[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Pages 14003-14004]
[FR Doc No: 2017-05245]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Product-Specific Guidances for Rifaximin; Revised Draft Guidance
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a revised draft guidance for industry on
generic rifaximin oral tablets entitled ``Draft Guidance on
Rifaximin.'' The revised draft guidance, when finalized, will provide
product-specific recommendations on, among other things, the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for rifaximin oral tablets.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 15, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2007-D-0369 for ``Draft Guidance on Rifaximin.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' will be publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more

information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002,
301-796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific
guidances available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and to provide a meaningful
opportunity for the public to consider and comment on the guidances.
This notice announces the availability of a revised draft guidance for
generic rifaximin oral tablets.
    FDA initially approved new drug application (NDA) 021361 for
XIFAXAN (rifaximin oral tablets) 200 milligram (mg) in May 2004 and NDA
022554 for XIFAXAN (rixaximin oral tablets) 550 mg in March 2010. In
November 2011, FDA issued a draft guidance for industry on generic 200
mg rifaximin oral tablets; in February 2012, FDA issued a draft
guidance for industry on generic 550 mg rifaximin oral tablets. We are
now consolidating these two guidances and issuing a single revised
draft guidance for industry on generic rifaximin oral tablets (``Draft
Guidance on Rifaximin'').
    In May 2008, Salix Pharmaceuticals, Inc. (Salix), manufacturer of
the reference listed drugs XIFAXAN 200 mg and XIFAXAN 550 mg, submitted
a citizen petition requesting that FDA refrain from approving any ANDA
referencing XIFAXAN 200 mg unless certain conditions were satisfied,
including conditions related to demonstrating BE. In October 2016,
Baker & Hostetler LLP submitted a citizen petition on behalf of Salix
requesting that FDA refrain from approving any ANDA referencing XIFAXAN
200 mg or XIFAXAN 550 mg unless certain conditions were satisfied,
including conditions related to demonstrating BE. FDA has reviewed the
issues raised in these citizen petitions and is responding to the
citizen petitions separately in the dockets for those citizen petitions
(Docket Nos. FDA-2008-P-0300 and FDA-2016-P-3418, available at https://www.regulations.gov).
    The revised draft guidance is being issued consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The revised draft
guidance, when finalized, will represent the current thinking of FDA on
``Draft Guidance on Rifaximin.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons with access to the Internet may obtain the draft guidances
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05245 Filed 3-15-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: May 31, 2006 (Volume 71, Number 104)]
[Notices]
[Page 30905]
[DOCID:fr31my06-72]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-302-001]

Northern Natural Gas Company; Notice of Compliance Filing

May 24, 2006.
    Take notice that on May 22, 2006, Northern Natural Gas Company
(Northern) tendered for filing information regarding certain non-
conforming service agreements, in compliance with the Commission's May
5, 2006 order.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-8338 Filed 5-30-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: September 16, 2009 (Volume 74, Number 178)]
[Notices]
[Page 47628]
[DOCID:fr16se09-94]

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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: Form T-6, OMB Control No. 3235-0391, SEC File No.
270-344.

    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 a request for extension of the previously approved
collection of information discussed below.
    Form T-6 (17 CFR 269.9) is a statement of eligibility and
qualification for a foreign corporate trustee under the Trust Indenture
Act of 1939 (15 U.S.C. 77aaa et seq.). Form T-6 provides the basis for
determining if the foreign corporate trustee is qualified. Form T-6 is
filed on occasion. The information collected must be filed with the
Commission and is publicly available. Form T-6 takes approximately 17
burden hours per response and is filed by approximately 15 respondents
annually. We estimate that 25% of the 17 hours (4.25 hours) is prepared
by the filer for an annual reporting burden of 64 hours (4.25 hours per
response x 15 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.
    Written comments regarding the above information should be directed
to the following persons: (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 send an e-mail to Shagufta_
<EMAIL_ADDRESS>and (ii) Charles Boucher, Director/CIO, Securities
and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way,
Alexandria, Virginia 22312; or send an e-mail to<EMAIL_ADDRESS>
Comments must be submitted to OMB within 30 days of this notice.

    Dated: September 8, 2009.
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-22247 Filed 9-15-09; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: November 7, 2007 (Volume 72, Number 215)]
[Notices]
[Page 62894]
[DOCID:fr07no07-98]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Fourth Meeting, Special Committee 213 Enhanced Flight Vision
Systems/Synthetic Vision System (EFVS/SVS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 213, Enhanced Flight Vision
Systems/Synthetic Vision System, (EFVS/SVS).

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 213, Enhanced Flight Vision Systems/
Synthetic Vision System, (EFVS/SVS).

DATES: The meeting will be held November 27-29, 2007 from 9 a.m.-5 p.m.

ADDRESSES: The meeting will be held at Hilton Savannah DeSoto Hotel, 15
East Liberty Street, Savannah, Georgia 31401.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC, 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org for directors. Hilton Gardens:

telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., Appendix 2), notice
is hereby given for a Special Committee 213 meeting. The agenda will
include:
     November 27th.
     Opening Plenary Session (Welcome, Introductions, and
Agenda Review).
     Review SC-213 Objectives, Action Items, and SC-213 website
content.
     Review initial reports from WG 1, and WG 2.
     Presentations.
     WG 1 and WG 2 meetings:
     Review/edit most recent MASPS.
     Consensus of draft MASPS among WG 1.
     Incorporate helicopter issues.
     WG 2A:
     Review/edit draft MASPS.
     WG 2B:
     Continue to formulate plan performance criteria.
     November 28th.
     Continuation of WG 1 and WG 2 meetings.
     November 29th.
     Review of action items.
     Define next steps for continued MASPS development.
     Closing Plenary Session (Other Business, Establish date
and time for next meeting, Adjourn).
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairmen, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on November 29, 2007.
Francisco Estrada C.,
RTCA Advisory Committee.
[FR Doc. 07-5543 Filed 11-6-07; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 81, Number 231 (Thursday, December 1, 2016)]
[Proposed Rules]
[Pages 86627-86630]
[FR Doc No: 2016-28618]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9430; Directorate Identifier 2016-NM-051-AD]
RIN 2120-AA64

Airworthiness Directives; ATR-GIE Avions de Transport
R[eacute]gional Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain ATR-GIE Avions de Transport R[eacute]gional Model ATR42-500 and
Model ATR72-102, -202, -212, and -212A airplanes. This proposed AD was
prompted by reports of failure of emergency power supply units (EPSUs)
in production and in service. This proposed AD would require an
inspection to determine the part number and serial number of each EPSU,
and replacement if necessary. We are proposing this AD to address the
unsafe condition on these products.

DATES: We must receive comments on this proposed AD by January 17,
2017.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For ATR service information identified in this NPRM, contact ATR--
GIE Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre Nadot,
31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21; fax +33
(0) 5 62 21 67 18; email<EMAIL_ADDRESS>Internet
http://www.aerochain.com.
    For COBHAM service information identified in this NPRM, contact
COBHAM 174-178 Quai de Jemmapes, 75010, Paris, France; telephone +33
(0) 1 53 38 98 98; fax +33 (0) 1 42 00 67 83.
    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 425-
227-1221.

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-2016-
9430; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed 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: Shahram Daneshmandi, Aerospace
Engineer, International Branch, ANM-116, Transport Airplane
Directorate,

FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-
1112; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2016-9430;
Directorate Identifier 2016-NM-051-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed 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 proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2016-0070, dated April 11, 2016; corrected April 12, 2016 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''); to correct an unsafe condition for certain ATR-GIE
Avions de Transport R[eacute]gional Model ATR42-500 and Model ATR72 -
102, -202, -212, and -212A airplanes. The MCAI states:

    Some failure cases have been reported of emergency power supply
units (EPSU), Part Number (P/N) 301-3100 Amdt [Amendment] A, both on
the production line and in service. The results of the technical
investigations revealed that these failures could have been caused
by a defective internal electronic component, which could affect the
EPSU internal battery charge.
    To address this potential unsafe condition, ATR issued Service
Bulletin (SB) ATR42-33-0050 and SB ATR72-33-1043 to provide
instructions to inspect EPSUs.
    For the reason described above, this [EASA] AD requires
identification and replacement of the affected EPSUs with
serviceable units.
    This [EASA] AD was republished to correct two typographical
errors in paragraph (3) of the [EASA] AD and to specify the correct
Revision (3) of the Cobham SB 301-3100-33-002.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9430.

Related Service Information Under 1 CFR Part 51

    ATR has issued Service Bulletin ATR42-33-0050, Revision 01, dated
January 26, 2016; and ATR Service Bulletin ATR72-33-1043, Revision 01,
dated January 26, 2016. This service information describes procedures
for inspecting an EPSU to determine the part number, serial number, and
amendment level, and replacing the EPSU. These documents are distinct
since they apply to different airplane models.
    Cobham has issued COBHAM Service Bulletin 301-3100-33-002, Revision
3, dated July 30, 2015, which describes procedures for modifying an
EPSU by replacing the printed circuit board.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed 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 proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 11 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on  U.S.
              Action                     Labor cost          Parts cost      Cost per product       operators
----------------------------------------------------------------------------------------------------------------
Inspection........................  1 work-hour x $85                 $0   $85 per EPSU (4               $3,740
                                     per hour = $85 per                     EPSUs per airplane).
                                     EPSU.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary replacements
that would be required based on the results of the proposed inspection.
We have no way of determining the number of airplanes that might need
these replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                Action                            Labor cost                  Parts cost             product
----------------------------------------------------------------------------------------------------------------
Replacement...........................  1 work-hour x $85 per hour =   Not available...........             $85
                                         $85 per EPSU.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

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 proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    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.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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):

ATR--GIE Avions de Transport R[eacute]gional: Docket No. FAA-2016-
9430; Directorate Identifier 2016-NM-051-AD.

(a) Comments Due Date

    We must receive comments by January 17, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the ATR-GIE Avions de Transport
R[eacute]gional airplanes, certificated in any category, identified
in paragraphs (c)(1) and (c)(2) of this AD.
    (1) Model ATR42-500 airplanes, all manufacturer serial numbers
(MSNs), except those on which ATR Modification 6780 has been
embodied in production.
    (2) Model ATR72-102, -202, -212, and -212A airplanes, all MSNs
on which ATR Model 3715 has been embodied in production, except
those on which ATR Modification 6780 has been embodied in
production.

(d) Subject

    Air Transport Association (ATA) of America Code 33, Lights.

(e) Reason

    This AD was prompted by reports of failure of emergency power
supply units (EPSUs) in production and in service. We are issuing
this AD to detect and correct defective internal electronic
components, which could adversely affect the EPSU internal battery.
This condition could result in a partial or total loss of emergency
lighting, possibly affecting passenger evacuation during an
emergency situation.

(f) Compliance

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

(g) Inspection of EPSU and Corrective Action

    Within 12 months after the effective date of this AD, inspect
each EPSU on the airplane to determine the part number and serial
number. For any EPSU having part number (P/N) 301-3100 Amendment
(Amdt) A and a serial number identified in figure 1 to paragraph (g)
of this AD, and that does not have a control sticker marked with
``SIL 301-3100-33-001'': Except as provided by paragraph (i) of this
AD, before further flight, replace the EPSU with a serviceable unit,
as specified in paragraph (h) of this AD, in accordance with the
Accomplishment Instructions of ATR Service Bulletin ATR42-33-0050,
Revision 01, dated January 26, 2016; or Service Bulletin ATR72-33-
1043, Revision 01, dated January 26, 2016; as applicable. A review
of airplane maintenance records may be done in lieu of inspection of
the EPSUs on the airplane if the part number and serial number of
each EPSU can be positively determined from that review.

            Figure 1 to Paragraph (g) of This AD--Affected Serial Numbers of EPSU P/N 301-3100 Amdt A
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                               Affected Serial Numbers of EPSU P/N 301-3100 Amdt A
----------------------------------------------------------------------------------------------------------------
        2905           4929          4960          4994          5025          5077          5113          5156
        2906           4930          4961          4995          5026          5079          5114          5157
        3401           4931          4962          4996          5027          5080          5115          5158
        3697           4932          4963          4997          5028          5081          5116          5159
        3825           4933          4964          4998          5029          5082          5117          5160
        4343           4934          4965          4999          5031          5083          5118          5161
        4420           4935          4966          5000          5032          5084          5119          5162
        4634           4936          4967          5001          5033          5085          5120          5163
        4706           4937          4968          5002          5034          5086          5121          5164
        4707           4938          4969          5003          5038          5087          5122          5166
        4708           4939          4970          5004          5041          5088          5123          5171
        4709           4940          4971          5005          5042          5089          5124          5172
        4710           4941          4972          5006          5046          5090          5125          5173
        4711           4942          4973          5007          5047          5091          5126          5174
        4712           4943          4976          5008          5050          5092          5127          5175
        4713           4944          4977          5009          5052          5096          5128          5176
        4714           4945          4978          5010          5054          5097          5129          5177
        4715           4946          4979          5011          5055          5098          5130          5178
        4716           4947          4980          5012          5056          5099          5131          5179
        4717           4948          4981          5013          5058          5100          5132          5180
        4718           4949          4982          5014          5059          5101          5133          5181
        4719           4950          4983          5015          5065          5103          5134          5182
        4720           4951          4984          5016          5067          5104          5135          5183
        4721           4952          4985          5017          5068          5105          5136          5184
        4722           4953          4986          5018          5069          5106          5138          5185
        4723           4954          4987          5019          5070          5107          5139          5186
        4724           4955          4988          5020          5071          5108          5140          5187

        4745           4956          4989          5021          5072          5109          5147          None
        4926           4957          4990          5022          5073          5110          5153          None
        4927           4958          4991          5023          5075          5111          5154          None
        4928           4959          4993          5024          5076          5112          5155          None
----------------------------------------------------------------------------------------------------------------

(h) Definition of Serviceable EPSU

    For the purpose of this AD, a serviceable EPSU is one that meets
the criteria in paragraph (h)(1), (h)(2), or (h)(3) of this AD.
    (1) Has P/N 301-3100 Amdt A and a serial number that is not
included figure 1 to paragraph (g) of this AD.
    (2) Has P/N 301-3100 Amdt A, a serial number that is included in
figure 1 to paragraph (g) of this AD, but has a control sticker
marked with ``SIL 301-3100-33-001.''
    (3) Has P/N 301-3100 Amdt B, or later amendment.

(i) Alternative Modification of Affected EPSU

    In lieu of the replacement required by paragraph (g) of this AD,
modification of an affected EPSU may be done in accordance with the
Accomplishment Instructions of COBHAM Service Bulletin 301-3100-33-
002, Revision 3, dated July 30, 2015.

(j) Parts Installation Prohibition

    As of the effective date of this AD, no person may install on
any airplane any EPSU having P/N 301-3100 Amdt A and a serial number
identified in figure 1 to paragraph (g) of this AD, unless it has a
control sticker marked with ``SIL 301-3100-33-001''.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by paragraph
(g) of this AD, if those actions were performed before the effective
date of this AD using the service information identified in
paragraph (k)(1) or (k)(2) of this AD, provided it can be determined
that no EPSU having a serial number listed in figure 1 to paragraph
(g) of this AD has been installed on that airplane since the actions
in the applicable service bulletin were completed.
    (1) ATR Service Bulletin ATR42-33-0050, dated December 11, 2015.
    (2) ATR Service Bulletin ATR72-33-1043, dated December 11, 2015.

(l) 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: Shahram
Daneshmandi, 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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the
European Aviation Safety Agency (EASA); or ATR--GIE Avions de
Transport R[eacute]gional's EASA Design Organization Approval (DOA).
If approved by the DOA, the approval must include the DOA-authorized
signature.

(m) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2016-0070, dated April 11, 2016; corrected April 12,
2016; for related information. This MCAI may be found in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2016-9430.
    (2) For ATR service information identified in this AD, contact
ATR-GIE Avions de Transport R[eacute]gional, 1, All[eacute]e Pierre
Nadot, 31712 Blagnac Cedex, France; telephone +33 (0) 5 62 21 62 21;
fax +33 (0) 5 62 21 67 18; email<EMAIL_ADDRESS>
Internet http://www.aerochain.com. For Cobham service information
identified in this AD, contact COBHAM 174-178 Quai de Jemmapes,
75010, Paris, France; telephone +33 (0) 1 53 38 98 98; fax +33 (0) 1
42 00 67 83. 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<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 17, 2016.
Phil Forde,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-28618 Filed 11-30-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: October 30, 2007 (Volume 72, Number 209)]
[Rules and Regulations]
[Page 61288-61291]
[DOCID:fr30oc07-3]

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

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29235; Directorate Identifier 2007-NM-232-AD;
Amendment 39-15245; AD 2007-22-09]
RIN 2120-AA64

Airworthiness Directives; Bombardier Model DHC-8-400 Series
Airplanes

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

ACTION: Final rule; request for comments.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bombardier Model DHC-8-400 series airplanes. This AD requires
an inspection to detect discrepancies of the main landing gear (MLG)
system, an inspection of the jam nut of the retract actuator of the
MLGs to ensure the wire lock is in place and the nut is secured, an
inspection of the retract actuator for any signs of corrosion or wear,
and applicable related investigative and corrective actions if
necessary. This AD also requires submitting an inspection report to
Bombardier. This AD results from two reports of collapse of MLGs within
a few days of each other. We are issuing this AD to detect and correct
potential failure of major components of the MLG assembly and
attachments, which could result in the possible collapse of a MLG and
consequent damage to the airplane and injury to people or damage to
property on the ground.

DATES: This AD becomes effective November 14, 2007.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in the AD as of November 14,
2007.
    We must receive comments on this AD by November 29, 2007.

ADDRESSES: You may send comments 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 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Bombardier,
Inc., Bombardier Regional Aircraft Division, 123 Garratt Boulevard,
Downsview, Ontario M3K 1Y5, Canada.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

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 Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jon Hjelm, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone (516)
228-7323; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    Transport Canada Civil Aviation (TCCA), which is the airworthiness
authority for Canada, notified us that an unsafe condition may exist on
certain Bombardier Model DHC-8-400 series airplanes. TCCA advises that,
on September 9, 2007, a main landing gear (MLG) collapsed on a
Bombardier Model DHC-8-400 series airplane during landing, and that two
days later on September 11, 2007, another MLG collapsed on a Bombardier
Model DHC-8-400 series airplane during landing. It has been determined
that the root cause of both MLG failures was a failure of the retract
actuator during gear extension. This failure allowed the gear to fall
unrestricted with sufficient force to break the over-center drag strut.
The reason for the component failure was determined to be caused by
internal corrosion of the threads at the rod end of the retract
actuator. Potential failure of the major components of the MLG assembly
and attachments, if not corrected, could result in the possible
collapse of the MLG and consequent damage to the airplane and injury to
people or damage to property on the ground.

Relevant Service Information

    Bombardier has issued DHC-8 Series 400 Maintenance Requirements
Manual (PSM 1-84-7), Part 1 (Maintenance Review Board Report), tasks
Z700-03E (left hand) and Z700-04E (right hand). These tasks describe
procedures for doing a general visual inspection to detect
discrepancies of the left- and right-hand MLG systems.
    Bombardier also has issued Repair Drawing (RD) 8/4-32-059, Issue 4,
dated September 14, 2007. Bombardier RD 8/4-32-059 refers to Goodrich
Service Concession Request SCR 086-07, Revision C, dated September 14,
2007, as an additional source of service information for accomplishing
the procedures in the RD. These documents describe procedures for doing
an inspection of the retract actuator for any signs of corrosion or
wear, and doing applicable corrective actions if necessary, which
include adjusting the retracted length of the rod end, torquing the jam
nut, installing a wire lock, and lubricating the piston if necessary.
These documents also describe procedures for doing a detailed
inspection of affected parts for any signs of corrosion or wear, and
doing applicable related investigative and corrective actions if
necessary. The related investigative actions involve visually
inspecting the threads of the piston pin and the thread relief area for
evidence of corrosion. The corrective actions include, but are not
limited to, removing the wire lock, backing off the jam nut and rod end
out of the piston, replacing any discrepant retract actuator or
actuator assembly, coating certain parts with a corrosion inhibitor
compound, and reworking any corroded threaded area of the piston.
    TCCA mandated the RD and Bombardier DHC-8 Series 400 Maintenance
Requirements Manual (PSM 1-84-7), Part 1 (Maintenance Review Board
Report), tasks Z700-03E (left hand) and Z700-04E (right hand), and
issued Canadian airworthiness directive CF-2007-20, dated September 12,
2007, to ensure the continued airworthiness of these airplanes in
Canada.

FAA's Determination and Requirements of this AD

    These airplanes are manufactured in Canada and are type
certificated for operation in the United States under the provisions of
section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and
the applicable bilateral airworthiness agreement. Pursuant to this
bilateral airworthiness agreement, TCCA has kept the FAA informed of
the situation described above. We have examined TCCA's findings,
evaluated all pertinent information, and determined that we need to
issue an AD for products of this type design that are certificated for
operation in the United States.
    Therefore, we are issuing this AD to detect and correct potential
failure of major components of the MLG assembly and attachments, which
could result in the possible collapse of a MLG and consequent damage to
the airplane and injury to people or damage to property on the ground.
This AD requires doing a general visual inspection to detect
discrepancies of the left- and right-hand MLG systems, doing a general
visual inspection of the jam nut of the retract actuator of the left-
and right-hand MLGs to ensure the wire lock is in place and the nut is
secured, doing a detailed

inspection of the retract actuator for any signs of corrosion or wear,
and doing applicable related investigative and corrective actions if
necessary. This AD also requires reporting the inspection results to
Bombardier.

Interim Action

    We consider this AD interim action. The inspection reports that are
required by this AD will enable the manufacturer to obtain better
insight into the nature, cause, and extent of the problem, and
eventually to develop final action to address the unsafe condition.
Once final action has been identified, we might consider further
rulemaking.

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD; therefore, providing notice and opportunity for public comment
before the AD is issued is impracticable, and good cause exists to make
this AD effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2007-29235; Directorate Identifier 2007-NM-232-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 because of 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.

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 have 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 the regulation:
    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); and
    3. 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.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
adding the following new airworthiness directive (AD):

2007-22-09 Bombardier, Inc. (Formerly de Havilland, Inc.): Amendment
39-15245. Docket No. FAA-2007-29235; Directorate Identifier 2007-NM-
232-AD.

Effective Date

    (a) This AD becomes effective November 14, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier Model DHC-8-400 series
airplanes, certificated in any category; serial number 003 and
subsequent.

Unsafe Condition

    (d) This AD results from two reports of collapse of the main
landing gear (MLG) within a few days of each other. We are issuing
this AD to detect and correct potential failure of major components
of the MLG assembly and attachments, which could result in the
possible collapse of the MLG and consequent damage to the airplane
and injury to people or damage to property on the ground.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

General Visual Inspection of MLG System and Corrective Actions

    (f) Before further flight, do a general visual inspection to
detect discrepancies of the left- and right-hand MLG system and do
all applicable corrective actions, in accordance with a method
approved by the Manager, New York Aircraft Certification Office
(ACO), FAA; or the Transport Canada Civil Aviation (TCCA) (or its
delegated agent). Bombardier DHC-8 Series 400 Maintenance
Requirements Manual (PSM 1-84-7), Part 1 (Maintenance Review Board
Report), tasks Z700-03E (left hand) and Z700-04E (right hand), is
one approved method for accomplishing the general visual inspection.

    Note 1: For the purposes of this AD, a general visual inspection
is: ``A visual examination of an interior or exterior area,
installation, or assembly to detect obvious damage, failure, or
irregularity. This level of inspection is made from within touching
distance unless otherwise specified. A mirror may be necessary to
ensure visual access to all surfaces in the inspection area. This
level of inspection is made under normally available lighting
conditions such as daylight, hangar lighting, flashlight, or
droplight and may require removal or opening of access panels or
doors. Stands, ladders, or platforms may be required to gain
proximity to the area being checked.''

General Visual Inspection of the Jam Nut of the Retract Actuator of the
MLG and Corrective Actions

    (g) Before further flight, do a general visual inspection of the
jam nut of the retract actuator of the left- and right-hand MLG to
ensure the wire lock is in place and the nut is secured. If the wire
lock is not in place or if the jam nut is not secured, before
further flight, adjust the retracted length of the rod end, torque
the jam nut, install a wire lock, and lubricate the piston, as
applicable, in

accordance with Bombardier Repair Drawing (RD) 8/4-32-059, Issue 4,
dated September 14, 2007.

    Note 2: Bombardier Repair Drawing 8/4-32-059 refers to Goodrich
Service Concession Request SCR 086-07, Revision C, dated September
14, 2007 (specifically item 14), as an additional source of service
information for adjusting the retracted length of the rod end,
torquing the jam nut, installing a wire lock, and lubricating the
piston if necessary, as required by paragraph (g) of this AD.

Detailed Inspection of the Retract Actuator of the MLG

    (h) For airplanes on which the retract actuator of the MLG, part
number 46550-7 or 46550-9, has accumulated 8,000 or more total
landings or has been in-service 4 or more years since new as of the
effective date of this AD: Before further flight, do a detailed
inspection of affected parts for any signs of corrosion or wear, and
applicable related investigative and corrective actions, in
accordance with Bombardier Repair Drawing 8/4-32-059, Issue 4, dated
September 14, 2007.

    Note 3: For the purposes of this AD, a detailed inspection is:
``An intensive examination of a specific item, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at an intensity deemed appropriate. Inspection aids such as
mirror, magnifying lenses, etc., may be necessary. Surface cleaning
and elaborate procedures may be required.''

    (i) For airplanes other than those identified in paragraph (h)
of this AD with a retract actuator of the MLG, part number 46550-7
or 46550-9: Do a detailed inspection of affected parts for any signs
of corrosion or wear, and applicable related investigative and
corrective actions, in accordance with Bombardier RD 8/4-32-059,
Issue 4, dated September 14, 2007; at the later of the times
specified in paragraphs (i)(1) and (i)(2) of this AD.
    (1) Before the accumulation of 4,000 total landings or 2 years
since new, whichever occurs first.
    (2) Within 500 flight hours after the effective date of this AD.

    Note 4: Bombardier Repair Drawing 8/4-32-059 refers to Goodrich
Service Concession Request SCR 086-07, Revision C, dated September
14, 2007, as an additional source of service information for
accomplishing the applicable related investigative and corrective
actions required by paragraphs (h) and (i) of this AD.

Actions Done in Accordance with Previous Issues of Service Information

    (j) Actions done before the effective date of this AD in
accordance with Bombardier Repair Drawing 8/4-32-059, Issue 1, dated
September 12, 2007; Issue 2, dated September 13, 2007; or Issue 3,
dated September 13, 2007; are acceptable for compliance with the
corresponding actions specified in paragraphs (g) through (i) of
this AD.

Reporting Requirement

    (k) Submit a report of any discrepancy found during any
inspection required by this AD to the Bombardier Technical Help
Desk, at the applicable time specified in paragraph (k)(1) or (k)(2)
of this AD; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail:
<EMAIL_ADDRESS>Under the provisions of the

Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the Office of
Management and Budget (OMB) has approved the information collection
requirements contained in this AD and has assigned OMB Control
Number 2120-0056.
    (1) If the inspection was done after the effective date of this
AD: Submit the report within 7 days after the inspection.
    (2) If the inspection was done before the effective date of this
AD: Submit the report within 7 days after the effective date of this
AD.

Special Flight Permit

    (l) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the airplane can be inspected (if the operator elects to do so),
provided that the procedures and limitations in paragraphs (l)(1)
and (l)(2) of this AD are adhered to.
    (1) Flight Crew Limitations and Procedures:
    (i) Ferry flight with gear extended and pinned.
    (ii) Landing to be conducted at a minimum descent rate.
    (iii) Minimize braking on landing.
    (iv) Flight to be conducted in accordance with Section 4.8 of
the Aircraft Operating Manual (AOM).
    (v) Essential crew only on board.
    (vi) Flight in known or forecast icing condition is prohibited.
    (2) Maintenance Procedures:
    (i) Do the general visual inspection required by paragraph (g)
of this AD.
    (ii) Do the general visual inspections of the stabilizer stay
and the hinge points of the MLG for general condition and security,
in accordance with Bombardier Q400 All Operator Message 236A, dated
September 11, 2007.
    (iii) If no discrepancy is detected during the inspections
required by paragraph (l)(2)(i) and (l)(2)(ii) of this AD, before
further flight, insert the ground lock pins and a wire lock of the
MLG in place.
    (iv) Ensure the ground lock of the nose landing gear is engaged.

Alternative Methods of Compliance (AMOCs)

    (m)(1) The Manager, New York ACO, has the authority to approve
AMOCs for this AD, if requested in accordance with the procedures
found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Related Information

    (n) Canadian airworthiness directive CF-2007-20, dated September
12, 2007, also addresses the subject of this AD.

Material Incorporated by Reference

    (o) You must use Bombardier Repair Drawing 8/4-32-059, Issue 4,
dated September 14, 2007, to perform the actions that are required
by this AD, unless the AD specifies otherwise. The Director of the
Federal Register approved the incorporation by reference of this
document in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
Contact Bombardier, Inc., Bombardier Regional Aircraft Division, 123
Garratt Boulevard, Downsview, Ontario M3K 1Y5, Canada, for a copy of
this service information. You may review copies at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington; or 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 October 19, 2007.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E7-21178 Filed 10-29-07; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register: August 23, 2010 (Volume 75, Number 162)]
[Notices]
[Page 51859-51861]
[DOCID:fr23au10-131]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62735; File No. SR-NASDAQ-2010-101]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Delete Rule 4770 in Its Entirety and To Eliminate a Related Reference
From the Rules

August 17, 2010.
    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 10, 2010, The NASDAQ Stock Market LLC (``NASDAQ'') filed with
the Securities and Exchange Commission (``Commission'') the proposed
rule change as described in Items I, II, and III below, which Items
have been prepared by NASDAQ. The Commission is publishing this notice
to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

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

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

    NASDAQ is proposing to delete Rule 4770 in its entirety from the
NASDAQ rulebook and to also eliminate a reference to Rule 4770 from
Rule 4751(f)(13). The text of the proposed rule change is below.
Proposed new language is italicized and proposed deletions are in
[brackets].
* * * * *

4751. Definitions

    The following definitions apply to the Rule 4600 and 4750 Series
for the trading of securities listed on Nasdaq or a national
securities exchange other than Nasdaq.
    (a)--(e) No change.
    (f) The term ``Order Type'' shall mean the unique processing
prescribed for designated orders that are eligible for entry into
the System, and shall include:
    (1)--(12) No change.
    (13) ``Collared Orders'' are all Unpriced Orders except: (1)
Market On Open Orders as defined in Rule 4752; (2) Market On Close
Orders as defined in Rule 4754; or (3) Unpriced Orders included by
the System in any Nasdaq Halt Cross or Nasdaq Imbalance Cross, each
as defined in Rule 4753[; or (4) Unpriced Orders that are Reference
Price Cross Orders as defined in Rule 4770]. Any portion of a
Collared Order that would execute (either on NASDAQ or when routed
to another market center) at a price more than $0.25 or 5 percent
worse than the NBBO at the time when the order reaches the System,
whichever is greater, will be cancelled.
    (g)--(i) No change.
* * * * *

4770. Reserved[Nasdaq Crossing Network

    (a) Definitions. For the purposes of this rule the term:
    (1) ``Nasdaq Reference Price Cross'' shall mean the process for
executing orders at a predetermined reference price at a randomly
selected point in time during a five-second trading window beginning
at 10:45 a.m., 12:45 p.m. and 2:45 p.m. Eastern Time during the
regular hours session and at 4:30 p.m. during the after hours
session.
    (2) ``Nasdaq Reference Price Cross eligible securities'' shall
mean Nasdaq-listed securities and securities listed on the New York
Stock Exchange, the American Stock Exchange or a regional exchange.
    (3) (A) ``Reference Price Cross Order'' or ``RPC'' shall mean a
market or limit order to buy or sell in Nasdaq Reference Price
eligible securities that may be executed only during a Nasdaq
Reference Price Cross. RPC orders shall not be displayed and must be
designated with a time-in-force value to participate either:
    (i) in the next scheduled regular hours cross with unexecuted
shares being immediately canceled back to the market participant
after that cross (NXT);
    (ii) in all remaining crosses during the trading day with
unexecuted shares being immediately canceled back to the market
participant after the final regular hours cross (REG); or
    (iii) in all remaining crosses in the current day with
unexecuted shares immediately canceled back to the market
participant after the after hours cross (ALX).
    (B) Starting at 7:30 a.m. Eastern Time until the time of the
last after hours session Reference Price Cross, participants may
enter, cancel or correct RPC orders, but such orders shall not be
available for execution until the next eligible Reference Price
Cross. RPC orders must be entered in round lots with a minimum size
of one round lot and may designate a minimum acceptable execution
quantity. All RPC orders must be available for automatic execution.
    (b) Processing of Nasdaq Reference Price Cross.
    (1) Each Nasdaq Reference Price Cross shall occur during the
regular hours session or the after hours session window commencing
at such times as may be designated by Nasdaq upon prior notice to
market participants.
    (2) Nasdaq Reference Price Crosses that occur during the regular
hours session shall be executed at the midpoint of the national best
bid and offer, trade reported without identifying the contra party,
and disseminated via the consolidated tape.
    (3) Nasdaq Reference Price Crosses that occur during the after
hours session shall execute at the Nasdaq Official Closing Price for
Nasdaq-listed securities or at the official closing price of the
primary market for securities listed on the New York Stock Exchange,
the American Stock Exchange or a regional exchange, shall be trade
reported without identifying the contra party, and disseminated via
the consolidated tape.
    (4) RPC orders will be allocated on a pro-rata basis, such that
shares will be allocated pro-rata in round lots to eligible orders
based on the original size of the order. If additional shares remain
after the initial pro-rata allocation, those shares will continue to
be allocated pro-rata to eligible orders until a number of round
lots remain that is less than the number of eligible orders. Any
remaining shares will be allocated to the order which has designated
the smallest minimum acceptable execution quantity. If more than one
such order exists, any remaining shares will be allocated to the
oldest eligible order. If the allocation to an eligible order would
be less than the minimum acceptable execution quantity for that
order, the order shall not be eligible for execution in that cross.
    (5) If the reference price described in subparagraph (3) above
is outside the benchmarks established by Nasdaq by a threshold
amount at the time an after hours cross is scheduled to occur, the
Nasdaq Reference Price Cross shall not occur for that security.
Nasdaq management shall set and modify such benchmarks and
thresholds from time to time upon prior notice to market
participants.

    (6) If the national best bid and offer is crossed at the time of
a Reference Price Cross during the regular hours session, the cross
shall be delayed for up to five minutes beyond the time the
Reference Price Cross was scheduled to occur and shall execute at
the midpoint of the national best bid and offer when the quote
becomes uncrossed. In the event the quote remains crossed beyond
five minutes after the time of the scheduled Reference Price Cross,
the cross will not occur and unexecuted NXT orders shall be returned
to market participants.
    (7) If the national best bid and offer is locked at the time of
a Reference Price Cross during the regular hours session, the cross
shall execute at the lock price.
    (8) If trading in a security is halted for regulatory or other
reasons at the time a cross is scheduled to occur, the cross will
not occur and all unexecuted NXT orders shall be returned to market
participants.]
* * * * *
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.nasdaq.com, on the Commission's Web site at
http://www.sec.gov, at the Exchange, and at the Commission's Public
Reference Room. A copy of this filing is available on the Exchange's
Web site at http://www.nasdaq.com, at the Exchange's principal office
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, NASDAQ included statements
concerning the purpose of, and basis for, the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below, and is set forth in Sections A, B, and C below.

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

1. Purpose
    NASDAQ is proposing to eliminate Rule 4770 in its entirety. Rule
4770 sets forth the rules applicable to the Nasdaq Crossing Network.
The Commission approved the Nasdaq Crossing Network on July 5, 2006.\3\
The Nasdaq Crossing Network provides an execution option to market
participants trading in NASDAQ and other exchange-listed securities
that facilitates the execution of trades quickly and anonymously. The
Nasdaq Crossing Network executes the Nasdaq Reference Price Cross, an
automated and random matching mechanism, at certain pre-determined
points during the day. All eligible orders for the Nasdaq Reference
Price Crosses are executed in accordance with a predetermined algorithm
at the NBBO midpoint on a pro-rata basis and at the NOCP or Primary
Market Close, as applicable, for post-close cross executions. The
likelihood that a participant will be able to execute all or some of
its orders in the Nasdaq Reference Price Cross is directly related to
the number of participants acting as counterparties in the cross at any
one time. NASDAQ notes that there is light participation in the Nasdaq
Reference Price Cross, and is therefore proposing to cease offering the
cross and to remove Rule 4770 from NASDAQ's rules. NASDAQ is also
eliminating reference to Rule 4770 from Rule 4751(f)(13).
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 54248 (July 31, 2006),
71 FR 44738 (August 7, 2006) (SR-NASDAQ-2006-019). Prior to the
effective date of NASDAQ's operation as an exchange for NASDAQ-
listed securities, the rule governing the Nasdaq Crossing Network
had been approved as an NASD rule (NASD Rule 4716). Securities
Exchange Act Release No. 54101 (July 5, 2006), 71 FR 39382 (July 12,
2006) (SR-NASD-2005-140).
---------------------------------------------------------------------------

2. Statutory Basis
    NASDAQ believes the proposed rule change is consistent with the
provisions of Section 6 of the Act,\4\ in general and with Section
6(b)(5) of the Act,\5\ in particular, which requires that the rules of
an exchange be designed to prevent fraudulent and manipulative acts and
practices, promote just and equitable principles of trade, foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, protect investors and the public interest. The
proposed rule change is consistent with these requirements in that
NASDAQ has determined that it will eliminate an automated crossing
mechanism based on low usage and lack of customer demand, which negate
its usefulness in facilitating transactions in securities.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f.
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    NASDAQ does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received.

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

    The proposed rule change is effective upon filing pursuant to
Section 19(b)(3)(A) of the Act and paragraph (f)(6) of Rule 19b-4
thereunder, in that the proposed rule change: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) does not become operative for 30 days after the date of the
filing, or such shorter time as the Commission may designate if
consistent with the protection of investors and the public interest;
provided the self-regulatory organization has given the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission.
    NASDAQ believes that the proposed rule change will eliminate a
little-used crossing process from NASDAQ's rules, which, because of the
low number of participants, does not benefit the price-discovery
process and overall market confidence in any material manner. NASDAQ
will remove Rule 4770 from its rules effective September 13, 2010.
    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 e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NASDAQ-2010-101 on the subject line.

Paper Comments

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

All submissions should refer to File No. SR-NASDAQ-2010-101. 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 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
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of NASDAQ. 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 No. SR-NASDAQ-2010-101 and should be
submitted on or before September 13, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-20818 Filed 8-20-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register: April 6, 2010 (Volume 75, Number 65)]
[Notices]
[Page 17406]
[DOCID:fr06ap10-51]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AC10-62-000]

Hawthorn Oil Transportation; Notice of Filing

March 31, 2010.
    Take notice that on February 12, 2010, Hawthorn Oil Transportation
submitted a request for the waiver of the requirement to file the 2009
FERC Form No. 6 Annual Report from December 15, 2009 through December
31, 2009.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 or 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: April 13, 2010.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2010-7706 Filed 4-5-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Rules and Regulations]
[Page 15961]
[FR Doc No: 2012-6553]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

[Docket No. FDA-2011-N-0003]

Oral Dosage Form New Animal Drugs; Phenylpropanolamine

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an original new animal drug
application (NADA) filed by Pegasus Laboratories, Inc. The NADA
provides for the veterinary prescription use of phenylpropanolamine
hydrochloride chewable tablets for the control of urinary incontinence
due to urethral sphincter hypotonus in dogs.

DATES: This rule is effective March 19, 2012.

FOR FURTHER INFORMATION CONTACT: Lisa M. Troutman, Center for
Veterinary Medicine (HFV-116), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pegasus Laboratories, Inc., 8809 Ely Rd.,
Pensacola, FL 32514, filed NADA 141-324 that provides for the
veterinary prescription use of PROIN (phenylpropanolamine
hydrochloride) Chewable Tablets for the control of urinary incontinence
due to urethral sphincter hypotonus in dogs. The NADA is approved as of
August 4, 2011, and the regulations are amended in 21 CFR part 520 to
reflect the approval.
    A summary of safety and effectiveness data and information
submitted to support approval of this application may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 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.
    Under section 512(c)(2)(F)(i) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(i)), this approval qualifies for
5 years of marketing exclusivity beginning on the date of approval.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Add Sec.  520.1760 to read as follows:

Sec.  520.1760  Phenylpropanolamine.

    (a) Specifications. Each chewable tablet contains 25, 50, or 75
milligram (mg) phenylpropanolamine hydrochloride.
    (b) Sponsors. See No. 055246 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use in dogs--(1) Amount. Administer 2 mg/kg of
body weight twice daily.
    (2) Indications for use. For the control of urinary incontinence
due to urethral sphincter hypotonus in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

    Dated: March 14, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-6553 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P