have been prepared by the self-regulatory
organization. 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\ 15 U.S.C. 78a.
    \3\ 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 reflect a change to the means of achieving
the investment objective applicable to shares of the RiverFront
Strategic Income Fund, which has been approved by the Securities and
Exchange Commission (``Commission''), and is currently listed and
traded on the Exchange, under NYSE Arca Equities Rule 8.600. The
proposed rule change is available on the Exchange's Web site at
www.nyse.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 self-regulatory organization
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 those 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 parts of such statements.

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

1. Purpose
    The Commission has approved listing and trading on the Exchange of
shares (``Shares'') of the RiverFront Strategic Income Fund (the
``Fund''), a series of the ALPS ETF Trust (the ``Trust''),\4\ under
NYSE Arca Equities Rule 8.600, which governs the listing and trading of
Managed Fund Shares. The Fund is an actively managed exchange traded
fund. The Shares are offered by the Trust.\5\ Shares of the Fund are
currently listed and traded on the Exchange under NYSE Arca Equities
Rule 8.600.
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    \4\ See Securities Exchange Act Release No. 68030 (October 10,
2012), 77 FR 63380 (October 16, 2012) (SR-NYSEArca-2012-88) (``Prior
Order''). See also Securities Exchange Act Release No. 67715 (August
22, 2012), 77 FR 52083 (August 28, 2012) (``Prior Notice'', and
together with the Prior Order, the ``Prior Release'').
    \5\ The Trust is registered under the Investment Company Act of
1940 (``1940 Act''). On March 30, 2015, the Trust filed with the
Commission an amendment to its registration statement on Form N-1A
under the Securities Act of 1933 (``Securities Act'') and the1940
Act relating to the Fund (File Nos. 333-148826 and 811-22175)
(``Registration Statement''). The description of the operation of
the Trust and the Fund herein is based, in part, on the Registration
Statement.
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    RiverFront Investment Group, LLC (``RiverFront'') is the investment
sub-adviser for the Fund (the ``Sub-Adviser'').
    As stated in the Prior Release, the Fund's investment objective is
to seek total return, with an emphasis on income as the source of that
total return. The Fund seeks to achieve its investment objective by
investing in a global portfolio of fixed income securities of various
maturities, ratings and currency denominations. The Fund utilizes
various investment strategies in a broad array of fixed income sectors.
The Fund allocates its investments based upon the analysis of the Sub-
Adviser of the pertinent economic and market conditions, as well as
yield, maturity and currency considerations.
    In this proposed rule change, the Exchange proposes to reflect a
change to the description of the investments the Sub-Adviser will
utilize to implement the Fund's investment objective, as described
below.\6\
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    \6\ The changes described herein will be effective upon filing
with the Commission of another amendment to the Trust's Registration
Statement and/or a supplement to the Fund's prospectus and/or
Statement of Additional Information. See note 5, supra. The Sub-
Adviser represents that the Sub-Adviser will not implement the
changes described herein until the instant proposed rule change is
operative.
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    First, the Prior Release stated that the Fund may invest up to 5%
of its assets in mortgage-backed securities (``MBS'') (which may
include commercial MBS) or other asset-backed securities (``ABS'')
issued or guaranteed by private issuers.\7\ The Sub-Adviser wishes to
change this representation to state that the Fund may invest up to 20%
of its total assets in MBS and ABS that are privately issued, non-
agency and non-government sponsored entity (``Private MBS/ABS'').\8\
Such holdings would be subject to the limitation on the Fund's
investments in illiquid assets. The liquidity of a security, especially
in the case of Private MBS/ABS, will be a substantial factor in the
Fund's security selection process.
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    \7\ This limitation does not apply to securities issued or
guaranteed by federal agencies and/or U.S. government sponsored
instrumentalities, such as the Government National Mortgage
Administration (``GNMA''), the Federal Housing Administration
(``FHA''), the Federal National Mortgage Association (``FNMA''), and
the Federal Home Loan Mortgage Corporation (``FHLMC'').
    \8\ As described in the Prior Release, the MBS in which the Fund
may invest are either pass-through securities or collateralized
mortgage obligations (``CMOs'').
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    The Sub-Adviser believes the revised representations will permit
the Sub-Adviser, through such additional flexibility, to better achieve
the Fund's stated investment objective to seek total return, with an
emphasis on income as the source of that total return. The Fund will
continue to primarily invest in fixed income instruments. The Sub-
Adviser represents that the purpose of this change is to provide
additional flexibility to the Sub-Adviser to meet the Fund's investment
objective by potentially expanding the percentage of the Fund's assets
that may be allocated to Private MBS/ABS that would provide the Fund
with an enhanced ability to identify debt issues that have sound
investment characteristics while providing the potential for an
increased yield for investors.
    Second, the Prior Release stated that the Fund may not hold more
than 15% of its net assets in: (1) illiquid securities (which include
participation interests); and (2) Rule 144A securities. Going forward,
the Fund wishes to change this representation to state that, as an
investment restriction of the Fund, the Fund may not hold more than 15%
of its net assets in illiquid assets (calculated at the time of
investment),\9\ including Rule 144A securities deemed illiquid by the
Sub-Adviser, consistent with Commission guidance.\10\ The Exchange
notes that the Commission has approved similar representations relating
to issues of Managed Fund Shares proposed to be listed and traded on
the Exchange.\11\ The Sub-Adviser represents that the Sub-Adviser and
the Trust's Board of Trustees will continue to evaluate each Rule 144A
security based on the Fund's valuation procedures to oversee liquidity
and valuation concerns.
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    \9\ In reaching liquidity decisions, the Sub-Adviser may
consider the following factors: the frequency of trades and quotes
for the security; the number of dealers wishing to purchase or sell
the security and the number of other potential purchasers; dealer
undertakings to make a market in the security; and the nature of the
security and the nature of the marketplace trades (e.g., the time
needed to dispose of the security, the method of soliciting offers,
and the mechanics of transfer).
    \10\ The Commission has stated that long-standing Commission
guidelines have required open-end funds to hold no more than 15% of
their net assets in illiquid securities and other illiquid assets.
See Investment Company Act Release No. 28193 (March 11, 2008), 73 FR
14618 (March 18, 2008), footnote 34. See also, Investment Company
Act Release No. 5847 (October 21, 1969), 35 FR 19989 (December 31,
1970) (Statement Regarding ``Restricted Securities''); Investment
Company Act Release No. 18612 (March 12, 1992), 57 FR 9828 (March
20, 1992) (Revisions of Guidelines to Form N-1A). A fund's portfolio
security is illiquid if it cannot be disposed of in the ordinary
course of business within seven days at approximately the value
ascribed to it by the fund. See Investment Company Act Release No.
14983 (March 12, 1986), 51 FR 9773 (March 21, 1986) (adopting
amendments to Rule 2a-7 under the 1940 Act); Investment Company Act
Release No. 17452 (April 23, 1990), 55 FR 17933 (April 30, 1990)
(adopting Rule 144A under the 1933 Act).
    \11\ See, e.g., Securities Exchange Act Release No. 70282
(August 29, 2013), 78 FR 54700 (September 5, 2013) (SR-NYSEArca-
2013-70) (order approving listing and trading on the exchange of
First Trust Inflation Managed Fund).
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    Third, the Prior Release stated that the Fund may also invest in
structured notes.\12\ Going forward, the Fund proposes that the Fund
may invest up to 20% of its total assets in structured notes. The
Exchange notes that the Commission has previously approved listing and
trading on the Exchange of issues of Managed Fund Shares that may hold
up to 20% of total assets in structured notes.\13\
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    \12\ As noted in the Prior Release, structured notes are notes
on which the amount of principal repayment and interest payments are
based on the movement of one or more specified factors, such as the
movement of a particular bond or bond index.
    \13\ See, e.g., Securities Exchange Act Release No. 74093
(January 20, 2015), 80 FR 4015 (January 26, 2015) (SR-NYSEArca-2014-
126) (order approving listing and trading of Shares of the
AdvisorShares Pacific Asset Enhanced Floating Rate ETF under NYSE
Arca Equities Rule 8.600).
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    Fourth, the Prior Release stated the Fund may invest without
limitation in debt securities denominated in foreign

currencies and in U.S. dollar-denominated debt securities of foreign
issuers, including securities of issuers located in emerging markets.
Going forward, the Fund wishes to change this representation to state
that the debt securities in which the Fund may invest may be
denominated in foreign currencies or U.S. dollars.
    The Sub-Adviser represents that there is no change to the Fund's
investment objective. The Fund will continue to comply with all initial
and continued listing requirements under NYSE Arca Equities Rule 8.600.
    Except for the changes noted above, all other facts presented
(except the statement ``[t]he Fund will be managed by WisdomTree Asset
Management, Inc.'', given that ALPS Advisors, Inc. currently serves as
the Fund's investment adviser) and representations made in the Prior
Release remain unchanged.
    All terms referenced but not defined herein are defined in the
Prior Release.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under Section 6(b)(5) \14\ that an exchange have rules that
are designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to remove
impediments to, and perfect the mechanism of a free and open market
and, in general, to protect investors and the public interest.
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    \14\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed rule change is designed to
prevent fraudulent and manipulative acts and practices in that the
Shares will continue to be listed and traded on the Exchange pursuant
to the initial and continued listing criteria in NYSE Arca Equities
Rule 8.600. The Sub-Adviser represents that increasing the Fund's
flexibility to invest in Private MBS/ABS would allow the Sub-Adviser to
better achieve the Fund's investment objective. In addition, the
liquidity of Private MBS/ABS will be a substantial factor in the Fund's
security selection process. The Fund's proposed limitation on
investments in structured notes to up to 20% of its total assets is
comparable to the limitation for investments in structured notes
previously approved by the Commission for other issues of Managed Fund
Shares.\15\ The Exchange believes that the proposed changes are
consistent with the representation in the Prior Release that the
operation of the Fund as described in the Prior Release is designed to
prevent fraudulent and manipulative acts and practices. The proposed
expansion of permitted investments would provide the Fund with an
enhanced ability to identify debt issues that have sound investment
characteristics while providing the potential for an increased yield
for investors. The Fund will continue to comply with all initial and
continued listing requirements under NYSE Arca Equities Rule 8.600.
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    \15\ See note 13, supra.
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    The proposed rule change is designed to promote just and equitable
principles of trade and to protect investors and the public interest in
that the Sub-Adviser represents that there is no change to the Fund's
investment objective. As noted above, the liquidity of Private MBS/ABS
will be a substantial factor in the Fund's security selection process.
The Sub-Adviser also represents that the purpose of this change is to
provide additional flexibility to the Sub-Adviser to meet the Fund's
investment objective by potentially expanding the percentage of the
Fund's assets that may be allocated to Private MBS/ABS that would
provide the Fund with an enhanced ability to identify debt issues that
have sound investment characteristics while providing the potential for
an increased yield for investors.
    With respect to the 15% limitation on investments in illiquid
assets, the Exchange notes that the Commission has approved similar
representations relating to issues of Managed Fund Shares proposed to
be listed and traded on the Exchange.\16\ The Sub-Adviser represents
that the Sub-Adviser and the Trust's Board of Trustees will continue to
evaluate each Rule 144A security based on the Fund's valuation
procedures to oversee liquidity and valuation concerns.
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    \16\ See note 11, supra.
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    The proposed rule change is designed to perfect the mechanism of a
free and open market and, in general, to protect investors and the
public interest in that the Fund will continue to comply with all
initial and continued listing requirements under NYSE Arca Equities
Rule 8.600. Except for the changes noted above, all other
representations made in the Rule 19b-4 filing underlying the Prior
Release remain unchanged.

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. The Exchange believes the
proposed rule change regarding investments in asset-backed and/or
mortgage-backed debt securities is consistent with other similar
actively managed fixed income funds which the Commission has approved
for listing and trading \17\ and will promote competition among
actively managed funds utilizing such investments, to the benefit of
the investing public.
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    \17\ See, e.g., Securities Exchange Act Release No. 75566 (July
30, 2015), 80 FR 46612 (August 5, 2015) (SR-NYSEArca-2015-42) (order
approving listing and trading of shares of the Newfleet Multi-Sector
Unconstrained Bond ETF under NYSE Arca Equities Rule 8.600).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

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

    Because the proposed rule change does not (i) significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \18\ and Rule 19b-
4(f)(6) thereunder.\19\
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    \18\ 15 U.S.C. 78s(b)(3)(A).
    \19\ 17 CFR 240.19b-4(f)(6). As required under Rule 19b-
4(f)(6)(iii), the Exchange provided the Commission with written
notice of its intent to file the proposed rule change, along with a
brief description and the text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) of the Act \20\ to determine whether the proposed
rule change should be approved or disapproved.
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    \20\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule

change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEArca-2015-111 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-NYSEArca-2015-111. 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 Section, 100 F Street
NE., Washington, DC 20549 on official business days between 10 a.m. and
3 p.m. Copies of the filing will also be available for inspection and
copying at the NYSE's principal office and on its Internet Web site at
www.nyse.com. 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-
NYSEArca-2015-111 and should be submitted on or before December 8,
2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\21\
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    \21\ 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-29232 Filed 11-16-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 19 (Tuesday, January 29, 2013)]
[Notices]
[Pages 6111-6112]
[FR Doc No: 2013-01815]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0012]

Statement of Organization, Functions, and Delegations of
Authority

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA), Office of Foods has
modified its structure and reorganized to the Office of Foods and
Veterinary Medicine (OFVM). This new organizational structure was
approved by the Secretary of Health and Human Services on July 20,
2012, and implemented on October 1, 2012.

FOR FURTHER INFORMATION CONTACT:
Erik Mettler, Office of Foods and Veterinary Medicine, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-4500.

SUPPLEMENTARY INFORMATION:

I. Summary

    Part D, Chapter D-B (Food and Drug Administration), Statement of
Organization, Functions, and Delegations of Authority for the
Department of Health and Human Services (35 FR 3685, February 25, 1970;
60 FR 56605, November 9, 1995; 64 FR 36361, July 6, 1999; 72 FR 50112,
August 30, 2007; 74 FR 41713, August 18, 2009; and 76 FR 45270, July
28, 2011) is amended in recognition of the fact that most of the work
of the Center for Food Safety and Applied Nutrition and the Center for
Veterinary Medicine affects the food system as a whole and requires an
integrated approach, FDA has modified the Office of Foods structure and
reorganized to the OFVM. This reorganization will allow for effective
implementation of the new, risk-based mandates of the FDA Food Safety
Modernization Act (Pub. L. 111-353) and the demand the law places on
FDA for an integrated implementation

effort and a systematic approach to risk-based priority setting and
resource allocation. This reorganization is explained in Staff Manual
Guides 1160.1, 1160.10, 1160.20, 1230.1, and 1241.1.
    The Food and Drug Administration, OVFM has been restructured as
follows:
    DJJ. ORGANIZATION--OVFM is headed by the Deputy Commissioner for
Foods and Veterinary Medicine and includes the following organizational
units:

Office of Foods and Veterinary Medicine
Communications and Public Engagement Staff
Executive Secretariat Staff
Office of Coordinated Outbreak Response and Evaluation Network
Prevention Staff
Response Staff
Office of Resource Planning and Strategic Management
Strategic Planning and Budget Formulation Staff
Risk Analytics Staff
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine

II. Delegations of Authority

    Pending further delegation, directives, or orders by the
Commissioner of Food and Drugs, all delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegations, provided they are consistent with this reorganization.

III. Electronic Access

    Persons interested in seeing the complete Staff Manual Guide can
find it on FDA's Web site at: http://www.fda.gov/AboutFDA/ReportsManualsForms/StaffManualGuides/default.htm.

    Dated: January 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-01815 Filed 1-28-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 145 (Thursday, July 28, 2016)]
[Notices]
[Pages 49708-49709]
[FR Doc No: 2016-17820]

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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:

    Rule 15Ba2-5, SEC File No. 270-91, OMB Control No. 3235-0088.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
existing collection of information provided for in Rule 15Ba2-5 (17 CFR
240.15Ba2-5), under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.) (``Exchange Act'').
    On July 7, 1976, effective July 16, 1976 (see 41 FR 28948, July 14,
1976), the Commission adopted Rule 15Ba2-5 under the Exchange Act to
permit a duly-appointed fiduciary to assume immediate responsibility
for the operation of a municipal securities dealer's business. Without
the rule, the fiduciary would not be able to assume operation until it
registered as a municipal securities dealer. Under the rule, the
registration of a municipal securities dealer is deemed to be the
registration of any executor, administrator, guardian, conservator,
assignee for the benefit of creditors, receiver, trustee in insolvency
or bankruptcy, or other fiduciary, appointed or qualified by order,
judgment, or decree of a court of competent jurisdiction to continue
the business of such municipal securities dealer, provided that such
fiduciary files with the Commission, within 30 days after entering upon
the performance of his duties, a statement setting forth as to such
fiduciary substantially the same information required by Form MSD or
Form BD. The statement is necessary to ensure that the Commission and
the public have adequate information about the fiduciary.
    There is approximately 1 respondent per year that requires an
aggregate total of 4 hours to comply with this rule. This respondent
makes an estimated 1 annual response. Each response takes approximately
4 hours to complete. Thus, the total compliance burden per year is 4
burden hours. The approximate cost per hour is $20, resulting in a
total internal cost of compliance for the respondent of approximately
$80 (i.e., 4 hours x $20).
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: July 22, 2016.
Brent J. Fields,
Secretary.
[FR Doc. 2016-17820 Filed 7-27-16; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 34 (Thursday, February 20, 2014)]
[Proposed Rules]
[Pages 9670-9671]
[FR Doc No: 2014-03593]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. FDA-2012-N-0378]

Physical Medicine Devices; Withdrawal of Proposed Effective Date
of Requirement for Premarket Approval for Shortwave Diathermy for All
Other Uses

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing the
proposed rule the Agency issued in the Federal Register of July 6,
2012. In that document, FDA proposed to require the filing of a
premarket approval application (PMA) or a notice of completion of a
product development protocol (PDP) for the class III preamendment
device, shortwave diathermy (SWD) for all other uses. In response to
the requirements issued in the Food and Drug Administration Safety and
Innovation Act (FDASIA) and new information received during a panel
meeting, FDA is withdrawing the proposed rule and proposing a different
action.

DATES: The proposed rule is withdrawn on February 20, 2014.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    In the Federal Register of July 6, 2012 (77 FR 39953), FDA issued a
proposed rule to require the filing of a PMA or a notice of completion
of a PDP for the class III preamendments device, SWD for all other
uses. This device applies electromagnetic energy to the body in the
radio frequency bands that are currently identified as 13.56 megahertz
or 27.12 megahertz and is intended for the treatment of medical
conditions by means other than the generation of deep heat within body
tissues (also referred to as nonthermal SWD). It is not intended for
treatment of malignancies. The Agency also summarized its proposed
findings regarding the degree of risk of illness or injury designed to
be eliminated or reduced by requiring the devices to meet the statute's
approval requirements and the benefits to the public from the use of
the devices. In addition, FDA announced the opportunity for interested
persons to request that the Agency change the classification of any of
the aforementioned devices based on new information.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) (U.S.C. 360c(e)) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) changing the process for
reclassifying a device from rulemaking to an administrative order.
Subsequent to the publication of the proposed rule, FDASIA's amendments
to section 513 of the FD&C Act required FDA to hold a classification
panel (an FDA advisory committee) meeting on the classification of this
device. On May 21, 2013, FDA held a meeting of the Orthopedic and
Rehabilitation Devices Panel (the Panel), to discuss the classification
of nonthermal SWD devices. There was panel consensus that although the
effectiveness data were very limited, nonthermal SWD devices did not
fit the regulatory definition of a class III device. Coupled with the
rationale that special controls could be established to reasonably
demonstrate an assurance of safety and effectiveness, the Panel
recommended class II (special controls) for nonthermal SWD devices
(Ref. 1).

II. Withdrawal of the Proposed Rule

    FDA provided an opportunity for interested parties to comment on
the proposed rule for SWD for all other uses (77 FR 39953, July 6,
2012). FDA received over 240 comments to the docket in response to the
2012 proposed rule. Comments that expressed an opinion about the
classification of nonthermal SWD devices were usually in favor of a
class II designation. Some comments did not openly state an opinion,
but included arguments against the proposed rule that could reasonably
be interpreted as support for a class II designation. There were also
comments that agreed with a class III designation. In addition to the
comments, FDA received five separate submissions to request a change in
the classification of nonthermal SWD from class III to class II. In
response to these comments and findings at the Panel meeting, FDA is
withdrawing the proposed rule to call for PMAs for these devices and is
proposing reclassification to class II (special controls).

III. Proposed Reclassification

    Elsewhere in this issue of the Federal Register, FDA is proposing
to reclassify SWD for all other uses, currently a preamendments class
III device, into class II (special controls), and to rename the device
``nonthermal shortwave therapy.'' FDA continues to review the merits of
the submissions for requests for reclassification that meet the
requirements under 21 CFR 860.123, submitted in response to the
proposed rule.

IV. Reference

    The following reference has been placed on display in the Division
of Dockets Management (see ADDRESSES), and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday, and are
available electronically at http://www.regulations.gov. (FDA has
verified the Web site address, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA's Orthopedic and Rehabilitation Devices Panel transcript and
other meeting materials are available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ucm352525.htm.

    Dated: February 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03593 Filed 2-19-14; 8:45 am]
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[Federal Register Volume 76, Number 18 (Thursday, January 27, 2011)]
[Notices]
[Pages 4913-4914]
[FR Doc No: 2011-1760]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0544]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for
Participation in the Medical Device Fellowship Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
February 28, 2011.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0551.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Application for Participation in the Medical Device Fellowship
Program--(OMB Control Number 0910-0551)--Extension

    Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of
Title 5 of the United States Code authorize Federal Agencies to rate
applicants for Federal jobs. Collecting applications for the Medical
Device Fellowship Program will allow FDA's Center for Devices and
Radiological Health (CDRH) to easily and efficiently elicit and review
information from students and health care professionals who are
interested in becoming involved in CDRH activities. The process will
reduce the time and cost of submitting written documentation to the
Agency and lessen the likelihood of applications being misrouted within
the Agency mail system. It will assist the Agency in promoting and
protecting the public health by encouraging outside persons to share
their expertise with CDRH.
    In the Federal Register of October 27, 2010 (75 FR 66103), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of     Annual frequency    Total annual        Hours per
              5 U.S.C. Section                  FDA Form No.       respondents      per response        responses         response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1104, 1302, 3301, 3304, 3320, 3361, 3393,                 3608               250                 1               250                 1               250
 3394.......................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on the number of inquiries that have been
received concerning the program and the number of requests for
application forms over the past 3 years.

    Dated: January 19, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1760 Filed 1-26-11; 8:45 am]
BILLING CODE 4160-01-P