[Federal Register Volume 88, Number 71 (Thursday, April 13, 2023)]
[Rules and Regulations]
[Pages 22357-22359]
[FR Doc No: 2023-07746]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2023-0019; Project Identifier MCAI-2022-01155-T;
Amendment 39-22393; AD 2023-06-07]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A330-202, -203, -223, and -243 airplanes; Model A330-
200 Freighter series airplanes; Model A330-300 series airplanes; Model
A340-200 series airplanes; and Model A340-300 series airplanes. This AD
was prompted by a report that damage was found to the firewall and
fuselage skin in the auxiliary power unit (APU) compartment area on
Model A330 airplanes. This AD requires replacing affected tee ducts
with serviceable parts, as specified in a European Union Aviation
Safety Agency (EASA) AD, which is incorporated by reference. This AD
also prohibits the installation of affected parts. The FAA is issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective May 18, 2023.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 18,
2023.

ADDRESSES:

    AD Docket: You may examine the AD docket at regulations.gov under
Docket No. FAA-2023-0019; 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 mandatory continuing airworthiness
information (MCAI), any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Material Incorporated by Reference:
     For material incorporated by reference in this AD, contact
EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email [email protected]easa.europa.eu; website easa.europa.eu. You may
find this material on the EASA website at ad.easa.europa.eu.
     You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available in the AD docket at
regulations.gov under Docket No. FAA-2023-0019.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, Aerospace Engineer,
Large Aircraft Section, FAA, International Validation Branch, 2200
South 216th St., Des Moines, WA 98198; telephone<PHONE_NUMBER>; email
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to all Airbus SAS Model
A330-202, A330-203, A330-223, A330-223F, A330-243, A330-243F, A330-301,
A330-302, A330-303, A330-321, A330-322, A330-323, A330-341, A330-342,
A330-343, A340-211, A340-212, A340-213, A340-311, A340-312, and A340-
313 airplanes. The NPRM published in the Federal Register on January
20, 2023 (88 FR 3678). The NPRM was prompted by AD 2022-0175, dated
August 23, 2022, issued by EASA, which is the Technical Agent for the
Member States of the European Union (EASA AD 2022-0175) (also referred
to as the MCAI). The MCAI states that damage was found to the firewall
and fuselage skin in the APU compartment area on Model A330 airplanes.
Subsequent investigation determined that cracks started because of high
cycle fatigue in the tee duct, which led to a hot air leak. Due to the
design similarity, this condition could also exist or develop on Model
A340 airplanes. This condition, if not corrected, could lead to damage
to the APU compartment firewall, possibly jeopardizing its capability
to contain a fire.
    In the NPRM, the FAA proposed to require replacing affected tee
ducts with serviceable parts, as specified in EASA AD 2022-0175. The
NPRM also proposed to prohibit the installation of affected parts. The
FAA is issuing this AD to address the unsafe condition on these
products.
    You may examine the MCAI in the AD docket at regulations.gov under
Docket No. FAA-2023-0019.

Discussion of Final Airworthiness Directive

Comments

    The FAA received a comment from Air Line Pilots Association,
International (ALPA), who supported the NPRM without change.

Conclusion

    This product has been approved by the aviation authority of another
country and is approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with this State of Design Authority, it
has notified the FAA of the unsafe condition described in the MCAI
referenced above. The FAA reviewed the relevant data, considered the
comment received, and determined that air safety requires adopting this
AD as proposed. Accordingly, the FAA is issuing this AD to address the
unsafe condition on this product. Except for minor editorial changes,
this AD is adopted as proposed in the NPRM. None of the changes will
increase the economic burden on any operator.

Related Service Information Under 1 CFR Part 51

    EASA AD 2022-0175 specifies procedures for replacement of affected
tee ducts (Part Number (PN) 3884654-4 or PN 3884654-5) with serviceable
parts (PN 3884654-6). EASA AD 2022-0175 also prohibits the installation
of affected parts. This material 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 123 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
4 work-hours x $85 per hour = $340...........................         $35,931          $36,271       $4,461,333
----------------------------------------------------------------------------------------------------------------

    The FAA has included all known costs in its cost estimate.
According to the manufacturer, however, some or all of the costs of
this AD may be covered under warranty, thereby reducing the cost impact
on affected operators.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the

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

List of Subjects in 14 CFR Part 39

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

The Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2023-06-07 Airbus SAS: Amendment 39-22393; Docket No. FAA-2023-0019;
Project Identifier MCAI-2022-01155-T.

(a) Effective Date

    This airworthiness directive (AD) is effective May 18, 2023.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS airplanes specified in
paragraphs (c)(1) through (5) of this AD, certificated in any
category.
    (1) Model A330-202, -203, -223, and -243 airplanes.
    (2) Model A330-223F and -243F airplanes.
    (3) Model A330-301, -302, -303, -321, -322, -323, -341, -342,
and -343 airplanes.
    (4) Model A340-211, -212, and -213 airplanes.
    (5) Model A340-311, -312, and -313 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 49, Airborne
Auxiliary Power.

(e) Unsafe Condition

    This AD was prompted by a report that damage was found to the
firewall and fuselage skin in the auxiliary power unit (APU)
compartment area on Model A330 airplanes. Subsequent investigation
determined that cracks started because of high cycle fatigue in the
tee duct, which led to a hot air leak. The FAA is issuing this AD to
address cracks in the tee duct. This condition, if not corrected,
could lead to a hot air leak from the tee duct and damage to the APU
compartment firewall, possibly jeopardizing its capability to
contain a fire.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2022-0175, dated August 23, 2022 (EASA AD 2022-0175).

(h) Exceptions to EASA AD 2022-0175

    (1) Where EASA AD 2022-0175 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) The ``Remarks'' section of EASA AD 2022-0175 does not apply
to this AD.

(i) Additional AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): 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 responsible Flight Standards Office, as
appropriate. If sending information directly to the International
Validation Branch, send it to the attention of the person identified
in paragraph (j) of this AD. Information may be emailed to: [email protected]. Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, International
Validation Branch, FAA; or EASA; or Airbus SAS's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (i)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(j) Additional Information

    For more information about this AD, contact Vladimir Ulyanov,
Aerospace Engineer, Large Aircraft Section, FAA, International
Validation Branch, 2200 South 216th St., Des Moines, WA 98198;
telephone<PHONE_NUMBER>; email [email protected].

(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2022-0175,
dated August 23, 2022.
    (ii) [Reserved]
    (3) For EASA AD 2022-0175, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
[email protected]; website easa.europa.eu. You may find this EASA
AD on the EASA website at ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
[email protected], or go to: www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on March 16, 2023.
Christina Underwood,
Acting Director, Compliance & Airworthiness Division, Aircraft
Certification Service.
[FR Doc. 2023-07746 Filed 4-12-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 72 (Thursday, April 14, 2011)]
[Rules and Regulations]
[Pages 20840-20842]
[FR Doc No: 2011-8944]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2011-N-0188]

Medical Devices; General and Plastic Surgery Devices;
Classification of the Low Level Laser System for Aesthetic Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is classifying the low
level laser system for aesthetic use into class II (special controls).
The special control(s) that will apply to the device is entitled
``Class II Special Controls Guidance Document: Low Level Laser System
for Aesthetic Use.'' The Agency is classifying the device into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a guidance document
that will serve as the special control for this device type.

DATES: This rule is effective May 16, 2011. The classification was
effective on August 24, 2010.

FOR FURTHER INFORMATION CONTACT: Richard Felten, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1436, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What is the background of this rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval, unless and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and 21 CFR part 807 of the regulations.
    Section 513(f)(2) of the FD&C Act provides that any person who
submits a premarket notification under section 510(k) of the FD&C Act
for a device that has not previously been classified may, within 30
days after receiving an order classifying the device into class III
under section 513(f)(1) of the FD&C Act, request FDA to classify the
device under the criteria set forth in section 513(a)(1) of the FD&C
Act. FDA will, within 60 days of receiving this request, classify the
device by written order. This classification will be the initial
classification of the device. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register announcing this classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an
order on

December 22, 2008, classifying the Erchonia Low Level Laser System for
Aesthetic Use into class III because it was not substantially
equivalent to a device that was introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, or a device which was subsequently reclassified
into class I or class II. On January 5, 2009, Erchonia, Inc., submitted
a petition requesting classification of the Erchonia Low Level Laser
System for Aesthetic Use under section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the device be classified into class II.
(Ref. 1)
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the petition in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies 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 to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the petition, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls will provide reasonable
assurance of the safety and effectiveness of the device.
    The device is assigned the generic name Low Level Laser System for
Aesthetic Use, and it is identified as a device using low level laser
energy for the disruption of adipocyte cells within the fat layer for
the release of fat and lipids from these cells for noninvasive
aesthetic use.
    FDA has identified the following risks to health associated
specifically with this type of device and the recommended measures to
mitigate these risks.
     Ocular injury is a recognized hazard from laser optical
systems because of the unique physical characteristics of laser light;
that is, this optical radiation is easily transmitted into the eye as a
very bright, intense light beam that may produce lesions on the retina.
This hazard is addressed by device labeling, which includes
recommendations for not looking directly at the laser beam and the
wearing of appropriate laser safety eyewear by both the user and
patient. The labeling also includes information defining the size of
the area within which this optical hazard exists.
     Electrical shock is addressed by recommended testing of
the device according to recognized U.S. and international standards
specifically designed to determine and measure potential electrical
safety. Again, the recommended device labeling also includes specific
warnings for the user in terms of device placement, appropriate
electrical wiring needs, reminders to periodically check device wiring
and accessories for damage, and avoidance of use of the device in
environments where electrical shock is possible.
     Unintended cell damage is a potential risk from use of low
level lasers if improper or incorrect energy is used to initiate the
process of causing lipid and fat leakage from the target adipocyte
cells. The intended effect on the adipocyte cells is the creation of
pores that results in the lipid or fat leaving these specialized cells;
however, if the laser parameters are not correct, no effect may occur
in terms of adipocyte change or other non-adipocyte cells may be
affected, resulting in alteration of other cellular membranes or
transport systems that could result in unintended cell death.
     Use error represents those risks to the patient that can
occur from improper use of the device. In order to address this
potential risk, we recommend the manufacturer provide a detailed
operator manual, which contains information on possible risks and
hazards and how these should be avoided and clear recommended safe
treatment procedures that include information on device settings for
treatment, clear information on how the device is to be used during
treatment, and recommended posttreatment care.
    FDA believes that the class II special controls guidance document
will aid in mitigating the potential risks to health as described in
table 1 of this document.

            Table 1--Risks to Health and Mitigation Measures
------------------------------------------------------------------------
            Identified risk              Recommended mitigation measures
------------------------------------------------------------------------
Ocular Injury..........................  Section 6. Bench Testing.
                                         Section 7. Software Validation.
                                         Section 8. Clinical Testing.
                                         Section 12. Labeling.
Electrical Shock.......................  Section 11. Electrical and
                                          Mechanical Safety Performance
                                          Testing (IEC 60601-1).
                                         Section 12. Labeling.
Unintended Cell Damage.................  Section 6. Bench Testing.
                                         Section 7. Software Validation.
                                         Section 8. Clinical Testing.
                                         Section 9. Biocompatibility.
                                         Section 10. Electromagnetic
                                          Compatibility (IEC 60601-1-2).
                                         Section 12. Labeling.
Use Error..............................  Section 12. Labeling.
------------------------------------------------------------------------

    FDA believes that the special controls guidance, ``Low Level Laser
System for Aesthetic Use,'' in addition to general controls, address
the risks to health and provide reasonable assurance of the safety and
effectiveness of the device. Therefore, on August 24, 2010, FDA issued
an order to the petitioner classifying the device into class II. FDA is
codifying the classification of the device by adding Sec.  878.5400.
    Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for low level laser
system for aesthetic use will need to address the issues covered in the
special controls guidance. However, the firm need only show that its
device meets the recommendations of the guidance or in some other way
provides equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the

safety and effectiveness of the device. For this type of device, FDA
has determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this device type is not exempt from premarket notification
requirements. Persons who intend to market this type of device must
submit to FDA a premarket notification, prior to marketing the device,
which contains information about the low level laser system for
aesthetic use they intend to market.

II. What is the environmental impact of this rule?

    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.

III. What is the analysis of impacts of this rule?

    FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs Agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this final rule is not a significant regulatory action as defined by
the Executive order and so it is not subject to review under the
Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of this device from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the FD&C Act (21 U.S.C. 360e), and may permit small potential
competitors to enter the marketplace by lowering their costs, the
Agency certifies that the final rule will not have a significant
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

IV. Does this rule have federalism implications?

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires Agencies to ``construe * * * a Federal statute to preempt
State law only where the statute contains an express preemption
provision or there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Federal law includes an express preemption provision
that preempts certain state requirements ``different from or in
addition to'' certain Federal requirements applicable to devices. (See
section 521 of the FD&C Act (21 U.S.C. 360k); See Medtronic, Inc., v.
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc., 128 S. Ct.
999 (2008)). The special controls established by this final rule
creates ``requirements'' for specific medical devices under 21 U.S.C.
360k, even though product sponsors have some flexibility in how they
meet those requirements. (See Papike v. Tambrands, Inc., 107 F.3d 737,
740-42 (9th Cir. 1997)).

V. How does this rule comply with the Paperwork Reduction Act of 1995?

    FDA concludes that this final rule contains no new collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520) is not required. This final rule establishes as special
controls a guidance document that refers to previously approved
collections of information found in other FDA regulations. These
collections of information are subject to review by OMB under the PRA.
Elsewhere in this issue of the Federal Register, FDA is issuing a
notice announcing the availability of the guidance document entitled
``Class II Special Controls Guidance Document: Low Level Laser System
for Aesthetic Use'' that will serve as the special control for this
device. This notice contains an analysis of the paperwork burden for
the guidance document.

VI. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Erchonia, Inc., January 5, 2009.

List of Subjects in 21 CFR Part 878

    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
878 is amended as follows:

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

0
1. The authority citation for 21 CFR part 878 continues to read as
follows:

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

0
2. Section 878.5400 is added to subpart F to read as follows:

Sec.  878.5400  Low Level Laser System for Aesthetic Use

    (a) Identification. A Low Level Laser System for Aesthetic Use is a
device using low level laser energy for the disruption of adipocyte
cells within the fat layer for the release of fat and lipids from these
cells for noninvasive aesthetic use.
    (b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled
``Guidance for Industry and Food and Drug Administration Staff; Class
II Special Controls Guidance Document: Low Level Laser System for
Aesthetic Use.'' See Sec.  878.1(e) for the availability of this
guidance document.

    Dated: April 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8944 Filed 4-13-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 24, 2008 (Volume 73, Number 207)]
[Rules and Regulations]
[Page 63352-63353]
[DOCID:fr24oc08-5]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0734; Directorate Identifier 2008-NM-004-AD;
Amendment 39-15697; AD 2008-22-02]
RIN 2120-AA64

Airworthiness Directives; Maryland Air Industries, Inc., Model
Fairchild F-27 and FH-227 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for
Maryland Air Industries, Inc., Model Fairchild F-27 and FH-227 Series
Airplanes. This AD requires operators to modify their airplanes and
revise their inspection or maintenance programs to incorporate
instructions for maintenance and inspection of the fuel tank systems,
as appropriate, by December 16, 2008, using information developed in
accordance with Special Federal Aviation Regulation 88 (SFAR 88). This
AD results from fuel system safety reviews done on similar airplane
models in accordance with SFAR 88. These safety reviews identified
potential unsafe conditions on Model Fairchild F-27 and FH-227 series
airplanes for which the type certificate holder, Maryland Air
Industries, Inc., has not conducted SFAR 88 safety reviews, has not
provided corrective actions, and does not plan to do so. We are issuing
this AD to reduce the potential of ignition sources inside fuel tanks,
which, in combination with flammable fuel vapors, could result in fuel
tank explosions and consequent loss of the airplane.

DATES: This AD is effective November 28, 2008.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building, Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: James Delisio, Aerospace Engineer,
Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
all Maryland Air Industries, Inc., Model Fairchild F-27 and FH-227
series airplanes. That NPRM was published in

the Federal Register on July 21, 2008 (73 FR 42282). That NPRM proposed
to require operators to modify their airplanes and revise their
inspection or maintenance programs to incorporate instructions for
maintenance and inspection of the fuel tank systems, as appropriate, by
December 16, 2008, using information developed in accordance with
Special Federal Aviation Regulation 88.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the relevant data and determined that air safety and
the public interest require adopting the AD as proposed.

Costs of Compliance

    We estimate that this AD affects 29 airplanes of U.S. registry. We
recognize that this AD might impose certain costs. However, we cannot
calculate those costs because we cannot anticipate the complexity or
content of the plans that operators will submit to the FAA. However,
continued operational safety necessitates the imposition of these costs
because of the severity of the unsafe condition.

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

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
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 AD:

2008-22-02 Maryland Air Industries, Inc.: Amendment 39-15697. Docket
No. FAA-2008-0734; Directorate Identifier 2008-NM-004-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective November 28,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Model Fairchild F-27, F-27A, F-27B,
F-27F, F-27G, F-27J, F-27M, FH-227, FH-227B, FH-227C, FH-227D, and
FH-227E series airplanes, certificated in any category.

Unsafe Condition

    (d) This AD results from fuel system safety reviews done on
similar airplane models in accordance with Special Federal Aviation
Regulation No. 88 (SFAR 88). These safety reviews identified
potential unsafe conditions on Model Fairchild F-27 and FH-227
series airplanes for which the type certificate holder, Maryland Air
Industries, Inc., has not conducted SFAR 88 safety reviews, has not
provided corrective actions, and does not plan to do so. We are
issuing this AD to reduce the potential of ignition sources inside
fuel tanks, which, in combination with flammable fuel vapors, could
result in fuel tank explosions and consequent loss of the airplane.

Compliance

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

Report

    (f) Within 45 days after the effective date of this AD, submit a
report to the Manager, New York Aircraft Certification Office, FAA.
The report must include the information listed in paragraphs (f)(1)
and (f)(2) of this AD. Under the provisions of the Paperwork
Reduction Act (44 U.S.C. 3501 et seq.), the Office of Management and
Budget (OMB) has approved the information collection requirements
contained in this AD, and assigned OMB Control Number 2120-0056.
    (1) The airplane registration and operational status.
    (2) A plan for how the airplane operator plans to comply with
paragraph (g) of this AD.

SFAR 88 Design Modifications and Inspection or Maintenance Program
Changes

    (g) Before December 16, 2008, modify the airplane and revise the
inspection or maintenance program to incorporate instructions for
maintenance and inspection of the fuel tank system, using
information developed in accordance with the applicable provisions
SFAR 88, Amendment 21-78, and subsequent Amendments 21-82 and 21-83,
which are included in a regulation titled ``Transport Airplane Fuel
Tank System Design Review, Flammability Reduction, and Maintenance
and Inspection Requirements'' (66 FR 23086, May 7, 2001).

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, New York Aircraft Certification Office, FAA,
ATTN: James Delisio, Aerospace Engineer, Airframe and Propulsion
Branch, ANE-171, 1600 Stewart Avenue, Suite 410, Westbury, New York
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (i) None.

    Issued in Renton, Washington, on October 9, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
 [FR Doc. E8-25304 Filed 10-23-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Notices]
[Pages 48234-48237]
[FR Doc No: 2021-18545]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2161]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table 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.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

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 Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    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).
    These 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. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table 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.

(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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                         Online location of
        State and county           Location and case       officer of         Community map        letter of map       Date of modification   Community
                                          No.               community          repository             revision                                   No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Colorado: Denver................  City and County of   The Honorable       Department of       https://msc.fema.gov/  Dec. 3, 2021.........       080046
                                   Denver, (21-08-      Michael B.          Public Works, 201   portal/advanceSearch.
                                   0769X).              Hancock, Mayor,     West Colfax
                                                        City and County     Avenue, Denver,
                                                        of Denver, 1437     CO 80202.
                                                        Bannock Street,
                                                        Room 350, Denver,
                                                        CO 80202.

Connecticut: Middlesex..........  Town of Clinton,     Mr. Karl Kilduff,   Planning and        https://msc.fema.gov/  Nov. 12, 2021........       090061
                                   (21-01-0179P).       Manager, Town of    Zoning              portal/advanceSearch.
                                                        Clinton, 54 East    Department, 54
                                                        Main Street,        East Main Street,
                                                        Clinton, CT 06413.  Clinton, CT 06413.
Florida:
    Alachua.....................  City of              The Honorable       City Hall, 200      https://msc.fema.gov/  Dec. 1, 2021.........       125107
                                   Gainesville, (21-    Lauren Poe,         East University     portal/advanceSearch.
                                   04-1261P).           Mayor, City of      Avenue,
                                                        Gainesville, 200    Gainesville, FL
                                                        East University     32601.
                                                        Avenue,
                                                        Gainesville, FL
                                                        32601.
    Alachua.....................  Unincorporated       Ms. Michele L.      Alachua County      https://msc.fema.gov/  Dec. 1, 2021.........       120001
                                   areas of Alachua     Lieberman,          Public Works        portal/advanceSearch.
                                   County, (21-04-      Manager, Alachua    Department, 5620
                                   1261P).              County, 12 South    Northwest 120th
                                                        East 1st Street,    Lane,
                                                        Gainesville, FL     Gainesville, FL
                                                        32601.              32653.
    Bay.........................  City of Panama       Mr. Mark McQueen,   City Hall, 501      https://msc.fema.gov/  Nov. 10, 2021........       120012
                                   City, (20-04-        Manager, City of    Harrison Avenue,    portal/advanceSearch.
                                   4646P).              Panama City, 501    Panama City, FL
                                                        Harrison Avenue,    32401.
                                                        Panama City, FL
                                                        32401.
    Bay.........................  Unincorporated       The Honorable       Bay County          https://msc.fema.gov/  Nov. 10, 2021........       120004
                                   areas of Bay         Philip ``Griff''    Planning and        portal/advanceSearch.
                                   County, (20-04-      Griffitts,          Zoning Division,
                                   4646P).              Chairman, Bay       840 West 11th
                                                        County Board of     Street, Panama
                                                        Commissioners,      City, FL 32401.
                                                        840 West 11th
                                                        Street, Panama
                                                        City, FL 32401.
    Collier.....................  City of Naples, (21- The Honorable       Building            https://msc.fema.gov/  Nov. 29, 2021........       125130
                                   04-3345P).           Teresa Heitmann,    Department, 295     portal/advanceSearch.
                                                        Mayor, City of      Riverside Circle,
                                                        Naples, 735 8th     Naples, FL 34102.
                                                        Street South,
                                                        Naples, FL 34102.
    Duval.......................  City of              The Honorable       Development         https://msc.fema.gov/  Nov. 17, 2021........       120077
                                   Jacksonville, (21-   Lenny Curry,        Services            portal/advanceSearch.
                                   04-0334P).           Mayor, City of      Department, 214
                                                        Jacksonville, 117   North Hogan
                                                        West Duval          Street,
                                                        Street, Suite       Jacksonville, FL
                                                        400,                32202.
                                                        Jacksonville, FL
                                                        32202.
    Hillsborough................  Unincorporated       Ms. Bonnie Wise,    Hillsborough        https://msc.fema.gov/  Dec. 2, 2021.........       120112
                                   areas of             Hillsborough        Public Works        portal/advanceSearch.
                                   Hillsborough         County              Department, 601
                                   County, (21-04-      Administrator,      East Kennedy
                                   0492P).              601 East Kennedy    Boulevard, 22nd
                                                        Boulevard, 26th     Floor, Tampa, FL
                                                        Floor, Tampa, FL    33602.
                                                        33602.
    Lee.........................  Town of Fort Myers   The Honorable Ray   Community           https://msc.fema.gov/  Nov. 10, 2021........       120673
                                   Beach, (21-04-       Murphy, Mayor,      Development         portal/advanceSearch.
                                   3079P).              Town of Fort        Department, 2525
                                                        Myers Beach, 2525   Estero Boulevard,
                                                        Estero Boulevard,   Fort Myers Beach,
                                                        Fort Myers Beach,   FL 33931.
                                                        FL 33931.
    Polk........................  Unincorporated       Mr. Bill Beasley,   Polk County         https://msc.fema.gov/  Dec. 9, 2021.........       120261
                                   areas of Polk        Polk County         Floodplain          portal/advanceSearch.
                                   County, (21-04-      Manager, 330 West   Department, 330
                                   3382P).              Church Street,      West Church
                                                        Bartow, FL 33830.   Street, Bartow,
                                                                            FL 33830.
    Sarasota....................  Unincorporated       The Honorable Alan  Sarasota County     https://msc.fema.gov/  Nov. 24, 2021........       125144
                                   areas of Sarasota    Maio, Chairman,     Planning and        portal/advanceSearch.
                                   County, (21-04-      Sarasota County     Development
                                   3524P).              Board of            Services
                                                        Commissioners,      Department, 1001
                                                        1660 Ringling       Sarasota Center
                                                        Boulevard,          Boulevard,
                                                        Sarasota, FL        Sarasota, FL
                                                        34236.              34240.
    Seminole....................  City of Lake Mary,   The Honorable       Public Works        https://msc.fema.gov/  Nov. 22, 2021........       120416
                                   (21-04-1242P).       David J. Mealor,    Department, 911     portal/advanceSearch.
                                                        Mayor, City of      Wallace Court,
                                                        Lake Mary, 100      Lake Mary, FL
                                                        North Country       32746.
                                                        Club Road, Lake
                                                        Mary, FL 32746.
Maine: Aroostook................  Town of Fort Kent,   Ms. Suzie Paradis,  Town Hall, 416      https://msc.fema.gov/  Nov. 26, 2021........       230019
                                   (21-01-0663P).       Manager, Town of    West Main Street,   portal/advanceSearch.
                                                        Fort Kent, 416      Fort Kent, ME
                                                        West Main Street,   04743.
                                                        Fort Kent, ME
                                                        04743.
Maryland: Howard................  Unincorporated       The Honorable       Department of       https://msc.fema.gov/  Nov. 19, 2021........       240044
                                   areas of Howard      Calvin Ball,        Public Works,       portal/advanceSearch.
                                   County, (21-03-      Howard County       Bureau of
                                   0871P).              Executive, 3430     Environmental
                                                        Court House         Services, 9801
                                                        Drive, Ellicott     Broken Land
                                                        City, MD 21043.     Parkway,
                                                                            Columbia, MD
                                                                            21046.
Massachusetts:
    Bristol.....................  Town of Dartmouth,   Mr. Shawn           Town Hall, 400      https://msc.fema.gov/  Dec. 2, 2021.........       250051
                                   (21-01-0847P).       MacInnes, Town of   Slocum Road,        portal/advanceSearch.
                                                        Dartmouth           Dartmouth, MA
                                                        Administrator,      02747.
                                                        400 Slocum Road,
                                                        Dartmouth, MA
                                                        02747.

    Middlesex...................  City of Waltham,     The Honorable       City Hall, 610      https://msc.fema.gov/  Dec. 3, 2021.........       250222
                                   (20-01-1644P).       Jeannette A.        Main Street,        portal/advanceSearch.
                                                        McCarthy, Mayor,    Waltham, MA 02452.
                                                        City of Waltham,
                                                        610 Main Street,
                                                        2nd Floor,
                                                        Waltham, MA 02452.
    Middlesex...................  Town of Belmont,     The Honorable Adam  Community           https://msc.fema.gov/  Dec. 3, 2021.........       250182
                                   (20-01-1644P).       Dash, Chairman,     Development         portal/advanceSearch.
                                                        Town of Belmont     Department, 19
                                                        Select Board, 455   Moore Street,
                                                        Concord Avenue,     Belmont, MA 02478.
                                                        2nd Floor,
                                                        Belmont, MA 02478.
North Dakota:
    Ransom......................  City of Lisbon, (20- The Honorable Tim   City Hall, 423      https://msc.fema.gov/  Nov. 16, 2021........       380091
                                   08-0874P).           Meyer, Mayor,       Main Street,        portal/advanceSearch.
                                                        City of Lisbon,     Lisbon, ND 58054.
                                                        P.O. Box 1079,
                                                        Lisbon, ND 58054.
    Ransom......................  Unincorporated       The Honorable Norm  Ransom County       https://msc.fema.gov/  Nov. 16, 2021........       380089
                                   areas of Ransom      Hansen, Chairman,   Courthouse, 204     portal/advanceSearch.
                                   County, (20-08-      Ransom County       5th Avenue West,
                                   0874P).              Board of            Lisbon, ND 58054.
                                                        Commissioners,
                                                        P.O. Box 668,
                                                        Lisbon, ND 58054.
Pennsylvania:
    Columbia....................  Town of Bloomsburg,  The Honorable       Town Hall, 301      https://msc.fema.gov/  Nov. 24, 2021........       420339
                                   (21-03-0940P).       William Kreisher,   East 2nd Street,    portal/advanceSearch.
                                                        Mayor, Town of      Bloomsburg, PA
                                                        Bloomsburg, 301     17815.
                                                        East 2nd Street,
                                                        Bloomsburg, PA
                                                        17815.
    Columbia....................  Township of          The Honorable       Township Hall, 153  https://msc.fema.gov/  Nov. 24, 2021........       420342
                                   Catawissa, (21-03-   James Kitchen,      Old Reading Road,   portal/advanceSearch.
                                   0940P).              Chairman,           Catawissa, PA
                                                        Township of         17820.
                                                        Catawissa Board
                                                        of Supervisors,
                                                        153 Old Reading
                                                        Road, Catawissa,
                                                        PA 17820.
    Cumberland..................  Borough of           The Honorable Jack  Borough Hall, 36    https://msc.fema.gov/  Dec. 3, 2021.........       420362
                                   Mechanicsburg (21-   Ritter, Mayor,      West Allen          portal/advanceSearch.
                                   03-0690P).           Borough of          Street,
                                                        Mechanicsburg, 36   Mechanicsburg, PA
                                                        West Allen          17055.
                                                        Street,
                                                        Mechanicsburg, PA
                                                        17055.
    Cumberland..................  Township of Upper    The Honorable       Township Hall, 100  https://msc.fema.gov/  Dec. 3, 2021.........       420372
                                   Allen (21-03-        Kenneth M.          Gettysburg Pike,    portal/advanceSearch.
                                   0690P).              Martin,             Mechanicsburg, PA
                                                        President,          17055.
                                                        Township of Upper
                                                        Allen Board of
                                                        Commissioners,
                                                        100 Gettysburg
                                                        Pike,
                                                        Mechanicsburg, PA
                                                        17055.
Texas:
    Angelina....................  City of Lufkin, (20- The Honorable Mark  Engineering         https://msc.fema.gov/  Dec. 9, 2021.........       480009
                                   06-3596P).           Hicks, Mayor,       Services            portal/advanceSearch.
                                                        City of Lufkin,     Department, 300
                                                        300 East Shepherd   East Shepherd
                                                        Avenue, Lufkin,     Avenue, Lufkin,
                                                        TX 75901.           TX 75901.
    Brazoria and Harris.........  City of Pearland     The Honorable Tom   City Hall, 3519     https://msc.fema.gov/  Nov. 22, 2021........       480077
                                   (19-06-2864P).       Reid, Mayor, City   Liberty Drive,      portal/advanceSearch.
                                                        of Pearland, 3519   Pearland, TX
                                                        Liberty Drive,      77581.
                                                        Pearland, TX
                                                        77581.
    Denton......................  City of Lewisville,  The Honorable T.J.  Engineering         https://msc.fema.gov/  Dec. 13, 2021........       480195
                                   (21-06-1150P).       Gilmore, Mayor,     Department, 151     portal/advanceSearch.
                                                        City of             West Church
                                                        Lewisville, P.O.    Street,
                                                        Box 299002,         Lewisville, TX
                                                        Lewisville, TX      75057.
                                                        75029.
    Harris......................  City of Houston (19- The Honorable       Floodplain          https://msc.fema.gov/  Nov. 22, 2021........       480296
                                   06-2864P).           Sylvester Turner,   Management          portal/advanceSearch.
                                                        Mayor, City of      Department, 1002
                                                        Houston, P.O. Box   Washington
                                                        1562, Houston, TX   Avenue, Houston,
                                                        77251.              TX 77002.
    Harris......................  Unincorporated       The Honorable Lina  Harris County       https://msc.fema.gov/  Nov. 22, 2021........       480287
                                   areas of Harris      Hidalgo, Harris     Permit Office,      portal/advanceSearch.
                                   County, (19-06-      County Judge,       10555 Northwest
                                   2864P).              1001 Preston        Freeway, Suite
                                                        Street, Suite       120, Houston, TX
                                                        911, Houston, TX    77092.
                                                        77002.
    Harris......................  Unincorporated       The Honorable Lina  Harris County       https://msc.fema.gov/  Nov. 22, 2021........       480287
                                   areas of Harris      Hidalgo, Harris     Permit Office,      portal/advanceSearch.
                                   County, (20-06-      County Judge,       10555 Northwest
                                   0474P).              1001 Preston        Freeway, Suite
                                                        Street, Suite       120, Houston, TX
                                                        911, Houston, TX    77002.
                                                        77002.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2021-18545 Filed 8-26-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Notices]
[Page 19437-19439]
[DOCID:fr14ap10-110]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61866; File No. SR-ISE-2010-31]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Order Granting Accelerated Approval to a
Proposed Rule Change Relating to the Amounts That Direct Edge ECN, in
Its Capacity as an Introducing Broker for Non-ISE Members, Passes
Through to Such Non-ISE Members

April 7, 2010.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on April 6, 2010, the International Securities Exchange, LLC (the
``Exchange'' or the ``ISE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the self-
regulatory organization. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons,
and is approving the proposal on an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to modify the amounts that Direct Edge ECN
(``DECN''), in its capacity as an introducing broker for non-ISE
Members, passes through to such non-ISE Members.
    The text of the proposed rule change is available on the Exchange's
Internet Web site at http://www.ise.com.

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

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of these statements may be examined at
the places specified in Item III below. The self-regulatory
organization has prepared summaries, set forth in sections A, B and C
below, of the most significant aspects of such statements.

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

1. Purpose
    DECN, a facility of ISE, operates two trading platforms, EDGX and
EDGA.\3\ The changes made pursuant to SR-ISE-2010-29 became operative
on April 5, 2010. On April 5, 2010, the ISE filed for immediate
effectiveness a proposed rule change to amend Direct Edge ECN's
(``DECN'') fee schedule for ISE Members \4\ to: (i) Eliminate a rebate
on EDGX for securities priced less than $1; and (ii) to lower the
removal rate on EDGX for securities priced less than $1.\5\ The changes
made pursuant to SR-ISE-2010-29 became operative on April 5, 2010.
---------------------------------------------------------------------------

    \3\ This fee filing relates to the trading facility operated by
ISE and not EDGA Exchange, Inc. and EDGX Exchange, Inc. Direct Edge
ECN LLC (EDGA and EDGX) will cease to operate in its capacity as an
electronic communications network following the commencement of
operations of EDGA Exchange, Inc. and EDGX Exchange, Inc. as
national securities exchanges.
    \4\ References to ISE Members in this filing refer to DECN
Subscribers who are ISE Members.
    \5\ In SR-ISE-2010-29, the Exchange made the following changes
to the fee schedule: (i) Eliminated the current rebate for adding
liquidity on EDGX of 0.15% of the total dollar value of the
transaction (number of shares multiplied by price) for securities
priced less than $1.00; and (ii) lowered the removal rate on EDGX
for removing liquidity in securities priced less than $1.00 from
.30% of the total dollar value of the transaction to 0.10% of the
total dollar value of the transaction. This was done because: (i)
There was not an appropriate relationship between the size of the
rebate offered and the minimum trading increment for securities
priced less than $1.00; and (2) the Exchange sought to incentivize
the removal of liquidity from EDGX in securities priced less than
$1.00.
---------------------------------------------------------------------------

    In its capacity as a member of ISE, DECN currently serves as an
introducing broker for the non-ISE Member subscribers of DECN to access
EDGX and EDGA. DECN, as an ISE Member and introducing broker, receives
rebates and is assessed charges from DECN for transactions it executes
on EDGX or EDGA in its capacity as introducing broker for non-ISE
Members. Since the amounts of such rebates and charges were changed
pursuant to SR-ISE-2010-29, DECN wishes to make corresponding changes
to the amounts it passes through to non-ISE Member subscribers of DECN
for which it acts as introducing broker. As a result, the per share
amounts that non-ISE Member subscribers receive and are charged will be
the same as the amounts that ISE Members receive and are charged.
    ISE is seeking accelerated approval of this proposed rule change,
as well an effective date of April 5, 2010. ISE represents that this
proposal will ensure that both ISE Members and non-ISE Members (by
virtue of the pass-through described above) will in effect receive and
be charged equivalent amounts and that the imposition of such amounts
will begin on the same April 5, 2010 start date.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the objectives of Section 6 of the Act,\6\ in general, and
furthers the objectives of Section 6(b)(4),\7\ in particular, in that
it is designed to provide for the equitable allocation of reasonable
dues, fees and other charges among its members and other persons using
its facilities. In particular, this proposal will ensure that dues,
fees and other charges imposed on ISE Members are equitably allocated
to both ISE Members and non-ISE Members (by virtue of the pass-through
described above).
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

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

III. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2010-31 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2010-31. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission,\8\ all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing also will be available for
inspection and copying at the principal office of the ISE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2010-31 and should be
submitted on or before May 5, 2010.
---------------------------------------------------------------------------

    \8\ The text of the proposed rule change is available on ISE's
Web site at http://www.ise.com, on the Commission's Web site at
http://www.sec.gov, at ISE, and at the Commission's Public Reference
Room.
---------------------------------------------------------------------------

IV. Commission's Findings and Order Granting Accelerated Approval of
Proposed Rule Change

    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange.\9\
Specifically, the Commission finds that the proposed rule change is
consistent with Section 6(b)(4) \10\ of the Act, which requires that
the rules of a national securities exchange provide for the equitable
allocation of reasonable dues, fees, and other charges among members
and issuers and other persons using its facilities.
---------------------------------------------------------------------------

    \9\ In approving this proposal, the Commission has considered
its impact on efficiency, competition, and capital formation. 15
U.S.C. 78c(f).
    \10\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    As described more fully above, ISE recently amended DECN's fee
schedule for ISE Members pursuant to SR-ISE-

2010-29 (the ``Member Fee Filing''). The fee changes made pursuant to
the Member Fee Filing became operative on April 5, 2010. DECN receives
rebates and is charged fees for transactions it executes on EGDX or
EDGA in its capacity as an introducing broker for its non-ISE member
subscribers. The current proposal, which will apply retroactively to
April 5, 2010, will allow DECN to pass through the revised rebates and
fees to the non-ISE member subscribers for which it acts as an
introducing broker. The Commission finds that the proposal is
consistent with the Act because it will provide rebates and charge fees
to non-ISE member subscribers that are equivalent to those established
for ISE member subscribers in the Member Fee Filing.\11\
---------------------------------------------------------------------------

    \11\ Id.
---------------------------------------------------------------------------

    ISE has requested that the Commission find good cause for approving
the proposed rule change prior to the thirtieth day after publication
of notice of filing thereof in the Federal Register. As discussed
above, the proposal will allow DECN to pass through to non-ISE member
subscribers the revised rebate and fees established for ISE member
subscribers in the Member Fee Filing, resulting in equivalent rebates
and fees for ISE member and non-member subscribers. In addition,
because the proposal will apply the revised rebates and fees
retroactively to April 5, 2010, the revised rebates and fees will have
the same effective date, thereby promoting consistency in the DECN's
fee schedule. Accordingly, the Commission finds good cause, pursuant to
Section 19(b)(2) of the Act, for approving the proposed rule change
prior to the thirtieth day after the date of publication of notice of
filing thereof in the Federal Register.

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\12\ that the proposed rule change (SR-ISE-2010-31) be, and hereby
is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-8538 Filed 4-13-10; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 7 (Monday, January 12, 2015)]
[Notices]
[Page 1500]
[FR Doc No: 2015-00190]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

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

    Docket Numbers: ER13-62-003.
    Applicants: NorthWestern Corporation.
    Description: Compliance filing per 35: Order No 1000 Compliance
Filing--South Dakota to be effective 1/2/2015.
    Filed Date: 1/2/15.
    Accession Number: 20150102-5218.
    Comments Due: 5 p.m. ET 2/2/15.

    Docket Numbers: ER15-704-001.
    Applicants: Pacific Gas and Electric Company.
    Description: Tariff Amendment per 35.17(b): Amendment to WDT SA,
Request for Immediate Deletion of Tariff Records and Other to be
effective 7/1/2015.
    Filed Date: 1/2/15.
    Accession Number: 20150102-5223.
    Comments Due: 5 p.m. ET 1/23/15.

    Docket Numbers: ER15-820-000.
    Applicants: Zone One Energy, LLC.
    Description: Initial rate filing per 35.12 Baseline New to be
effective 2/1/2015.
    Filed Date: 1/5/15.
    Accession Number: 20150105-5013.
    Comments Due: 5 p.m. ET 1/26/15.

    Docket Numbers: ER15-821-000.
    Applicants: New York State Reliability Council, L.L.C., WHITEMAN,
OSTERMAN & HANNA (NY)
    Description: Informational filing of Installed Capacity Requirement
for the New York Control Area of the New York State Reliability
Council, L.L.C.
    Filed Date: 1/5/15.
    Accession Number: 20150105-5096.
    Comments Due: 5 p.m. ET 1/26/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: January 5, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-00190 Filed 1-9-15; 8:45 am]
BILLING CODE 6717-01-P