[Federal Register Volume 85, Number 39 (Thursday, February 27, 2020)]
[Rules and Regulations]
[Pages 11291-11293]
[FR Doc No: 2020-03964]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0871; Product Identifier 2019-NM-139-AD; Amendment
39-19846; AD 2020-03-22]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain The Boeing Company Model 787-8 airplanes. This AD was prompted
by a report of fatigue cracking at certain frame tie rod locations of
the wing. This AD requires repetitive inspections for cracking of the
left- and right-side frame tie rod assemblies and stub beam upper
chords, and applicable on-condition actions. The FAA is issuing this AD
to address the unsafe condition on these products.

DATES: This AD is effective April 2, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publications listed in this AD as of April 2,
2020.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0871.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0871; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations is U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Greg Rutar, Aerospace Engineer,
Airframe Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des
Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain The Boeing
Company Model 787-8 airplanes. The NPRM published in the Federal
Register on November 19, 2019 (84 FR 63825). The NPRM was prompted by a
report of fatigue cracking at certain frame tie rod locations of the
wing. The NPRM proposed to require repetitive inspections for cracking
of the left- and right-side frame tie rod assemblies and stub beam
upper chords, and applicable on-condition actions.
    The FAA is issuing this AD to address cracking in the frame tie rod
assemblies and consequent failure of a principal structural element to
sustain limit load, which could adversely affect the structural
integrity of the airplane and result in possible decompression of the
airplane.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA has considered the comment
received. Boeing indicated its support for the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comment
received, and determined that air safety and the public interest
require adopting this final rule as proposed, except for minor
editorial changes. The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-
SB570041-00 RB, Issue 001, dated March 7, 2019. The service information
describes procedures for repetitive high frequency eddy current (HFEC)
inspections for cracking of the left- and right-side frame tie rod
assemblies, repetitive ultrasonic (UT) inspections for cracking of the
left- and right-side stub beam upper chords, and applicable on-
condition actions. On-condition actions include repair. 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.

Costs of Compliance

    The FAA estimates that this AD affects 55 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
        Action                  Labor cost            Parts cost       Cost per product          operators
----------------------------------------------------------------------------------------------------------------
Inspections...........  19 work-hours x $85 per                 $0  $1,615 per inspection  $88,825 per
                         hour = $1,615 per                           cycle.                 inspection cycle.
                         inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA has received no definitive data that enables the agency to
provide cost estimates for the on-condition actions specified in this
AD.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2020-03-22 The Boeing Company: Amendment 39-19846 ; Docket No. FAA-
2019-0871; Product Identifier 2019-NM-139-AD.

(a) Effective Date

    This AD is effective April 2, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 787-8 airplanes,
certificated in any category, as identified in Boeing Alert
Requirements Bulletin B787-81205-SB570041-00 RB, Issue 001, dated
March 7, 2019.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of fatigue cracking at certain
frame tie rod locations of the wing. The FAA is issuing this AD to
address cracking in the frame tie rod assemblies and consequent
failure of a principal structural element to sustain limit load,
which could adversely affect the structural integrity of the
airplane and result in possible decompression of the airplane.

(f) Compliance

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

(g) Required Actions

    Except as specified by paragraph (h) of this AD: At the
applicable times specified in the ``Compliance'' paragraph of Boeing
Alert Requirements Bulletin B787-81205-SB570041-00 RB, Issue 001,
dated March 7, 2019, do all applicable actions identified in, and in
accordance with, the Accomplishment Instructions of Boeing Alert
Requirements Bulletin B787-81205-SB570041-00 RB, Issue 001, dated
March 7, 2019.

    Note 1 to paragraph (g) of this AD:  Guidance for accomplishing
the actions required by this AD can be found in Boeing Alert Service
Bulletin B787-81205-SB570041-00, Issue 001, dated March 7, 2019,
which is referred to in Boeing Alert Requirements Bulletin B787-
81205-SB570041-00 RB, Issue 001, dated March 7, 2019.

(h) Exceptions to Service Information Specifications

    (1) For purposes of determining compliance with the requirements
of this AD: Where Boeing Alert Requirements Bulletin B787-81205-
SB570041-00 RB, Issue 001, dated March 7, 2019, uses the phrase
``the issue 001 date of Requirements Bulletin B787-81205-SB570041-00
RB,'' this AD requires using the effective date of this AD.
    (2) Where Boeing Alert Requirements Bulletin B787-81205-
SB570041-00 RB, Issue 001, dated March 7, 2019, specifies contacting
Boeing for repair instructions: This AD requires doing the repair
and applicable on-condition actions before further flight using a
method approved in accordance with the procedures specified in
paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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 (j) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.

(j) Related Information

    For more information about this AD, contact Greg Rutar,
Aerospace Engineer, Airframe Section, FAA, Seattle ACO Branch, 2200
South 216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Requirements Bulletin B787-81205-SB570041-00
RB, Issue 001, dated March 7, 2019.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com..
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on February 14, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-03964 Filed 2-26-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 24 (Friday, February 5, 2016)]
[Notices]
[Pages 6330-6332]
[FR Doc No: 2016-02300]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2015-0068]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA confirms its decision to exempt 44 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions enable these individuals to operate CMVs in interstate
commerce.

DATES: The exemptions were effective on November 21, 2015. The
exemptions expire on November 21, 2017.

FOR FURTHER INFORMATION CONTACT: Christine A. Hydock, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200

New Jersey Avenue SE., Room W64-113, Washington, DC 20590-0001. Office
hours are from 8:30 a.m. to 5 p.m. e.t., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On October 21, 2015, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 44 individuals and requested
comments from the public (80 FR 63863). The public comment period
closed on November 20, 2015, and no comments were received.
    FMCSA has evaluated the eligibility of the 44 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals with Insulin-Treated
Diabetes Mellitus to Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 44 applicants have had ITDM over a range of 1 to 34 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the October 21, 2015, Federal
Register notice and they will not be repeated in this notice.

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's or optometrist's report to the medical
examiner at the time of the annual medical examination; and (4) that
each individual provide a copy of the annual medical certification to
the employer for retention in the driver's qualification file, or keep
a copy in his/her driver's qualification file if he/she is self-
employed. The driver must also have a copy of the certification when
driving, for presentation to a duly authorized Federal, State, or local
enforcement official.

VI. Conclusion

    Based upon its evaluation of the 44 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above 949 CFR
391.64(b)):

Raul L. Armenta (CA)
Leonel Barrera, Jr. (TX)
James R. Barry, II (WV)
Alfred T. Benelli (PA)
Oliver T. Bridges (MO)
Rickie J. Burgess (NC)
Edson M. Chick (VT)
Jerome E. Collins (LA)
Jean K. Cyr, Sr. (ME)
Alvah R. Daniel, Jr. (WY)
Clarence P. Finch, Jr. (NJ)
John M. Fisher (VA)
Kent E. Fry (IL)
Stanley M. Garrison (AR)
Eric T. Herron (NV)
Lyle E. Hinspeter, Jr. (IA)
Burton W. Holliday (AL)
Justin L. Howe (IL)
Walter J. Leaders (MN)
Robert M. Manko (NY)
Raul D. Martinez (NY)
Roy T. McLeran (TX)
Clarance McNeill (NC)
Joe R. Minga (MS)

William H. Mowery (IA)
Tyna M. Murphy (PA)
Ojuang Okello (MN)
Jose A. Ortega (IL)
Troy D. Ostrowski (MN)
Terry G. Parker (OR)
Anthony T. Quaglieri (NJ)
Antonio Ramos (RI)
Robert G. Rosenbaum (IN)
Robert N. Ruhs (IA)
Louis A. Scandurro (LA)
Casey C. Small (CA)
Michael J. Soto (MI)
Ralph L. Staples (NY)
Ford J. stevens, Jr. (MA)
Donald T. Streich (WA)
Dale A. Stydinger (PA)
Raymond E. Thomason (CA)
Robert M. Wright (PA)
Joe L. Zamora (TX)

    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption is
valid for two years unless revoked earlier by FMCSA. The exemption will
be revoked if the following occurs: (1) The person fails to comply with
the terms and conditions of the exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: January 19, 2016.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2016-02300 Filed 2-4-16; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Notices]
[Page 24133]
[FR Doc No: 2018-11186]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0281]

Information Collection Request to Office of Management and
Budget; OMB Control Number: 1625-0094

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICR) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting an extension of
its approval for the following collection of information: 1625-0094,
Ships Carrying Bulk Hazardous Liquids, without change. Our ICR
describes the information we seek to collect from the public. Before
submitting this ICR to OIRA, the Coast Guard is inviting comments as
described below.

DATES: Comments must reach the Coast Guard on or before July 23, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0281] to the Coast Guard using the Federal
eRulemaking Portal at http://www.regulations.gov. See the ``Public
participation and request for comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.
    A copy of the ICR is available through the docket on the internet
at http://www.regulations.gov. Additionally, copies are available from:
Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast
Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710, Washington, DC
20593-7710.

FOR FURTHER INFORMATION: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. In response to
your comments, we may revise this ICR or decide not to seek an
extension of approval for the Collection. We will consider all comments
and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2018-0281], and
must be received by July 23, 2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at http://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

Information Collection Request

    Title: Ships Carrying Bulk Hazardous Liquids.
    OMB Control Number: 1625-0094.
    Summary: This information is needed to ensure the safe transport of
bulk hazardous liquids on chemical tank vessels and to protect the
environment from pollution.
    Need: Under 46 U.S.C. 3703, the Coast Guard is authorized to
prescribe regulations for protection against hazards to life, property,
and navigation and vessel safety, and protection of the marine
environment. The regulations for the safe transport by vessel of
certain bulk dangerous cargoes are contained in 46 CFR part 153.
    Forms: CG-4602B, Cargo Record Book; CG-5148, International
Certificate of Fitness for the Carriage of Liquefied Gases in Bulk; CG-
5148A, Certificate of Fitness for the Carriage of Dangerous Chemicals
in Bulk; CG-5148B, Certificate of Fitness for the Carriage of Dangerous
Chemicals in Bulk; and CG-5461, International Pollution Prevention
Certificate for the Carriage of Noxious Liquid Substances in Bulk.
    Respondents: Owners and operators of chemical tank vessels.
    Frequency: On occasion.
    Hour burden estimate: The estimated burden has increased from 5,539
hours to 7,611 hours a year due to an increase in the estimated annual
number of respondents.

    Authority: The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: May 21, 2018.
James D. Roppel,
 Acting Chief, U.S. Coast Guard, Office of Information Management.
[FR Doc. 2018-11186 Filed 5-23-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62642-62643]
[FR Doc No: 2013-24329]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0018; OMB No. 1660-0061]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Federal Assistance to Individuals and
Households Program (IHP)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is submitting a
request for review and approval of a collection of information under
the emergency processing procedures in Office of Management and Budget
(OMB) regulation 5 CFR 1320.13. FEMA is requesting that this
information collection be approved by November 12, 2013. The approval
will authorize FEMA to use the collection through May 12, 2014. FEMA
plans to follow this emergency request with a request for a 3-year
renewal approval. The request will be processed under OMB's normal
clearance procedures in accordance with the provisions of OMB
regulation 5 CFR 1320.10. To help us with the timely processing of the
emergency and normal clearance submissions to OMB, FEMA invites the
general public to comment on the proposed collection of information.

DATES: Comments must be submitted to OMB on or before November 12,
2013. You may submit comments to FEMA on or before November 12, 2013.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency (Proposed change to existing collection, FEMA Form
010-0-11<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>.
Comments may also be submitted to the following:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2013-0018. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Regulatory Affairs Division,
Office of Chief Counsel, DHS/FEMA, 500 C Street SW., Room 840,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Records Management Division, Office of the Chief Administrative
Officer, Mission Support Bureau, Federal Emergency Management Agency,
1800 South Bell Street, Arlington, VA 20598-3005, facsimile number
(202) 646-3347, or at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Act) is the legal
basis for FEMA to provide disaster related assistance and services to
individuals who apply for disaster assistance benefits in the event of
a federally declared disaster. The Individuals and Households Program
(IHP) (the Act at 5174, Federal Assistance to Individuals and
Households) provides financial assistance to eligible individuals and
households who, as a direct result of a major disaster or emergency
have necessary expenses and serious needs. The ``Other Needs
Assistance'' (ONA) provision of IHP provides disaster assistance to
address needs other than housing, such as personal property,
transportation, etc.
    The delivery of the ONA provision of IHP is contingent upon the
State/Tribe choosing an administrator for the assistance. States/Tribes
satisfy the selection of an administrator of ONA by completing the
Administrative Option Agreement (FEMA Form 010-0-11), which establishes
a plan for the delivery of ONA. This agreement establishes a
partnership with FEMA and inscribes the plan for the delivery of
disaster assistance. The agreement is used to identify the State/
Tribe's proposed level of support and participation during disaster
recovery. In response to Super Storm Sandy (October 2012), Congress
added ``child care'' expenses as a category of ONA through the Sandy
Recovery Improvement Act of 2013 (SRIA), Public Law 113-2. Section 1108
of the SRIA amends section 408(e)(1) of the Stafford Act (42 U.S.C.
5174(e)(1)), giving FEMA the specific authority to pay for ``child
care'' expenses as disaster assistance under ONA.
    In light of this legislation, FEMA needs to change FEMA Form 010-0-
11 so that States/Tribes who want to administer ONA can choose ``child
care'' expenses as one of the categories. Without having this option on
the form, FEMA cannot meet statutory requirement to consult with the
Governor of a State (or Tribal Executive) with respect to providing IHP
ONA.

Collection of Information

    Title: Federal Assistance to Individuals and Households Program,
(IHP).
    Type of Information Collection: Revision of a currently approved
collection.
    OMB Number: 1660-0061.
    FEMA Form: FEMA Form 010-0-11, Administrative Option Agreement for
the Other Needs provision of Individuals and Households Program, (IHP).
    Abstract: FEMA seeks to add a line item for to provide a maximum
dollar amount for Child Care assistance as part of ONA.
    Affected Public: State, Local or Tribal Government.
    Number of Respondents: 56.
    Estimated Time per Respondent: 1.08 (65 minutes).
    Estimated Total Annual Burden Hours: 60.5.
    Estimated Cost: $2,236.08.
    Frequency of Response: Once.

Comments

    Written comments are solicited to (a) evaluate whether the proposed
data collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the

use of appropriate automated, electronic, mechanical, or other
technology, e.g., permitting electronic submission of responses. Submit
comments to OMB within November 12, 2013. To ensure that FEMA is fully
aware of any comments or concerns that you share with OMB, please
provide FEMA with a copy of your comments. Submit comments to the FEMA
address listed in the FOR FURTHER INFORMATION CONTACT caption.

    Dated: September 30, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-24329 Filed 10-21-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 145 (Friday, July 29, 2022)]
[Proposed Rules]
[Pages 45715-45719]
[FR Doc No: 2022-16163]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0015; Project Identifier AD-2021-00832-R]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM).

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

SUMMARY: The FAA is revising a notice of proposed rulemaking (NPRM)
that would have applied to certain Airbus Helicopters Model EC225LP
helicopters. This action revises the NPRM by removing the requirement
to remove main rotor (M/R) rotating swashplates (swashplates) from
service that have accumulated less than 7 years since the date of
manufacture; increasing the life limit for certain swashplates;
requiring additional visual inspections, and adding repetitive
inspections for certain swashplates that have accumulated 7 or more
years, but less than 13 years, since the date of manufacture; and
updating the service information. The FAA is proposing this
airworthiness directive (AD) to address the unsafe condition on these
products. Since these actions would impose an additional burden over
those in the NPRM, the agency is requesting comments on this SNPRM.

DATES: The FAA must receive comments on this SNPRM by September 12,
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 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 between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this SNPRM, contact Airbus
Helicopters, 2701 North Forum Drive, Grand Prairie, TX 75052; phone:
(972) 641-0000 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
www.airbus.com/helicopters/technical-services/support.html. 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 www.regulations.gov by searching
for and locating Docket No. FAA-2022-0015; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains the NPRM, this SNPRM, the
European Union Aviation Safety Agency (EASA) AD, any comments received,
and other information. The street address for Docket Operations is
listed above.

FOR FURTHER INFORMATION CONTACT: Hal Jensen, Aerospace Engineer,
Operational Safety Branch, Compliance & Airworthiness Division, FAA,
950 L'Enfant Plaza N SW, Washington, DC 20024; phone:<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-2022-0015; Project Identifier
AD-2021-00832-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 again
revise 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
www.regulations.gov, including any personal information you provide.
The agency will also post a report summarizing each substantive verbal
contact received about this proposed AD.

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 SNPRM 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 SNPRM, 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 SNPRM. Submissions containing CBI should
be sent to Hal Jensen, Aerospace Engineer, Operational Safety Branch,
Compliance & Airworthiness Division, FAA, 950 L'Enfant Plaza N SW,
Washington, DC 20024; telephone:<PHONE_NUMBER>; 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 issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to Airbus Helicopters Model EC225LP helicopters, with an M/
R swashplate part number (P/N) 332A31-3074-00 or P/N 332A31-3074-01
installed. The NPRM published in the Federal Register on January 26,
2022 (87 FR 3943). The NPRM proposed to supersede AD 2020-23-05,
Amendment 39-21321 (85 FR 73604, November 19, 2020) (AD 2020-23-05),
which applies to certain Airbus Helicopters Model EC225LP helicopters.
AD 2020-23-05 requires inspecting the swashplate control rod attachment
yokes (yokes) of certain swashplates, establishing a life limit,
performing a one-time inspection of stripped yokes, and applicable
corrective actions. AD 2020-23-05 was prompted by a crack in a yoke,
which could result in failure of the yoke, loss of M/R control, and
subsequent loss of control of the helicopter. AD 2020-23-05 was also
prompted by EASA AD 2019-0074, dated March 28, 2019 (EASA AD 2019-
0074), issued by EASA, which is the Technical Agent for the Member
States of the European Union, to correct an unsafe condition for Airbus
Helicopters (AH), formerly Eurocopter, Eurocopter France, Model EC 225
LP helicopters. EASA advised that Airbus Helicopters established a life
limit (also called a service life limit) of 12 years for the swashplate
and added a reporting requirement if there is a crack or corrosion in a
yoke. EASA further advised that additional analysis determined that it
is necessary to introduce a new life limit for the affected
swashplates.
    In the NPRM, the FAA proposed to retain all the requirements of AD
2020-23-05. The NPRM also proposed to include a revised compliance time
for the initial visual inspection of the yokes

on swashplates that have accumulated less than seven years since the
date of manufacture; and clarification that dye penetrant inspection of
the yoke is required before further flight if no cracks are detected
during the visual inspection.
    The NPRM was prompted by the determination that a revised
compliance time is necessary for swashplates that have accumulated less
than seven years since the date of manufacture. The FAA has also
determined that clarification is necessary regarding when it is
necessary to do a dye penetrant inspection of the yoke.

Actions Since the NPRM Was Issued

    Since the NPRM was issued, EASA issued EASA AD 2019-0074R1, dated
March 8, 2022 (EASA AD 2019-0074R1), which supersedes EASA AD 2019-
0074. EASA advises that additional investigation confirmed that the
life limit of certain swashplates can be extended and Airbus
Helicopters has issued updated service information to reflect the new
life limit.
    Also, since the NPRM was issued, the FAA determined that
swashplates that have accumulated less than 7 years since the date of
manufacture are not susceptible to the unsafe condition and should be
removed from paragraph (g) of the proposed AD. The FAA also determined
that paragraph (g) of the proposed AD needs to be revised to include
repetitive inspections for swashplates that have accumulated 7 or more
years, but less than 13 years, since the date of manufacture, and the
criteria for when to perform a dye penetrant inspection needs to be
revised.
    The FAA determined there was an error in the Background section of
the NPRM, which stated, ``AD 2020-23-05 was prompted by a crack in a
swashplate yoke.'' The FAA determined AD 2020-23-05 was not prompted by
a crack in a yoke, but was prompted by testing conducted by Airbus
Helicopters, which determined cracks may develop overtime. The FAA also
determined that the applicable service information required by the
proposed AD needs to be revised in order to include the updated
revision.
    Finally, the FAA determined that the time estimated for inspecting
the yokes needed to be increased from 0.25 work-hour to 0.50 work-hour,
which increased the estimated cost for that inspection from $21 to $43
per helicopter per inspection cycle.

Comments

    The following discussion presents the comments received on the NPRM
and the FAA's response.

Request To Revise the Required Actions Paragraph of the Proposed AD

    Five commenters requested the FAA revise the Required Actions
paragraph of the proposed AD by removing the visual inspection for
swashplates that have accumulated less than 7 years since the date of
manufacture. Airbus Helicopters stated that testing was performed for
certain aluminum alloys and as a result Airbus Helicopters defined a
calendar threshold of 7 years, after which the swashplate may present
crack initiation. Airbus Helicopters further explained due to this
testing, there is no rationale to require the visual inspection prior
to the 7 year threshold. An additional commenter stated the inspection
for swashplates that have accumulated less than 7 years since the date
of manufacture is not in line with the required service information.
Additionally, Air Center Helicopters Inc., explained that the EASA AD
and the service information do not require repetitive visual
inspections for any swashplates that have accumulated less than 7 years
since the date of manufacture and that these repetitive inspections are
not required until after the swashplate has accumulated 7 or more years
since the date of manufacture.
    The FAA agrees and has revised the Required Actions paragraph of
this proposed AD by removing the inspection requirements for
swashplates that have accumulated less than 7 years since the date of
manufacture.
    Four commenters requested the FAA revise the Required Actions
paragraph to include a repetitive visual inspection, at intervals not
to exceed 15 hours time-in-service (TIS) or 7 days, after certain
swashplates have accumulated 7 or more years since the date of
manufacture. Three commenters also requested that the FAA revise the
Required Actions paragraph of this proposed AD to require that this
repetitive visual inspection be performed utilizing a bright light and
10X magnifying glass.
    The FAA partially agrees. The FAA agrees to revise the Required
Actions paragraph of this proposed AD to include a repetitive visual
inspection, at intervals not to exceed 15 hours TIS or 7 days,
whichever occurs first, for swashplates that have accumulated 7 or more
years, but less than 13 years, since the date of manufacture, until the
swashplate accumulates 13 years since the date of manufacture. The FAA
disagrees with mandating the use of a bright light and 10X magnifying
glass for this repetitive visual inspection because the FAA has not
determined that a bright light or 10X magnifying glass are necessary
for this repetitive visual inspection; however an operator may choose
to use this inspection method.
    Five commenters requested the FAA revise the Required Actions
paragraph to remove the dye penetrant inspection in situations where no
crack is detected. Airbus Helicopters stated with regards to crack
detectability, the dye penetrant inspection creates an unnecessary
burden if no crack is detected visually, and should only be performed
if a scratch or surface degradation is detected. Two commenters also
stated performing the dye penetrant inspection, if a crack is not
detected, would increase the estimated costs and downtime for
operators.
    The FAA agrees to revise the Required Actions paragraph of this
proposed AD to include an additional visual inspection for a scratch
and surface degradation, if no crack is detected. The FAA determined if
any indications of scratches or surface degradation are detected during
the visual inspection, a dye penetrant inspection must be performed to
address the unsafe condition. Accordingly, the FAA has revised the
Required Actions paragraph to require a visual inspection for a scratch
and surface degradation if no cracks are visually detected, and a dye
penetrant inspection if there is any scratch or surface degradation.
    Five commenters requested the FAA revise the Required Actions
paragraph to extend the life limit of the swashplate from 12 years to
13 years, in accordance with the revised service information.
    The FAA agrees and has revised the Required Actions paragraph of
this proposed AD by increasing the life limit of the swashplate to 13
years.

Request To Use Latest Revision of the Applicable Service Information

    Three commenters requested that the FAA revise the proposed AD to
reference EASA AD 2019-0074R1 instead of EASA AD 2019-0074. The
commenters also requested that the FAA revise the proposed AD to
reference Airbus Helicopters Emergency Alert Service Bulletin (EASB)
No. 05A051, Revision 4, dated February 28, 2022 (EASB 05A051 Rev 4),
instead of Airbus Helicopters EASB No. 05A051 and EASB No. 05A046, each
Revision 2, and dated February 26, 2019.
    The FAA agrees EASA AD 2019-0074R1 and EASB 05A051 Rev 4 are the
appropriate sources of related information for the actions specified,
and has revised this proposed AD to reference this updated information.

Request To Approve Future Revisions of the Service Information

    Three commenters requested that the FAA revise the proposed AD to
consider the accomplishment of future revisions of EASB 05A051 Rev 4 as
acceptable for compliance with the proposed AD. Two commenters stated
EASA AD 2019-0074R1 allows the use of future revisions of the
applicable service information and requested that the FAA also allow
compliance with later revisions. One commenter stated later revisions
of the applicable service information should be allowed in order to
capture future applicable appendixes, swashplate serial numbers, and
swashplate manufacture dates.
    The FAA disagrees with the request to allow future revisions of the
applicable service information as acceptable for compliance with the
proposed AD. Referring to documents that do not exist at the time the
final rule is published violates Office of the Federal Register (OFR)
regulations regarding approval of materials ``incorporated by
reference'' in rules. These OFR regulations require that either the
service document be submitted for approval by the OFR as ``referenced''
material, in which case it may be simply called out in the text of an
AD, or the service document contents be published as part of the actual
AD language. An AD may reference only the specific service document
that was submitted and approved by the OFR for ``incorporation by
reference.'' In order for operators to use later revisions of the
referenced document (issued after the publication of the AD), either
the FAA must revise the AD to reference the specific later revisions,
or operators must request the approval of their use as an alternative
method of compliance under the provisions of paragraph (j) of this
proposed AD.

Request To Revise the Background Section of the Proposed AD

    One commenter requested that the FAA revise the background section
of the NPRM to indicate that no cracks to the swashplate have been
detected in service, but testing by Airbus Helicopters determined that
cracks could develop over time.
    The FAA agrees with the commenter and has revised the Actions Since
the NPRM was Issued section in this proposed AD accordingly.

FAA's Determination

    These helicopters have been approved by EASA and are approved for
operation in the United States. Pursuant to the FAA's bilateral
agreement with the European Union, EASA has notified the FAA about the
unsafe condition described in its AD. The FAA is proposing this AD
after determining the unsafe condition described previously is likely
to exist or develop in other helicopters of the same type design.
Certain changes described above expand the scope of the NPRM. As a
result, it is necessary to reopen the comment period to provide
additional opportunity for the public to comment on this SNPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed one document that co-publishes two Airbus
Helicopters EASB identification numbers: EASB 05A051 Rev 4 for Model
EC225LP helicopters and EASB No. 05A046 for non-FAA type-certificated
Model EC725AP helicopters, Revision 4, dated February 28, 2022 (EASB
05A046 Rev 4). This service information specifies inspections for
swashplate P/N 332A31-3074-00 and P/N 332A31-3074-01. This service
information specifies procedures for a repetitive inspection of the
yokes for a crack and a one-time inspection of the stripped yokes for
corrosion and a crack. If in doubt about whether there is a crack, this
service information specifies performing a nondestructive inspection.
    Additionally, this service information specifies touching up the
swashplate with varnish if there is corrosion, removing any damage
within allowable limits, and refinishing the yokes. If there is a crack
in a yoke, this service information specifies replacing the swashplate.
This service information also specifies a life limit of 13 years since
the date of manufacture for the swashplates and reporting requirements
if a crack or corrosion is discovered. EASB 05A051 Rev 4 also updates
the list of serial numbers and manufacture dates of the swashplates.
EASB 05A046 Rev 4, dated February 28, 2022, is not proposed for
incorporation by reference in this SNPRM.
    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.

Proposed AD Requirements in This SNPRM

    This proposed AD would retain some of the requirements of AD 2020-
23-05. This proposed AD would also require compliance with a revised
life limit, a repetitive visual inspection of the yokes on swashplates
that have accumulated 7 or more years, but less than 13 years, since
the date of manufacture; and if a crack is detected, removing the
swashplate from service. If no cracks are detected but a scratch or
surface degradation is detected, this proposed AD would require
performing a dye penetrant inspection of the yoke. If a crack is
detected during the dye penetrant inspection, this proposed AD would
require removing the swashplate from service.

Differences Between This SNPRM and EASA AD 2019-0074R1 or the Service
Information

    EASB 05A051 Rev 4 requires performing a non-destructive inspection
if in doubt about whether there is a crack in a yoke. This proposed AD
would require a visual inspection and if no cracks are detected,
visually inspecting for a scratch and surface degradation. If a scratch
or surface degradation is detected, this proposed AD would require a
non-destructive inspection (dye penetrant inspection). EASB 05A051 Rev
4 also specifies sending the swashplate back to Airbus Helicopters if
cracks are found, whereas this proposed AD would not require sending
any affected parts back to Airbus Helicopters.
    EASA AD 2019-0074R1 specifies instructions for reporting inspection
results, whereas this proposed AD would not require reporting
inspection results.

Costs of Compliance

    The FAA estimates that this AD, if adopted as proposed, would
affect 28 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.

                                                          Estimated Costs for Required Actions
--------------------------------------------------------------------------------------------------------------------------------------------------------
                Action                          Labor cost           Parts cost             Cost per product                 Cost on U.S. operators
--------------------------------------------------------------------------------------------------------------------------------------------------------
Determination of the manufacture date   0.5 work-hour x $85 per                $0  $43...............................  $1,204.
 of the swashplate.                      hour = $43.

Inspecting the yokes..................  0.5 work-hour x $85 per                 0  43 per inspection cycle...........  1,204 per inspection cycle.
                                         hour = $43 per
                                         inspection cycle.
Removing grease, stripping the yokes,   8 work-hours x $85 per                  0  680...............................  19,040.
 and inspecting the stripped yokes.      hour = $680.
Creating a life limit record..........  1 work-hour x $85 per                   0  85................................  2,380.
                                         hour = $85.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
aircraft that might need these on-condition actions:

                                     Estimated Costs of On-Condition Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
----------------------------------------------------------------------------------------------------------------
Removing any corrosion or repairing damage      3 work-hours x $85 per hour =                 $0            $255
 within the allowable limit.                     $255.
Replacing the swashplate......................  6 work-hours x $85 per hour =             85,661          86,171
                                                 $510.
Dye-penetrant inspection......................  6 work-hours x $85 per hour =                 50             560
                                                 $510.
----------------------------------------------------------------------------------------------------------------

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, 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:
0
a. Removing Airworthiness Directive 2020-23-05, Amendment 39-21321 (85
FR 73604, November 19, 2020; and
0
b. Adding the following new airworthiness directive:

Airbus Helicopters: Docket No. FAA-2022-0015; Project Identifier AD-
2021-00832-R.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) action by September 12, 2022.

(b) Affected ADs

    This AD replaces AD 2020-23-05, Amendment 39-21321 (85 FR 73604,
November 19, 2020) (AD 2020-23-05).

(c) Applicability

    This AD applies to Airbus Helicopters Model EC225LP helicopters,
certificated in any category, with a main rotor (M/R) rotating
swashplate (swashplate) part number (P/N) 332A31-3074-00 or P/N
332A31-3074-01 installed.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 6230, Main Rotor
Mast/Swashplate.

(e) Unsafe Condition

    This AD was prompted by results of testing, which determined
that a crack could develop in a swashplate control rod attachment
yoke (yoke), and the notification of a new life limit for certain
swashplates. The FAA is issuing this AD to detect and correct a
crack in a yoke. The unsafe condition, if not addressed, could
result in failure of the yoke, loss of M/R control, and subsequent
loss of control of the helicopter.

(f) Compliance

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

(g) Required Actions

    Before further flight, review Appendix 4.A. of Airbus
Helicopters Emergency Alert Service Bulletin (EASB) No. 05A051,
Revision 4, dated February 28, 2022 (EASB 05A051 Rev 4) to determine
the date of manufacture of the swashplate.
    (1) If the swashplate has accumulated 13 or more years since the
date of manufacture, remove the swashplate from service.
    (2) If the swashplate has accumulated less than 13 years since
the date of manufacture, create a component history card or
equivalent record indicating a life limit of 13 years since the date
of manufacture. Thereafter, continue to record the life limit of the
swashplate on its component history card or equivalent record and
remove any

swashplate from service before accumulating 13 years since the date
of manufacture.
    (3) For each swashplate that has accumulated 7 or more years,
but less than 13 years, since the date of manufacture, within 15
hours time-in-service (TIS) or 7 days, whichever occurs first after
the effective date of this AD, and thereafter at intervals not to
exceed 15 hours TIS or 7 days, whichever occurs first, until the
swashplate accumulates 13 years since the date of manufacture,
visually inspect each yoke for a crack, paying particular attention
to the areas shown in Details B, C, and D of Figure 1 of EASB 05A051
Rev 4. If there is any crack on the yoke, before further flight,
remove the swashplate from service.
    (i) If no cracks are visually detected, before further flight,
visually inspect for a scratch and surface degradation on the yoke.
    (ii) If there is any scratch or surface degradation on the yoke,
before further flight, perform a dye penetrant inspection of the
yoke for a crack.
    (iii) If there is any crack on the yoke, before further flight,
remove the swashplate from service.
    (4) For each swashplate that has accumulated 7 or more years,
but less than 13 years, since the date of manufacture, within 100
hours TIS after the effective date of this AD:
    (i) Remove the grease from areas (E), (F), (G), (H), (J), and
(K) of each yoke as shown in Details B, C, and D of Figure 1 of EASB
05A051 Rev 4. Using a plastic spatula, strip areas (E), (F), (G),
(H), (J), and (K) of each yoke as shown in Details B, C, and D of
Figure 1 of EASB 05A051 Rev 4. Do not use a metal tool to strip any
area of a yoke.
    (ii) Inspect areas (E), (F), (G), (H), (J), and (K) of each yoke
as shown in Details B, C, and D of Figure 1 of EASB 05A051 Rev 4 for
corrosion, pitting, and loss of material.
    (A) If there is any corrosion less than 0.0078 in. (0.2 mm),
before further flight, remove the corrosion and apply varnish
(Vernelec 43022 or equivalent) to the surface of areas (E), (F),
(G), (H), (J), and (K).
    (B) If there is any pitting or loss of material of less than
0.0078 in. (0.2 mm), before further flight, remove the damage by
sanding with sandpaper 200/400 or 330.
    (C) If there is any corrosion, pitting, or loss of material of
0.0078 in. (0.2 mm) or greater, before further flight, remove the
swashplate from service.
    (iii) Visually inspect each yoke for a crack, paying particular
attention to the areas shown in Details B, C, and D of Figure 1 of
EASB 05A051 Rev 4.
    (A) If there is any crack on the yoke, before further flight,
remove the swashplate from service.
    (B) If no cracks are visually detected, before further flight,
perform the actions as required in paragraphs (g)(3)(i) through
(iii) of this AD.

(h) Credit for Previous Actions

    If you performed the actions in paragraph (g)(4) of this AD
before the effective date of this AD using Airbus Helicopters EASB
No. 05A051, Revision 1, dated November 16, 2017; Airbus Helicopters
EASB No. 05A051, Revision 2, dated February 26, 2019; or Airbus
Helicopters EASB No. 05A051 Revision 3, dated December 7, 2021, you
have met the requirements of paragraph (g)(4) of this AD.

(i) Special Flight Permit

    Special flight permits are prohibited.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation 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 International Validation Branch, send
it to the attention of the person identified in paragraph (k)(1) 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.

(k) Related Information

    (1) For more information about this AD, contact Hal Jensen,
Aerospace Engineer, Operational Safety Branch, Compliance &
Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC
20024; telephone:<PHONE_NUMBER>; email: [email protected].
    (2) For service information identified in this AD, contact
Airbus Helicopters, 2701 North Forum Drive, Grand Prairie, TX 75052;
phone:<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
www.airbus.com/helicopters/services/technical-support.html. You may
view this referenced 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>.
    (3) The subject of this AD is addressed in European Union
Aviation Safety Agency (EASA) AD 2019-0074R1, dated March 8, 2022.
You may view the EASA AD at www.regulations.gov in Docket No. FAA-
2022-0015.

    Issued on July 22, 2022.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2022-16163 Filed 7-28-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Notices]
[Pages 50744-50746]
[FR Doc No: 2011-20826]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2011-0705]

Merchant Marine Personnel Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Notice of Federal Advisory Committee meeting.

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

SUMMARY: The Merchant Marine Personnel Advisory Committee (MERPAC) will
meet on October 6, 2011 and October 7, 2011 in Washington, DC to
discuss various issues related to the training and fitness of merchant
marine personnel. This meeting will be open to the public.

DATES: MERPAC working groups will meet on October 6, 2011, from 8 a.m.
until 4 p.m., and the full committee will meet on October 7, 2011, from
8 a.m. until 4 p.m. This meeting may adjourn early if all business is
finished. Written comments to be distributed to committee members and
placed on MERPAC's website are due September 23, 2011.

ADDRESSES: The Committee will meet in Room 2501 of Coast Guard
Headquarters, 2100 Second Street, SW., Washington, DC 20593. To
facilitate public participation, we are inviting public comment on the
issues to be considered by the committee and working groups. Written
comments must be identified by Docket No. USCG-2011-0705 and submitted
by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments (preferred method to
avoid delays in processing).
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590-0001.
     Hand delivery: Same as mail address above, between 9 a.m.
and 5 p.m., Monday through Friday, except Federal Holidays. The
telephone number is<PHONE_NUMBER>.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov.
    Any requests to make oral presentations should be made in advance
using one of the methods highlighted above. This notice may be viewed
in our online docket, USCG-2011-0705, at http://www.regulations.gov. We
request that members of the public who plan to attend this meeting
notify Mr. Rogers Henderson at<PHONE_NUMBER> no later than October 3,
2011, so that he may notify building security officials.

Attendees will be required to provide a picture identification card in
order to gain admittance to the Coast Guard Headquarters building.

FOR FURTHER INFORMATION CONTACT: Mr. Mark Gould, Alternate Designated
Federal Officer (ADFO) to the Designated Federal Officer (DFO) of
MERPAC, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).
    MERPAC is an advisory committee authorized under section 871 of the
Homeland Security Act of 2002, Title 6, United States Code, section
451, and chartered under the provisions of the FACA. The Committee will
act solely in an advisory capacity to the Secretary of the Department
of Homeland Security (DHS) through the Commandant of the Coast Guard
and the Director of Commercial Regulations and Standards on matters
relating to personnel in the U.S. merchant marine, including but not
limited to training, qualifications, certification, documentation, and
fitness standards. The Committee will advise, consult with, and make
recommendations reflecting its independent judgment to the Secretary.

Agenda of Meeting

Day 1

    The agenda for the October 6, 2011, meeting is as follows:
    (1) The full committee will meet briefly to discuss the working
groups' business/task statements, which are listed under paragraph 2
below.
    (2) Working groups addressing the following task statements,
available for viewing at http://homeport.uscg.mil/merpac will meet to
deliberate:
    (a) Task Statement 58, concerning Stakeholder Communications during
Merchant Mariner Licensing and Documentation Program (MLD)
Restructuring and Centralization;
    (b) Task Statement 71, concerning Review of USCG/IMO Operational
Level Examination (3rd Mate/2nd Mate and 3rd/2nd Assistant Engineer)
Topics and Questions and Alignment with the STCW Code;
    (c) Task Statement 75, concerning Review of the Supplemental Notice
of Proposed Rulemaking Concerning the Implementation of the Amendments
to the International Convention on Standards of Training, Certification
and Watchkeeping for Seafarers, 1978, and Changes to Domestic
Endorsements;
    (d) Task Statement 76, concerning Review of Performance Measures
(Assessment Criteria); and
    (e) Task Statement 77, concerning Development of Performance
Measures (Assessment Criteria).
    (3) If time allows, working groups addressing the following task
statements, available for viewing at http://homeport.uscg.mil/merpac
may meet to deliberate:
    (a) Task Statement 30, concerning Utilizing Military Education,
Training and Assessment for STCW (the International Convention on
Standards of Training, Certification & Watchkeeping for Seafarers
(1978), as amended) and U.S. Coast Guard Certifications;
    (b) Task Statement 73, concerning Development of Training Guidance
for Engineers Serving on Near-Coastal Vessels; and
    (c) Task Statement 74, concerning Merchant Mariner Credential (MMC)
Components.
    (4) The Coast Guard may form new working groups to address any
additional issues emanating from the existing task statements.
    (5) Reports of working groups. At the end of the day, the working
groups will make a report to the full committee on what was
accomplished in their meetings. The full committee will not take action
on these reports on this date. Any official action taken as a result of
this working group meeting will be taken on day 2 of the meeting.
    (6) Adjournment of meeting.

Day 2

    The agenda for the October 7, 2011, Committee meeting is as
follows:
    (1) Introduction;
    (2) Remarks from Coast Guard Leadership, Mr. Jeff Lantz;
    (3) Introduction of the new members;
    (4) Roll call of committee members and determination of a quorum;
    (5) DFO announcements;
    (6) Reports from the following working groups;
    (a) Task Statement 30, concerning Utilizing Military Education,
Training and Assessment for STCW and U.S. Coast Guard Certifications;
    (b) Task Statement 58, concerning Stakeholder Communications during
MLD Program Restructuring and Centralization;
    (c) Task Statement 71, concerning Review of USCG/IMO Operational
Level Examination (3rd Mate/2nd Mate and 3rd/2nd Assistant Engineer)
Topics and Questions and Alignment with the STCW Code;
    (d) Task Statement 73, concerning Development of Training Guidance
for Engineers Serving on Near-Coastal Vessels;
    (e) Task Statement 74, concerning Merchant Mariner Credential (MMC)
Components;
    (f) Task Statement 75, concerning Review of the Supplemental Notice
of Proposed Rulemaking Concerning the Implementation of the Amendments
to the International Convention on Standards of Training, Certification
and Watchkeeping for Seafarers, 1978, and Changes to Domestic
Endorsements;
    (g) Task Statement 76, concerning Review of Performance Measures
(Assessment Criteria); and
    (h) Task Statement 77, concerning Development of Performance
Measures (Assessment Criteria).
    (7) Other items which will be discussed:
    (a) Report on National Maritime Center (NMC) activities from NMC
Commanding Officer;
    (b) Reporting on IMO/ILO related activities; and
    (c) Briefings concerning on-going Coast Guard projects related to
personnel in the U.S. Merchant Marine.
    (8) Period for public comments/presentations.
    (9) Discussion of working group recommendations. The committee will
review the information presented on each issue, deliberate on any
recommendations presented by the working groups and approve/formulate
recommendations for the Department's consideration. Official action on
these recommendations may be taken on this date.
    (10) Closing remarks/plans for next meeting.
    (11) Adjournment of meeting.
    Procedural: This meeting will be open to the public. Please note
that the meeting may adjourn early if all business is finished.
    A copy of all meeting documentation is available at the https://www.fido.gov Web site or by contacting Mark Gould. Once you have
accessed the MERPAC Committee page, click on the meetings tab and then
the ``View'' button for the meeting dated 10/6/2011 to access the
information for this meeting. Minutes will be available 90 days after
this meeting. Both minutes and documents applicable for this meeting
can also be found at an alternative site using the following Web
address: https://homeport.uscg.mil and use these key strokes: Missions;
Port and Waterways Safety; Advisory Committees; MERPAC; and then use
the event key.
    Public participation: To facilitate public participation, we are
inviting public comment on the issues to be considered by the committee
and working groups. Written comments must be identified by Docket No.

USCG-2011-0705 and submitted by one of the methods specified in
ADDRESSES. Written comments received will be posted without alteration
at http://www.regulations.gov, including any personal information
provided. Anyone can search the electronic form of comments received
into the docket by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). For access to the docket to read
background documents or comments received in response to this notice,
go to http://www.regulations.gov. An opportunity for public oral
comment will be held during the MERPAC public meeting on October 7,
2011. Speakers are requested to limit their comments to 3 minutes.
Please note that the public oral comment period may end before the
prescribed ending time indicated following the last call for comments.
Contact Mark Gould at<EMAIL_ADDRESS>to register as a speaker.
    Information on services for individuals with disabilities: For
information on facilities or services for individuals with disabilities
or to request special assistance at the meeting, contact the ADFO as
soon as possible.

    Dated: August 10, 2011.
J.G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2011-20826 Filed 8-15-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 216 (Wednesday, November 7, 2012)]
[Notices]
[Pages 66847-66848]
[FR Doc No: 2012-27068]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Circulatory System Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on December 5 and 6, 2012,
from 8 a.m. to 6 p.m.
    Location: Holiday Inn, Grand Ballroom, 2 Montgomery Village Ave.,
Gaithersburg, MD. The hotel phone number is<PHONE_NUMBER>.
    Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On December 5, 2012, during session I, the committee will
discuss and make recommendations regarding the 515(i) order issued by
FDA on April 9, 2009 [Docket No. FDA-2009-M-0101], for the external
counter-pulsating (ECP) devices, one of the remaining pre-Amendment
Class III devices. These systems typically consist of a treatment
table, pressure cuffs and a controller. They are intended to provide
noninvasive circulatory support by applying external pressure to the
lower extremities during diastole to increase coronary perfusion
pressure, and releasing external pressure during systole to reduce left
ventricular workload.
    On March 9, 1979 (44 FR 13426), FDA published a proposed rule for
classification of ECP devices as class III requiring premarket
approval. The Cardiovascular Device Classification Panel (the Panel)
recommended class III because the device is life supporting and
potentially hazardous to life or health even when used properly. In
addition, the Panel believed that sufficient information did not exist
to determine the adequacy of general controls or to establish standards
to provide a reasonable assurance of the safety and effectiveness of
the device. Subsequent to the proposed rule, in 1980, FDA classified
external counter-pulsating devices into class III after receiving no
comments on the proposed rule (45 FR 7966, February 5, 1980). In 1987,
FDA published a clarification by inserting language in the codified
language stating that no effective date had been established for the
requirement for premarket approval for ECP devices (52 FR 17737, May
11, 1987).
    The discussion at the panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to premarket approval application [PMA]) or
reclassify to class I or class II (subject to premarket notification
[510(k)]), as directed by section 515(i) of the Federal Food, Drug and
Cosmetic Act.
    On December 5, 2012, during session II, the committee will discuss
and make recommendations regarding the 515(i) order issued by FDA on
April 9, 2009 [Docket No. FDA-2009-M-0101], for Intra-aortic balloon
and control systems, one of the remaining pre-Amendment Class III
devices. Intra-aortic balloon pump (IABP) systems consist of an
inflatable balloon and a console which inflates in synchronization with
the cardiac cycle. During diastole, the balloon will inflate, creating
a rise in pressure in the aorta, thus increasing blood flow to the
coronary arteries and increasing myocardial oxygen supply. During
systole, deflation of the balloon causes a fall in pressure in the
aorta, which assists the left ventricle by reducing the pressure that
needs to be generated to achieve ejection through the aortic valve.
    On March 9, 1979 (44 FR 13369), FDA published a proposed rule for
classification of IABP devices as class III requiring premarket
approval. The Panel recommended class III because the device is life
supporting and because the Panel believed that insufficient medical and
scientific information existed to establish a standard to assure the
safety and effectiveness of the device. The Panel also stated that
controversy exists as to whether the device is beneficial in many
situations in which it is used, and that it is difficult to use the
device safely and effectively. Subsequent to the proposed rule, in
1980, FDA classified IABP devices into class III after receiving no
comments on the proposed rule (45 FR 7939, February 5, 1980). In 1987,
FDA published a clarification by inserting language in the codified
language stating that no effective date had been established for the
requirement for premarket approval for IABP devices (52 FR 17736, May
11, 1987).
    The discussion at the panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to premarket approval application [PMA]) or
reclassify to class I or class II (subject to premarket notification
[510(k)]), as directed by section 515(i) of the Federal Food, Drug and
Cosmetic Act.
    On December 6, 2012, the committee will discuss and make
recommendations regarding the 515(i) order issued by FDA on April 9,
2009 [Docket No. FDA-2009-M-0101], for Nonroller-type cardiopulmonary
bypass blood pumps, one of the remaining pre-Amendment Class III
devices. A nonroller-type cardiopulmonary bypass blood pump is a device
that uses a method other than revolving rollers to pump blood. There
are two types of

nonroller-type pumps which have been reviewed by the Agency: (1)
Centrifugal type pumps utilize a rotor to impart energy to the blood in
an extracorporeal circuit through centrifugal forces. These pumps are
part of an extracorporeal circuit usually containing an oxygenator and
are intended to provide cardiopulmonary support, during procedures such
as cardiopulmonary bypass surgery, for periods lasting 6 hours or less.
(2) Micro-axial type pumps are comprised of a pump motor, a cannula and
a catheter that connects to a console. These pumps are not designed to
be used with an oxygenator but are temporarily placed within the heart
or vasculature to provide cardiac support only.
    On March 9, 1979 (44 FR 13409), FDA published a proposed rule for
classification of nonroller-type cardiopulmonary bypass blood pumps as
class III requiring premarket approval. The Panel recommended class III
because the device is life sustaining and life supporting and is
potentially hazardous to life or health even when properly used. The
Panel indicated that general controls alone would not provide
sufficient control over the performance characteristics of the device,
and that a performance standard would not provide reasonable assurance
of the safety and effectiveness of the device and, moreover, that there
was not sufficient information to establish a performance standard.
Consequently, the Panel believed that premarket approval was necessary
to assure the safety and effectiveness of the device. Subsequent to the
proposed rule, in 1980, FDA classified nonroller-type cardiopulmonary
bypass blood pumps into class III after receiving no comments on the
proposed rule (45 FR 7959, February 5, 1980). In 1987, FDA published a
clarification by inserting language in the codified language stating
that no effective date had been established for the requirement for
premarket approval for nonroller-type cardiopulmonary bypass blood
pumps (52 FR 17737, May 11, 1987).
    In 1993, FDA published a proposed rule requiring filing a PMA or
Product Development Protocol (PDP) for nonroller type cardiopulmonary
bypass blood pumps, and provided an opportunity to request a change in
classification in the form of a reclassification petition (58 FR 36290,
July 6, 1993). On July 21, 1993, FDA received a reclassification
petition from manufacturers of these devices recommending
reclassification to Class II (special controls). In 1995, FDA convened
the Panel to review the proposed reclassification and proposed special
controls for nonroller-type cardiopulmonary blood pumps for use in
cardiopulmonary bypass circuits for periods of up to six hours. Micro-
axial type pumps as described previously were not included in the scope
of the reclassification. Reclassification to Class II with special
controls was supported by the Panel for nonroller-type cardiopulmonary
blood pumps for use in cardiopulmonary bypass circuits for periods of
up to six hours, but FDA did not issue a regulation codifying the
proposed reclassification. In 2004, the July 6, 1993 proposed rule (58
FR 36290) was withdrawn because the proposed rule was no longer
considered a viable candidate for final action (69 FR 68831, November
26, 2004).
    The discussion at the panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to premarket approval application [PMA]) or
reclassify to class I or class II (subject to premarket notification
[510(k)]), as directed by section 515(i) of the Federal Food, Drug and
Cosmetic Act.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 26, 2012. Oral presentations from the public will be scheduled
between approximately 9:30 a.m. and 10 a.m. for session I and between 2
p.m. and 2:30 p.m. for session II. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before November 13, 2012. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 14, 2012.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Conference Management Staff, at<EMAIL_ADDRESS>or<PHONE_NUMBER>
at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 31, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-27068 Filed 11-6-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 167 (Friday, August 28, 2015)]
[Notices]
[Pages 52268-52269]
[FR Doc No: 2015-21387]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-93-000]

Eric S. Morris v. North American Electric Reliability
Corporation, SERC Reliability Corporation; Notice of Complaint

    Take notice that on August 21, 2015, pursuant to sections 306 of
the Federal Power Act, 16 U.S.C. 825(e) and Rule 206 of the Federal
Energy Regulatory Commission's (Commission) Rules of Practice and
Procedure, 18 CFR 385.206, Eric S. Morris (Complainant) filed a formal
complaint against the North American Electric Reliability Corporation
(NERC) and SERC Reliability Corporation (SERC) (collectively,
Respondents), alleging that the Respondents violated the NERC on Rules
of Procedure Appendix 4B Sanction Guidelines in NERC Full Notice of
Penalty regarding Entergy, FERC Docket No. NP15-31 filed July 30, 2015.
    Eric S. Morris certifies that copies of the complaint were served
on the contacts for NERC and SERC as listed on

the Commission's list of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on September 10, 2015.

    Dated: August 24, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-21387 Filed 8-27-15; 8:45 am]
 BILLING CODE 6717-01-P