[Federal Register: April 17, 2009 (Volume 74, Number 73)]
[Proposed Rules]
[Page 17795-17797]
[DOCID:fr17ap09-11]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-0201; Directorate Identifier 2008-NE-47-AD]
RIN 2120-AA64

Airworthiness Directives; Thielert Aircraft Engines GmbH (TAE)
Models TAE 125-01 and TAE 125-02-99 Reciprocating Engines Installed in,
but not Limited to, Diamond Aircraft Industries Model DA42 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) issued by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    In-flight shutdown incidents have been reported on Diamond
Aircraft Industries DA42 aircraft equipped with TAE 125 engines.
Preliminary investigations showed that it was mainly the result of
failure of the propeller control valve. This condition, if not
corrected, could lead to further cases of engine in-flight shutdown,
possibly resulting in reduced control of the aircraft.

We are proposing this AD to prevent engine in-flight shutdown, possibly
resulting in reduced control of the aircraft.

DATES: We must receive comments on this proposed AD by May 18, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
the same as the Mail address provided in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Jason Yang, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-0201;
Directorate Identifier 2008-NE-47-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2008-0145, dated August 1, 2008 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products.] The MCAI states:

    In-flight shutdown incidents have been reported on Diamond
Aircraft Industries DA42 aircraft equipped with TAE 125 engines.
Preliminary investigations showed

that it was mainly the result of failure of the propeller control
valve. This condition, if not corrected, could lead to further cases
of engine in-flight shutdown, possibly resulting in reduced control
of the aircraft.

You may obtain further information by examining the MCAI in the AD
docket.

Differences Between This Proposed AD and the MCAI

    We have reviewed the MCAI and, in general, agree with its
substance. But we have found it necessary to not reference the last
sentence of the unsafe condition from the MCAI. That sentence stated
that the problem has only manifested itself on those Thielert engines
installed on Diamond Aircraft Industries DA-42 aircraft. The affected
engines, which require a propeller control valve, could be used on
other make and model airplanes in the future.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of Germany
and is approved for operation in the United States. Pursuant to our
bilateral agreement with Germany, EASA has notified us of the unsafe
condition described in the MCAI. We are proposing this AD because we
evaluated all information provided by EASA and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 300 TAE 125-01 and TAE 125-02-99 reciprocating
engines installed in Diamond Aircraft Industries Model DA42 airplanes
of U.S. registry. We also estimate that it would take about 0.2 work-
hour per engine to comply with this proposed AD. The average labor rate
is $80 per work-hour. Required parts would cost about $275 per product.
Based on these figures, we estimate the cost of the proposed AD on U.S.
operators for one replacement of the propeller control valve, to be
$87,300.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, 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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Thielert Aircraft Engines GmbH: Docket No. FAA-2009-0201;
Directorate Identifier 2008-NE-47-AD.

Comments Due Date

    (a) We must receive comments by May 18, 2009.

Affected Airworthiness Directives (ADs)

    (b) None.

Applicability

    (c) This AD applies to Thielert Aircraft Engines GmbH (TAE)
models TAE 125-01 and TAE 125-02-99 reciprocating engines installed
in, but not limited to, Diamond Aircraft Industries Model DA42
airplanes.

Reason

    (d) In-flight shutdown incidents have been reported on Diamond
Aircraft Industries DA42 aircraft equipped with TAE 125 engines.
Preliminary investigations showed that it was mainly the result of
failure of the propeller control valve. This condition, if not
corrected, could lead to further cases of engine in-flight shutdown,
possibly resulting in reduced control of the aircraft.
    We are issuing this AD to prevent engine in-flight shutdown,
possibly resulting in reduced control of the aircraft.

Actions and Compliance

    (e) Unless already done, do the following actions.
    (1) If the engine is installed with propeller control valve,
part number (P/N) NM-0000-0124501, replace the propeller control
valve no later than the following times:

                        Table 1--Compliance Times
------------------------------------------------------------------------
 If the gearbox accumulated time-since-
  new on the effective date of this AD                Then:
                  is:
------------------------------------------------------------------------
(i) 400 or more flight hours (FH)......  Replace within 55 FH or during
                                          the next scheduled
                                          maintenance, whichever occurs
                                          first, after the effective
                                          date of this AD.
(ii) Fewer than 400 FH.................  Initially replace upon
                                          accumulating 300 FH (first
                                          scheduled maintenance), or
                                          within 110 FH, whichever
                                          occurs later, after the
                                          effective date of this AD.
------------------------------------------------------------------------

                         Repetitive Replacements
------------------------------------------------------------------------
(iii) After completing (i) or (ii)       Replace the propeller control
 above.                                   valve at intervals not to
                                          exceed 300 FH.
------------------------------------------------------------------------

    (2) If the engine is not installed with propeller control valve,
P/N NM-0000-0124501, no action is required.

Alternative Methods of Compliance (AMOCs)

    (f) The Manager, Engine Certification Office, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.

Related Information

    (g) Refer to MCAI EASA Airworthiness Directive 2008-0145, dated
August 1, 2008.
    (h) Refer to Thielert Service Bulletin TM TAE 125-0018, dated
June 19, 2008 (TAE 125-01), and Thielert Service Bulletin TM TAE
125-1007 P1, dated July 11, 2008 (TAE 125-02-99) for related
information.
    (i) Contact Thielert Aircraft Engines GmbH, Platanenstrasse 14
D-09350, Lichtenstein, Germany, telephone: +49-37204-696-0; fax:
+49-37204-696-55; e-mail<EMAIL_ADDRESS>for a copy of
this service information.
    (j) Contact Jason Yang, Aerospace Engineer, Engine Certification
Office, FAA, Engine and Propeller Directorate, 12 New England
Executive Park, Burlington, MA 01803; e-mail<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>, for more information
about this AD.

    Issued in Burlington, Massachusetts, on April 13, 2009.
Peter A. White,
Assistant Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E9-8785 Filed 4-16-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 185 (Friday, September 23, 2011)]
[Notices]
[Pages 59126-59127]
[FR Doc No: 2011-24515]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0674; FRL-8888-8]

Pesticide Experimental Use Permit; Receipt of Application;
Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's receipt of an application 100-EUP-
RRL from Syngenta Crop Protection, LLC requesting an experimental use
permit (EUP) for the acibenzolar S-methyl. The Agency has determined
that the permit may be of regional and national significance.
Therefore, in accordance with 40 CFR 172.11(a), the Agency is
soliciting comments on this application.

DATES: Comments must be received on or before October 24, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0674, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington,VA. Deliveries are only accepted
during the Docket Facility's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0674. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rose Mary Kearns, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who are or may be required to
conduct testing of chemical substances under the Federal Food, Drug,
and Cosmetic Act (FFDCA) or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since other entities may also be interested,
the Agency has not attempted to describe all the specific entities that
may be affected by this action. If you have any questions regarding the
applicability of this action

to a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the
pesticide(s) discussed in this document, compared to the general
population.

II. What action is the agency taking?

    Under section 5 of FIFRA, 7 U.S.C. 136c, EPA can allow
manufacturers to field test pesticides under development. Manufacturers
are required to obtain an EUP before testing new pesticides or new uses
of pesticides if they conduct experimental field tests on 10 acres or
more of land or one acre or more of water.
    Pursuant to 40 CFR 172.11(a), the Agency has determined that the
following EUP application may be of regional and national significance,
and therefore is seeking public comment on the EUP application:
    Submitter: Syngenta Crop Protection, LLC, (100-EUP-RRL).
    Pesticide Chemical: Acibenzolar S-methyl.
    Summary of Request: Syngenta proposes that an EUP be allowed and
initiated on May 1, 2012 and extended for up to two years ending on
September 1, 2014. The purpose is to allow broader acres to be treated
in order to better evaluate the diseases. Due to the nature of the
crops, small plots are not feasible and crop destruct is very
expensive. The formulation to be used for the EUP will be Actigard
50WG[reg]. Geographic areas: 10 states, representing diverse agronomic
zones; permission to conduct the EUP is requested within EPA Regions 1,
2, 3, 5, 10, and 11. Distribution within each EPA Region will be
determined based upon state regulatory approval, availability of
suitable testing sites, and availability/participation of non-Syngenta
personnel, e.g., university cooperators or other factors. Use of test
product will be closely monitored and records will accurately document
the disposition of all testing material. Trial applications will be
made by licensed applicators. A temporary tolerance of 0.05 parts per
million (ppm) for acibenzolar S-methyl is proposed in pome fruit and
0.05 ppm in citrus fruit during the experimental use period requested
from 2012 through 2014.
    A copy of the application and any information submitted is
available for public review in the docket established for this EUP
application as described under ADDRESSES.
    Following the review of the application and any comments and data
received in response to this solicitation, EPA will decide whether to
issue or deny the EUP request, and if issued, the conditions under
which it is to be conducted. Any issuance of an EUP will be announced
in the Federal Register.

List of Subjects

    Environmental protection, Experimental use permits.

    Dated: September 14, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-24515 Filed 9-22-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 154 (Friday, August 9, 2019)]
[Rules and Regulations]
[Pages 39176-39177]
[FR Doc No: 2019-17078]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-0352; Product Identifier 2019-NE-09-AD; Amendment
39-19705; AD 2019-16-02]
RIN 2120-AA64

Airworthiness Directives; GE Honda Aero Engines Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
GE Honda Aero Engines (GHAE) HF120 model turbofan engines with a
certain fuel pump metering unit (FPMU) assembly. This AD was prompted
by damage found on the permanent magnetic alternator (PMA) drive gear
within the FPMU assembly. This AD requires removal of a certain FPMU
assembly and its replacement with a part eligible for installation. The
FAA is issuing this AD to address the unsafe condition on these
products.

DATES: This AD is effective September 13, 2019.

ADDRESSES: For service information identified in this final rule,
contact GE Honda Aero Engines, LLC, 9050 Centre Pointe Drive, Suite
exception occurred on : 2019-17078.htm
exception occurred on : 2019-17078.htm
350, West Chester, OH, 45069; phone<PHONE_NUMBER>; email: aero.com">[email protected]aero.com; internet: www.gehonda.com. You may view this service
information at the FAA, Engine and Propeller Standards Branch, 1200
District Avenue, Burlington MA, 01803. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at http://www.regulations.gov by searching
for and locating Docket No. FAA-2019-0352.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2019-
0352; 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: Michael Richardson-Bach, Aerospace
Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; 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 all GHAE HF120 model
turbofan engines with a certain FPMU assembly. The NPRM published in
the Federal Register on May 21, 2019 (84 FR 22986). The NPRM was
prompted by an incident on a flight test engine that resulted in the
loss of over-speed protection warning. GHAE's subsequent investigation
found damage on the PMA drive gear teeth within the FPMU assembly,
which was likely due to dynamic loads on the drive gear that exceeded
the material capability. The NPRM proposed to require removal of a
certain FPMU assembly and its replacement with a part eligible for
installation. The FAA is issuing this AD to address the unsafe
condition on these products.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Request To Update Service Information

    GHAE commented that the Related Service Information section of the
NPRM refers to ``GHAE HF120 Service Bulletin (SB) 73-0016 R01, dated
November 08, 2018.'' GHAE recommended that the FAA revise the AD to
refer to Revision 02, dated May 13, 2019. GHAE noted that GHAE HF120 SB
73-0016 R02 clarifies the interchangeability statement to eliminate
confusion as to the FPMU part numbers that are eligible for
installation.
    The FAA agrees. The FAA revised the Related Service Information
paragraph in this AD to refer to GHAE HF120 SB 73-0016 R02, dated May
13, 2019.

Request To Revise JASC Code

    GHAE commented that it considers the FPMU an engine fuel control,
falling under JASC Code 7321, Fuel Control/Turbine Engines. GHAE
classifies the FPMU as 73-21-00 in its Engine Illustrated Parts
Catalog. GHAE therefore recommended that the FAA change the JASC Code
from 7314, Engine Fuel Pump, to 7321, Fuel Control/Turbine Engines.
    The FAA agrees. The FAA revised the JASC Code in this AD as
suggested by the commenter.

Request To Update Address

    GHAE commented that the GHAE business address listed in the NPRM is
incorrect. GHAE indicated its office suite number has changed. GHAE
requested that the FAA change the address in this AD to Suite 350.
    The FAA agrees. The FAA updated the address in this AD as suggested
by the commenter.

Conclusion

    The FAA reviewed the relevant data, considered the comments
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

    The FAA reviewed GHAE HF120 SB 73-0016 R02, dated May 13, 2019. The
SB describes procedures for replacement of the FPMU assembly with a
part eligible for installation.

Costs of Compliance

    The FAA estimates that this AD affects 161 engines installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost            Parts cost      Cost per product      operators
----------------------------------------------------------------------------------------------------------------
Replace the FPMU...............  6.5 work-hours x $85              $50,000         $50,552.50      $8,138,952.50
                                  per hour = $552.50.
----------------------------------------------------------------------------------------------------------------

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to engines, propellers, and
associated appliances to the Manager, Engine and Propeller Standards
Branch, Policy and Innovation Division.

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):

2019-16-02 GE Honda Aero Engines: Amendment 39-19705; Docket No.
FAA-2019-0352; Product Identifier 2019-NE-09-AD.

(a) Effective Date

    This AD is effective September 13, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all GE Honda Aero Engines (GHAE) HF120 model
turbofan engines with fuel pump metering unit (FPMU) assembly, part
number (P/N) 24100-Q0A-F000, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7321, Fuel Control/
Turbine Engines.

(e) Unsafe Condition

    This AD was prompted by damage found on the permanent magnetic
alternator drive gear within the FPMU assembly. The FAA is issuing
this AD to prevent failure of the FPMU assembly. The unsafe
condition, if not addressed, could result in failure of one or more
engines, loss of thrust control, and loss of the airplane.

(f) Compliance

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

(g) Required Actions

    Within 20 engine hours after the effective date of this AD, or
before accumulating 600 engine hours since new, whichever occurs
later, remove the affected FPMU assembly from service and replace it
with a part eligible for installation.

(h) Installation Prohibition

    After the effective date of this AD, do not install on any
engine an FPMU assembly, P/N 24100-Q0A-F000.

(i) Definition

    For the purposes of this AD, a ``part eligible for
installation'' is:
    (1) an FPMU assembly, P/N 24100-Q0A-G000 or P/N 24100-Q0A-F100;
or
    (2) an FPMU assembly, P/N 24100-Q0A-F000, that is rebuilt and
marked as P/N 24100-Q0A-G000 or P/N 24100-Q0A-F100.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, ECO Branch, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the manager of the
certification office, send it to the attention of the person
identified in paragraph (k) of this AD. You may email your request
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.

(k) Related Information

    For more information about this AD, contact Michael Richardson-
Bach, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    None.

    Issued in Burlington, Massachusetts, on August 6, 2019.
Robert J. Ganley,
Manager, Engine & Propeller Standards Branch, Aircraft Certification
Service.
[FR Doc. 2019-17078 Filed 8-8-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Page 40038]
[FR Doc No: 2021-15859]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-2408-000]

SR Lumpkin, LLC. Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
SR Lumpkin, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is August 9, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: July 20, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-15859 Filed 7-23-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 232 (Tuesday, December 3, 2019)]
[Notices]
[Pages 66216-66217]
[FR Doc No: 2019-26109]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0746]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0118

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, 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: 1625-0118,
Various International Agreement Certificates and Documents; without
change. Our ICR describe the information we seek to collect from the
public. Review and comments by OIRA ensure we only impose paperwork
burdens commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
January 2, 2020.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2019-0746] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. Alternatively, you
may submit comments to OIRA using one of the following means:
    (1) Email<EMAIL_ADDRESS>    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    (3) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, attention Desk Officer for the Coast
Guard.
    A copy of the ICR is available through the docket on the internet
at https://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. Consistent with
the requirements of Executive Order 13771, Reducing Regulation and
Controlling Regulatory Costs, and Executive Order 13777, Enforcing the
Regulatory Reform Agenda, the Coast Guard is also requesting comments
on the extent to which this request for information could be modified
to reduce the burden on respondents. These comments will help OIRA
determine whether to approve the ICR referred to in this Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2019-0746], and must be received by January 2,
2020.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://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 https://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 https://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).
    OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0118.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard has published the 60-day notice (84 FR 48361, September 13,
2019) required by 44 U.S.C. 3506(c)(2). That Notice elicited no
comments. Accordingly, no changes have been made to the Collection.

Information Collection Request

    Title: Various International Agreement Certificates and Documents.
    OMB Control Number: 1625-0118.
    Summary: This information collection is associated with the
Maritime Labour Convention, 2006. The Coast Guard established a
voluntary inspection program for vessels who wish to document
compliance with the requirements of the MLC. U.S. commercial vessels
that operate on international routes are eligible to participate. The
Coast Guard issues voluntary compliance certificates as proof of
compliance with the MLC.
    Need: This information is needed to determine if a vessel is in
compliance with the Maritime Labour Convention, 2006.
    Forms:

 CG-16450, Maritime Labour Certificate (Statement of Voluntary
Compliance)
 CG-16450A, Interim Maritime Labour Certificate (Statement of
Voluntary Compliance)
 CG-16450B, Declaration of Maritime Labour Certficiate--Part I
(Statement of Voluntary Compliance)
 CG-16450C, United States Coast Guard, Maritime Labour
Convention, 2006 Inspection Report

    Respondents: Vessel owners and operators.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has increased from 625
hours to 653 hours a year, due to an increase in the estimated annual
number of responses.

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

    Dated: November 27, 2019.
James D. Roppel,
 Chief, U.S. Coast Guard, Office of Information Management.
[FR Doc. 2019-26109 Filed 12-2-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36591-36593]
[FR Doc No: 2020-13079]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0345]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Drug Product Communications as Used by
the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a generic clearance to collect information
to support communications used by FDA about drug products.

DATES: Submit either electronic or written comments on the collection
of information by August 17, 2020.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 17, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 17, 2020. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely

if they are postmarked or the delivery service acceptance receipt is on
or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-0345 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Data To Support Drug Product
Communications as Used by the Food and Drug Administration.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Data To Support Drug Product Communications as Used by the Food and
Drug Administration

OMB Control Number 0910-0695--Extension

    This information collection supports Agency outreach efforts.
Testing of communication messages in advance of a communication
campaign provides an important role in improving FDA communications as
they allow for an indepth understanding of individuals' attitudes,
beliefs, motivations, and feelings. The methods to be employed include
individual in-depth interviews, general public focus group interviews,
intercept interviews, self-administered surveys, gatekeeper surveys,
and professional clinician focus group interviews, all on a voluntary
basis. The methods to be used serve the narrowly defined need for
direct and informal opinion on a specific topic and, as a qualitative
research tool, have two major purposes: (1) To obtain information that
is useful for developing variables and measures for formulating the
basic objectives of risk communication campaigns; and (2) to assess the
potential effectiveness of messages and materials in reaching and
successfully communicating with their intended audiences. We will use
these methods to test and refine our ideas and to help develop messages
and other communications but will generally conduct further research
before making important decisions, such as adopting new policies and
allocating or

redirecting significant resources to support these policies. We will
use this mechanism to test messages about regulated drug products on a
variety of subjects related to consumer, patient, or health care
professional perceptions and about use of drug products and related
materials, including but not limited to, direct-to-consumer
prescription drug promotion, physician labeling of prescription drugs,
medication guides, over-the-counter drug labeling, emerging risk
communications, patient labeling, online sale of medical products, and
consumer and professional education. Annually, we project about 45
communication studies using the variety of test methods listed in this
document. We are requesting an extension of these burden hours so as
not to restrict our ability to gather information on public sentiment
for its proposals in its regulatory and communications programs.
    We estimate the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Number of
                    Activity                         Number of      responses per     Total annual       Average burden per response       Total hours
                                                    respondents       respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys..............................          43,875                1           43,875   0.21925 (12 minutes)..............          9,620
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection has not changed
since the last OMB approval.

    Dated: June 5, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13079 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 184 (Monday, September 23, 2019)]
[Notices]
[Pages 49747-49748]
[FR Doc No: 2019-20478]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1961]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before December 23, 2019.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1961, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each

community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
   City and County of San Francisco, California and Incorporated Areas
           Project: 11-09-1225S Preliminary Date: May 31, 2019
------------------------------------------------------------------------
City and County of San Francisco.......  Office of the City
                                          Administrator, City Hall, Room
                                          362, 1 Dr. Carlton B. Goodlett
                                          Place, San Francisco, CA
                                          94102.
------------------------------------------------------------------------
                Lake County, Ohio and Incorporated Areas
          Project: 13-05-1798S Preliminary Date: April 23, 2019
------------------------------------------------------------------------
City of Mentor.........................  Municipal Center, 8500 Civic
                                          Center Boulevard, Mentor, OH
                                          44060.
City of Mentor-on-the-Lake.............  City Hall, 5860 Andrews Road,
                                          Mentor-on-the-Lake, OH 44060.
Unincorporated Areas of Lake County....  County Engineer's Office, 550
                                          Blackbrook Road, Painesville,
                                          OH 44077.
Village of Fairport Harbor.............  Village Hall, 220 Third Street,
                                          Fairport Harbor, OH 44077.
Village of Grand River.................  Village Hall, 205 Singer
                                          Avenue, Grand River, OH 44045.
------------------------------------------------------------------------

[FR Doc. 2019-20478 Filed 9-20-19; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 86, Number 236 (Monday, December 13, 2021)]
[Rules and Regulations]
[Pages 70731-70733]
[FR Doc No: 2021-26926]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 882

[Docket No. FDA-2021-N-0575]

Medical Devices; Neurological Devices; Classification of the
Temporary Coil Embolization Assist Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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

SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the temporary coil embolization assist device into class II (special
controls). The special controls that apply to the device type are
identified in this order and will be part of the codified language for
the temporary coil embolization assist device's classification. We are
taking this action because we have determined that classifying the
device into class II (special controls) will provide a reasonable
assurance of safety and effectiveness of the device. We believe this
action will also enhance patients' access to beneficial innovative
devices.

DATES: This order is effective December 13, 2021. The classification
was applicable on April 24, 2019.

FOR FURTHER INFORMATION CONTACT: Xiaolin Zheng, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4224, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the temporary coil embolization
assist device as class II (special controls), which we have determined
will provide a reasonable assurance of safety and effectiveness. In
addition, we believe this action will enhance patients' access to
beneficial innovation, by placing the device into a lower device class
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section

510(k) of the FD&C Act (21 U.S.C. 360(k) and part 807 (21 CFR part
807).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device
was automatically within class III, the De Novo classification is
considered to be the initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo
process, the device can serve as a predicate for future devices of that
type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application to market a substantially equivalent
device (see 21 U.S.C. 360c(i), defining ``substantial equivalence'').
Instead, sponsors can use the less-burdensome 510(k) process, when
necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 29, 2017, finding the
Comaneci Embolization Assist Device not substantially equivalent to a
predicate not subject to a premarket approval application. Thus, the
device remained in class III in accordance with section 513(f)(1) of
the FD&C Act when we issued the order.
    On September 28, 2017, Rapid-Medical Ltd. submitted a request for
De Novo classification of the Comaneci Embolization Assist Device. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves
are insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to the
general controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on April 24, 2019, FDA issued an order to the requester
classifying the device into class II. In this final order, FDA is
codifying the classification of the device by adding 21 CFR
882.5955.\1\ We have named the generic type of device temporary coil
embolization assist device, and it is identified as a prescription
device intended for temporary use in the neurovasculature to
mechanically assist in the embolization of intracranial aneurysms with
embolic coils. The device is delivered into the neurovasculature with
an endovascular approach. This device is not intended to be permanently
implanted and is removed from the body when the procedure is completed.
---------------------------------------------------------------------------

    \1\ FDA notes that the ``ACTION'' caption for this final order
is styled as ``Final amendment; final order,'' rather than ``Final
order.'' Beginning in December 2019, this editorial change was made
to indicate that the document ``amends'' the Code of Federal
Regulations. The change was made in accordance with the Office of
Federal Register's (OFR) interpretations of the Federal Register Act
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and
parts 21 and 22), and the Document Drafting Handbook.
---------------------------------------------------------------------------

    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

 Table 1--Temporary Coil Embolization Assist Device Risks and Mitigation
                                Measures
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Infection..............................  Sterilization validation,
                                          Pyrogenicity testing, Shelf
                                          life testing, and Labeling.
Adverse tissue reaction................  Biocompatibility evaluation.
Tissue or vessel damage:...............  Non-clinical performance
 Dissection....................   testing, Clinical performance
 Perforation...................   testing, and Labeling.
 Hemorrhage....................
 Vasospasm.....................
Thromboembolic event...................  Non-clinical performance
                                          testing, Clinical performance
                                          testing, and Labeling.
Coils ensnarement......................  Non-clinical performance
                                          testing, Clinical performance
                                          testing, and Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. We encourage sponsors to consult
with us if they wish to use a non-animal testing method they believe is
suitable, adequate, validated, and feasible. We will consider if such
an alternative method could be assessed for equivalency to an animal
test method.

This device is subject to premarket notification requirements under
section 510(k) of the FD&C Act.
    At the time of classification, temporary coil embolization assist
devices are for prescription use only. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21
CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations and guidance. These collections of information are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections
of information in the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in 21 CFR part 814, subparts A through E, regarding
premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding
premarket notification submissions, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
820, regarding quality system regulation, have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR
part 801, regarding labeling, have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 882

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 882 is amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for part 882 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  882.5955 to subpart F to read as follows:

Sec.  882.5955   Temporary coil embolization assist device.

    (a) Identification. A temporary coil embolization assist device is
a prescription device intended for temporary use in the
neurovasculature to mechanically assist in the embolization of
intracranial aneurysms with embolic coils. The device is delivered into
the neurovasculature with an endovascular approach. This device is not
intended to be permanently implanted and is removed from the body when
the procedure is completed.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Clinical performance testing of the device must demonstrate the
device performs as intended for temporary use as an endovascular device
to assist in the coil embolization of intracranial aneurysms and must
evaluate all adverse events, including tissue or vessel damage that
could lead to dissection, perforation, hemorrhage, or vasospasm,
thrombo-embolic events, and coil entanglement.
    (2) The patient-contacting components of the device must be
demonstrated to be biocompatible.
    (3) Non-clinical performance testing must demonstrate the device
performs as intended under anticipated conditions of use, including:
    (i) Mechanical testing to demonstrate the device can withstand
anticipated tensile, torsional, compressive, and tip deflection forces;
    (ii) Mechanical testing to evaluate the radial forces exerted by
the device;
    (iii) Simulated use testing to demonstrate the device can be
delivered to the target location in the neurovasculature and is
compatible with embolic coils;
    (iv) Dimensional verification testing;
    (v) Radiopacity testing; and
    (vi) Performance testing to evaluate the coating integrity and
particulates under simulated use conditions.
    (4) Animal testing under anticipated use conditions must evaluate
all adverse events, including damage to vessels or tissues.
    (5) Performance data must support the sterility and pyrogenicity of
the device.
    (6) Performance data must support the shelf life of the device by
demonstrating continued sterility, package integrity, and device
functionality over the labeled shelf life.
    (7) The labeling must include:
    (i) Instructions for use;
    (ii) A detailed summary of the device technical parameters,
including compatible delivery catheter dimensions and device sizing
information;
    (iii) A summary of the clinical testing results, including a
detailed summary of the device- and procedure-related complications and
adverse events; and
    (iv) A shelf life.

    Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26926 Filed 12-10-21; 8:45 am]
BILLING CODE 4164-01-P