[Federal Register Volume 80, Number 158 (Monday, August 17, 2015)]
[Notices]
[Pages 49281-49283]
[FR Doc No: 2015-20158]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75662; File No. SR-NYSEARCA-2015-67]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change Relating to
Holdings By the iShares Interest Rate Hedged Corporate Bond ETF and
iShares Interest Rate Hedged High Yield Bond ETF

August 11, 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 August 3, 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 holdings to be
implemented by the iShares Interest Rate Hedged Corporate Bond ETF and
iShares Interest Rate Hedged High Yield Bond ETF relating to the use of
interest rate futures contracts, and interest rate swaps. The text of
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 a proposal to list and trade on the
Exchange shares (``Shares'') of the iShares Interest Rate Hedged
Corporate Bond ETF and iShares Interest Rate Hedged High Yield Bond ETF
(each a ``Fund'' and, together, the ``Funds'') under NYSE Arca Equities
Rule 8.600,\4\ which governs the listing and trading of Managed Fund
Shares.\5\
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    \4\ See Securities Exchange Act Release Nos. 71778 (March 24,
2014), 79 FR 17585 (March 28, 2014 (SR-NYSEArca-2014-23) (Notice of
Filing of Proposed Rule Change to List and Trade Shares of the
iShares Interest Rate Hedged Corporate Bond ETF and iShares Interest
Rate Hedged High Yield Bond ETF under NYSE Arca Equities Rule 8.600)
(``Prior Notice''); 72138 (May 9, 2014), 79 FR 27958 (May 15, 2014)
(SR-NYSEArca-2014-23) (order approving listing and trading on the
Exchange of Shares of the iShares Interest Rate Hedged Corporate
Bond ETF and iShares Interest Rate Hedged High Yield Bond ETF under
NYSE Arca Equities Rule 8.600) (``Prior Order'' and, together with
the Prior Notice, the ``Prior Release'').
    \5\ A Managed Fund Share is a security that represents an
interest in an investment company registered under the Investment
Company Act of 1940 (15 U.S.C. 80a-1) (``1940 Act'') organized as an
open-end investment company or similar entity that invests in a
portfolio of securities selected by its investment adviser
consistent with its investment objectives and policies. In contrast,
an open-end investment company that issues Investment Company Units,
listed and traded on the Exchange under NYSE Arca Equities Rule
5.2(j)(3), seeks to provide investment results that correspond
generally to the price and yield performance of a specific foreign
or domestic stock index, fixed income securities index or
combination thereof.
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    The Shares of the Funds are offered by iShares U.S. ETF Trust (the
``Trust'').\6\ The Trust is registered with the Commission as an open-
end management investment company. BlackRock Fund Advisors (``BFA'')
serves as the investment adviser to the Funds (the ``Adviser''). BFA is
an indirect wholly-owned subsidiary of BlackRock, Inc. BlackRock
Investments, LLC is the principal underwriter and distributor of the
Funds' Shares. State Street Bank and Trust Company serves as
administrator, custodian and transfer agent for the Funds. The Funds'
Shares are currently listed and traded on the Exchange under NYSE Arca
Equities Rule 8.600.
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    \6\ The Trust is registered under the 1940 Act. On August 22,
2013, the Trust filed with the Commission post-effective amendments
on Form N-1A under the Securities Act of 1933 (15 U.S.C. 77a) and
under the 1940 Act relating to the iShares Interest Rate Hedged
Corporate Bond ETF (the ``Corporate Bond Registration Statement'')
and the iShares Interest Rate Hedged High Yield Bond ETF (the ``High
Yield Registration Statement'' and together with the Corporate Bond
Registration Statement, the ``Registration Statements'') (File Nos.
333-179904 and 811-22649). In addition, the Commission has issued an
order granting certain exemptive relief to the Trust under the 1940
Act. See Investment Company Act Release No. 29571 (File No. 812-
13601) (``Exemptive Order'').
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    The Exchange proposes to revise the representations made in the
Prior Release regarding the Funds' investments to accommodate use of
interest rate futures contracts \7\ and interest rate swaps by the
Funds, as described below, consistent with the use of such financial
instruments permitted for other funds of the Trust previously approved
by the Commission for Exchange listing and trading.\8\
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    \7\ As described in the Prior Release, both Funds may use U.S.
Treasury futures contracts to mitigate interest rate risk. In this
proposed rule change, the Exchange proposes, among other things, to
accommodate use by the Funds of other interest rate futures to
mitigate interest rate risk.
    \8\ See Securities Exchange Act Release No. 74058 (January 15,
2015), 80 FR 3294 (January 22, 2015) (SR-NYSEArca-2014-114), (order
approving listing and trading on the Exchange of shares of the
iShares Interest Rate Hedged 0-5 Year High Yield Bond ETF, iShares
Interest Rate Hedged 10+ Year Credit Bond ETF, and the iShares
Interest Rate Hedged Emerging Markets Bond ETF under NYSE Arca
Equities Rule 8.600).
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iShares Interest Rate Hedged Corporate Bond ETF
    As described in the Prior Release, according to the Corporate Bond
Registration Statement, the Fund seeks to mitigate the interest rate
risk of a portfolio composed of U.S. dollar-denominated, investment
grade corporate bonds. The Fund seeks to achieve its investment
objective by investing, under normal circumstances, at least 80% of its
net assets in U.S. dollar-denominated investment grade bonds, in one or
more investment companies (exchange-traded and non-exchange-traded
funds) that principally invest in investment-grade bonds, in U.S.
Treasury securities (or cash equivalents), and by taking short
positions in U.S. Treasury futures and other interest rate futures
contracts.
    The Exchange proposes to amend this statement to provide that,
going forward, the Fund will seek to achieve its investment objective
by investing, under normal circumstances, at least 80% of its net
assets in U.S. dollar-denominated investment grade bonds, in one or
more investment companies (exchange-traded and non-exchange-traded
funds) that principally invest in investment-grade bonds, in U.S.
Treasury securities (or cash

equivalents), and by taking short positions in U.S. Treasury futures,
other interest rate futures contracts, and interest rate swaps.\9\
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    \9\ The Funds will invest only in futures contracts that are
traded on an exchange that is a member of the Intermarket
Surveillance Group (``ISG'') or with which the Exchange has in place
a comprehensive surveillance sharing agreement. Swaps will be
centrally cleared. All derivatives held by the Funds will be
collateralized.
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    The Prior Release also stated that, according to the Corporate Bond
Registration Statement, the Fund initially intends to invest a
substantial portion of its assets in the iShares iBoxx $ Investment
Grade Corporate Bond ETF (the ``Underlying Corporate Bond Fund''). The
Fund attempts to mitigate interest rate risk primarily through the use
of U.S. Treasury futures contracts.
    The Exchange proposes to amend the statement in the last sentence
of the preceding paragraph to state that, going forward, the Fund will
attempt to mitigate interest rate risk primarily through the use of
U.S. Treasury futures contracts, interest rate futures, and interest
rate swaps.
    The Prior Release stated that BFA will utilize a model-based
proprietary investment process to assemble an investment portfolio
comprised of (i) long positions in the Underlying Corporate Bond Fund,
(ii) long positions in U.S. dollar-denominated investment-grade
corporate bonds, (iii) long positions in U.S. Treasury securities and
(iv) short positions in U.S. Treasury futures and other interest rate
futures contracts.
    The Exchange proposes to amend the statement in item (iv) of the
preceding paragraph to provide that, going forward, the investment
portfolio referred to in the preceding paragraph may be comprised of
short positions in U.S. Treasury futures, other interest rate futures
contracts, and interest rate swaps.
iShares Interest Rate Hedged High Yield Bond ETF
    According to the High Yield Registration Statement, the Fund seeks
to mitigate the interest rate risk of a portfolio composed of U.S.
dollar-denominated, high yield corporate bonds. The Fund seeks to
achieve its investment objective by investing, under normal
circumstances, at least 80% of its net assets in U.S. dollar-
denominated high yield corporate bonds, in one or more investment
companies (exchange-traded and non-exchange-traded funds) that
principally invest in high yield bonds, in U.S. Treasury securities (or
cash equivalents), and by taking short positions in U.S. Treasury
futures and other interest rate futures contracts.
    The Exchange proposes to amend this statement to provide that,
going forward, the Fund will seek to achieve its investment objective
by investing, under normal circumstances, at least 80% of its net
assets in U.S. dollar-denominated high yield corporate bonds, in one or
more investment companies (exchange-traded and non-exchange-traded
funds) that principally invest in high yield bonds, in U.S. Treasury
securities (or cash equivalents), and by taking short positions in U.S.
Treasury futures, other interest rate futures contracts, and interest
rate swaps.\10\
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    \10\ See note 9, supra.
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    The Prior Release also stated that, according to the High Yield
Registration Statement, the Fund initially intends to invest a
substantial portion of its assets in the iShares iBoxx $ High Yield
Corporate Bond ETF. The Fund will attempt to mitigate interest rate
risk primarily through the use of U.S. Treasury futures contracts.
    The Exchange proposes to amend the last sentence of the preceding
paragraph to provide that, going forward, the Fund will attempt to
mitigate interest rate risk primarily through the use of U.S. Treasury
futures contracts, other interest rate futures contracts, and interest
rate swaps.
    The Prior Release stated that BFA will utilize a model-based
proprietary investment process to assemble an investment portfolio
comprised of (i) long positions in the Underlying High Yield Bond Fund,
(ii) long positions in U.S. dollar-denominated high yield corporate
bonds, (iii) long positions in U.S. Treasury securities and (iv) short
positions in U.S. Treasury futures and other interest rate futures
contracts.
    The Exchange proposes to amend the statement in item (iv) of the
preceding paragraph to provide that, going forward, the investment
portfolio referred to in the preceding paragraph may be comprised of
short positions in U.S. Treasury futures, other interest rate futures
contracts, and interest rate swaps.
    The section ``Determination of Net Asset Value'' in the Prior
Release did not include reference to swaps. The Exchange proposes to
state that swaps and other derivatives will generally be valued based
upon quotations from market makers or by a pricing service in
accordance with valuation procedures approved by Trust's Board of
Directors.
    On a daily basis, each of the Funds will disclose for each
portfolio security or other financial instrument the following
information on the Funds' Web site: Ticker symbol, if any; CUSIP number
or other identifier, if any; a description of the holding (including
the type of holding, such as the type of swap); the identity of the
security or other asset or instrument underlying the holding, if any;
for options, the option strike price; quantity held (as measured by,
for example, par value, notional value or number of shares, contracts
or units); maturity date, if any; coupon rate, if any; market value of
the holding; and the percentage weighting of the holding in the
portfolio. The Web site information will be publicly available at no
charge.
    The Adviser represents that the proposed changes relating to the
Funds' holdings in interest rate swaps, as described above, are
consistent with the Fund's investment objective, and will further
assist the Adviser to achieve such investment objective. In addition,
such proposed changes are consistent with the use of swaps permitted
for shares of other funds of the Trust previously approved by the
Commission for Exchange listing and trading.\11\
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    \11\ See note 8, supra.
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    Except for the changes noted above, all other representations made
in the Prior Release remain unchanged. The Funds will continue to
comply with all initial and continued listing requirements under NYSE
Arca Equities Rule 8.600.
2. Statutory Basis
    The basis under the Act for this proposed rule change is the
requirement under section 6(b)(5) \12\ 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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    \12\ 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 be listed and traded on the Exchange pursuant to the
initial and continued listing criteria in NYSE Arca Equities Rule
8.600. The Funds will invest only in futures contracts that are traded
on an exchange that is a member of the ISG or with which the Exchange
has in place a comprehensive surveillance sharing agreement. Swaps will
be centrally cleared. All derivatives held by the Funds will be
collateralized.
    The proposed rule change is designed to promote just and equitable
principles

of trade and to protect investors and the public interest. The Adviser
represents that the proposed changes relating to the Funds' holdings in
U.S. Treasury futures, other interest rate futures contracts, and
interest rate swaps, as described above, are consistent with each
Fund's investment objective, and will further assist the Adviser to
achieve each such investment objective. In addition, such proposed
changes are consistent with the use of U.S. Treasury futures, other
interest rate futures contracts, and interest rate swaps permitted for
shares of other funds of the Trust previously approved by the
Commission for Exchange listing and trading.\13\
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    \13\ See note 8, 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. The Adviser represents that the proposed changes
relating to the Funds' holdings in U.S. Treasury futures, other
interest rate futures contracts, and interest rate swaps, as described
above, are consistent with each Fund's investment objective, and will
further assist the Adviser to achieve each such investment objective.
In addition, such proposed changes are consistent with the use of U.S.
Treasury futures, other interest rate futures contracts, and interest
rate swaps permitted for shares of other funds of the Trust previously
approved by the Commission for Exchange listing and trading.\14\ Such
changes would enhance the ability of the Funds to mitigate interest
rate risk. The Funds will invest only in futures contracts that are
traded on an exchange that is a member of the ISG or with which the
Exchange has in place a comprehensive surveillance sharing agreement.
Swaps will be centrally cleared. All derivatives held by the Funds will
be collateralized. The Adviser represents that the investment objective
of each Fund has not changed. Except for the changes noted above, all
other representations made in the Prior Release remain unchanged. The
Funds will continue to comply with all initial and continued listing
requirements under NYSE Arca Equities Rule 8.600.
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    \14\ See note 8, supra.
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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 purpose of the Act. The Exchange believes the
proposed rule change, in permitting each Fund to utilize other interest
rate futures and interest rate swaps as part of its portfolio to
achieve its investment objective, will enhance competition among issues
of Managed Fund Shares that invest principally in fixed income
securities.

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

    The Exchange has filed the proposed rule change pursuant to section
19(b)(3)(A)(iii) of the Act \15\ and Rule 19b-4(f)(6) thereunder.\16\
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 prior to
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 and Rule 19b-
4(f)(6)(iii) thereunder.
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    \15\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \16\ 17 CFR 240.19b-4(f)(6).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

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-2015-67 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2015-67. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing will also be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEArca-2015-67 and should
be submitted on or before September 8, 2015.

For the Commission, by the Division of Trading and Markets, pursuant
to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-20158 Filed 8-14-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Pages 13863-13865]
[FR Doc No: 2018-06308]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 890, 900, 1020, and 1040

[Docket No. FDA-2018-N-0011]

Medical Devices; Technical Amendment

AGENCY: Food and Drug Administration; HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is amending
certain medical device regulations. This action is editorial in nature
to correct typographical errors and to ensure accuracy and clarity in
the Agency's regulations.

DATES: This rule is effective April 2, 2018.

FOR FURTHER INFORMATION CONTACT: Karen Fikes, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is amending our regulations in 21 CFR
parts 890, 900, 1020, and 1040 to correct typographical errors and to
update addresses, office titles, and wording to ensure accuracy and
clarity in the Agency's medical device regulations.
    FDA is making nonsubstantive changes to the following regulations:
    1. FDA is revising Sec.  890.5525(b)(2)(i)(A) by replacing
``Testing using a drug approved for iontophoretic delivery, or a
solution, if identified in the labeling, to demonstrate safe use of the
device as intended'' with ``Testing using a drug approved for
iontophoretic delivery, or a solution if identified in the labeling, to
demonstrate safe use of the device as intended''.
    2. FDA is revising Sec.  900.3(b)(1) by replacing ``Division of
Mammography Quality and Radiation Programs (DMQRP), Center for Devices
and Radiology Health (HFZ-240), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, marked Attn: Mammography Standards
Branch'' with ``Division of Mammography Quality Standards, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993, Attn:
Program Management Branch''.
    3. FDA is revising Sec.  900.11(b)(2)(i) by replacing ``42 U.S.C.
263b(c)(2)'' with ``42 U.S.C. 263b(c)(4)''.
    4. FDA is revising Sec.  1020.30(c) by replacing ``Director of the
Office of Communication, Education, and Radiation Programs of the
Center for Devices and Radiological Health'' with ``Director, Center
for Devices and Radiological Health''.
    5. FDA is revising Sec.  1040.10(a)(3)(i) by replacing ``Food and
Drug Administration, Center for Devices and Radiological Health,
Director, Office of Compliance, 10903 New Hampshire Ave., Bldg. 66, Rm.
3521, Silver Spring, MD 20993-0002'' with ``Director, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993-0002''.
    6. FDA is revising Sec.  1040.10(f)(6)(ii) by replacing ``Director,
Office of

Compliance (HFZ-300), Center for Devices and Radiological Health'' with
``Director, Center for Devices and Radiological Health''.
    7. FDA is revising Sec.  1040.10(g)(10) by replacing ``Director,
Office of Compliance (HFZ-300), Center for Devices and Radiological
Health'' with ``Director, Center for Devices and Radiological Health''.
    8. FDA is revising Sec.  1040.20(d)(3)(iii) by replacing
``Director, Office of Communication, Education, and Radiation Programs
10903 New Hampshire Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993-
0002, Center for Devices and Radiological Health'' with ``Director,
Center for Devices and Radiological Health''.
    9. FDA is revising Sec.  1040.20(d)(3)(iv) by replacing
``manfacturer'' with ``manufacturer,'' and replacing ``Director, Office
of Compliance (HFZ-300), Center for Devices and Radiological Health''
with ``Director, Center for Devices and Radiological Health''.

List of Subjects

21 CFR Part 890

    Medical devices, Physical medicine devices.

21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.

21 CFR Part 1020

    Electronic products, Medical devices, Radiation protection,
Reporting and recordkeeping requirements, Television, X-rays.

21 CFR Part 1040

    Electronic funds transfers, Incorporation by reference, Labeling,
Lasers, Medical devices, Radiation protection, Reporting and
recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
890, 900, 1020, and 1040 are amended as follows:

PART 890--PHYSICAL MEDICINE DEVICES

0
1. The authority citation for part 890 continues to read as follows:

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

0
2. Revise Sec.  890.5525(b)(2)(i)(A) to read as follows:

Sec.  890.5525   Iontophoresis device.

* * * * *
    (b) * * *
    (2) * * *
    (i) * * *
    (A) Testing using a drug approved for iontophoretic delivery, or a
solution if identified in the labeling, to demonstrate safe use of the
device as intended;
* * * * *

PART 900--MAMMOGRAPHY

0
3. The authority citation for part 900 continues to read as follows:

    Authority:  21 U.S.C. 360i, 360nn, 374(e), 42 U.S.C. 263b.

0
4. Revise Sec.  900.3(b)(1) to read as follows:

Sec.  900.3   Application for approval as an accreditation body.

* * * * *
    (b) * * *
    (1) An applicant seeking initial FDA approval as an accreditation
body shall inform the Division of Mammography Quality Standards, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4445, Silver Spring, MD 20993,
Attn: Program Management Branch, of its desire to be approved as an
accreditation body and of its requested scope of authority.
* * * * *

0
5. Revise Sec.  900.11(b)(2)(i) to read as follows:

Sec.  900.11   Requirements for certification.

* * * * *
    (b) * * *
    (2) * * *
    (i) A new facility beginning operation after October 1, 1994, is
eligible to apply for a provisional certificate. The provisional
certificate will enable the facility to perform mammography and to
obtain the clinical images needed to complete the accreditation
process. To apply for and receive a provisional certificate, a facility
must meet the requirements of 42 U.S.C. 263b(c)(4) and submit the
necessary information to an approved accreditation body or other entity
designated by FDA.
* * * * *

PART 1020--PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING
PRODUCTS

0
6. The authority citation for part 1020 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360e-360j, 360hh-360ss, 371,
381.

0
7. Revise Sec.  1020.30(c) to read as follows:

Sec.  1020.30   Diagnostic x-ray systems and their major components.

* * * * *
    (c) Manufacturers' responsibility. Manufacturers of products
subject to Sec. Sec.  1020.30 through 1020.33 shall certify that each
of their products meets all applicable requirements when installed into
a diagnostic x-ray system according to instructions. This certification
shall be made under the format specified in Sec.  1010.2 of this
chapter. Manufacturers may certify a combination of two or more
components if they obtain prior authorization in writing from the
Director, Center for Devices and Radiological Health. Manufacturers
shall not be held responsible for noncompliance of their products if
that noncompliance is due solely to the improper installation or
assembly of that product by another person; however, manufacturers are
responsible for providing assembly instructions adequate to assure
compliance of their components with the applicable provisions of
Sec. Sec.  1020.30 through 1020.33.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
8. The authority citation for part 1040 continues to read as follows:

    Authority:  21 U.S.C. 351, 352, 360, 360e-360j, 360hh-360ss,
371, 381.

0
9. In Sec.  1040.10 revise paragraphs (a)(3)(i), (f)(6)(ii), and
(g)(10) to read as follows:

Sec.  1040.10   Laser products.

    (a) * * *
    (3) * * *
    (i) Registers, and provides a listing by type of such laser
products manufactured that includes the product name, model number, and
laser medium or emitted wavelength(s), and the name and address of the
manufacturer. The manufacturer must submit the registration and listing
to the Director, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring,
MD 20993-0002.
* * * * *
    (f) * * *
    (6) * * *
    (ii) If the configuration, design, or function of the laser product
would make unnecessary compliance with the requirement in paragraph
(f)(6)(i) of this section, the Director, Center for Devices and
Radiological Health, may, upon written application by the manufacturer,
approve alternate means to accomplish

the radiation protection provided by the beam attenuator.
* * * * *
    (g) * * *
    (10) Label specifications. Labels required by this section and
Sec.  1040.11 shall be permanently affixed to, or inscribed on, the
laser product, legible, and clearly visible during operation,
maintenance, or service, as appropriate. If the size, configuration,
design, or function of the laser product would preclude compliance with
the requirements for any required label or would render the required
wording of such label inappropriate or ineffective, the Director,
Center for Devices and Radiological Health, on the Director's own
initiative or upon written application by the manufacturer, may approve
alternate means of providing such label(s) or alternate wording for
such label(s) as applicable.
* * * * *

0
10. In Sec.  1040.20 revise paragraphs (d)(3)(iii) and (iv) to read as
follows:

Sec.  1040.20   Sunlamp products and ultraviolet lamps intended for use
in sunlamp products.

* * * * *
    (d) * * *
    (3) * * *
    (iii) If the size, configuration, design, or function of the
sunlamp product or ultraviolet lamp would preclude compliance with the
requirements for any required label or would render the required
wording of such label inappropriate or ineffective, or would render the
required label unnecessary, the Director, Center for Devices and
Radiological Health, on the center's own initiative or upon written
application by the manufacturer, may approve alternate means of
providing such label(s), alternate wording for such label(s), or
deletion, as applicable.
    (iv) In lieu of permanently affixing or inscribing tags or labels
on the ultraviolet lamp as required by Sec. Sec.  1010.2(b) and
1010.3(a), the manufacturer of the ultraviolet lamp may permanently
affix or inscribe such required tags or labels on the lamp packaging
uniquely associated with the lamp, if the name of the manufacturer and
month and year of manufacture are permanently affixed or inscribed on
the exterior surface of the ultraviolet lamp so as to be legible and
readily accessible to view. The name of the manufacturer and month and
year of manufacture affixed or inscribed on the exterior surface of the
lamp may be expressed in code or symbols, if the manufacturer has
previously supplied the Director, Center for Devices and Radiological
Health, with the key to such code or symbols and the location of the
coded information or symbols on the ultraviolet lamp. The label or tag
affixed or inscribed on the lamp packaging may provide either the month
and year of manufacture without abbreviation, or information to allow
the date to be readily decoded.
* * * * *

    Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06308 Filed 3-30-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 17, 2010 (Volume 75, Number 116)]
[Rules and Regulations]
[Page 34361-34362]
[DOCID:fr17jn10-14]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2010-0446]

Safety Zone, Milwaukee Harbor, Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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

SUMMARY: The Coast Guard will enforce the Milwaukee Harbor safety zone
during eight separate periods between 10 p.m. on July 15, 2010 through
10 p.m. on July 25, 2010. This action is necessary and intended to
ensure safety of life on the navigable waters immediately prior to,
during, and immediately after fireworks events. This rule will
establish restrictions upon, and control movement of, vessels in a
specified area immediately prior to, during, and immediately after
fireworks events. During the enforcement period, no person or vessel
may enter the safety zones without permission of the Captain of the
Port, Sector Lake Michigan.

DATES: The regulations in 33 CFR 165.935 will be enforced during eight
separate periods between from 10 p.m. on July 15, 2010 through 10 p.m.
on July 25, 2010.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call

or e-mail BM1 Adam Kraft, Prevention Department, Coast Guard Sector
Lake Michigan, Milwaukee, WI at<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATON: The Coast Guard will enforce the safety zone
listed in 33 CFR 165.935, Safety Zone, Milwaukee Harbor, Milwaukee, WI,
for the following events:
    (1) Festa Italiana fireworks display; on July 15, 2010 from 10 p.m.
through 10:45 p.m.
    (2) Festa Italiana fireworks display; on July 16, 2010 from 10 p.m.
through 10:45 p.m.
    (3) Festa Italiana fireworks display; on July 17, 2010 from 10 p.m.
through 10:45 p.m.
    (4) Festa Italiana fireworks display; on July 18, 2010 from 10 p.m.
through 10:45 p.m.
    (5) German Festival fireworks display; on July 22, 2010 from 10:15
p.m. through 11 p.m.
    (6) German Festival fireworks display; on July 23, 2010 from 10:15
p.m. through 11 p.m.
    (7) German Festival fireworks display; on July 24, 2010 from 10:15
p.m. through 11 p.m.
    (8) German Festival fireworks display; on July 25, 2010 from 9:15
p.m. through 10 p.m.
    All vessels must obtain permission from the Captain of the Port,
Sector Lake Michigan, or his or her designated on-scene representative
to enter, move within or exit the safety zone. Vessels and persons
granted permission to enter the safety zone shall obey all lawful
orders or directions of the Captain of the Port, Sector Lake Michigan,
or his or her designated on-scene representative. While within a safety
zone, all vessels shall operate at the minimum speed necessary to
maintain a safe course.
    This notice is issued under authority of 33 CFR 165.935 Safety
Zone, Milwaukee Harbor, Milwaukee, WI and 5 U.S.C. 552(a). In addition
to this notice in the Federal Register, the Coast Guard will provide
the maritime community with advance notification of these enforcement
periods via Broadcast Notice to Mariners or Local Notice to Mariners.
The Captain of the Port, Sector Lake Michigan, will issue a Broadcast
Notice to Mariners notifying the public when enforcement of the safety
zone established by this section is suspended. If the Captain of the
Port, Sector Lake Michigan, determines that the safety zone need not be
enforced for the full duration stated in this notice, he or she may use
a Broadcast Notice to Mariners to grant general permission to enter the
safety zone.
    The Captain of the Port, Sector Lake Michigan, or his or her
designated on-scene representative may be contacted via VHF-FM Channel
16.

    Dated: June 2, 2010.
L. Barndt,
Captain, U.S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2010-14584 Filed 6-16-10; 8:45 am]
BILLING CODE 9110-04-P