[Federal Register: August 28, 2007 (Volume 72, Number 166)]
[Notices]
[Page 49341-49342]
[DOCID:fr28au07-155]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56295; File No. SR-NYSEArca-2007-82]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change, as Modified by
Amendment No. 1 Thereto, Amending Fees for the Entry of Mid-Point
Passive Liquidity or Primary Sweep Orders

August 21, 2007.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on August 3, 2007, NYSE Arca, Inc. (``NYSE Arca'' or the ``Exchange''),
through its wholly owned subsidiary NYSE Arca Equities, Inc. (``NYSE
Arca Equities''), filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been substantially prepared by the
Exchange. On August 20, 2007, the Exchange submitted Amendment No. 1 to
the proposed rule change.\3\ The Exchange filed the proposed rule
change pursuant to section 19(b)(3)(A) of the Act \4\ and Rule 19b-
4(f)(2) thereunder,\5\ which renders it effective upon filing with the
Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Amendment No. 1 replaced and superseded the original filing
in its entirety.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend the section of its Schedule of Fees
and Charges for Exchange Services (the ``Fee Schedule'') as it applies
to orders submitted by Users \6\ designated as a (1) Mid-Point Passive
Liquidity Order (``MPL Order'') \7\ or (2) Primary Sweep Order
(``PSO'').\8\ The text of the proposed rule change is available at the
Exchange, the Commission's Public Reference Room, and http://www.nyse.com
.

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    \6\ See NYSE Arca Rule 1.1(yy) for the definition of ``User.''
    \7\ See NYSE Arca Equities Rule 7.31(h)(5). See also Securities
Exchange Act Release No. 56072 (July 13, 2007), 72 FR 39867 (July
20, 2007) (SR-NYSEArca-2007-61).
    \8\ See NYSE Arca Equities Rule 7.31(kk). See also Securities
Exchange Act Release No. 55896 (June 11, 2007), 72 FR 33795 (June
19, 2007) (SR-NYSEArca-2007-50)
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II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, NYSE Arca 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
Exchange has prepared summaries set forth in sections A, B, and C below
of the most significant aspects of such statements.

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

1. Purpose
    The Exchange proposes to amend its Fee Schedule as it applies to
Users submitting any order that is designated as either an MPL Order or
PSO.
    First, with the adoption of the MPL Order and the changes to the
Fee Schedule proposed herein, any order designated as an MPL Order
shall not be eligible for a per share credit, if such order executes
against an incoming marketable order, regardless of order

type. According to the proposal, MPL Orders will be exempted from
credits that currently appear in the following sections of the
Exchange's Fee Schedule: NYSE ARCA MARKETPLACE: TRADE RELATED CHARGES,
NYSE ARCA MARKETPLACE: MARKET MAKER FEES AND CHARGES, and the ETP
Holder Transaction Credit and Market Data Revenue Sharing Credit under
NYSE ARCA MARKETPLACE: OTHER FEES AND CHARGES. Consistent with the
proposal to exempt MPL Orders from any credits, the Exchange will not
assess fees to ETP Holders submitting MPL Orders for execution, as such
orders shall not be viewed as removing liquidity from the NYSE Arca
book.
    Secondly, consistent with the proposal to exempt Users submitting
MPL Orders from any credits, the Exchange will not assess fees to Users
submitting MPL Orders for execution, as such orders shall not be viewed
as removing liquidity from the NYSE Arca book. Accordingly, MPL Orders
will be exempted from fees that currently appear in the following
sections of the Exchange's Fee Schedule: NYSE ARCA MARKETPLACE: TRADE
RELATED CHARGES and NYSE ARCA MARKETPLACE: MARKET MAKER FEES AND
CHARGES.
    Finally, the Exchange proposes to amend the Fee Schedule to exempt
Users from the $0.001 per share fee for any order routed to the New
York Stock Exchange, L.L.C. (``NYSE'') if such order is for a security
listed on the NYSE and is designated as a PSO. Accordingly, PSOs will
be exempted from the $0.001 per share fee for orders routed outside the
book to the NYSE that currently appears in the following section of the
Exchange's Fee Schedule: NYSE ARCA MARKETPLACE: TRADE RELATED CHARGES.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
section 6(b) of the Act \9\ in general and furthers the objectives of
section 6(b)(4) \10\ in particular that it is intended to provide for
the equitable allocation of reasonable dues, fees, and other charges
among its members and other persons using its facilities.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(4).
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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 purposes of the Act.

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

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

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

    The foregoing proposed rule change is subject to section
19(b)(3)(A)(ii) of the Act \11\ and subparagraph (f)(2) of Rule 19b-4
thereunder \12\ because it establishes or changes a due, fee, or other
charge applicable only to a member imposed by a self-regulatory
organization. Accordingly, the proposal is effective upon Commission
receipt of the filing. At any time within 60 days of the filing of the
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
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    \11\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \12\ 17 CFR 240.19b-4(f)(2).
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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 e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSEArca-2007-82 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEArca-2007-82. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F. Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NYSE Arca. 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-2007-82 and should
be submitted on or before September 18, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-16908 Filed 8-27-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57486-57487]
[FR Doc No: 2019-23295]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Agency Information Collection Activities: Announcement of the
Office of Management and Budget (OMB) Control Numbers Under the
Paperwork Reduction Act

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice; announcement of the Office of Management and Budget's
(OMB) approval of information collection requirements.

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SUMMARY: Comporting with Executive Order 13563, ``Improving Regulations
and Regulatory Review,'' and consistent with Executive Order 13777,
``Enforcing the Regulatory Reform Agenda,'' OSHA removed or revised
outdated, duplicative, unnecessary, and inconsistent requirements in
safety and health standards. Standards Improvement Project--Phase IV
(SIP-IV) was published May 14, 2019 (84 FR 21416, Docket Number OSHA-
2012-0007). This final rule reduces regulatory burden while maintaining
or enhancing worker safety and health, and improving privacy
protections.
    The Occupational Safety and Health Administration announces an OMB
extension of approval for a number of information collection
requirements found in the final rule. OSHA sought approval of these
requirements under the Paperwork Reduction Act of 1995 (PRA), and, as
required by that Act, is announcing the approval numbers and expiration
dates for these requirements.

DATES: This notice is effective October 25, 2019.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The purposes of the Paperwork Reduction Act
of 1995 (PRA), 44 U.S.C. 3501 et seq., include enhancing the quality
and utility of information the Federal government requires and
minimizing the paperwork and reporting burden on affected entities. The
public is not required to respond to a collection of information unless
it displays a currently valid OMB control number (44 U.S.C. 3507).
Also, notwithstanding any other provisions of law, no person shall be
subject to penalty for failing to comply with a collection of
information if there is not a current valid OMB control number (44
U.S.C. 3512).

    The Department submitted a series of Information Collection
Requests (ICRs) to revise the collections in accordance with the SIP-IV
Final Rule, as required by the PRA. See 44 U.S.C. 3507(d). Some of the
revisions resulted in changes to the existing burden hour and/or cost
estimates. Other revisions were less significant and did not change the
ICR burden hour and cost estimates.
    SIP-IV modified twenty-five Information Collections currently
approved by the Office of Management and Budget (OMB) under the PRA.
They are listed in the table along with the OMB Control Number and
their current expiration date. In accordance with 5 CFR 1320.5(b), an
agency cannot conduct, sponsor, or require a response to a collection
of information unless the collection displays a valid OMB control
number and the agency informs respondents that they need not respond to
the collection of information.

------------------------------------------------------------------------
 Title of the information collection
               request                 OMB Control No.   Expiration date
------------------------------------------------------------------------
1,2-Dibromo-3-Choropropane (DBCP)            1218-0101        08/31/2022
 Standard (29 CFR 1910.1044)........
1,3-Butadiene Standard (29 CFR               1218-0170        01/31/2020
 1910.1051).........................
4,4'-Methylenedianiline (MDA) in             1218-0183        07/31/2022
 Construction (29 CFR 1926.60)......
4,4'-Methylenedianiline (MDA) for            1218-0184        01/31/2020
 General Industry (29 CFR 1910.1050)
Acrylonitrile (29 CFR 1910.1045)....         1218-0126        07/31/2022
Asbestos in Construction Standard            1218-0134        10/31/2021
 (29 CFR 1926.1101).................
Asbestos in General Industry (29 CFR         1218-0133        04/30/2020
 1910.1001).........................
Asbestos in Shipyards (29 CFR                1218-0195        04/30/2020
 1915.1001).........................
Benzene (29 CFR 1910.1028)..........         1218-0129        01/31/2020
Bloodborne Pathogens Standard (29            1218-0180        08/31/2021
 CFR 1910.1030).....................
Cadmium in Construction (29 CFR              1218-0186        01/31/2020
 1926.1127).........................
Cadmium in General Industry (29 CFR          1218-0185        01/31/2020
 1910.1027).........................
Coke Oven Emissions (29 CFR                  1218-0128        07/31/2022
 1910.1029).........................
Construction Standards on Posting            1218-0093        07/31/2022
 Emergency Telephone Numbers and
 Floor Load Limits (29 CFR 1926.50
 and 29 CFR 1926.250)...............
Cotton Dust (29 CFR 1910.1043)......         1218-0061        08/31/2021
Ethylene Oxide (EtO) Standard (29            1218-0108        09/30/2020
 CFR 1910.1047).....................
Formaldehyde Standard (29 CFR                1218-0145        04/30/2020
 1910.1048).........................
Hazardous Waste Operations and               1218-0202        01/31/2020
 Emergency Response for General
 Industry (29 CFR 1910.120) and
 Construction (29 CFR 1926.65)......
Hexavalent Chromium Standards for            1218-0252        01/31/2020
 General Industry (29 CFR 1910.1026)
Inorganic Arsenic Standard (29 CFR           1218-0104        07/31/2022
 1910.1018).........................
Lead in Construction Standard (29            1218-0189        07/31/2022
 CFR 1926.62).......................
Lead in General Industry Standard            1218-0092        01/31/2020
 (29 CFR 1910.1025).................
Methylene Chloride (29 CFR                   1218-0179        08/31/2021
 1910.1052).........................
Respirable Crystalline Silica                1218-0266        01/31/2020
 Standards for General Industry,
 Shipyard Employment and Marine
 Terminals (29 CFR 1910.1053) and
 Construction (29 CFR 1926.1153)....
Vinyl Chloride Standard (29 CFR              1218-0010        08/31/2021
 1910.1017).........................
------------------------------------------------------------------------

Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on October 18, 2019.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2019-23295 Filed 10-24-19; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 78, Number 25 (Wednesday, February 6, 2013)]
[Notices]
[Page 8600]
[FR Doc No: 2013-02563]

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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 Investor Education and Advocacy, Washington, DC
20549-0213.

Extension: Rule 13e-1;
    OMB Control No. 3235-0305, SEC File No. 270-255.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget this request for extension of the previously approved
collection of information discussed below.
    Rule 13e-1 (17 CFR 240.13e-1) under the Securities Exchange Act of
1934 (U.S.C. 78 et seq.) makes it unlawful for an issuer who has
received notice that it is the subject of a tender offer made under
Section 14(d)(1) of the Exchange Act to purchase any of its equity
securities during the tender offer, unless it first files a statement
with the Commission containing information required by the rule. This
rule is in keeping with the Commission's statutory responsibility to
prescribe rules and regulations that are necessary for the protection
of investors. Public companies are the respondents. We estimate that it
takes approximately 10 burden hours per response to provide the
information required under Rule 13e-1 and that the information is filed
by approximately 20 respondents. We estimate that 25% of the 10 hours
per response (2.5 hours) is prepared by the company for a total annual
reporting burden of 50 hours (2.5 hours per response x 20 responses)
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    The public may view the 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) Thomas Bayer, Director/Chief Information
Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon,
6432 General Green Way, Alexandria, VA 22312 or send an email to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30 days of
this notice.

    Dated: January 31, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-02563 Filed 2-5-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Rules and Regulations]
[Pages 22525-22530]
[FR Doc No: 2016-08898]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0650]

Cardiovascular Devices; Reclassification of External Pacemaker
Pulse Generator Devices; Reclassification of Pacing System Analyzers

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify external pacemaker pulse generator (EPPG) devices,
which are currently preamendments class III devices (regulated under
product code

DTE), into class II (special controls) and to reclassify pacing system
analyzers (PSAs) into class II (special controls) based on new
information and subject to premarket notification. This final order
also creates a separate classification regulation for PSAs and places
single and dual chamber PSAs, which are currently classified with EPPG
devices, and triple chamber PSAs (TCPSAs), which are currently
postamendments class III devices, into that new classification
regulation.

DATES: This order is effective April 18, 2016.

FOR FURTHER INFORMATION CONTACT: Hina Pinto, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act (Pub. L.
108-214), the Food and Drug Administration Amendments Act of 2007 (Pub.
L. 110-85), and the Food and Drug Administration Safety and Innovation
Act (FDASIA) (Pub. L. 112-144), among other amendments, establishes a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes
three categories (classes) of devices, reflecting the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type (both the preamendments and substantially
equivalent devices are referred to as preamendments class III devices)
may be marketed without submission of a premarket approval application
(PMA) until FDA issues a final order under section 515(b) of the FD&C
Act (21 U.S.C. 360e(b)) requiring premarket approval or until the
device is subsequently reclassified into class I or class II.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or class II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA acting by order can
reclassify the device into class I or class II on its own initiative,
or in response to a petition from the manufacturer or importer of the
device. To change the classification of the device, the proposed new
class must have sufficient regulatory controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the mechanism for
reclassifying a device under that section from rulemaking to an
administrative order.
    Section 513(e) of the FD&C Act provides that FDA may, by
administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
an eligible device type. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F. Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers Assoc.
v. FDA, 766 F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062
(1986).) FDA relies upon ``valid scientific evidence'' in the
reclassification process to determine the level of regulation for
devices. To be considered in the reclassification process, the ``valid
scientific evidence'' upon which the Agency relies must be publicly
available. Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order to reclassify a device under that section.
Specifically, prior to the issuance of a final order reclassifying a
device, the following must occur: (1) Publication of a proposed order
in the Federal Register; (2) a meeting of a device classification panel
described in section 513(b) of the FD&C Act and (3) consideration of
comments to a public docket. FDA published a proposed order to
reclassify EPPG and PSA devices in the Federal Register of September
15, 2014 (79 FR 54927) (the ``proposed order''). On September 11, 2013,
FDA held a meeting of a device classification panel described in
section 513(b) to discuss reclassification of EPPG and PSA devices (the
``2013 Panel''). FDA

has also received and considered comments on the proposed order as
discussed in section III. Therefore, FDA has satisfied the requirements
for issuing a final order under section 513(e)(1) of the FD&C Act.

II. Regulatory History of the Devices

    As noted in the proposed order, on March 9, 1979, the Agency
published a proposed rule for the classification of EPPG devices into
class III (44 FR 13284). FDA subsequently published a final rule
classifying EPPG devices into class III under Sec.  [thinsp]870.3600
(21 CFR 870.3600) after receiving no comments on the March 9, 1979,
proposed rule (45 FR 7904, February 5, 1980). In 1987, FDA published a
final rule to codify language clarifying that no effective date had
been established for the requirement for premarket approval for EPPG
devices (52 FR 17732, May 11, 1987). In 2009, FDA published an order
(the ``515(i) Order'') requiring manufacturers of remaining class III
devices for which regulations requiring PMAs had not been issued,
including EPPGs, to submit a summary of information concerning those
devices by August 7, 2009 (74 FR 16214, April 9, 2009). On October 17,
2011, FDA published a proposed rule proposing the reclassification of
EPPG devices from class III to class II (76 FR 64224), which the Agency
subsequently withdrew on September 15, 2014 (79 FR 54927). FDA withdrew
the proposed rule in response to the new process for reclassifications
under section 513(e) of the FD&C Act, as amended by FDASIA, and new
information, including new information discussed during the 2013 Panel
meeting.
    Single and dual chamber PSAs have historically been classified with
EPPG devices. Single and dual chamber PSAs combine the functionality of
a single or dual chamber EPPG, which is currently a class III device,
and the functionality of a pacemaker electrode function tester, which
is regulated as a class II device under Sec.  870.3720 (21 CFR
870.3720). Single and dual chamber PSA devices have been found
substantially equivalent to EPPG devices through the 510(k) process.
TCPSA devices have not been determined to be substantially equivalent
to a predicate device through the 510(k) process and, because TCPSAs
were not on the market before May 28, 1976, TCPSAs have been reviewed
through the PMA process as postamendments class III devices. This order
creates a new classification regulation for single, dual, and triple
chamber PSA devices, which combine the functionality of an EPPG and the
functionality of a pacemaker electrode function tester.
    As discussed in the proposed order, FDA considered the available
information on these devices (EPPG and PSA devices) and concluded that
reclassifying these devices to class II, subject to the identified
special controls, would provide reasonable assurance of their safety
and effectiveness. As required by section 513(e)(1) of the FD&C Act,
FDA convened a meeting of a device classification panel described in
section 513(b) of the FD&C Act to discuss whether EPPG and PSA devices
should be reclassified or remain in class III on September 11, 2013 (78
FR 49272). The reclassification of EPPG and PSA devices was supported
by the 2013 Panel. The 2013 Panel recommended that EPPG devices
(including single and dual chamber PSAs) be reclassified to class II
with special controls when intended for cardiac rate control or
prophylactic arrhythmia prevention. In addition, the 2013 Panel agreed
that EPPG devices are life-supporting and, per Sec.  860.93 (21 CFR
860.93), explained that its rationale for recommending that EPPG
devices be reclassified to class II was based on the proposed special
controls FDA presented, which the 2013 Panel believed were adequate
(along with general controls) to mitigate the risks of the device.
    The 2013 Panel also recommended that TCPSA devices be reclassified
to class II with special controls when intended for use during the
pulse generator implant procedure. The 2013 Panel acknowledged that
TCPSA devices are life-supporting devices and provided the following
rationale per Sec.  860.93 for recommending that TCPSA devices be
reclassified to class II: (1) These devices are used only during the
implant procedure where backup monitoring is continuous, hazards can be
recognized and treated immediately, and where there is a reasonable
expectation that users are adequately trained; (2) these devices are
not intended to provide the long-term hemodynamic benefit of
biventricular pacing or cardiac resynchronization therapy; and (3) the
recommended special controls will mitigate the health risks associated
with the device. The 2013 Panel transcript and other meeting materials
are available on FDA's Web site (Ref. 1). Since the 2013 Panel meeting,
FDA has not become aware of new information that would provide a basis
for a device classification panel to make a different recommendation or
different findings.

III. Public Comments in Response to the Proposed Order

    In response to the September 15, 2014, proposed order to reclassify
EPPG and PSA devices (79 FR 54927), FDA received two comments. FDA
previously received three sets of comments on the October 17, 2011,
proposed rule to reclassify EPPG devices that was subsequently
withdrawn (79 FR 54927). The Agency has considered all of these
comments in drafting this final order.
    The comments and FDA's responses to the comments are summarized in
this section. Certain comments are grouped together under a single
number because the subject matter of the comments is similar. The
number assigned to each comment is purely for organizational purposes
and does not signify the comment's value or importance or the order in
which it was submitted.
    (Comment 1) Four comments suggested that EPPG devices are life-
sustaining and should be subject to premarket approval to provide
better assurance of safety and effectiveness; as such, the comments
asserted that EPPG devices should remain in class III. Further, one
comment indicated that the proposed special controls are not sufficient
to mitigate the risks associated with EPPG devices. Three other
comments also discussed the risks associated with these devices and the
need for adequate mitigation through premarket approval.
    (Response 1) These comments were considered by FDA in drafting this
final order. Per 21 CFR 860.3(c)(3), a device is in class III if two
conditions are met: (1) Insufficient information exists to determine
that general controls are sufficient to provide reasonable assurance of
its safety and effectiveness or that application of special controls
described in 21 CFR 860.3(c)(2) would provide such assurance, and (2)
the device is life-supporting or life-sustaining, or for a use which is
of substantial importance in preventing impairment of human health, or
if the device presents a potential unreasonable risk of illness or
injury. FDA has concluded that for EPPG devices, special controls will
provide reasonable assurance of safety and effectiveness to
appropriately mitigate risks to health. Therefore, these life-
supporting devices can be reclassified into class II. As discussed in
section II, the 2013 Panel agreed with FDA's recommendation of class II
for EPPG and TCPSA devices.
    EPPG devices are therapeutic devices designed to be used
temporarily and in a controlled clinical setting. The expected presence
of clinical support

and physician monitoring mitigates many potential complications.
Specifically, EPPG devices are used exclusively in hospital
environments with the patients supervised by qualified medical
personnel. The environment of care for EPPG devices includes
resuscitation equipment, hospital level monitoring of heart rhythm, and
patient vital status by other devices with alarm functions. The special
controls require labeling for EPPG devices to ``clearly state that
these devices are intended for use in a hospital environment and under
the supervision of a clinician trained in their use.'' Further, the
non-clinical performance testing and labeling special controls
appropriately mitigate the risks for EPPG devices by helping to ensure
adequate device performance/pacing, as well as proper maintenance of
the device.
    (Comment 2) Three comments referenced the number of medical device
reports (MDRs) associated with EPPG devices and suggested that MDR data
support keeping EPPG devices in class III. Two of those comments also
discussed the number of MDR reports for malfunctions associated with
EPPG devices and suggested that this shows the performance standards
that have been developed and used to support EPPG marketing
applications are insufficient to provide reasonable assurance of safety
and effectiveness.
    (Response 2) Increased premarket regulatory requirements cannot be
assumed to result in fewer MDRs, nor are MDRs necessarily an indicator
of poor device performance. FDA performed multiple analyses of MDRs for
EPPG devices in the Manufacturer and User Facility Device Experience
(MAUDE) database. The Agency's analysis of the available data shows
that over 85 percent of reports had either no patient involvement or no
known consequences to the patient. These types of malfunction reports
were generally discovered during routine servicing, which may be
anticipated for reusable electrical devices. FDA's MDR analyses were
conducted multiple times during the reclassification process and showed
trends of increased reporting, but with an associated sharp decline in
the relative number of death and injury reports over the last several
years (i.e., the increased reporting was largely for device
malfunctions). FDA believes these trends are indicative of tighter
adherence to MDR requirements and a related change in reporting
practices rather than a change in device performance. FDA's detailed
review of MDRs for EPPG devices also did not suggest design or
functional issues that would be decreased by requiring premarket
approval for EPPG devices.
    FDA also reviewed device recalls for EPPGs over the past 15 years
and did not find evidence indicating the need for class III premarket
approval regulation of these devices. FDA presented its analysis of MDR
and recall data to the 2013 Panel that ultimately recommended
reclassification of EPPG devices from class III to class II (special
controls). The 2013 Panel identified no new or different risks for EPPG
devices based on that information. Therefore, FDA believes that the
identified special controls provide adequate mitigation of the health
risks posed by the EPPG device.
    (Comment 3) One comment suggested that EPPG devices remain in class
III and require PMAs because FDA failed to identify new information on
which to base the reclassification recommendation, specifically noting:
(1) Performance standards developed in support of PMAs are not publicly
available, and (2) FDA used information submitted in response to the
515(i) Order that was not publicly available in the Agency's analysis
of risks to health for EPPG devices.
    (Response 3) FDA's presentation to the 2013 Panel included a
summary of the available safety and effectiveness information for EPPG
devices, including FDA's analysis of adverse event reports from FDA's
MAUDE database and available literature. The 2013 Panel agreed with
FDA's conclusion that the available scientific evidence is adequate to
support reasonable assurance of the safety and effectiveness of EPPG
devices and to reclassify EPPG devices to class II. While the 2013
Panel agreed with the identified risks to health presented at the
September 11, 2013, meeting, it recommended that FDA consider rewording
some of the language for clarity and also to ensure that certain
hazards, such as asynchronous pacing and arrhythmia induction, are
included in the risks to health. FDA agreed with the 2013 Panel's
recommendations and modified the risks to health accordingly as
outlined in section V of the 2014 proposed order. The Agency identified
in the proposed order special controls, including non-clinical
performance testing data and labeling that, together with general
controls (including prescription use), would provide reasonable
assurance of the safety and effectiveness of EPPG devices. Since the
2013 Panel, FDA has not become aware of new information that would
provide a basis for a different recommendation or finding for these
devices.
    Information submitted in response to the 2009 515(i) Order that FDA
used in its reclassification determination was incorporated in what the
Agency presented to the 2013 Panel (see Ref. 1). In addition, that
information was listed in the September 15, 2014, proposed order and is
publicly available through other sources. The information presented to
the 2013 Panel and discussed in the 2014 proposed order also identified
and provided information regarding the two recognized consensus
standards that address various aspects of design and performance of
EPPG devices (IEC 60601-1 and IEC 60601-2-31). The information provided
by these consensus standards is particularly important as design
control measures and aided in forming part of the basis for FDA's
reclassification determination. Therefore, the information that forms
the basis for FDA's reclassification determination has been made
publicly available.
    (Comment 4) One comment suggested that PSA devices remain in class
III because the special controls rely heavily on labeling to mitigate
risks, and expressed doubt that labeling would be sufficient to protect
the health of patients.
    (Response 4) It should be noted that labeling is not the only
mitigation that is proposed to reasonably assure safety and
effectiveness of PSAs. Further, neither FDA nor the 2013 Panel believed
that clinical performance testing was necessary to provide reasonable
assurance of safety or effectiveness. The environment of care for PSAs
is limited to the surgical implant suite, which must have backup
pacing, defibrillation and resuscitation equipment, and capabilities
including intensive care level monitoring of heart rhythm and patient
vital signs. Therefore, FDA believes that the non-clinical performance
testing and labeling special controls, in addition to general controls,
can be established to mitigate the identified risks and provide
reasonable assurance of the safety and effectiveness of PSA devices
when indicated for use during the implant procedure of pacemakers and
defibrillators for the evaluation of the placement and integrity of
pacing leads to determine the appropriate pacing parameters for the
implanted device. Furthermore, the 2013 Panel agreed that the special
controls would mitigate the health risks associated with the PSA
devices.

IV. The Final Order

    Based on the information discussed in the preamble to the proposed
order (79 FR 54927, September 15, 2014), the comments received, a
review of the

MAUDE database and recall data, a review of current scientific
literature, and the 2013 Panel deliberations (see the 2013 Panel
transcript (Ref. 1)), FDA concludes that special controls, in
conjunction with general controls, will provide reasonable assurance of
the safety and effectiveness of EPPG and PSA devices. Under sections
513(e) and 513(f) of the FD&C Act, FDA is adopting its findings, as
published in the preamble to the proposed order. FDA is issuing this
final order to reclassify EPPG devices from class III to class II
(special controls), as well as to create a separate classification
regulation for PSA devices and reclassify PSA devices into class II
(special controls). As noted in the proposed order, FDA is also making
a slight modification to the identification for EPPG devices in Sec.
[thinsp]870.3600 to clarify that these are prescription devices.
    Following the effective date of this final order, firms marketing
an EPPG or PSA device must comply with the applicable mitigation
measures set forth in the codified special controls. Manufacturers of
EPPG or PSA devices that have not been legally marketed prior to the
effective date of this final order, or models (if any) that have been
marketed but are required to submit a new 510(k) under 21 CFR
807.81(a)(3) because the device is about to be significantly changed or
modified, must obtain 510(k) clearance and demonstrate compliance with
the special controls included in this final order, before marketing the
new or changed device.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of EPPG and PSA devices for their intended uses, and
therefore, these device types are not exempt from premarket
notification requirements.

V. Analysis of Environmental Impact

    The Agency has 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.

VI. Paperwork Reduction Act of 1995

    This final order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; and the collections of information under 21 CFR part 801 have
been approved under OMB control number 0910-0485.

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) as amended requires FDA to issue final orders rather
than regulations, FDASIA also provides for FDA to revoke previously
promulgated regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, pursuant to section 513(e)(1)(A)(i)
of the FD&C Act, as amended by FDASIA, in this final order, we are
revoking the requirements in Sec.  [thinsp]870.3600 related to the
classification of EPPG devices as class III devices, and codifying the
reclassification of EPPG and PSA devices into class II (special
controls).

VIII. Reference

    The following reference is on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site address, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.

    1. The panel transcript and other meeting materials for the
September 11, 2013, Circulatory System Devices Panel are available
on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm342357.htm.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

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

0
2. Section 870.3600 is revised to read as follows:

Sec.  870.3600  External pacemaker pulse generator.

    (a) Identification. An external pacemaker pulse generator (EPPG) is
a prescription device that has a power supply and electronic circuits
that produce a periodic electrical pulse to stimulate the heart. This
device, which is used outside the body, is used as a temporary
substitute for the heart's intrinsic pacing system until a permanent
pacemaker can be implanted, or to control irregular heartbeats in
patients following cardiac surgery or a myocardial infarction. The
device may have adjustments for impulse strength, duration, R-wave
sensitivity, and other pacing variables.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during
intended use. This must include testing with the specific power source
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the
performance characteristics of the device. Testing must include the
following:
    (i) Testing must demonstrate the accuracy of monitoring functions,
alarms, measurement features, therapeutic features, and all adjustable
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate
that the device and connection cables will withstand forces or
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user
interface for adjustable parameters, performance of alarms, display
screens, interface with external devices (e.g. data storage, printing),
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard
analysis must be performed.

    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended
for use in a hospital environment and under the supervision of a
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on
the outside of the EPPG device. The markings should identify positive
(+) and negative (-) polarities. Dual chamber devices should clearly
identify atrial and ventricular terminals;
    (iii) The labeling must list all pacing modes available in the
device;
    (iv) Labeling must include a detailed description of any special
capabilities (e.g., overdrive pacing or automatic mode switching); and
    (v) Appropriate electromagnetic compatibility information must be
included.

0
3. In Subpart D, add Sec.  870.3605 to read as follows:

Sec.  870.3605  Pacing system analyzer.

    (a) Identification. A pacing system analyzer (PSA) is a
prescription device that combines the functionality of a pacemaker
electrode function tester (Sec.  870.3720) and an external pacemaker
pulse generator (EPPG) (Sec.  870.3600). It is connected to a pacemaker
lead and uses a power supply and electronic circuits to supply an
accurately calibrated, variable pacing pulse for measuring the
patient's pacing threshold and intracardiac R-wave potential. A PSA may
be a single, dual, or triple chamber system and can simultaneously
deliver pacing therapy while testing one or more implanted pacing
leads.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Appropriate analysis/testing must validate electromagnetic
compatibility (EMC) within a hospital environment.
    (2) Electrical bench testing must demonstrate device safety during
intended use. This must include testing with the specific power source
(i.e., battery power, AC mains connections, or both).
    (3) Non-clinical performance testing data must demonstrate the
performance characteristics of the device. Testing must include the
following:
    (i) Testing must demonstrate the accuracy of monitoring functions,
alarms, measurement features, therapeutic features, and all adjustable
or programmable parameters as identified in labeling;
    (ii) Mechanical bench testing of material strength must demonstrate
that the device and connection cables will withstand forces or
conditions encountered during use;
    (iii) Simulated use analysis/testing must demonstrate adequate user
interface for adjustable parameters, performance of alarms, display
screens, interface with external devices (e.g. data storage, printing),
and indicator(s) functionality under intended use conditions; and
    (iv) Methods and instructions for cleaning the pulse generator and
connection cables must be validated.
    (4) Appropriate software verification, validation, and hazard
analysis must be performed.
    (5) Labeling must include the following:
    (i) The labeling must clearly state that these devices are intended
for use in a hospital environment and under the supervision of a
clinician trained in their use;
    (ii) Connector terminals should be clearly, unambiguously marked on
the outside of the PSA. The markings should identify positive (+) and
negative (-) polarities. Dual chamber devices should clearly identify
atrial and ventricular terminals. Triple chamber devices should clearly
identify atrial, right ventricular, and left ventricular terminals;
    (iii) The labeling must list all pacing modes available in the
device;
    (iv) Labeling must include a detailed description of any special
capabilities (e.g., overdrive pacing or automatic mode switching);
    (v) Labeling must limit the use of external pacing to the implant
procedure; and
    (vi) Appropriate electromagnetic compatibility information must be
included.

    Dated: April 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08898 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Rules and Regulations]
[Pages 34403-34405]
[FR Doc No: 2014-13832]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0340; Directorate Identifier 2014-NM-084-AD;
Amendment 39-17867; AD 2014-12-06]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and
Model A300 C4-605R Variant F airplanes (collectively called Model A300-
600 series airplanes); and Airbus Model A310 series airplanes. This AD
requires inspections of the external area of the aft cargo door sill
beam for cracking, and repair if necessary. This AD was prompted by
reports of fatigue cracks on the cargo door sill beam, lock fitting,
and torsion box plate. We are issuing this AD to detect and correct
fatigue cracking of the cargo door sill beam, lock fitting, and torsion
box plate, which could result in the loss of the door locking function
and, subsequently, complete loss of the cargo door in flight with the
risk of rapid decompression.

DATES: This AD becomes effective July 2, 2014.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 2,
2014.
    We must receive comments on this AD by August 1, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this AD, contact Airbus SAS,
Airworthiness Office--EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51;
email<EMAIL_ADDRESS>Internet http://www.airbus.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0340; or in person at the Docket Operations office between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Emergency Airworthiness Directive 2014-0097-E, dated April 23, 2014
(referred to after this as the Mandatory Continuing Airworthiness
Information, or ``the MCAI''), to correct an unsafe condition for
certain Airbus Model A300 B4-600, B4-600R, and F4-600R series
airplanes, and Model A300 C4-605R Variant F airplanes (collectively
called Model A300-600 series airplanes); and Airbus Model A310 series
airplanes. The MCAI states:

    During accomplishment of Maintenance Review Board Report (MRBR)
task 531625-01-1 on an A300-600 aeroplane having accumulated more
than 25,000 flight cycles (FC) since aeroplane first flight,
multiple fatigue cracks were found on the following parts:

--Aft cargo door sill beam Part Number (P/N) A53973085210
--Lock fitting P/N A53978239002
--Torsion box plate P/N A53973318206.

    Prompted by these findings, a stress analysis was performed
during which it was discovered that there is no dedicated scheduled
maintenance task to inspect the affected area for fatigue damage.
    The loss of more than one lock fitting could lead to loss of the
door locking function and, subsequently, complete loss of the cargo
door in flight with associated risk of rapid decompression.
    To address this unsafe condition, Airbus issued Alert Operators
Transmission (AOT) A53W005-14 providing instructions for inspection
of the affected area.
    For the reason described above, this [EASA] AD requires
repetitive ultrasonic inspections or detailed inspections (DET) for
cracking of the aft cargo door sill beam external area, or a one-
time High Frequency Eddy Current (HFEC) inspection [for cracking] of
the aft cargo door sill beam internal structure and, depending on
findings, accomplishment of corrective action(s) [e.g. repair].
    This [EASA] AD is considered an interim measure and further AD
action may follow.

You may examine the MCAI on the Internet at http://www.regulations.gov
by searching for and locating Docket No. FAA-2014-0340.

Relevant Service Information

    Airbus has issued Alert Operators Transmission A53W005-14, dated
April 22, 2014. The actions described in this service information are
intended to correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are issuing this AD because we
evaluated all pertinent information and determined the unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Interim Action

    We consider this AD interim action. If final action is later
identified, we might consider further rulemaking then.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because
fatigue cracking of the cargo door sill beam, lock fitting, and torsion
box plate could result in the loss of the door locking function and
subsequently, complete loss of the cargo door in flight with the risk
of rapid decompression. Therefore, we determined that notice and
opportunity for public comment before issuing this AD are impracticable
and that good cause exists for making this amendment effective in fewer
than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2014-0340; Directorate
Identifier 2014-NM-084-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this AD based on
those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    We estimate that this AD affects 170 airplanes of U.S. registry.
    We also estimate that it will take about 11 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $158,950, or $935 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this AD.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2014-12-06 Airbus: Amendment 39-17867. Docket No. FAA-2014-0340;
Directorate Identifier 2014-NM-084-AD.

(a) Effective Date

    This AD becomes effective July 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), (c)(3), (c)(4), and (c)(5) of this AD, certificated
in any category, all certified models, all manufacturer serial
numbers on which Airbus Modification 05438 has been embodied in
production, except those on which Modification 12046 has been
embodied in production.
    (1) Airbus Model A300 B4-601, B4-603, B4-620, and B4-622
airplanes.
    (2) Airbus Model A300 B4-605R and B4-622R airplanes.
    (3) Airbus Model A300 F4-605R and F4-622R airplanes.

    (4) Airbus Model A300 C4-605R Variant F airplanes.
    (5) Airbus Model A310-203, -204, -221, -222, -304, -322, -324,
and -325 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports of fatigue cracks on the cargo
door sill beam, lock fitting, and torsion box plate. We are issuing
this AD to detect and correct fatigue cracking of the cargo door
sill beam, lock fitting, and torsion box plate, which could result
in the loss of the door locking function and subsequently, complete
loss of the cargo door in flight with the risk of rapid
decompression.

(f) Compliance

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

(g) Inspection and Repair

    (1) Within the compliance time identified in paragraph
(g)(1)(i), (g)(1)(ii), or (g)(1)(iii) of this AD, as applicable, do
an ultrasonic inspection or detailed inspection of the aft cargo
door sill beam external area for cracking, in accordance with Airbus
Alert Operators Transmission (AOT) A53W005-14, dated April 22, 2014.
Repeat the inspection thereafter at intervals not to exceed 275
flight cycles.
    (i) For airplanes that have accumulated 30,000 flight cycles or
more since the airplane's first flight as of the effective date of
this AD: Within 50 flight cycles after the effective date of this
AD.
    (ii) For airplanes that have accumulated 18,000 flight cycles or
more, but less than 30,000 flight cycles since the airplane's first
flight as of the effective date of this AD: Within 275 flight cycles
after the effective date of this AD.
    (iii) For airplanes that have accumulated less than 18,000
flight cycles since the airplane's first flight as of the effective
date of this AD: Before exceeding 18,275 flight cycles since the
airplane's first flight.
    (2) If any crack is found during any inspection required by
paragraph (g)(1) of this AD: Before further flight, repair using a
method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; or the European Aviation Safety
Agency (EASA) (or its delegated agent, or the Design Approval Holder
(DAH) with EASA design organization approval).

(h) Optional Terminating Action

    Accomplishment of the high frequency eddy current (HFEC)
inspection for cracking in accordance with Airbus AOT A53W005-14,
dated April 22, 2014, terminates the repetitive inspections required
by paragraph (g)(1) of this AD for that airplane. If any cracking is
found during the HFEC inspection, before further flight, repair
using a method approved by the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or the EASA (or its
delegated agent, or the DAH with EASA design organization approval).

(i) Reporting Requirement

    Submit a report of the findings (both positive and negative) of
the inspection required by paragraph (g)(1) of this AD to Airbus as
specified in paragraph 7., ``Reporting'' of the Airbus AOT A53W005-
14, dated April 22, 2014, at the applicable time specified in
paragraph (i)(1) or (i)(2) of this AD. The report must include
inspection results, including no findings.
    (1) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Dan Rodina,
Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer, use these actions if they
are FAA-approved. Corrective actions are considered FAA-approved if
they were approved by the State of Design Authority (or its
delegated agent, or the DAH with a State of Design Authority's
design organization approval, as applicable). You are required to
ensure the product is airworthy before it is returned to service.
    (3) Reporting Requirements: A federal agency may not conduct or
sponsor, and a person is not required to respond to, nor shall a
person be subject to a penalty for failure to comply with a
collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 5
minutes per response, including the time for reviewing instructions,
completing and reviewing the collection of information. All
responses to this collection of information are mandatory. Comments
concerning the accuracy of this burden and suggestions for reducing
the burden should be directed to the FAA at: 800 Independence Ave.
SW., Washington, DC 20591, Attn: Information Collection Clearance
Officer, AES-200.

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA Emergency Airworthiness Directive 2014-0097-E, dated April 23,
2014, for related information. You may examine the MCAI on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2014-0340.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Alert Operators Transmission A53W005-14, dated April
22, 2014.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAW, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 44 51; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on: June 4, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-13832 Filed 6-16-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Rules and Regulations]
[Pages 12824-12825]
[FR Doc No: 2016-05540]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0181]

Drawbridge Operation Regulation; North Landing River, Chesapeake,
VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the S165 (North Landing Road) Bridge
across the North Landing River, mile 20.2, at Chesapeake, VA. This
deviation is necessary to perform emergency bridge repairs. This
deviation allows the bridge to remain in the closed-to-navigation
position.

DATES: This deviation is effective without actual notice from March 11,
2016 through 6 p.m. on June 30, 2016. For the purposes of enforcement,
actual notice will be used from March 8, 2016 at 8:45 a.m., until March
11, 2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0181] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Hal R. Pitts, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6222, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The United States Army Corps of Engineers,
Norfolk District Office, that owns and operates the S165 (North Landing
Road) Bridge, has requested a temporary deviation from the current
operating regulations to perform emergency repairs to the south swing
span of the bridge due to damage sustained as a result of a vessel
allision with the bridge. The bridge is a double swing draw bridge and
has a vertical clearance in the closed position of 6 feet above mean
high water.
    The current operating schedule is set out in 33 CFR 117.1021. Under
this temporary deviation, the north span of the bridge will open-to-
navigation on the hour and half hour, upon request, from 6 a.m. to 7
p.m., and on demand from 7 p.m. to 6 a.m. The North and South spans of
the bridge will open to navigation concurrently, with the south span
only opening partially due to damage, upon request, for scheduled
openings at 10 a.m., noon and 2 p.m., Monday through Friday. The
horizontal clearance of the bridge with the south span closed-to-
navigation is 38 feet and the horizontal clearance of the bridge with
the south span partially open-to-navigation is 70 feet.
    The North Landing River is used by a variety of vessels including
small U. S. government and public vessels, small commercial vessels,
tug and barge, and recreational vessels. The Coast Guard has carefully
considered the nature and volume of vessel traffic on the waterway in
publishing this temporary deviation.
    During the closure times there will be limited opportunity for
vessels able to safely pass through the bridge in the closed position
to do so. Vessels able to safely pass through the bridge in the closed
position may do so, after receiving confirmation from the bridge tender
that it is safe to transit through the bridge. The north span of the
bridge will be able to open for emergencies. The Coast Guard will also
inform the users of the waterways through our Local and Broadcast
Notices to Mariners of the change in operating schedule for the bridge
so that vessel operators can arrange their transit to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular

operating schedule immediately at the end of the effective period of
this temporary deviation. This deviation from the operating regulations
is authorized under 33 CFR 117.35.

    Dated: March 8, 2016.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-05540 Filed 3-10-16; 8:45 am]
BILLING CODE 9110-04-P