[Federal Register Volume 85, Number 185 (Wednesday, September 23, 2020)]
[Notices]
[Pages 59801-59803]
[FR Doc No: 2020-20960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-7012]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Use of Public Human Genetic Variant Databases To
Support Clinical Validity for Genetic and Genomic-Based In Vitro
Diagnostics

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with FDA
recognition of public human genetic variant databases to support
clinical validity for genetic and genomic-based in vitro diagnostics.

DATES: Submit either electronic or written comments on the collection
of information by November 23, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 23, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 23, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2017-N-7012 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Use of Public Human Genetic
Variant Databases to Support Clinical Validity for Genetic and Genomic-
Based In Vitro Diagnostics.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     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 Dockets Management Staff. 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.govinfo.gov/content/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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical

utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Agency Information Collection Activities; Proposed Collection; Comment
Request; Use of Public Human Genetic Variant Databases To Support
Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics

OMB Control Number 0910-0850--Extension

    Section 2011 of the 21st Century Cures Act of 2016 (Pub. L. 114-
255) encourages the FDA to develop new approaches for addressing
regulatory science issues as part of the Precision Medicine Initiative
(PMI).
    In the Federal Register of January 17, 2018 (83 FR 2451), FDA
announced the availability of a guidance for industry entitled ``Use of
Public Human Genetic Variant Databases To Support Clinical Validity for
Next Generation Sequencing-Based In Vitro Diagnostics.'' The guidance
describes one part of FDA's PMI effort to create a flexible and
adaptive regulatory approach to the oversight of next generation
sequencing (NGS)-based tests. The goal of this effort is to help ensure
patients receive accurate and meaningful test results, while promoting
innovation in test development. The guidance describes how publicly
accessible databases of human genetic variants can serve as sources of
valid scientific evidence to support the clinical validity of genotype-
phenotype relationships in FDA's regulatory review of both NGS-based
tests and genetic and genomic tests based on other technologies.
Publicly accessible genetic databases may be useful to support the
clinical validity of NGS tests as well as single gene or panel tests
that use other technology.
    The guidance describes FDA's considerations in determining whether
a genetic variant database is a source of valid scientific evidence
that could support the clinical validity of an NGS-based test. The
guidance further outlines the process by which administrators \1\ of
genetic variant databases could voluntarily apply to FDA for
recognition, and how FDA would review such applications and
periodically reevaluate recognized databases. The guidance also
recommends that, at the time of recognition, the database administrator
make information regarding policies, procedures, and conflicts of
interest publicly available and accessible on the genetic variant
database's website.
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    \1\ FDA acknowledges that many databases may not use the term
``administrator'' or may have a committee of individuals that
oversee the database. Therefore, for the purpose of this guidance, a
genetic variant database administrator is the entity or entities
that oversee database operations.
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    Respondents are administrators of genetic databases. Our estimate
of five respondents per year is based on the current number of
databases that may meet FDA recommendations for recognition and seek
such recognition.
    Based on our experience and the nature of the information, we
estimate that it will take an average of 80 hours to complete and
submit an application for recognition. We estimate that maintenance of
recognition activities will take approximately one-fourth of that time
(20 hours) annually. We estimate that it will take approximately 1 hour
to post the information on the website.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total  hours
                                                                       respondents       respondent       responses       per response
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Application for recognition of genetic database....................               5                1                5               80              400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                Number of                      Average  burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of recognition activities..............................               5                1                5               20              100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                Number of
                              Activity                                  Number of     disclosures per   Total  annual   Average  burden    Total  hours
                                                                       respondents       respondent      disclosures    per  disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public disclosure of policies, procedures, and conflicts of                       5                1                5                1                5
 interest..........................................................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

    Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20960 Filed 9-22-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 76, Number 227 (Friday, November 25, 2011)]
[Notices]
[Pages 72694-72696]
[FR Doc No: 2011-30338]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC12-28-000.
    Applicants: Richland-Stryker Generation LLC, SQ2, LLC,BR-HIYLD
Rich-Stryker, LLC, R3 Capital Partners Master (DE) L.P.
    Description: Application for Authorization Pursuant to Section 203
of the Federal Power Act and Requests for Waivers of Filing
Requirements, Confidential Treatment, and Expedited Review of Richland-
Stryker Generation LLC, et al.
    Filed Date: 11/10/2011.
    Accession Number: 20111110-5173.
    Comment Date: 5 p.m. ET on 12/1/2011.

    Docket Numbers: EC12-31-000.
    Applicants: Chestnut Flats Wind, LLC.
    Description: Application for Authorization for Disposition of
Jurisdictional Facilities and Request for Expedited Action of Chestnut
Flats Wind, LLC.
    Filed Date: 11/15/2011.
    Accession Number: 20111115-5190.
    Comment Date: 5 p.m. ET on 12/6/2011.

    Docket Numbers: EC12-32-000.
    Applicants: Twin Cities Power, LLC, Twin Cities Energy, LLC, TC
Energy Trading, LLC.
    Description: Application of Twin Cities Energy, LLC, et al. for
Authorization under Section 203 of the Federal Power Act and request
for Expedited Consideration.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5155.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG12-12-000.
    Applicants: Kaheawa Wind Power II, LLC.
    Description: Self-Certification of EG or FC of Kaheawa Wind Power
II, LLC.
    Filed Date: 11/14/2011.
    Accession Number: 20111114-5412.
    Comment Date: 5 p.m. ET on 12/5/2011.

    Docket Numbers: EG12-13-000.
    Applicants: Broken Bow Wind, LLC.
    Description: Self-Certification of EG or FC of Broken Bow Wind,
LLC.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5137.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: EG12-14-000.
    Applicants: Crofton Bluffs Wind, LLC.
    Description: Self-Certification of EG or FC of Crofton Bluffs Wind,
LLC.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5138.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER10-1342-002; ER10-1343-002; ER10-1345-002; ER11-
2534-001; ER10-2759-002; ER10-2631-002; ER10-2632-002.
    Applicants: Rumford Power Inc., Bridgeport Energy, LLC, CP Energy
Marketing (US) Inc., CPIDC, Inc., Tiverton Power Inc., Morris
Cogeneration, LLC, CPI Energy Services (US) LLC.
    Description: Supplement to Triennial Market-Based Rate Update for
the Northeast Region.
    Filed Date: 11/15/2011.
    Accession Number: 20111115-5189.
    Comment Date: 5 p.m. ET on 12/6/2011.

    Docket Numbers: ER10-2310-001; ER10-2314-001; ER10-2311-001; ER10-
2312-001; ER10-2313-001; ER10-2316-001; ER10-2318-001; ER10-2321-001;
ER10-2315-001.
    Applicants: Covanta Maine, LLC, Covanta Essex Company Covanta
Plymouth Renewable Energy Limited, Covanta Delaware Valley, L.P.,
Covanta Union, Inc., Covanta Hempstead Company, Covanta Niagara, L.P.,
Covanta Power, LLC, Covanta Energy Marketing LLC.
    Description: Covanta MBR Entities submit Supplement to Updated
Market Power Analysis.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5113.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER11-2895-002.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Formula Rate Compliance Filing to be effective 6/1/
2011.
    Filed Date: 11/10/2011.
    Accession Number: 20111110-5089.
    Comment Date: 5 p.m. ET on 12/1/2011.

    Docket Numbers: ER11-3415-001.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
American Transmission Systems, Incorporated.
    Description: 11-16-11 ATSI Exit Fee Compliance to be effective 5/
31/2011.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5127.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER11-3979-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
PJM Interconnection, LLC.
    Description: Compliance Filing in Docket ER11-3979 re MISO-PJM JOA
Attachment 2 Section 6.6 to be effective 9/17/2010.
    Filed Date: 11/10/2011.
    Accession Number: 20111110-5172.
    Comment Date: 5 p.m. ET on 12/1/2011.
    Docket Numbers: ER11-4318-001.
    Applicants: San Diego Gas & Electric Company.
    Description: San Diego Gas & Electric Company submits compliance
filing re the Order on Annual Formula Rate Filing etc.
    Filed Date: 11/14/2011.
    Accession Number: 20111115-0201.
    Comment Date: 5 p.m. ET on 12/5/2011.

    Docket Numbers: ER11-4632-001.
    Applicants: Southwestern Electric Power Company.
    Description: 20111116 Bentonville PSA to be effective 12/17/2010.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5071.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-368-001.
    Applicants: ITC Midwest LLC.
    Description: Errata Filing to be effective 1/10/2012.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5044.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-381-001.
    Applicants: California Independent System Operator Corporation.
    Description: 2011-11-10 Errata to Amendment 2 of CAISO SRP ICAOA to
be effective 11/12/2011.
    Filed Date: 11/10/2011.
    Accession Number: 20111110-5115.
    Comment Date: 5 p.m. ET on 12/1/2011.

    Docket Numbers: ER12-423-000.
    Applicants: California Independent System Operator Corporation.
    Description: 2011-11-16 CAISO LMPM Amendment to be effective 4/11/
2012.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5095.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-424-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
International Transmission Company.
    Description: J122 ITCTransmission-Detroit Edison to be effective
10/19/2011.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5115.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-425-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.,
Michigan Electric Transmission Company, LLC.
    Description: J132 METC-Beebe to be effective 10/24/2011.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5118.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-426-000.
    Applicants: The United Illuminating Company.
    Description: Amended Interconnection Agreement By and Between UI
and PSEG to be effective 10/31/2011.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5124.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-427-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: 11-16-11 CMMPA Regulatory Asset Filing to be effective
3/21/2011.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5129.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-428-000.
    Applicants: New York Independent System Operator, Inc.
    Description: Amended and Restated LGIA Among NYISO, NYSEG, and
Howard Wind to be effective 10/27/2011.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5146.
    Comment Date: 5 p.m. ET on 12/7/2011.

    Docket Numbers: ER12-429-000.
    Applicants: ISO New England Inc.
    Description: Capacity Supply Obligation Resource Termination.
    Filed Date: 11/17/2011.
    Accession Number: 20111117-5098.
    Comment Date: 5 p.m. ET on 12/8/2011.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES11-52-000.
    Applicants: PPL Electric Utilities Corporation.
    Description: PPL Electric Utilities Corporation's supplement to its
application for approval to issue promissory notes and other evidences
of secured and unsecured short-term indebtedness.
    Filed Date: 11/16/2011.
    Accession Number: 20111116-5078.
    Comment Date: 5 p.m. ET on 11/28/2011.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM12-1-000.
    Applicants: ALLETE, Inc.
    Description: Application to Terminate Mandatory PURPA Purchase
Obligation of ALLETE, Inc.

    Filed Date: 11/16/2011.
    Accession Number: 20111116-5165.
    Comment Date: 5 p.m. ET on 12/14/2011.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: November 17, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-30338 Filed 11-23-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Proposed Rules]
[Pages 41938-41940]
[FR Doc No: 2014-16948]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0452; Directorate Identifier 2013-NM-185-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus 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 all
Airbus Model A318, A319, A320, and A321 series airplanes. This proposed
AD was prompted by a determination that more restrictive airworthiness
limitations are necessary. This proposed AD would require revising the
maintenance or inspection program as applicable. We are proposing this
AD to prevent a safety-significant latent failure (which is not
annunciated) which, in combination with one or more other specific
failures or events, would result in a hazardous or catastrophic failure
condition.

DATES: We must receive comments on this proposed AD by September 2,
2014.

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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this referenced service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA.
For information on the availability of this material at the FAA, call
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-2014-
0452; 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: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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-2014-0452;
Directorate Identifier 2013-NM-185-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 Community, has issued EASA
Airworthiness Directive 2013-0148, dated July 16, 2013 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all Airbus Model
A318, A319, A320, and A321 series airplanes. The MCAI states:

    The airworthiness limitations for Airbus aeroplanes are
currently published in Airworthiness Limitations Section (ALS)
documents. The airworthiness limitations applicable to the
Certification Maintenance Requirements (CMR) were previously
specified in AIRBUS A318/A319/A320/A321 CMR document referenced AI/
ST4/993.436/88.
    DGAC France issued AD F-2005-101 [(http://ad.easa.europa.eu/blob/easa_ad_2005_5886_F20051010tb_superseded.pdf/AD_F-2005-101_2)] (EASA approval 2005-5886) to require compliance with the
maintenance tasks as specified in that document.
    Since that [DGAC France] AD was issued, the CMR tasks are
specified in Airbus A318/A319/A320/A321 ALS Part 3, which is
approved by EASA. The original issue of this document introduced
more restrictive maintenance requirements and/or airworthiness
limitations. Failure to comply with the maintenance requirements
contained in this document could result in an unsafe condition.
    For the reasons described above, this [EASA] AD supersedes DGAC
France AD F-2005-101 and requires the implementation of the
instructions and airworthiness limitations as specified in Airbus
A318/A319/A320/A321 ALS Part 3 Revision 01.

    The unsafe condition is a safety-significant latent failure (which
is not annunciated) which, in combination with one or more other
specific failures or events, would result in a hazardous or
catastrophic failure condition. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching for
and locating it in Docket No. FAA-2014-0452.

Relevant Service Information

    Airbus has issued Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 3, Certification Maintenance
Requirements (CMR), Revision 1, dated June 15, 2012. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This 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 the same
type design.

Differences Between This Proposed AD and the MCAI or Service
Information

    The EASA MCAI specifies that if there are findings from the ALS
inspection tasks, corrective actions must be accomplished in accordance
with Airbus maintenance documentation. However, this proposed AD does
not include that requirement because operators of U.S.-registered
airplanes are required by general airworthiness and operational
regulations to use FAA-acceptable methods when performing maintenance.
We consider those methods to be adequate to address any corrective
actions necessitated by the findings of ALS inspections required by
this proposed AD.

``Contacting the Manufacturer'' Paragraph in This Proposed AD

    Since late 2006, we have included a standard paragraph titled
``Airworthy Product'' in all MCAI ADs in which the FAA develops an AD
based on a foreign authority's AD.
    We have become aware that some operators have misunderstood or
misinterpreted the Airworthy Product paragraph to allow the owner/
operator to use messages provided by the manufacturer as approval of
deviations during the accomplishment of an AD-mandated action. The
Airworthy Product paragraph does not approve messages or other
information provided by the manufacturer for deviations to the
requirements of the AD-mandated actions. The Airworthy Product
paragraph only addresses the requirement to contact the manufacturer
for corrective actions for the identified unsafe condition and does not
cover deviations from other AD requirements. However, deviations to AD-
required actions are addressed in 14 CFR 39.17, and anyone may request
the approval for an alternative method of compliance to the AD-required
actions using the procedures found in 14 CFR 39.19.
    To address this misunderstanding and misinterpretation of the
Airworthy Product paragraph, we have changed the paragraph and retitled
it ``Contacting the Manufacturer.'' This paragraph now clarifies that
for any requirement in this proposed AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the FAA, the European Aviation Safety Agency (EASA), or
Airbus's EASA DOA.
    The Contacting the Manufacturer paragraph also clarifies that, if
approved by the DOA, the approval must include the DOA-authorized
signature. The DOA signature indicates that the data and information
contained in the document are EASA-approved, which is also FAA-
approved. Messages and other information provided by the manufacturer
that do not contain the DOA-authorized signature approval are not EASA-
approved, unless EASA directly approves the manufacturer's message or
other information.
    This clarification does not remove flexibility previously afforded
by the Airworthy Product paragraph. Consistent with long-standing FAA
policy, such flexibility was never intended for required actions. This
is also consistent with the recommendation of the Airworthiness
Directive Implementation Aviation Rulemaking Committee to increase
flexibility in complying with ADs by identifying those actions in
manufacturers' service instructions that are ``Required for
Compliance'' with ADs. We continue to work with manufacturers to
implement this recommendation. But once we determine that an action is
required, any deviation from the requirement must be approved as an
alternative method of compliance.
    We also have decided not to include a generic reference to either
the ``delegated agent'' or ``design approval holder (DAH) with State of
Design Authority design organization approval,'' but instead we have
provided the specific delegation approval granted by the State of
Design Authority for the DAH throughout this AD.

Costs of Compliance

    We estimate that this proposed AD affects 851 airplanes of U.S.
registry.
    We also estimate that it would take about 1 work-hour per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about $0 per
product. Based on these figures, we estimate the cost of this proposed
AD on U.S. operators to be $72,335, or $85 per product.

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):

Airbus: Docket No. FAA-2014-0452; Directorate Identifier 2013-NM-
185-AD.

(a) Comments Due Date

    We must receive comments by September 2, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A318-111, -112, -121, and -122
airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -
133 airplanes; and Model A320-111, -211, -212, -214, -231, -232, and
-233 airplanes; Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes; certificated in any category; all manufacturer
serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits
and Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that more restrictive
airworthiness limitations are necessary. We are issuing this AD to
prevent a safety-significant latent failure (which is not
annunciated) which, in combination with one or more other specific
failures or events, would result in a hazardous or catastrophic
failure condition.

(f) Compliance

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

(g) Maintenance or Inspection Program Revision

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, by incorporating
Airbus A318/A319/A320/A321 Airworthiness Limitations Section (ALS)
Part 3, Certification Maintenance Requirements (CMR), Revision 1,
dated June 15, 2012. The initial compliance time for accomplishing
the tasks specified in Airbus A318/A319/A320/A321 ALS Part 3, CMR,
Revision 1, dated June 15, 2012, is at the applicable time specified
in the Record of Revisions of Airbus A318/A319/A320/A321 ALS Part 3,
CMR, Revision 1, dated June 15, 2012; or within 30 days after the
effective date of this AD, whichever occurs later.

(h) No Alternative Actions or Intervals

    After accomplishing the revisions required by paragraph (g) of
this AD, no alternative actions (e.g., inspections) or intervals may
be used unless the actions or intervals are approved as an
alternative method of compliance in accordance with the procedures
specified in paragraph (i) of this AD.

(i) 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: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington
98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
local flight standards district office/certificate holding district
office. The AMOC approval letter must specifically reference this
AD.
    (2) 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 Airbus's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) European Aviation Safety Agency Airworthiness Directive 2013-
0148, dated July 16, 2013, 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 it in Docket No. FAA-2014-0452.
    (2) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com. You may view this 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 July 13, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-16948 Filed 7-17-14; 8:45 am]
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