[Federal Register Volume 82, Number 59 (Wednesday, March 29, 2017)]
[Rules and Regulations]
[Pages 15457-15458]
[FR Doc No: 2017-06117]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2016-0986; Airspace Docket No. 15-AEA-7]

Amendment of Air Traffic Service (ATS) Routes; Eastern United
States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; delay of effective date.

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SUMMARY: This action changes the effective date of a final rule
published in the Federal Register on February 27, 2017, amending area
navigation (RNAV) routes Q-39 and Q-67 in the eastern United States.
The FAA is delaying the effective date to coincide with the expected
completion of associated enroute and terminal procedures.

DATES: The effective date of the final rule published on February 27,
2017 (82 FR 11804) is delayed from April 27, 2017 to October 12, 2017.
The Director of the Federal Register approved this incorporation by
reference action under Title 1, Code of Federal Regulations, part 51,
subject to the annual revision of FAA Order 7400.11 and publication of
conforming amendments.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy Group,
Office of Airspace Services, Federal Aviation Administration, 800
Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Background

    The FAA published a final rule amending area navigation (RNAV)
routes Q-39 and Q-67 in the eastern United States (82 FR 11804,
February 27, 2017), Docket No. FAA-2016-0986. The effective date for
that final rule is April 27, 2017. The FAA expects to complete
associated enroute and terminal procedures for these routes by for
October 12, 2017; therefore the rule

amending Q-39 and Q-67 is delayed to coincide with that date.
    Area navigation routes are published in paragraph 2006 of FAA Order
7400.11A dated August 3, 2016, and effective September 15, 2016, which
is incorporated by reference in 14 CFR 71.1. The area navigation routes
listed in this document will be subsequently published in the Order.

Good Cause for No Notice and Comment

    Section 553(b)(3)(B) of Title 5, United States Code, (the
Administrative Procedure Act) authorizes agencies to dispense with
notice and comment procedures for rules when the agency for ``good
cause'' finds that those procedures are ``impracticable, unnecessary,
or contrary to the public interest.'' Under this section, an agency,
upon finding good cause, may issue a final rule without seeking comment
prior to the rulemaking. The FAA finds that prior notice and public
comment to this final rule is unnecessary due to the brief length of
the extension of the effective date and the fact that there is no
substantive change to the rule.

Delay of Effective Date

    Accordingly, pursuant to the authority delegated to me, the
effective date of the final rule, Airspace Docket 15-AEA-7, as
published in the Federal Register on February 27, 2017 (82 FR 11804),
FR. Doc. 2017-03507, is hereby delayed until October 12, 2017.

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., P. 389.

    Issued in Washington, DC, on March 22, 2017.
M. Randy Willis,
Acting Manager, Airspace Policy Group.
[FR Doc. 2017-06117 Filed 3-28-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Page 62551]
[FR Doc No: 2019-24843]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4455-DR; Docket ID FEMA-2019-0001]

West Virginia; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for Commonwealth of West Virginia (FEMA-4455-DR), dated August 2, 2019,
and related determinations.

DATES: This change occurred on October 24, 2019.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Michael Senycz,
of FEMA is appointed to act as the Federal Coordinating Officer for
this disaster.
    This action terminates the appointment of Jason Burroughs as
Federal Coordinating Officer for this disaster.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2019-24843 Filed 11-14-19; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 77, Number 14 (Monday, January 23, 2012)]
[Notices]
[Pages 3307-3308]
[FR Doc No: 2012-1176]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66170; File No. SR-ISE-2012-02]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Fees and Rebates for Adding and Removing Liquidity

January 17, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on January 3, 2012, the International Securities Exchange, LLC
(the ``Exchange'' or the ``ISE'') filed with the Securities and
Exchange Commission (the ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the Exchange. 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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The ISE is proposing to amend its transaction fees and rebates for
adding and removing liquidity. The text of the proposed rule change is
available on the Exchange's Web site (http://www.ise.com), at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item IV below. The self-regulatory organization
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 currently assesses per contract transaction fees and
rebates to market participants that add or remove liquidity from the
Exchange (``maker/taker fees'') in 103 options classes (the ``Select
Symbols'').\3\ The purpose of this proposed rule change is to amend the
list of Select Symbols on the Exchange's Schedule of Fees, titled
``Rebates and Fees for Adding and Removing Liquidity in Select Symbols
and Complex Order Maker/Taker fees for symbols that are in the Penny
Pilot Program'' in order to attract additional order flow to the
Exchange. The Exchange is proposing to delete Market Vectors
Semiconductor ETF (``SMH'') from the list of Select Symbols. With this
proposed rule change, SMH will no longer be subject to the Exchange's
maker/taker fees.
---------------------------------------------------------------------------

    \3\ Options classes subject to maker/taker fees are identified
by their ticker symbol on the Exchange's Schedule of Fees.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \4\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \5\ in particular,

in that it is an equitable allocation of reasonable fees and other
charges among Exchange members and other persons using its facilities.
---------------------------------------------------------------------------

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

    The Exchange believes that it is reasonable to remove SMH from its
list of Select Symbols to attract additional order flow to the
Exchange. The Exchange believes that applying non-maker/taker fees to
SMH, including the opportunity to receive payment for order flow, will
attract order flow in SMH to the Exchange.
    The Exchange believes that it is equitable and not unfairly
discriminatory to amend its list of Select Symbols to remove SMH
because the list of Select Symbols would apply uniformly to all
categories of participants in the same manner. All market participants
who trade the Select Symbols would be subject to the maker/taker fees
and rebates, which would not include SMH. Also, all market participants
would be uniformly subject to the non-maker/taker fees, which would
include SMH.

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

    The proposed rule change does not 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

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\6\ At any time within 60 days of the filing
of such proposed rule change, the Commission summarily may temporarily
suspend such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in furtherance of the purposes of
the Act. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
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    \6\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2012-02 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 Number SR-ISE-2012-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2012-02 and should be
submitted on or before February 13, 2012.
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    \7\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-1176 Filed 1-20-12; 8:45 am]
BILLING CODE 8011-01-P


To:                                    ...........
                                                              ------------------------------------------------------------------------------
    Other....................................................  ...........  ...........  ...........         2016            7           10  ...........
                                                              ------------------------------------------------------------------------------
    Annualized...............................................  ...........  ...........  ...........         2016            3           10  ...........
                                                              ------------------------------------------------------------------------------
    Monetized $millions/year.................................  From:
                                                               To:                                    ...........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.............................................................................................................
    Small Business: None................................................................................................................................
    Wages: None.........................................................................................................................................
    Growth: None........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Table 2 presents a summary of the Executive Order 13771 impacts of
the final rule over an infinite time horizon.

                                                            Table 2--E.O. 13771 Summary Table
                                               [In $ millions 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           101.7             7.9           311.6           232.0            13.0           721.7
Present Value of Cost Savings...........................             0.0             0.0             0.0             0.0             0.0             0.0
Present Value of Net Costs..............................           101.7             7.9           311.6           232.0            13.0           721.7
Annualized Costs........................................             7.1             0.6            21.8             7.0             0.4            21.7
Annualized Cost Savings.................................             0.0             0.0             0.0             0.0             0.0             0.0
Annualized Net Costs....................................             7.1             0.6            21.8             7.0             0.4            21.7
--------------------------------------------------------------------------------------------------------------------------------------------------------

VIII. Paperwork Reduction Act of 1995

    This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
title, description, and respondent description of the information
collection provisions are shown in the following paragraphs with an
estimate of the annual reporting and recordkeeping burden. Included in
the estimate is the time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and completing
and reviewing each collection of information.
    Title: Human Subject Protection; Data Requirements for Medical
Device Related Clinical Investigations (OMB control number 0910-0741)
    Description: In this document is a discussion of the regulatory
provisions we believe are subject to the PRA and the probable
information collection burden associated with these provisions.
    Description of Respondents: The reporting and recordkeeping
requirements referenced in this document are imposed on a medical
device sponsor or applicant.

Section 807.87--Information Required in a Premarket Notification
Submission (OMB Control Number 0910-0120)

    Section 807.87 is being amended to address requirements for 510(k)
submissions supported by clinical data. For clinical investigations
conducted in the United States, submitters will be required to submit a
statement as described in Sec.  807.87(j)(1). For clinical
investigations conducted outside the United States, submitters will be

required to submit the information as described in Sec.  807.87(j)(2).

Section 812.27--Report of Prior Investigations (OMB Control Number
0910-0078)

    Section 812.27 is being amended to address requirements for IDE
applications supported by clinical data. For clinical investigations
conducted in the United States, sponsors will be required to submit a
statement as described in Sec.  812.27(b)(4)(i). For clinical
investigations conducted outside the United States, sponsors will be
required to submit the information as described in Sec.
812.27(b)(4)(ii).

Section 812.28--Acceptance of Data From Clinical Investigations
Conducted Outside the United States (OMB Control Number 0910-0078)

    Section 812.28 is being added to address the requirements for
acceptance of foreign clinical data to support an IDE or a device
marketing application or submission. The sponsor or applicant will be
required to submit a statement as described in Sec.  812.28(a)(1);
provide a description of the actions the sponsor or applicant took to
ensure that the research conformed to GCP that includes the information
in Sec.  812.28(b)(1) through (12) or a cross-reference to another
section of the application or submission where the information is
located; submit requests for waivers as described in Sec.  812.28(c);
and retain the records as described in Sec.  812.28(d).

Section 812.140--Records Retention (OMB Control Number 0910-0078)

    Section 812.140 is being amended to address record retention
requirements for investigators and sponsors. An investigator or sponsor
will be required to maintain records as described in Sec.  812.140(d).

Section 814.20--Application (OMB Control Number 0910-0231)

    Section 814.20 is being amended to address requirements for a PMA
application supported by data from clinical investigations conducted
outside the United States. The applicant will be required to submit the
information as described in Sec.  814.20(b)(6)(ii)(C).

Section 814.104--Original Applications (OMB Control Number 0910-0332)

    Section 814.104 is being amended to address submission of data from
clinical investigations in an HDE application. To the extent the
applicant includes data from clinical investigations, the applicant
will be required to include the information and statements as described
in Sec.  814.104(b)(4)(i).

                                                     Table 3--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                    Number of
            21 CFR section/activity                 Number of     responses per   Total annual         Average burden per response          Total hours
                                                   respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.87(j)--Human subject protection statement             1,500               1           1,500  .25 (15 minutes).......................             375
 and information in a premarket notification
 submission supported by clinical data.
812.27(b)(4)(i)--Report of prior                            400               1             400  1......................................             400
 investigations; U.S.
812.27(b)(4)(ii)--Report of prior                           100               1             100  .25 (15 minutes).......................              25
 investigations; outside the U.S.
812.28(a)(1)--Data from clinical investigations           1,500               1           1,500  .25 (15 minutes).......................             375
 \2\.
812.28(b)--Description regarding GCP \2\.......           1,500               1           1,500  10.....................................          15,000
812.28(c)--Waivers \2\.........................              10               1              10  1......................................              10
814.20--Application information................              10               1              10  .50 (30 minutes).......................               5
814.104--Original applications statements and                10               1              10  8......................................              80
 information.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  .......................................          16,270
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ No precise data is available for requests for De Novo classifications.

                               Table 4--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     21 CFR section/activity         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
812.28(d)--Records from clinical           1,500               1           1,500               1           1,500
 investigations conducted
 outside the United States \2\..
812.140--Retention period.......              10               1              10               1              10
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,510
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ No precise data is available for requests for De Novo classifications.

    The total estimated burden imposed by these information collection
requirements is 17,780 annual hours. The estimated burden is based on
the most recent empirical data in the relevant collections with the
numbers updated to reflect the current burden of these requirements.
    It should be noted that while the information collection
requirements referenced in this document are revisions to current
approved information collections, these collection requirements are
being submitted to OMB as a new information collection (OMB control
number 0910-0741), with the expectation the currently approved
requirements will be amended. As such the following collections of
information will be amended and submitted to OMB for approval as
revisions to currently approved information collections once the rule
is finalized and the collections are due for renewal. The collections
to

be amended include: Investigational Device Exemptions Reports and
Records--21 CFR part 812, OMB control number 0910-0078; Premarket
Notification--21 CFR part 807, subpart E, OMB control number 0910-0120;
Premarket Approval of Medical Devices--21 CFR part 814, subparts A
through E, OMB control number 0910-0231; and Medical Devices:
Humanitarian Use Devices--21 CFR part 814, subpart H, OMB control
number 0910-0332.
    The information collection provisions in this final rule have been
submitted to OMB for review as required by section 3507(d) of the PRA.
    Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. 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 OMB control number.

IX. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

X. Reference

    The following reference is on display in the Dockets Management
Staff (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; it is also
available electronically at https://www.regulations.gov.

1. Regulatory Impact Analysis of the Final Rule to Human Subject
Protection; Acceptance of Data from Clinical Investigations for
Medical Devices, Docket No. FDA-2013-N-0080.

List of Subjects

21 CFR Part 807

    Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
807, 812, and 814 are amended as follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
1. The authority citation for part 807 is revised to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 360bbb-8b, 371, 374, 381, 393; 42 U.S.C. 264, 271.

0
2. Section 807.87 is amended by redesignating paragraphs (j), (k), and
(l) as paragraphs (k), (l), and (m), respectively, and by adding new
paragraph (j) to read as follows:

Sec.  807.87   Information required in a premarket notification
submission.

* * * * *
    (j) For a submission supported by clinical data:
    (1) If the data are from clinical investigations conducted in the
United States, a statement that each investigation was conducted in
compliance with applicable requirements in the protection of human
subjects regulations in part 50 of this chapter, the institutional
review boards regulations in part 56 of this chapter, or was not
subject to the regulations under Sec.  56.104 or Sec.  56.105, and the
investigational device exemptions regulations in part 812 of this
chapter, or if the investigation was not conducted in compliance with
those regulations, a brief statement of the reason for the
noncompliance.
    (2) If the data are from clinical investigations conducted outside
the United States, the requirements under Sec.  812.28 of this chapter
apply. If any such investigation was not conducted in accordance with
good clinical practice (GCP) as described in Sec.  812.28(a) of this
chapter, include either a waiver request in accordance with Sec.
812.28(c) of the chapter or a brief statement of the reason for not
conducting the investigation in accordance with GCP and a description
of steps taken to ensure that the data and results are credible and
accurate and that the rights, safety, and well-being of subjects have
been adequately protected.
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
3. The authority citation for part 812 is revised to read as follows:

    Authority:  21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 360bbb-8b, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C.
216, 241, 262, 263b-263n.

0
4. Section 812.3 is amended by adding paragraph (t) to read as follows:

Sec.  812.3   Definitions.

* * * * *
    (t) Independent ethics committee (IEC) means an independent review
panel that is responsible for ensuring the protection of the rights,
safety, and well-being of subjects involved in a clinical investigation
and is adequately constituted to ensure that protection. An
institutional review board (IRB), as defined in paragraph (f) of this
section and subject to the requirements of part 56 of this chapter, is
one type of IEC.

0
5. Section 812.27 is amended by adding paragraph (b)(4) to read as
follows:

Sec.  812.27   Report of prior investigations.

* * * * *
    (b) * * *
    (4)(i) If data from clinical investigations conducted in the United
States are provided, a statement that each investigation was conducted
in compliance with applicable requirements in the protection of human
subjects regulations in part 50 of this chapter, the institutional
review boards regulations in part 56 of this chapter, or was not
subject to the regulations under Sec.  56.104 or Sec.  56.105, and the
investigational device exemptions regulations in this part, or if any
such investigation was not conducted in compliance with those
regulations, a brief statement of the reason for the noncompliance.
Failure or inability to comply with these requirements does not justify
failure to provide information on a relevant clinical investigation.
    (ii) If data from clinical investigations conducted outside the
United States are provided to support the IDE, the requirements under
Sec.  812.28 apply. If any such investigation was not conducted in
accordance with good clinical practice (GCP) as described in Sec.
812.28(a), the report of prior investigations shall include either a
waiver request in accordance with Sec.  812.28(c) or a brief statement
of the

reason for not conducting the investigation in accordance with GCP and
a description of steps taken to ensure that the data and results are
credible and accurate and that the rights, safety, and well-being of
subjects have been adequately protected. Failure or inability to comply
with these requirements does not justify failure to provide information
on a relevant clinical investigation.

0
6. Section 812.28 is added to subpart B to read as follows:

Sec.  812.28   Acceptance of data from clinical investigations
conducted outside the United States.

    (a) Acceptance of data from clinical investigations conducted
outside the United States to support an IDE or a device marketing
application or submission (an application under section 515 or 520(m)
of the Federal Food, Drug, and Cosmetic Act, a premarket notification
submission under section 510(k) of the Federal Food, Drug, and Cosmetic
Act, or a request for De Novo classification under section 513(f)(2) of
the Federal Food, Drug, and Cosmetic Act). FDA will accept information
on a clinical investigation conducted outside the United States to
support an IDE or a device marketing application or submission if the
investigation is well-designed and well-conducted and the following
conditions are met:
    (1) A statement is provided that the investigation was conducted in
accordance with good clinical practice (GCP). For the purposes of this
section, GCP is defined as a standard for the design, conduct,
performance, monitoring, auditing, recording, analysis, and reporting
of clinical investigations in a way that provides assurance that the
data and results are credible and accurate and that the rights, safety,
and well-being of subjects are protected. GCP includes review and
approval (or provision of a favorable opinion) by an independent ethics
committee (IEC) before initiating an investigation, continuing review
of an ongoing investigation by an IEC, and obtaining and documenting
the freely given informed consent of the subject (or a subject's
legally authorized representative, if the subject is unable to provide
informed consent) before initiating an investigation. GCP does not
require informed consent in life-threatening situations when the IEC
reviewing the investigation finds, before initiation of the
investigation, that informed consent is not feasible and either that
the conditions present are consistent with those described in Sec.
50.23 or Sec.  50.24(a) of this chapter, or that the measures described
in the protocol or elsewhere will protect the rights, safety, and well-
being of subjects.
    (2) In addition to the information required elsewhere in parts 807,
812, and 814 of this chapter, as applicable, the information in
paragraph (b) of this section is submitted, as follows:
    (i) For an investigation of a significant risk device, as defined
in Sec.  812.3(m), the supporting information as described in paragraph
(b) of this section is submitted.
    (ii) For an investigation of a device, other than a significant
risk device, the supporting information as described in paragraphs
(b)(1), (4), (5), (7) through (9), and (11) of this section is
submitted, and the supporting information as described in paragraph
(b)(10) of this section and the rationale for determining the
investigation is of a device other than a significant risk device are
made available for agency review upon request by FDA.
    (iii) For a device investigation that meets the exemption criteria
in Sec.  812.2(c), the supporting information as described in
paragraphs (b)(1), (4), (5), (7) through (11) of this section and the
rationale for determining the investigation meets the exemption
criteria in Sec.  812.2(c) are made available for agency review upon
request by FDA.
    (3) FDA is able to validate the data from the investigation through
an onsite inspection, or through other appropriate means, if the agency
deems it necessary.
    (b) Supporting information. A sponsor or applicant who submits data
from a clinical investigation conducted outside the United States to
support an IDE or a device marketing application or submission, in
addition to information required elsewhere in parts 807, 812, and 814
of this chapter, as applicable, shall provide a description of the
actions the sponsor or applicant took to ensure that the research
conformed to GCP as described in paragraph (a)(1) of this section. The
description is not required to duplicate information already submitted
in the application or submission. Instead, the description must provide
either the following information, as specified in paragraph (a)(2) of
this section, or a cross-reference to another section of the
application or submission where the information is located:
    (1) The names of the investigators and the names and addresses of
the research facilities and sites where records relating to the
investigation are maintained;
    (2) The investigator's qualifications;
    (3) A description of the research facility(ies);
    (4) A detailed summary of the protocol and results of the
investigation and, should FDA request, case records maintained by the
investigator or additional background data such as hospital or other
institutional records;
    (5) Either a statement that the device used in the investigation
conducted outside the United States is identical to the device that is
the subject of the submission or application, or a detailed description
of the device and each important component (including all materials and
specifications), ingredient, property, and principle of operation of
the device used in the investigation conducted outside the United
States and a comparison to the device that is the subject of the
submission or application that indicates how the device used in the
investigation is similar to and/or different from the device that is
the subject of the submission or application;
    (6) If the investigation is intended to support the safety and
effectiveness of a device, a discussion demonstrating that the data and
information constitute valid scientific evidence within the meaning of
Sec.  860.7 of this chapter;
    (7) The name and address of the IEC that reviewed the investigation
and a statement that the IEC meets the definition in Sec.  812.3(t).
The sponsor or applicant must maintain records supporting such
statement, including records describing the qualifications of IEC
members, and make these records available for agency review upon
request;
    (8) A summary of the IEC's decision to approve or modify and
approve the investigation, or to provide a favorable opinion;
    (9) A description of how informed consent was obtained;
    (10) A description of what incentives, if any, were provided to
subjects to participate in the investigation;
    (11) A description of how the sponsor(s) monitored the
investigation and ensured that the investigation was carried out
consistently with the protocol; and
    (12) A description of how investigators were trained to comply with
GCP (as described in paragraph (a)(1) of this section) and to conduct
the investigation in accordance with the protocol, and a statement on
whether written commitments by investigators to comply with GCP and the
protocol were obtained. Any signed written commitments by investigators
must be maintained by the sponsor or applicant and made available for
agency review upon request.
    (c) Waivers. (1) A sponsor or applicant may ask FDA to waive any
applicable

requirements under paragraphs (a)(1) and (b) of this section. A waiver
request may be submitted in an IDE or in an amendment or supplement to
an IDE, in a device marketing application or submission (an application
under section 515 or 520(m) of the Federal Food, Drug, and Cosmetic
Act, a premarket notification submission under section 510(k) of the
Federal Food, Drug, and Cosmetic Act, or a request for De Novo
classification under section 513(f)(2) of the Federal Food, Drug, and
Cosmetic Act) or in an amendment or supplement to a device marketing
application or submission, or in a pre-submission. A waiver request is
required to contain at least one of the following:
    (i) An explanation why the sponsor's or applicant's compliance with
the requirement is unnecessary or cannot be achieved;
    (ii) A description of an alternative submission or course of action
that satisfies the purpose of the requirement; or
    (iii) Other information justifying a waiver.
    (2) FDA may grant a waiver if it finds that doing so would be in
the interest of the public health.
    (d) Records. A sponsor or applicant must retain the records
required by this section for a clinical investigation conducted outside
the United States as follows:
    (1) If the investigation is submitted in support of an IDE, for 2
years after the termination or completion of the IDE; and
    (2) If the investigation is submitted in support of a premarket
approval application, a notice of completion of a product development
protocol, a humanitarian device exemption application, a premarket
notification submission, or a request for De Novo classification, for 2
years after an agency decision on that submission or application.
    (e) Clinical investigations conducted outside of the United States
that do not meet conditions. For clinical investigations conducted
outside the United States that do not meet the conditions under
paragraph (a) of this section, FDA may accept the information from such
clinical investigations to support an IDE or a device marketing
application or submission if FDA believes that the data and results
from such clinical investigation are credible and accurate and that the
rights, safety, and well-being of subjects have been adequately
protected.

0
7. Section 812.140 is amended by revising paragraph (d) to read as
follows:

Sec.  812.140   Records.

* * * * *
    (d) Retention period. An investigator or sponsor shall maintain the
records required by this subpart during the investigation and for a
period of 2 years after the latter of the following two dates: The date
on which the investigation is terminated or completed, or the date that
the records are no longer required for purposes of supporting a
premarket approval application, a notice of completion of a product
development protocol, a humanitarian device exemption application, a
premarket notification submission, or a request for De Novo
classification.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
8. The authority citation for part 814 is revised to read as follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b,
371, 372, 373, 374, 375, 379, 379e, 381.

0
9. Section 814.15 is amended by revising paragraph (a); by removing
paragraphs (b) and (c); by redesignating paragraphs (d) and (e) as
paragraphs (b) and (c), respectively; and by removing the parenthetical
sentence at the end of the section to read as follows:

Sec.  814.15   Research conducted outside the United States.

    (a) Data to support PMA. If data from clinical investigations
conducted outside the United States are submitted to support a PMA, the
applicant shall comply with the provisions in Sec.  812.28 of this
chapter, as applicable.
* * * * *

0
10. Section 814.20 is amended by revising paragraphs (b)(6)(ii)(A) and
(B) and adding paragraph (b)(6)(ii)(C) to read as follows:

Sec.  814.20   Application.

* * * * *
    (b) * * *
    (6) * * *
    (ii) * * *
    (A) For clinical investigations conducted in the United States, a
statement with respect to each investigation that it either was
conducted in compliance with the institutional review board regulations
in part 56 of this chapter, or was not subject to the regulations under
Sec.  56.104 or Sec.  56.105, and that it was conducted in compliance
with the informed consent regulations in part 50 of this chapter; or if
the investigation was not conducted in compliance with those
regulations, a brief statement of the reason for the noncompliance.
Failure or inability to comply with these requirements does not justify
failure to provide information on a relevant clinical investigation.
    (B) For clinical investigations conducted in the United States, a
statement that each investigation was conducted in compliance with part
812 of this chapter concerning sponsors of clinical investigations and
clinical investigators, or if the investigation was not conducted in
compliance with those regulations, a brief statement of the reason for
the noncompliance. Failure or inability to comply with these
requirements does not justify failure to provide information on a
relevant clinical investigation.
    (C) For clinical investigations conducted outside the United States
that are intended to support the PMA, the requirements under Sec.
812.28 of this chapter apply. If any such investigation was not
conducted in accordance with good clinical practice (GCP) as described
in Sec.  812.28(a), include either a waiver request in accordance with
Sec.  812.28(c) or a brief statement of the reason for not conducting
the investigation in accordance with GCP and a description of steps
taken to ensure that the data and results are credible and accurate and
that the rights, safety, and well-being of subjects have been
adequately protected. Failure or inability to comply with these
requirements does not justify failure to provide information on a
relevant clinical investigation.
* * * * *

0
11. Section 814.45 is amended by revising paragraph (a)(5) to read as
follows:

Sec.  814.45   Denial of approval of a PMA.

    (a) * * *
    (5) Any clinical investigation involving human subjects described
in the PMA, subject to the institutional review board regulations in
part 56 of this chapter or informed consent regulations in part 50 of
this chapter or GCP referenced in Sec.  814.15(a) and described in
Sec.  812.28(a) of this chapter, was not conducted in compliance with
those regulations such that the rights or safety of human subjects were
not adequately protected or the supporting data were determined to be
otherwise unreliable.
* * * * *

0
12. Section 814.46 is amended by revising paragraph (a)(4) to read as
follows:

Sec.  814.46   Withdrawal of approval of a PMA.

    (a) * * *
    (4) Any clinical investigation involving human subjects described
in the PMA, subject to the institutional review board regulations in
part 56 of this chapter or informed consent regulations in part 50 of
this chapter or GCP referenced in Sec.  814.15(a) and described in
Sec.  812.28(a) of this chapter, was not conducted in compliance with
those regulations such that the rights or safety of human subjects were
not adequately protected or the supporting data were determined to be
otherwise unreliable.
* * * * *

0
13. Section 814.104 is amended by revising paragraph (b)(4)(i) to read
as follows:

Sec.  814.104   Original applications.

* * * * *
    (b) * * *
    (4) * * *
    (i) In lieu of the summaries, conclusions, and results from
clinical investigations required under Sec.  814.20(b)(3)(v)(B),
(b)(3)(vi), and the introductory text of (b)(6)(ii), the applicant
shall include the summaries, conclusions, and results of all clinical
experience or investigations (whether adverse or supportive) reasonably
obtainable by the applicant that are relevant to an assessment of the
risks and probable benefits of the device and to the extent the
applicant includes data from clinical investigations, the applicant
shall include the statements described in Sec.  814.20(b)(6)(ii)(A) and
(B) with respect to clinical investigations conducted in the United
States and the information described in Sec.  814.20(b)(6)(ii)(C) with
respect to clinical investigations conducted outside the United States;
and
* * * * *

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03244 Filed 2-20-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 11, 2006 (Volume 71, Number 132)]
[Notices]
[Page 39091-39092]
[DOCID:fr11jy06-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene, Protests, and Comments

July 3, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12698-000.
    c. Date Filed: June 15, 2006.
    d. Applicant: Public Utility District No. 1 of Snohomish County,
Washington.
    e. Name of Project: Guemes Channel Tidal Energy Project.
    f. Location: The project would be located in a section of Guemes
Channel between Guemes Island and Fidalgo Island in San Juan County,
Washington.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Mr. Steven Klein, General Manager, P.O. Box
1107, 2320 California Street, Everett, WA 98206,<PHONE_NUMBER>.
    i. FERC Contact: Chris Yeakel,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of:
(1) 166 Tidal In Stream Energy Conversion (TISEC) devices consisting
of, (2) rotating propeller blades 10 meters in diameter, (3) integrated
generators with a capacity of 66 kW, (4) anchoring systems, (5) mooring
lines, and (6) interconnection transmission lines. The project is
estimated to have an annual generation of 28.5 gigawatt-hours per-year,
which would be distributed by the Snohomish County Public Utility
District.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference

Room, located at 888 First Street, NE., Room 2A, Washington, DC 20426,
or by calling<PHONE_NUMBER>. This filing may also be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, call toll-
free 1-866-208-3676 or e-mail<EMAIL_ADDRESS>For TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item h above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR
4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``COMPETING APPLICATION'' OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-10804 Filed 7-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 105 (Wednesday, June 1, 2022)]
[Rules and Regulations]
[Pages 32975-32978]
[FR Doc No: 2022-11559]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1003; Project Identifier MCAI-2020-00962-A;
Amendment 39-22059; AD 2022-11-09]
RIN 2120-AA64

Airworthiness Directives; Viking Air Limited (Type Certificate
Previously Held by Bombardier Inc. and de Havilland, Inc.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Viking Air Limited (Viking) (type certificate previously held by
Bombardier Inc. and de Havilland, Inc.) Model DHC-6-1, DHC-6-100, DHC-
6-200, DHC-6-300, and DHC-6-400 airplanes. This AD results from
mandatory continuing airworthiness information (MCAI) originated by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI identifies the unsafe
condition as cracks and corrosion damage to the aileron internal
structure. This AD requires visually inspecting the entire aileron
internal structure, correcting any damage found, and reporting the
inspection results to Viking. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective July 6, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 6,
2022.

ADDRESSES: For service information identified in this final rule,
contact Viking Air Ltd., 1959 de Havilland Way, Sidney British
Columbia, Canada V8L 5V5; phone:<PHONE_NUMBER>; email:
[email protected]; website: https://www.vikingair.com. You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901 Locust,
Kansas City, MO 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-1003.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1003; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, the
MCAI, any comments received, and other information. The address for
Docket Operations is U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Deep Gaurav, Aviation Safety Engineer,
New York ACO Branch, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; phone:<PHONE_NUMBER>; email: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Viking Model DHC-6-
1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes. The NPRM
published in the Federal Register on January 21, 2022 (87 FR 3236). The
NPRM was prompted by MCAI from Transport Canada, which is the aviation
authority for Canada. Transport Canada issued AD CF-2020-05, dated
March 13, 2020 (referred to after this as ``the MCAI''), to correct an
unsafe condition on Viking Model DHC-6 series 1, DHC-6 series 100, DHC-
6 series 110, DHC-6 series 200, DHC-6 series 210, DHC-6 series 300,
DHC-6 series 310, DHC-6 series 320, and DHC-6 series 400 airplanes. The
MCAI states:

    Viking Air Ltd. (Viking) received reports of cracks and
corrosion damage to the aileron internal structure. During a repair
of an in-service aeroplane, an aileron hinge support rib was found
cracked at the lower flange along the bend radius near the hinge
fitting attachment at wing station 247.29. Preliminary investigation
by Viking determined that the observed crack was the result of
fatigue. During an inspection of another in-service aeroplane, the
aileron inboard rib and the vertical flange of the inboard aileron
forward spar near a fastener hole were also found cracked.
    The current inspection requirements of the affected aeroplanes
do not include a direct inspection of the aileron internal
structure. Cracks or other damage to the aileron ribs or to the
aileron spar flanges are not detectable from the aileron exterior
surfaces. Undetected cracks or other damage to the aileron internal
structure could lead to progressive looseness of the aileron at the
hinge support rib push-pull rod attachment and subsequent flutter
condition and degraded or loss of aileron control.
    To detect and correct any cracking or other damage to the
aileron internal structure, this [Transport Canada] AD mandates a
one-time Special Detailed Inspection (SDI) of all aileron internal
structure, including front and rear spars, all aileron ribs and
upper and lower skins for cracks, corrosion or other damage, and
rectification, as required, of the damaged parts.
    This [Transport Canada] AD also mandates reporting of all
inspection results to Viking. The reporting of the inspection
results is necessary to assess the overall aileron internal
structural condition on in-service aeroplanes and to determine
additional corrective action based on the results of the
inspections.
    Viking has published Service Bulletin (SB) V6/0066 Revision A,
dated 9 December 2019, (referred to as ``the SB'' in this [Transport
Canada] AD) providing accomplishment instructions for the
inspection, rectification of the damaged parts, and reporting
requirements.

    You may examine the MCAI in the AD docket at https://

www.regulations.gov by searching for and locating Docket No. FAA-2020-
1003.
    In the NPRM, the FAA proposed to require visually inspecting the
entire aileron internal structure, correcting any damage found, and
reporting the inspection results to Viking. The FAA is issuing this AD
to prevent progressive looseness of the aileron at the hinge support
rib push-pull rod attachment, flutter condition, and degraded or loss
of aileron control, which could lead to loss of control of the
airplane.

Ex Parte Contact

    After the comment period closed, the FAA requested additional
information from Transport Canada and Viking about the factory drilled
drain holes in the ailerons. A summary of this discussion can be found
in the rulemaking docket at https://www.regulations.gov in Docket No.
FAA-2020-1003.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from one commenter, Mile-Hi Skydiving
Center (Mile-Hi). The following presents the comment received on the
NPRM and the FAA's response.

Request Regarding Related Service Information

    Mile-Hi requested that Viking revise DHC-6 Twin Otter Service
Bulletin V6/0066, Revision A, dated December 9, 2019 (Viking SB V6/
0066, Revision A), to provide instructions for enlarging the aileron
drain holes. Mile-Hi stated that the existing factory-drilled aileron
drain holes are \3/16\ inch (0.1875 inch) in diameter and are too small
to accommodate the borescope used at its facility, which has a diameter
of \1/4\ inch (0.232 inch). Mile-Hi concluded that the existing aileron
drain holes will need to be enlarged to accommodate any borescope for
the proposed inspection. Mile-Hi also requested follow-on actions such
as reducing the enlarged holes to the original size to prevent ingress
of nesting insects such as wasps or hornets and static balancing the
ailerons. As, in the NPRM, the FAA proposed to require inspecting the
aileron in accordance with steps in Viking SB V6/0066, Revision A, the
FAA infers that Mile-Hi is requesting that the FAA revise the proposed
AD to include these actions.
    The FAA does not agree that this AD needs to mandate enlarging the
aileron drain holes. The FAA contacted Transport Canada and Viking to
obtain information on whether any other Model DHC-6 airplane operators
have had similar issues regarding the diameter of the existing aileron
drain holes. Viking advised that it has received approximately 170
service bulletin reply forms in response to Viking SB V6/0066, Revision
A, and operators have successfully done the borescope inspection with
no difficulty. In addition, Viking confirmed that the 0.1875-inch
diameter aileron drain hole size is standard per the Model DHC-6
airplane type design, and that commercially available borescope heads
fit into the standard-sized holes (as specified in the equipment list
in Section II.A.1 of Viking SB V6/0066, Revision A). Based on this
information, the FAA has determined that the borescope diameter is not
a fleet-wide issue that needs further attention.
    The FAA acknowledges field repairs to replace the aileron skins
could have been completed on some airplanes where, during replacement,
the drain holes were omitted or manufactured undersized. If field
repairs have been done that prevent compliance with the inspection in
this AD, then the operator will need approval of an alternative method
of compliance. The FAA did not change this AD based on this comment.

Conclusion

    These products have been approved by the aviation authority of
another country and are approved for operation in the United States.
Pursuant to the FAA's bilateral agreement with this State of Design
Authority, it has notified the FAA of the unsafe condition described in
the MCAI referenced above. The FAA reviewed the relevant data,
considered the comment received, and determined that air safety
requires adopting the AD as proposed. Accordingly, the FAA is issuing
this AD to address the unsafe condition on these products. This AD is
adopted as proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Viking DHC-6 Twin Otter Service Bulletin V6/0066,
Revision A, dated December 9, 2019. The service information specifies
procedures for visually inspecting the entire aileron internal
structure, including front and rear spars, all aileron ribs, and upper
and lower skins; repairing or replacing any damaged part; and reporting
inspection results to Viking Air Limited technical support. 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.

Other Related Service Information

    The FAA also reviewed Viking DHC-6 Twin Otter Service Bulletin V6/
0066, Revision NC, dated August 29, 2019. The service information
specifies procedures for visually inspecting the aileron ribs,
including ribs and both sides of the hinge arm; repairing or replacing
any damaged part; and reporting inspection results to Viking Air
Limited technical support.

Interim Action

    The FAA considers that this AD is an interim action. The inspection
reports will provide the FAA and Viking additional data for determining
the damage present in the fleet. After analyzing the data, the FAA may
take further rulemaking action.

Differences Between This AD and the MCAI

    The MCAI applies to Viking Air Limited Model DHC-6 series 110, DHC-
6 series 210, DHC-6 series 310, and DHC-6 series 320, and this AD does
not because these models do not have an FAA type certificate. Model
DHC-6 series 1, DHC-6 series 100, DHC-6 series 200, DHC-6 series 300,
and DHC-6 series 400 airplanes specified in the MCAI correspond to FAA
Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400
airplanes, respectively.

Costs of Compliance

    The FAA estimates that this AD affects 33 airplanes of U.S.
registry. The FAA also estimates that it would take about 3 work-hours
per airplane to comply with the inspection and 1 work-hour to comply
with the reporting requirement of this AD. The average labor rate is
$85 per work-hour.
    Based on these figures, the FAA estimates the cost of this AD on
U.S. operators will be $11,220 or $340 per airplane.
    In addition, the FAA estimates that any necessary follow-on actions
to replace an aileron would take 6 work-hours and require parts costing
$52,243, for a cost of $52,753 per airplane. The FAA has no way of
determining the number of airplanes that may need these actions.

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 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 currently 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 take
approximately 1 hour per response, including the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden to: Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

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.
    The FAA is 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

    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) Will not affect intrastate aviation in Alaska, 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.

List of Subjects in 14 CFR Part 39

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

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:

2022-11-09 Viking Air Limited (Type Certificate Previously Held by
Bombardier Inc. and de Havilland, Inc.): Amendment 39-22059; Docket
No. FAA-2020-1003; Project Identifier MCAI-2020-00962-A.

(a) Effective Date

    This airworthiness directive (AD) is effective July 6, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Viking Air Limited (type certificate
previously held by Bombardier Inc. and de Havilland, Inc.) Model
DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes,
all serial numbers, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 5700, Wing
Structure.

(e) Unsafe Condition

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI identifies the unsafe condition as cracks and
corrosion damage to the aileron internal structure. The FAA is
issuing this AD to detect and correct cracks and other damage to the
aileron internal structure. The unsafe condition, if not addressed,
could result in progressive looseness of the aileron at the hinge
support rib push-pull rod attachment, flutter condition, and
degraded or loss of aileron control, which could lead to loss of
control of the airplane.

(f) Compliance

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

(g) Inspection and Replacement of the Aileron

    At the compliance time specified in paragraph (g)(1) or (2) of
this AD, inspect the left-hand (LH) and right-hand (RH) aileron
internal structures for cracks, corrosion, and other damage and take
any necessary corrective actions in accordance with the
Accomplishment Instructions, steps II.A. through II.A.3. of Viking
DHC-6 Twin Otter Service Bulletin V6/0066, Revision A, dated
December 9, 2019 (Viking SB V6/0066, Revision A).
    (1) For each LH or RH aileron that has accumulated 16,000 or
more hours time-in-service (TIS), 32,000 or more flight cycles (FC),
or 10 or more years since first installation on an airplane,
whichever occurs first: Within 6 months after the effective date of
this AD.
    (2) For each LH or RH aileron that has accumulated less than
16,000 hours TIS, less than 32,000 FC, and less than 10 years since
first installation on an airplane: Within 6 months after
accumulating 16,000 hours TIS, 32,000 FC, or 10 years, whichever
occurs first.

(h) Reporting Requirement

    Within 30 days after the inspection required by paragraph (g)(1)
or (2) of this AD or within 30 days after the effective date of this
AD, whichever occurs later, report to Viking the information
requested on the Inspection Reply Form, page 7, of Viking SB V6/
0066, Revision A.

(i) Credit for Previous Actions

    You may take credit for the actions required by paragraphs
(g)(1) and (2) of this AD if you performed those actions before the
effective date of this AD using Viking DHC-6 Twin Otter Service
Bulletin V6/0066, Revision NC, dated August 29, 2019.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, New York ACO Branch, 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
manager of the certification office, send it to the attention of the
person identified in paragraph (k)(1) of this AD.
    (2) 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.

(k) Related Information

    (1) For more information about this AD, contact Deep Gaurav,
Aviation Safety Engineer, New York ACO Branch, FAA, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) Refer to Transport Canada AD CF-2020-05, dated March 13,
2020, for more information. You may examine the Transport Canada AD
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2020-1003.

(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 the AD specifies otherwise.
    (i) Viking DHC-6 Twin Otter Service Bulletin V6/0066, Revision
A, dated December 9, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Viking Air Ltd., 1959 de Havilland Way, Sidney, British Columbia,
Canada V8L 5V5; phone:<PHONE_NUMBER>; email:
[email protected]; website: https://www.vikingair.com.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, MO 64106. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>.
    (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, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on May 17, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-11559 Filed 5-31-22; 8:45 am]
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