[Federal Register: August 3, 2006 (Volume 71, Number 149)]
[Notices]
[Page 44067]
[DOCID:fr03au06-87]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54163A; File No. SR-NSCC-2006-06]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Relating to Enhancements to ACATS-Fund/SERV Processing
Capabilities

July 28, 2006.

Correction

    In Release No. 34-54163, FR Doc. E6-11681, revise the words
``delivering member'' to read ``relevant mutual fund'' in each of the
following places:
    a. page 41852, second column, fourth paragraph, tenth line;
    b. page 41852, third column, first paragraph, third line;
    c. page 41852, third column, second paragraph, fourteenth line;
    d. page 41852, third column, second paragraph, twenty-first line;
    e. page 41853, first column, second full paragraph, ninth line;
and.
    f. page 41853, first column, second full paragraph, twelfth line.

    For the Commission by the Division of Market Regulation,
pursuant to delegated authority.\1\
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    \1\ 17 CFR 200.30-3(a)(12).
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J. Lynn Taylor,
Assistant Secretary.
 [FR Doc. E6-12501 Filed 8-2-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 75 (Wednesday, April 18, 2018)]
[Notices]
[Pages 17171-17173]
[FR Doc No: 2018-08057]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC18-7-000]

Commission Information Collection Activities (FERC-725L); Comment
Request

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Comment request.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is submitting the FERC-725L (Mandatory Reliability Standards for
the Bulk-Power System: MOD Reliability Standards) to the Office of
Management and Budget (OMB) for review of the information collection
requirements. Any interested person may file comments directly with OMB
and should address a copy of those comments to the Commission as
explained below. The Commission previously issued a Notice in the
Federal Register requesting public comments. The Commission received no
comments on the FERC-725L and is making this notation in its submittal
to OMB.

DATES: Comments on the collection of information are due by May 18,
2018.

ADDRESSES: Comments filed with OMB, identified by the OMB Control No.
1902-0261, should be sent via email to the Office of Information and
Regulatory Affairs: [email protected]. Attention: Federal Energy
Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>.
    A copy of the comments should also be sent to the Commission, in
Docket No. IC18-7-000, by either of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at [email protected], or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this

docket or in viewing/downloading comments and issuances in this docket
may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected], by telephone at<PHONE_NUMBER>, and by fax at
(202) 273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725L, Mandatory Reliability Standards for the Bulk-
Power System: MOD Reliability Standards.
    OMB Control No.: 1902-0261.
    Type of Request: Three-year extension of the FERC-725L information
collection requirements with no changes to the reporting requirements.
    Abstract: MOD Reliability Standards ensure that generators remain
in operation during specified voltage and frequency excursions,
properly coordinate protective relays and generator voltage regulator
controls, and ensure that generator models accurately reflect the
generator's capabilities and equipment performance.
    On 5/30/2013, NERC filed a petition explaining that the reliability
of the Bulk-Power System benefits from ``good quality simulation models
of power system equipment,\2\ '' and that ``model validation ensures
the proper performance of the control systems and validates the
computer models used for stability analysis.'' NERC further stated that
the Reliability Standards will enhance reliability because the tests
performed to obtain model data may reveal latent defects that could
cause ``inappropriate unit response during system disturbances,\2\ ''
Subsequently, on 3/20/2014,\1\ the Commission approved Reliability
Standards MOD-025-2, MOD-026-1, and MOD-027-1. These Standards were
intended to address generator verifications needed to support Bulk-
Power System reliability that would also ensure that accurate data is
verified and made available for planning simulations.\2\
---------------------------------------------------------------------------

    \1\ Final Rule in Docket No. RM13-16-000.
    \2\ NERC Petition for Approval of Five Proposed Reliability
Standards MOD-025-2, MOD-026-1, MOD-027-1, PRC-019-1, and PRC-024-1
submitted to FERC on 5/30/2013.
---------------------------------------------------------------------------

    On 5/1/2014,\3\ the Commission approved Reliability Standards MOD-
032-1 and MOD-033-2. These Standards were to address ``system-level
modeling data and validation requirements necessary for developing
planning models and the Interconnection-wide cases that are integral to
analyzing the reliability of the Bulk-Power System.''
---------------------------------------------------------------------------

    \3\ Order in Docket No. RD14-5-000.
---------------------------------------------------------------------------

    MOD-025-2, MOD-026-1, MOD-027-1, MOD-032-1 and MOD-033-2 are all
currently approved within the FERC-725L information collection. The
reporting requirements associated with each standard will not change as
a result of this extension request.
    Type of Respondents: NERC-registered entities including generator
owners, transmission planners, planning authorities, balancing
authorities, resource planners, transmission service providers,
reliability coordinators, and transmission operators.\4\
---------------------------------------------------------------------------

    \4\ In subsequent portions of this notice, the following
acronyms will be used: PA = Planning Authority, GO = Generator
Owner, TP = Transmission Planner, BA = Balancing Authority, RP =
Resource Planner, TSP = Transmission Service Provider, RC =
Reliability Coordinator, TOP = Transmission Operator.
---------------------------------------------------------------------------

    Estimate of Annual Burden: \5\ The Commission estimates the annual
public reporting burden \6\ and cost for the information collection as:
---------------------------------------------------------------------------

    \5\ ``Burden'' is defined as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.
    \6\ Each of the five MOD standards in the FERC-725L information
collection previously contained ``one-time'' components to their
respondent burden. These one-time burden categories consisted
primarily of activities related to establishing industry practices
and developing data validation procedures tailored toward these
reliability standards and their reporting requirements. None of the
one-time burdens apply any longer, so they are being removed from
the FERC-725L information collection.

                                                                                MOD-025-2
                              [Verification and data reporting of generator real and reactive power capability and synchronous condenser reactive power capability]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                     Annual number
                                           Number of respondents     of responses    Total number       Average burden and cost per        Total annual burden hours and total       Cost per
                                                                    per respondent   of responses                 response                             annual cost                respondent ($)
                                        (1).......................             (2)     (1) * (2) =  (4)................................  (3) * (4) = (5)........................       (5) / (1)
                                                                                (3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Attachment 2..........................  933 (GO)..................               1             933  6 hrs.; $448.92 \7\................  5,598 hrs.; $418,842...................         $448.92
Evidence Retention....................  933 (GO)..................               1             933  1 hr.; $32.74 \8\..................  933 hrs.; $30,546......................           32.74
                                       ---------------------------------------------------------------------------------------------------------------------------------------------------------
    Total.............................  ..........................  ..............  ..............  ...................................  6,531 hrs.; $449,388...................  ..............
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                        MOD-026-1
                   [Verification of models and data for generator excitation control system or plant volt/variance control functions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Annual number
                                 Number of respondents    of responses    Total number    Average burden and   Total annual burden hours     Cost per
                                                         per respondent   of responses     cost per response     and total annual cost    respondent ($)
                               (1).....................             (2)     (1) * (2) =  (4).................  (3) * (4) = (5)..........       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for obtaining     185 (TP)................               1             185  8 hrs.; $598.56 \7\.  1,480 hrs.; $110,734.....         $598.56
 excitation control system or
 plant voltage/variance
 control function model.
Documentation on generator     466 (GO)................               1             466  8 hrs.; $598.56 \7\.  3,728 hrs.; $278,929.....          598.56
 verification.
Evidence Retention...........  651 (GO and TOP)........               1             651  1 hr.; $32.74 \8\...  651 hrs.; $21,314........           32.74
                              --------------------------------------------------------------------------------------------------------------------------
    Total....................  ........................  ..............  ..............  ....................  5,859 hrs.; $410,977.....  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                        MOD-027-1
                   [Verification of models and data for turbine/governor and load control or active power/frequency control functions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                          Annual number
                                 Number of respondents    of responses    Total number    Average burden and   Total annual burden hours     Cost per
                                                         per respondent   of responses     cost per response     and total annual cost    respondent ($)
                               (1).....................             (2)     (1) * (2) =  (4).................  (3) * (4) = (5)..........       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for obtaining     185 (TP)................               1             185  8 hrs.; $598.56 \7\.  1,480 hrs.; $110,734.....         $598.56
 excitation control system or
 plant voltage/variance
 control function model.
Documentation on generator     466 (GO)................               1             466  8 hrs.; $598.56 \7\.  3,728 hrs.;..............          598.56
 verification.                                                                                $278,929.................
Evidence Retention...........  651 (GO and TP).........               1             651  1 hr.; $32.74 \8\...  651 hrs.; $21,314........           32.74
                              --------------------------------------------------------------------------------------------------------------------------
    Total....................  ........................  ..............  ..............  ....................  5,859 hrs.; $410,977.....  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                        MOD-032-1
                   [Verification of models and data for turbine/governor and load control or active power/frequency control functions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                    Annual number
                                   Number of        of responses    Total number    Average burden and cost   Total annual burden hours      Cost per
                                  respondents      per respondent   of responses         per response           and total annual cost     respondent ($)
                              (1)................             (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)............       (5) / (1)
                                                                              (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submittal..............  1,197 (BA, GO, PA,                1           1,197  8 hrs.; $544.96 \9\.....  9,576 hrs.; $652,317.......         $544.96
                               RP, TO, TP, and
                               TSP).
Evidence Retention..........  1,197 (BA, GO, PA,                1           1,197  1 hr.; $32.74 \8\.......  1,197 hrs.; $39,190........           32.74
                               RP, TO, TP, and
                               TSP).
                             ---------------------------------------------------------------------------------------------------------------------------
    Total...................  ...................  ..............  ..............  ........................  10,773 hrs.; $691,507......  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                        MOD-033-1
                                                   [Steady-state and dynamics system model validation]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      Annual number
                                      Number of       of responses    Total number   Average burden and cost   Total annual burden hours     Cost per
                                     respondents     per respondent   of responses         per response          and total annual cost    respondent ($)
                                 (1)...............             (2)     (1) * (2) =  (4)....................  (3) * (4) = (5)...........       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submittal.................  188 (RC and TOP)..               1             188  8 hrs.; $544.96 \9\....  1,504 hrs.; $102,452......         $544.96
Evidence Retention.............  194 (PA, RC, and                 1             194  1 hr.; $32.74 \8\......  194 hrs.; $6,352..........           32.74
                                  TOP).
                                ------------------------------------------------------------------------------------------------------------------------
    Total......................  ..................  ..............  ..............  .......................  1,698 hrs.; $108,804......  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total annual estimated burden and cost for the FERC-725L
information collection is 30,720 hours and $2,071,653 respectively.
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    \7\ This wage figure uses the average hourly wage (plus
benefits) for electrical engineers (Occupation Code: 17-2071,
$68.12/hour) and managers (Occupation Code: 11-0000, $81.52/hour)
obtained from the Bureau of Labor Statistics (BLS). The average used
the following calculation: [$68.12/hour + $81.52/hour] / 2 = $74.82/
hour.
    \8\ The estimate uses the hourly average wage (plus benefits)
for file clerks obtained from the Bureau of Labor Statistics:
$32.74/hour (BLS Occupation Code: 43-4071).
    \9\ This uses the hourly average wage (plus benefits) for
electrical engineers obtained from the Bureau of Labor Statistics:
$68.12/hour (BLS Occupation Code: 17-2071).
---------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: April 11, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-08057 Filed 4-17-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16268-16270]
[FR Doc No: 2023-05362]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-1105]

Electronic Systems, Electronic Records, and Electronic Signatures
in Clinical Investigations: Questions and Answers; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Electronic
Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers.'' The draft guidance provides
information for sponsors, clinical investigators, institutional review
boards (IRBs), contract research organizations (CROs), and other
interested parties on the use of electronic systems, electronic
records, and electronic signatures in clinical investigations of foods,
medical products, tobacco products, and new animal drugs under FDA
regulations. This draft guidance revises the draft guidance for
industry issued in June 2017 entitled ``Use of Electronic Records and
Electronic Signatures in Clinical Investigations Under 21 CFR part 11--
Questions and Answers'' and, when finalized, will supersede the
guidance for industry entitled ``Computerized Systems Used in Clinical
Investigations'' (May 2007).

DATES: Submit either electronic or written comments on the draft
guidance by May 15, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): 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-D-1105 for ``Electronic Systems, Electronic Records, and
Electronic Signatures in Clinical Investigations: Questions and
Answers.'' Received comments 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>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002; or
Office of Policy, Guidance and Policy Development, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Kunkoski, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3332, Silver Spring, MD 20993-0002, 301-
796-6439, [email protected]; Diane Maloney, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911, [email protected]; Soma Kalb, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G318, Silver Spring, MD 20993-0002, 301-
796-6539, [email protected]; Yuguang Wang, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
Rm. 4A-012, College Park, MD 20740,<PHONE_NUMBER>,
[email protected]; the Center for Tobacco Products, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Silver Spring,
MD 20993-0002,<PHONE_NUMBER>, [email protected]; or Eric Nelson,
Center for Veterinary Medicine, Food and Drug Administration, 7519
Standish Pl., MPN #4, Rm. 106, HFV-230, Rockville, MD 20855, 240-402-
5642, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Electronic Systems, Electronic Records, and Electronic
Signatures in Clinical Investigations: Questions and Answers.'' The
draft guidance provides information for sponsors, clinical
investigators, IRBs, CROs, and other interested parties on the use of
electronic systems, electronic records, and electronic signatures in
clinical investigations of foods, medical products, tobacco products,
and new animal drugs. The goals of the draft guidance are to (1) update
recommendations for applying and implementing data integrity and data
security controls, including the use of audit trails and the protection
of records in the current environment of electronic systems used in
clinical investigations; (2) provide additional recommendations on the
risk-based approach to validation of electronic systems described in
the guidance for industry ``Part 11, Electronic Records; Electronic
Signatures--Scope and Application'' (August 2003); and (3) facilitate
the use of electronic systems, electronic records, and electronic
signatures to improve the quality and efficiency of clinical
investigations.
    In the Federal Register of June 21, 2017 (82 FR 28277), FDA
announced the availability of the draft guidance entitled ``Use of
Electronic Records and Electronic Signatures in Clinical

Investigations Under 21 CFR part 11--Questions and Answers.'' FDA
received numerous comments on the draft guidance, and those comments
were considered as the guidance was revised. A summary of changes
includes clarifying recommendations for the following: (1) using a
risk-based approach for validation of electronic systems used in
clinical investigations; (2) preparing for FDA inspections of sponsors
and CROs when electronic systems are owned, controlled, or outsourced
by the sponsors and CROs for use in clinical investigations; (3)
implementing, maintaining, and retaining audit trail information; (4)
determining the suitability of information technology (IT) service
providers contracted by sponsors or other regulated entities to provide
IT services in clinical investigations; and (5) implementing and
applying data integrity controls, data security solutions, and
electronic source data principles to digital health technology used in
clinical investigations. This guidance revises the draft guidance
issued in June 2017 and, when finalized, will supersede the guidance
for industry entitled ``Computerized Systems Used in Clinical
Investigations'' (May 2007).
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Electronic
Systems, Electronic Records, and Electronic Signatures in Clinical
Investigations: Questions and Answers.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by the OMB under the PRA. The
collections of information in 21 CFR part 11 have been approved under
OMB control number 0910-0303; the collections of information in 21 CFR
part 56 have been approved under OMB control number 0910-0130; the
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 511 have been approved under OMB control number 0910-0117; and the
collections of information in 21 CFR part 812 have been approved under
OMB control number 0910-0078.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05362 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Rules and Regulations]
[Pages 30608-30612]
[FR Doc No: 2015-11393]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0584; Directorate Identifier 2014-NM-092-AD;
Amendment 39-18158; AD 2015-10-03]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2014-09-05,
for certain Airbus Model A330-200 and -300 series airplanes, and Model
A340-200 and -300 series airplanes. AD 2014-09-05 required repetitive
inspections of certain sidestay upper cardan pins of the main landing
gear (MLG) and associated nuts and retainer assemblies, and pin
replacement if necessary. This AD was prompted by a determination that
a previously optional measurement is necessary to address the
identified unsafe condition. This new AD continues to require a
detailed inspection for visible chrome of each affected MLG sidestay
upper cardan pin, associated nuts, and retainer assembly, and pin
replacement if needed, and adds new requirements for measuring cardan
pin clearance dimensions (gap check), doing corrective actions, and
reporting all findings. We are issuing this AD to detect and correct
migration of the sidestay upper cardan pin, which could result in
disconnection of the sidestay upper arm from the airplane structure,
and could result in a landing

gear collapse and consequent damage to the airplane and injury to
occupants.

DATES: This AD becomes effective July 6, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 14, 2014
(79 FR 23909, April 29, 2014).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0584; or in person at the
Docket Management Facility, U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC.
    For service information identified in this AD, contact Airbus SAS--
Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac
Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80;
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. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0584.

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2014-09-05, Amendment 39-17840 (79 FR 23909,
April 29, 2014). AD 2014-09-05 applied to certain Airbus Model A330-200
and -300 series airplanes, and Model A340-200 and -300 series
airplanes. The NPRM published in the Federal Register on August 26,
2014 (79 FR 50863).
    The European Aviation Safety Agency, which is the Technical Agent
for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0066, corrected March 20, 2014 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition on certain Airbus Model
A330-200 and -300 series airplanes, and Model A340-200 and -300 series
airplanes. The MCAI states:

    An A330 aeroplane equipped with Basic (main landing gear) MLG
was rolling out after landing when it experienced a nose wheel
steering fault (unrelated to the safety subject addressed by this
[EASA] AD), which resulted in the crew stopping the aeroplane on the
taxiway after vacating the runway.
    The subsequent investigation revealed that the right-hand MLG
sidestay upper cardan pin had migrated out of position. The sidestay
upper cardan nut and retainer were found in the landing gear bay
detached from the upper cardan pin. The nut and the retainer were
still bolted together.
    This condition, if not detected and corrected, could lead to a
complete migration of the sidestay upper cardan pin and a
disconnection of the sidestay upper arm from the aeroplane
structure, possibly resulting in MLG collapse with consequent damage
to the aeroplane and injury to occupants.
    To address this potential condition, Airbus published Alert
Operators Transmission (AOT) A32L003-14, providing inspection
instructions.
    For the reasons described above, this [EASA] AD requires
accomplishment of repetitive [detailed inspections for visible
chrome] of the MLG upper cardan pin, nut and retainer [and pin
replacement if necessary]. This [EASA] AD also requires
accomplishment of a gap check between wing rear spar fitting lugs
and the bush flanges [and corrective actions if necessary.
Corrective actions include repair or replacement of the cardan pin
assembly].

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2014-0584-0003.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM (79
FR 50863, August 26, 2014) and the FAA's response to each comment.

Request To Match the Applicability of Terminating Action to Inspections

    U.S. Airways requested that we revise the affected airplanes of
paragraph (h) of the NPRM (79 FR 50863, August 26, 2014) to match those
of paragraph (g) of the NPRM. U.S. Airways stated that paragraph (g) of
the NPRM limits the repetitive inspections to MLG that have exceeded 8
years since first overhaul but not yet had a second overhaul; whereas
paragraph (h) of the NPRM provides a new terminating action to the
repetitive inspections, but does not limit the applicability to MLG
that have exceeded 8 years since first overhaul but not yet had a
second overhaul.
    We agree to revise the affected airplanes of paragraph (h) of this
AD because the terminating action provisions of paragraph (h) of the
NPRM (79 FR 50863, August 26, 2014) was intended to apply to the same
subset of affected airplanes identified in paragraph (g)(1) of the
NPRM. We have changed the language in paragraph (h) of this AD by
limiting the affected airplanes to those identified in paragraph (g)(1)
of this AD.

Request To Change Compliance Time of Sending Results of Gap Check

    U.S. Airways requested that we revise the compliance time for
sending the results of the inspection and gap check to Airbus from
``before further flight'' to ``within 30 days.'' U.S. Airways stated
that paragraph (h)(2)(i) of the NPRM (79 FR 50863, August 26, 2014)
states to send inspection findings to Airbus ``before further flight,''
if the gap check result measures between 0.6 mm and 1.5 mm, and
paragraph (h)(2)(ii) states to repair within 30 days. U.S. Airways
stated that mechanics who inspect the cardan pin typically do not send
data directly to Airbus and that since the repair is not required for
30 days after the inspection, communicating the inspection findings
should not restrict aircraft flight.
    We agree to revise the compliance time because the proposed
compliance time for sending the results of the inspection and gap check
does not affect the compliance time for accomplishment of the repair.
We have changed the compliance time in paragraph (h)(2)(i) of this AD
from before further flight, to 30 days. This difference has been
coordinated with EASA.

Request To Allow Replacement of Cardan Pin Assembly as Terminating
Action

    U.S. Airways requested that we allow the replacement of the cardan
pin assembly to be considered as a terminating action. Paragraph (h)(1)
of the NPRM (79 FR 50863, August 26, 2014) would mandate the
replacement of the cardan pin if the gap is found to be greater than
1.5mm. However paragraph (h)(2) of the NPRM would require an approved
repair for smaller gaps. US Airways suggested that the AD also allow
the replacement of the cardan pin assembly before further flight as an
alternative to the actions specified in paragraphs (h)(2)(i) and
(h)(2)(ii) of the NPRM.
    We agree with the request to allow replacement of the cardan pin
assembly as an alternative to small repairs because replacing the
cardan pin assembly is terminating action regardless of the size of the
gap. We have revised paragraph (h) of this AD to

provide for replacement of the cardan pin assembly as an option to
doing a repair.

Related Service Information Under 1 CFR Part 51

    The manufacturer has issued Airbus AOT A32L003-14, dated March 10,
2014. The service information describes procedures for inspecting
sidestay upper cardan pins of the MLG and associated nuts and retainer
assemblies. 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 of this
AD.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM (79 FR 50863, August 26, 2014) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (79 FR 50863, August 26, 2014).

Costs of Compliance

    We estimate that this AD affects 83 airplanes of U.S. registry.
    The actions required by AD 2014-09-05, Amendment 39-17840 (79 FR
23909, April 29, 2014), and retained in this AD take about 1 work-hour
per product, at an average labor rate of $85 per work-hour. Required
parts cost $0 per product. Based on these figures, the estimated cost
of the actions that were required by AD 2014-09-05 is $85 per product.
    We also estimate that it will take about 1 work-hour per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $7,055, or $85 per product.
    In addition, we estimate that any necessary follow-on actions will
take about 4 work-hours and require parts costing $7,530, for a cost of
$7,870 per product. We have no way of determining the number of
aircraft that might 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 penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information
Collection Clearance Officer, AES-200.

Authority for This Rulemaking

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

Regulatory Findings

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

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0584; or in person at the
Docket Management Facility between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Operations office (telephone 800-647-
5527) is in the ADDRESSES section.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2014-09-05, Amendment 39-17840 (79 FR 23909, April 29, 2014), and
adding the following new AD:

2015-10-03 Airbus: Amendment 39-18158. Docket No. FAA-2014-0584;
Directorate Identifier 2014-NM-092-AD.

(a) Effective Date

    This AD becomes effective July 6, 2015.

(b) Affected ADs

    This AD replaces AD 2014-09-05, Amendment 39-17840 (79 FR 23909,
April 29, 2014).

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
and (c)(2) of this AD, certificated in any category.
    (1) Airbus Model A330-201, -202, -203, -223, -243, -301, -302, -
303, -321, -322, -323, -341, -342, and -343 airplanes, all
manufacturer serial numbers (MSNs), equipped with basic (201252
series) main landing gear (MLG), or growth (201490 series) MLG.
    (2) Airbus Model A340-211, -212, -213, -311, -312, and -313
airplanes, all MSNs, equipped with basic (201252 series) MLG or
growth (201490 series) MLG.

(d) Subject

    Air Transport Association (ATA) of America Code 32, Landing
Gear.

(e) Reason

    This AD was prompted by a report of a sidestay upper cardan pin
of the MLG migrating out of position. We are issuing this AD to
detect and correct migration of the sidestay upper cardan pin, which
could result in disconnection of the sidestay upper arm from the
airplane structure, and could result in a landing gear collapse and
consequent damage to the airplane and injury to occupants.

(f) Compliance

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

(g) Retained Repetitive Detailed Inspections With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2014-09-05, Amendment 39-17840 (79 FR 23909, April 29, 2014), with
no changes.
    (1) For airplanes identified in paragraphs (g)(1)(i) and
(g)(1)(ii) of this AD on which the affected MLG has exceeded 8 years
since first overhaul, as of May 14, 2014 (the effective date of AD
2014-09-05, Amendment 39-17840 (79 FR 23909, April 29, 2014), except
those MLG that have had a second overhaul: Within 30 days after May
14, 2014, accomplish a detailed inspection for visible chrome of
each affected MLG sidestay upper cardan pin, and associated nut and
retainer assembly, in accordance with the instructions of Airbus
Alert Operators Transmission (AOT) A32L003-14, dated March 10, 2014,
including Appendices 1, 2, and 3 (the issue date is not specified on
the appendices).
    (i) Airplanes equipped with any MLG sidestay upper cardan pin
subassembly part number (P/N) 201267202 (on 201252 series MLG).
    (ii) Airplanes equipped with any MLG sidestay upper cardan pin
subassembly P/N 201483202 (on 201490 series MLG).
    (2) If, during any inspection required by paragraph (g)(1) of
this AD, no pin chrome is visible inboard of the wing rear spar
fitting lug, repeat the detailed inspection for visible chrome
specified in paragraph (g)(1) of this AD thereafter at intervals not
to exceed 10 days.
    (3) If, during any inspection required by paragraphs (g)(1) or
(g)(2) of this AD, a pin chrome is visible inboard of the wing rear
spar fitting lug, before further flight, replace the affected cardan
pin assembly, in accordance with the instructions of Airbus AOT
A32L003-14, dated March 10, 2014, including Appendices 1, 2, and 3
(the issue date is not specified on the appendices). Replacement of
the affected cardan pin assembly terminates the repetitive
inspections required by paragraph (g)(2) of this AD.
    Note 1 to paragraph (g) of this AD: MLG sidestay upper cardan
pin subassembly P/N 201267202 (found in Airbus Illustrated Parts
Catalogue (IPC) as item 32-11-18-01) includes the cardan pin P/N
201267600. MLG sidestay upper cardan pin subassembly P/N 201483202
(found in Airbus IPC as item 32-11-18-01) includes the cardan pin P/
N 201483600.

(h) New Terminating Action--Gap Check

    For airplanes identified in paragraphs (g)(1)(i) and (g)(1)(ii)
of this AD on which the affected MLG has exceeded 8 years since
first overhaul, as of May 14, 2014 (the effective date of AD 2014-
09-05, Amendment 39-17840 (79 FR 23909, April 29, 2014), except
those MLG that have had a second overhaul: Within 4 months after the
effective date of this AD: Measure the cardan pin clearance
dimensions (gap check) and do the applicable corrective action
specified in paragraph (h)(1) or (h)(2) of this AD. Measuring the
gap check and doing the applicable corrective action specified in
paragraph (h)(1) or (h)(2) of this AD, as applicable, terminates the
inspections required by paragraphs (g)(1) and (g)(2) of this AD for
that sidestay upper cardan pin, nut, and retainer only. The
measurement must be done in accordance with Airbus AOT A32L003-14,
dated March 10, 2014, including Appendices 1, 2, and 3 (the issue
date is not specified on the appendices).
    (1) If the total clearance dimension (gap check result) is equal
to or greater than 1.5 mm, before further flight, replace the cardan
pin assembly, in accordance with Airbus AOT A32L003-14, dated March
10, 2014, including Appendices 1, 2, and 3 (the issue date is not
specified on the appendices).
    (2) If the total clearance dimension (gap check) is less than
1.5 mm but greater than 0.6 mm, do the actions specified in
paragraphs (h)(2)(i) or (h)(2)(ii) of this AD.
    (i) Do the actions specified in paragraphs (h)(2)(i)(A) and
(h)(2)(i)(B) of this AD.
    (A) Within 30 days after accomplishing the gap check, send the
information (Appendix 2 proforma, photographs, and the movement
traceability sheet) specified in paragraph 4.2.3, ``Findings,'' of
Airbus AOT A32L003-14, dated March 10, 2014, including Appendices 1,
2, and 3 (the issue date is not specified on the appendices), to
Airbus at the address specified in Appendix 2 (the issue date is not
specified on this appendix) of Airbus AOT A32L003-14, dated March
10, 2014.
    (B) Within 30 days after accomplishing the gap check, repair
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.
    (ii) Within 30 days after accomplishing the gap check, replace
the cardan pin assembly, in accordance with Airbus AOT A32L003-14,
dated March 10, 2014, including Appendices 1, 2, and 3 (the issue
date is not specified on the appendices).

(i) New Reporting of Inspection Results

    For airplanes on which a gap check specified in paragraph (h) of
this AD has been done: Except as required by paragraph (h)(2)(i) of
this AD, at the applicable time specified in paragraphs (i)(1) and
(i)(2) of this AD, report all findings (including no findings) to
Airbus, in accordance with Airbus AOT A32L003-14, dated March 10,
2014, including Appendices 1, 2, and 3, (the issue date is not
specified on the appendices).
    (1) If the gap check was done on or after the effective date of
this AD: Submit the report within 30 days after the gap check.
    (2) If the gap check was done before the effective date of this
AD: Submit the report within 30 days after the effective date of
this AD.

(j) Other FAA AD Provisions

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

(k) Related Information

    Refer to Mandatory Continuing Airworthiness Information (MCAI)
EASA

Airworthiness Directive 2014-0066 (Corrected March 20, 2014), for
related information. You may examine the MCAI in the AD docket on
the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-
2014-0584.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 14, 2014, (79 FR 23909, April 29, 2014).
    (i) Airbus Alert Operators Transmission A32L003-14, dated March
10, 2014, including Appendices 1, 2, and 3 (the issue date is not
specified on the appendices).
    (ii) Reserved.
    (4) For service information identified in this AD, contact
Airbus SAS--Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com.
    (5) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (6) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 30, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-11393 Filed 5-28-15; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 26, 2008 (Volume 73, Number 124)]
[Notices]
[Page 36318-36319]
[DOCID:fr26jn08-45]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2007-1197; FRL-8685-7]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Proposed Collection; Comment Request;
Disinfectants/Disinfection Byproducts, Chemical and Radionuclides Rules
(Renewal); EPA ICR No. 1896.08, OMB Control No. 2040-0204

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before July 28, 2008.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2007-1197 to (1) EPA online using http://www.regulations.gov (our
preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Water Docket, MC:
28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB
by mail to: Office of Information and Regulatory Affairs, Office of
Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th
Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Richard Naylor, Drinking Water
Protection Division, Office of Ground Water and Drinking Water (4606M),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
564-3755; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On February 15, 2008 (73 FR 8865), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received two comments during the
comment period, which are addressed in the ICR. Any additional comments
on this ICR should be submitted to EPA and OMB within 30 days of this
notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2007-1197, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, confidential business information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Disinfectants/Disinfection Byproducts, Chemical, and
Radionuclides Rule (Renewal).
    ICR numbers: EPA ICR No. 1896.08, OMB Control No. 2040-0204.
    ICR Status: This ICR is scheduled to expire on June 30, 2008. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. 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. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The Disinfectants/Disinfection Byproducts, Chemical and
Radionuclides Rules ICR examines public water system (PWS), primacy
agency and EPA burden and costs for recordkeeping and reporting
requirements in support of the chemical drinking water regulations.
These recordkeeping and reporting requirements are mandatory for
compliance with 40 CFR parts 141 and 142. The following chemical
regulations are included: Stage 1 Disinfectants and Disinfection
Byproducts Rule (Stage 1 DBPR), Stage 2 Disinfectants and Disinfection
Byproducts Rule (Stage 2 DBPR), Chemical Phase Rules (Phases II/IIB/V),
1976 Radionuclides Rule and 2000 Radionuclides Rule, Total
Trihalomethanes (TTHM) Rule, Disinfectant Residual Monitoring and
Associated Activities under the Surface Water Treatment Rule, Arsenic
Rule, Lead and Copper Rule (LCR) and revisions. Future chemical-related
rulemakings, such as Radon, will be added to this consolidated ICR
after the regulations are finalized and the initial, rule-specific ICRs
are due to expire.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 0.48
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: New and existing public water
systems (PWSs), primacy agencies.
    Estimated Number of Respondents: 155,750.
    Frequency of Response: varies by requirement (i.e., on occasion,
monthly, quarterly, semi-annually, annually, biennially, and every 3,
6, and 9 years).

    Estimated Total Annual Hour Burden: 6,119,259.
    Estimated Total Annual Cost: $452,688,716, includes $240,118,273
annualized capital or O&M costs.
    Changes in the Estimates: There is a decrease of 604,910 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is primarily attributable to the
use of updated system inventories and entry points per system to
calculate monitoring costs.

    Dated: June 20, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-14522 Filed 6-25-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1682-1684]
[FR Doc No: 2012-212]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0996; FRL-9331-3]

Butylate, Fenoxycarb, Sodium Tetrathiocarbonate, and Temephos
Registration Review Final Decisions; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's final
registration review decisions for the pesticides butylate, case no.
0071; fenoxycarb, case no. 7401; sodium tetrathiocarbonate, case no.
7009; and temephos, case no. 0006. Registration review is EPA's
periodic review of pesticide registrations to ensure that each
pesticide continues to satisfy the statutory standard for registration,
that is, that the pesticide can perform its intended function without
causing unreasonable adverse effects on human health or the
environment. Through this program, EPA is ensuring that each
pesticide's registration is based on current scientific and other
knowledge, including its effects on human health and the environment.

FOR FURTHER INFORMATION CONTACT: For pesticide specific information,
contact: The chemical review manager identified in the Table of Unit
II. for the pesticide of interest.
    For general information on the registration review program,
contact: Kevin Costello, Pesticide Re-evaluation Division (7508P),
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone

number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the pesticide specific contact person listed under FOR FURTHER
INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2011-0996. Publicly available
docket materials are available either in the electronic docket at
http://www.regulations.gov, or, if only available in hard copy, at the
Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-
4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington,
VA. The hours of operation of this Docket Facility are from 8:30 a.m.
to 4 p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

II. Background

A. What action is the agency taking?

    Pursuant to 40 CFR 155.58(c), this notice announces the
availability of EPA's final registration review decisions for butylate,
case no. 0071; fenoxycarb, case no. 7401; sodium tetrathiocarbonate,
case no. 7009; and temephos, case no. 0006. Butylate is a thiocarbamate
soil-incorporated herbicide and was registered for use on field corn,
pop corn, and sweet corn. The last butylate pesticide product
registered for use in the United States was cancelled on March 23,
2011. Fenoxycarb is an O-ethyl carbamate derivative insecticide used to
control fire ants and big-headed ants on turf, home lawns, agricultural
areas, non-agricultural areas, horse farms, and ornamental nursery
stock, among other areas. Fenoxycarb is also used to control a variety
of insects in greenhouses in a total release fogger product. Sodium
tetrathiocarbonate is a soil fumigant used for the management of
nematodes and phytophthora root rot, oak root fungus, and phylloxera.
It was registered for use on grapes, citrus, almonds, peaches, prunes,
and plums only in the states of Arizona, California, Oregon, and
Washington. Temephos is a non-systemic organophosphate insecticide
which is applied to standing water, shallow ponds, lakes, woodland
pools, tidal waters, marshes, swamps, waters high in organic content,
highly polluted water, catch basins (and similar areas where mosquitoes
may breed), stream margins, and intertidal zones of sandy beaches.
Target pests include aquatic larvae of mosquitoes, midges, gnats,
punkies, and sandflies.

          Table--Registration Review Cases With Final Decisions
------------------------------------------------------------------------
                                                       Chemical review
  Registration review case     Pesticide docket ID   manager, telephone
        name and no.                   no.           No., email address
------------------------------------------------------------------------
Butylate Case Number 0071...  EPA-HQ-OPP-2008-0882  Steven Snyderman,
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Fenoxycarb Case Number 7401.  EPA-HQ-OPP-2006-0111  Tom Myers, (703) 308-
                                                     8589,
<EMAIL_ADDRESS>Sodium Tetrathiocarbonate     EPA-HQ-OPP-2007-1084  Tom Myers, (703) 308-
 Case Number 7009.                                   8589,
<EMAIL_ADDRESS>Temephos Case Number 0006...  EPA-HQ-OPP-2008-0444  Tom Myers, (703) 308-
                                                     8589,
<EMAIL_ADDRESS>------------------------------------------------------------------------

    Pursuant to 40 CFR 155.57, a registration review decision is the
Agency's determination whether a pesticide meets, or does not meet, the
standard for registration in FIFRA. EPA has considered butylate,
fenoxycarb, sodium tetrathiocarbonate, and temephos in light of the
FIFRA standard for registration. The butylate, fenoxycarb, sodium
tetrathiocarbonate, and temephos Final Decision documents in the
dockets describe the Agency's rationale for issuing registration review
final decisions for these pesticides.
    In addition to the final registration review decision document, the
registration review dockets listed in the Table of Unit II. for
butylate, fenoxycarb, sodium tetrathiocarbonate, and temephos also
include other relevant documents related to the registration review of
these cases. The proposed registration review decision documents were
posted to the respective dockets and the public was invited to submit
any comments or new information. During the 60-day comment period, no
public comments were received for butylate, fenoxycarb, and sodium
tetrathiocarbonate. Comments were received for temephos, from the
American Mosquito Control Association, Lee County Mosquito Control
District, the IR-4 Project, and Value Garden Supply. The comments
emphasized the benefits of temephos as it is used in public health for
mosquito control. The Agency recognizes the role of temephos in
mosquito control and has agreed to a 4-year phase-out of the product
registrations to accommodate the public health need and allow
registrants time to develop replacement products. The current temephos
products will not be cancelled until December 30, 2015. Also, Value
Garden Supply requested to rescind their voluntary cancellation. In
response to Value Garden Supply's request to rescind their voluntary
cancellation request, the Agency has been in discussions with the
registrant about the specific scientific data required to support their
temephos product registrations affected by the Cancellation Order. If
the required temephos data are submitted by the registrant, reviewed,
and found acceptable by the Agency prior to December 30, 2015, the
Agency may amend the Cancellation Order for the affected product
registrations. Pursuant to 40 CFR 155.58(c), the registration review
case dockets for butylate, fenoxycarb, sodium tetrathiocarbonate, and
temephos will remain open until all actions required in these final
decisions have been completed.
    Background on the registration review program is provided at:
http://www.epa.gov/oppsrrd1/

registration--review. Links to earlier documents related to the
registration review of these pesticide are provided at: http://www.epa.gov/oppsrrd1/registration_review/butylate/, http://www.epa.gov/oppsrrd1/registration_review/fenoxycarb/, http://www.epa.gov/oppsrrd1/registration_review/sodium_tetrathiocarbonate/,
and http://www.epa.gov/oppsrrd1/registration_review/temephos/.

B. What is the agency's authority for taking this action?

    Section 3(g) of FIFRA and 40 CFR part 155, subpart C, provide
authority for this action.

List of Subjects

    Environmental protection, Registration review, Pesticides and
pests, Butylate, Fenoxycarb, Sodium tetrathiocarbonate, and Temephos.

    Dated: December 21, 2011.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2012-212 Filed 1-10-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Proposed Rules]
[Pages 41263-41265]
[FR Doc No: 2022-14696]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 87, No. 132 / Tuesday, July 12, 2022 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0818; Project Identifier AD-2022-00299-R]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.a. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Leonardo S.p.a. Model A109, A109A, A109A II, A109C, A109K2,
A109E, A109S, and AW109SP helicopters modified by Supplemental Type
Certificate (STC) SR01812LA. This proposed AD was prompted by a report
of certain floats not deploying due to a faulty plunger assembly. This
proposed AD would require repairing or replacing certain float
assemblies. The FAA is proposing this AD to address the unsafe
condition on these products.

DATES: The FAA must receive comments on this proposed AD by August 26,
2022.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     For service information identified in this NPRM, contact
Apical Industries, Inc., Jason Gardiner, 3030 Enterprise Ct., Vista, CA
92081, United States; phone:<PHONE_NUMBER>; email:
[email protected]; website: https://www.dartaerospace.com/. You
may view this service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort
Worth, TX 76177. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0818; 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 NPRM, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Johann S. Magana, Aerospace Engineer,
Cabin Safety & Environmental Systems Section, Los Angeles ACO Branch,
Compliance & Airworthiness Division, FAA, 3960 Paramount Blvd.,
Lakewood, CA 90712; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2022-0818; Project Identifier
AD-2022-00299-R'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this NPRM.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Johann S. Magana, Aerospace Engineer, Cabin Safety & Environmental
Systems Section, Los Angeles ACO Branch, Compliance & Airworthiness
Division, FAA, 3960 Paramount Blvd., Lakewood, CA 90712; telephone
(562) 627-5322; email [email protected]. Any commentary that the
FAA receives which is not specifically designated as CBI will be placed
in the public docket for this rulemaking.

Background

    The FAA received a report of two forward floats not deploying after
an inadvertent activation. It was discovered that the plunger assembly
caused the forward floats to not deploy. Further investigation revealed
that a design change in 2009 of the plunger assembly inadvertently
changed the position of the bushing from a press fit to a threaded fit.
The dimensions for the threaded fit were preventing the bushing from
fully clearing the ball bearings when bottom out on the solenoid on the
valve assemblies. The plunger assembly is contained within the float
assembly and reservoir assembly. An emergency float kit consists of
float assemblies, reservoir assemblies, and additional components.
These emergency float kits (634.4100 Kit Series) are installed on
Leonardo S.p.a. Model A109, A109A, A109A II, A109C, A109K2, A109E,
A109S, and AW109SP helicopters modified by STC SR01812LA; this STC is
held by Apical Industries, Inc., d/b/a DART Aerospace (DART). This
condition, if not

addressed, could result in the helicopter either rolling to one side or
capsizing in an event of an emergency landing on water.

FAA's Determination

    The FAA is issuing this NPRM after determining that the unsafe
condition described previously is likely to exist or develop on other
products of the same type designs.

Related Service Information

    The FAA reviewed DART Service Bulletin SB2021-05, dated December 6,
2021. This service bulletin specifies replacing certain serial-numbered
float assemblies or, if the serial number is not included as part of
the service bulletin, contacting DART to validate effectivity. The
service bulletin also provides procedures for removing the float
assemblies from the helicopter, discharging the reservoirs, shipping
the float assemblies, and re-installing the float assemblies.
    The FAA also reviewed DART's Instructions for Continued
Airworthiness ICA109-1, Rev. U, dated October 27, 2020. This service
information provides description, operation, disassembly, inspection,
assembly, repair, and testing instructions as well as an illustrated
parts list for emergency float kits and emergency float with life raft
kits.

Proposed AD Requirements in This NPRM

    This proposed AD would require repairing or replacing each float
assembly part number 644.0501, 644.0502, 644.0503, 644.0504, 644.0505,
or 644.0506 in certain emergency float kits with a method approved by
the Manager, Los Angeles ACO Branch, FAA. These actions would be
required within 300 hours time-in-service or 6 months after the
effective date of the final rule of this proposed AD, whichever occurs
first.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 25 helicopters of U.S. registry. Labor rates are estimated at
$85 per work-hour. Based on these numbers, the FAA estimates the
following costs to comply with this proposed AD.
    Replacing each float assembly would take about 4 work-hours for an
estimated cost of $340 per helicopter and up to $8,500 for the U.S.
fleet. The FAA has received no definitive data that would enable the
FAA to provide parts cost estimates for the proposed actions; however,
according to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected operators. The FAA does not control warranty
coverage for affected operators. As a result, the FAA has included all
known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    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

    The FAA 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) Would not affect intrastate aviation in Alaska, and
    (3) Would 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:

Leonardo S.p.a.: Docket No. FAA-2022-0818; Project Identifier AD-
2022-00299-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) by August 26, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Leonardo S.p.a. Model A109, A109A, A109A II,
A109C, A109K2, A109E, A109S, and AW109SP helicopters, certificated
in any category, modified by Supplemental Type Certificate SR01812LA
with A109 Float (with/without Liferafts System) DART Aerospace
634.4100 Kit Series part number (P/N) 634.4101, 634.4102, 634.4103,
634.4104, 634.4106, or 634.4107 with float assembly P/N 644.0501,
644.0502, 644.0503, 644.0504, 644.0505, or 644.0506 installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code: 2560, Emergency
Equipment.

(e) Unsafe Condition

    This AD was prompted by a report of two forward floats not
deploying after an inadvertent activation. The FAA is issuing this
AD to ensure the affected floats work as intended. The unsafe
condition, if not addressed, could result in the helicopter either
rolling to one side or capsizing in an event of an emergency landing
on water.

(f) Compliance

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

(g) Required Actions

    Within 300 hours time-in-service or within 6 months after the
effective date of this AD, whichever occurs first, remove each float
assembly identified in paragraph (c) of this AD and repair or
replace it in accordance with a method approved by the Manager, Los
Angeles ACO Branch, FAA. For a repair or replacement method to be
approved by the Manager, Los Angeles ACO Branch, as required by this
paragraph, the Manager's approval letter must specifically refer to
this AD.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles 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 (i) of this AD. Information may
be emailed to: [email protected].
    (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.

(i) Related Information

    For more information about this AD, contact Johann S. Magana,
Aerospace Engineer, Cabin Safety & Environmental Systems Section,
Los Angeles ACO Branch, Compliance & Airworthiness Division, FAA,
3960 Paramount Blvd., Lakewood, CA 90712; telephone<PHONE_NUMBER>;
email [email protected].

    Issued on July 5, 2022.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2022-14696 Filed 7-11-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Proposed Rules]
[Pages 2952-2953]
[FR Doc No: 2018-00991]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2017-N-5319]

Devices Proposed for a New Use With an Approved, Marketed Drug;
Public Hearing; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; reopening of the comment
period.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
reopening the comment period for the document published in the Federal
Register on September 26, 2017, announcing a public hearing on a
potential approach for device sponsors who seek to obtain marketing
authorization for their products that are intended for a new use with
an approved, marketed drug when the sponsor for the approved, marketed
drug does not wish to pursue or collaborate on the new use. In the
document, in addition to seeking comments on the potential approach,
FDA also welcomed comments on public health, scientific, regulatory, or
legal considerations relating to other medical products intended for
new uses with approved, marketed medical products of a different type
where the sponsor for the approved, marketed product does not wish to
pursue or collaborate on the new use. We are reopening the comment
period in response to a request for an extension to allow interested
persons additional time to submit comments.

DATES: FDA is reopening the comment period on the document published on
September 26, 2017 (82 FR 44803). Submit either electronic or written
comments by February 21, 2018.

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 February 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of February 21, 2018. 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-5319 for ``Devices Proposed for a New Use With an Approved,
Marketed Drug; Public Hearing; Request for Comments.'' 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.
     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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of
Combination Products, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5129, Silver Spring,

MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register on September 26,
2017 (82 FR 44803), FDA published a document announcing a public
hearing on November 16, 2017, regarding a potential approach for device
sponsors who seek to obtain marketing authorization for their products
that are intended for a new use with an approved, marketed drug when
the sponsor for the approved, marketed drug does not wish to pursue or
collaborate on the new use. The purpose of the public hearing was to
obtain comments from stakeholders on the potential approach presented
in the Federal Register document as well as comments on public health,
scientific, regulatory, or legal considerations relating to other
medical products intended for new uses with approved, marketed medical
products of a different type where the sponsor for the approved,
marketed product does not wish to pursue or collaborate on the new use.
We sought this type of public engagement because of the potential
importance of the issue for public health and the need for input across
the medical product industry and among public health stakeholders
regarding how FDA should proceed. The comments that FDA receives in
relation to this public hearing may help inform the further development
of this approach.
    The document stated that comments would be accepted until January
15, 2018, and that untimely comments would not be considered. Near the
end of the comment period, we received a request, submitted on behalf
of several potential commenters, for more time to develop comments. We
have considered this request and are reopening the comment period for
an additional 30 days. We believe that this reopening allows adequate
time for interested persons to submit comments without delaying further
Agency efforts on this topic.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00991 Filed 1-19-18; 8:45 am]
 BILLING CODE 4164-01-P