[Federal Register Volume 79, Number 157 (Thursday, August 14, 2014)]
[Rules and Regulations]
[Pages 47553-47556]
[FR Doc No: 2014-19211]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 27

[Docket No. FAA-2014-0560; Special Conditions No. 27-033-SC]

Special Conditions: Robinson Model R44 and R44 II Helicopters,
Installation of HeliSAS Autopilot and Stabilization Augmentation System
(AP/SAS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions; request for comments.

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

SUMMARY: These special conditions are issued for the modification of
the Robinson Helicopter Company Model R44 and R44 II helicopters. These
model helicopters will have a novel or unusual design feature after
installation of the HeliSAS helicopter autopilot/stabilization
augmentation system (AP/SAS) that has potential failure conditions with
more severe adverse consequences than those envisioned by the existing
applicable airworthiness regulations. These special conditions contain
the added safety standards the Administrator considers necessary to
ensure the failures and their effects are sufficiently analyzed and
contained.

DATES: The effective date of these special conditions is August 4,
2014. We must receive your comments on or before September 29, 2014.

ADDRESSES: Send comments identified by docket number [FAA-2014-0560]
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery of Courier: Deliver comments to the Docket
Operations, in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC between 9 a.m., and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://regulations.gov, including any personal information
the commenter provides. Using the search function of the docket Web
site, anyone can find and read the electronic form of all comments
received into any FAA

docket, including the name of the individual sending the comment (or
signing the comment for an association, business, labor union, etc.).
DOT's complete Privacy Act Statement can be found in the Federal
Register published on April 11, 2000 (65 FR 19477-19478), as well as at
http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov. Follow the online instructions for
accessing the docket or go to the Docket Operations in Room W12-140 of
the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Mark Wiley, Aviation Safety Engineer,
FAA, Rotorcraft Directorate, Regulations and Policy Group (ASW-111),
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
facsimile<PHONE_NUMBER>; or email to<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Reason for No Prior Notice and Comment Before Adoption

    The FAA has determined that notice and opportunity for public
comment are unnecessary because the substance of these special
conditions has been subjected to the notice and comment period
previously and has been derived without substantive change from those
previously issued. As it is unlikely that we will receive new comments,
the FAA finds that good cause exists for making these special
conditions effective upon issuance.

Comments Invited

    While we did not precede this with a notice of proposed special
conditions, we invite interested people to take part in this action by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive by the closing date for
comments. We will consider comments filed late if it is possible to do
so without incurring expense or delay. We may change these special
conditions based on the comments we receive.
    If you want us to let you know we received your mailed comments on
these special conditions, send us a pre-addressed, stamped postcard on
which the docket number appears. We will stamp the date on the postcard
and mail it back to you.

Background

    On November 1, 2006, the Robinson Helicopter Company applied to
amend type certificate (TC) Number H11NM to install a HeliSAS AP/SAS on
the Robinson Helicopter Company model R44 and R44 II helicopters. The
Robinson Helicopter Company model R44 and R44 II helicopters are 14 CFR
part 27 normal category, single reciprocating engine, conventional
helicopters designed for civil operation. These helicopter models are
capable of carrying up to four passengers with one pilot, and have a
maximum gross weight of up to 2,500 pounds, depending on the model
configuration. The major design features include a 2-blade, fully
articulated main rotor, an anti-torque tail rotor system, a skid
landing gear, and a visual flight rule basic avionics configuration.
Robinson Helicopter Company proposes to modify these model helicopters
by installing a two-axis HeliSAS AP/SAS.

Type Certification Basis

    Under 14 CFR 21.101, Robinson Helicopter Company must show that the
model R44 and R44 II helicopters, as modified by the installed HeliSAS
AP/SAS, continue to meet the applicable regulations in effect on the
date of application for the change to the type certificate. The
baseline of the certification basis for the unmodified Robinson
Helicopter Company model R44 and R44 II helicopters is listed in TC
Number H11NM. Additionally, compliance must be shown to any applicable
equivalent level of safety findings, exemptions, and special conditions
prescribed by the Administrator as part of the certification basis.
    The Administrator has determined the applicable airworthiness
regulations (that is, 14 CFR part 27), as they pertain to this amended
TC, do not contain adequate or appropriate safety standards for the
Robinson Helicopter Company model R44 and R44 II helicopters because of
a novel or unusual design feature. Therefore, special conditions are
prescribed under Sec.  21.16.
    In addition to the applicable airworthiness regulations and special
conditions, the Robinson Helicopter Company must show compliance of the
HeliSAS AP/SAS amended TC altered model R44 and R44 II helicopters with
the noise certification requirements of 14 CFR part 36.
    The FAA issues special conditions, as defined in Sec.  11.19, in
accordance with Sec.  11.38 and they become part of the type
certification basis under Sec.  21.101(d).

Novel or Unusual Design Features

    The HeliSAS AP/SAS incorporates novel or unusual design features
for installation in a Robinson Helicopter Company model R44 and R44 II
helicopter, TC Number H11NM. This HeliSAS AP/SAS performs non-critical
control functions, since these model helicopters have been certificated
to meet the applicable requirements independent of this system.
However, the possible failure conditions for this system, and their
effect on the continued safe flight and landing of the helicopters, are
more severe than those envisioned by the present rules.

Discussion

    The effect on safety is not adequately covered under Sec.  27.1309
for the application of new technology and new application of standard
technology. Specifically, the present provisions of Sec.  27.1309(c) do
not adequately address the safety requirements for systems whose
failures could result in catastrophic or hazardous/severe-major failure
conditions, or for complex systems whose failures could result in major
failure conditions. The current regulations are inadequate because when
Sec.  27.1309(c) were promulgated, it was not envisioned that this type
of rotorcraft would use systems that are complex or whose failure could
result in ``catastrophic'' or ``hazardous/severe-major'' effects on the
rotorcraft. This is particularly true with the application of new
technology, new application of standard technology, or other
applications not envisioned by the rule that affect safety.
    To comply with the provisions of the special conditions, we require
that Robinson Helicopter Company provide the FAA with a systems safety
assessment (SSA) for the final HeliSAS AP/SAS installation
configuration that will adequately address the safety objectives
established by a functional hazard assessment (FHA) and a preliminary
system safety assessment (PSSA), including the fault tree analysis
(FTA). This will ensure that all failure conditions and their resulting
effects are adequately addressed for the installed HeliSAS AP/SAS. The
SSA process, FHA, PSSA, and FTA are all parts of the overall safety
assessment process discussed in FAA Advisory Circular 27-1B
(Certification of Normal Category Rotorcraft) and Society of Automotive
Engineers document Aerospace Recommended Practice 4761 (Guidelines and
Methods for Conducting the Safety Assessment Process on Civil Airborne
Systems and Equipment).

    These special conditions require that the HeliSAS AP/SAS installed
on Robinson Helicopter Company model R44 and R44 II helicopter meet the
requirements to adequately address the failure effects identified by
the FHA, and subsequently verified by the SSA, within the defined
design integrity requirements.
    Failure Condition Categories. Failure conditions are classified,
according to the severity of their effects on the rotorcraft, into one
of the following categories:
    1. No Effect. Failure conditions that would have no effect on
safety. For example, failure conditions that would not affect the
operational capability of the rotorcraft or increase crew workload;
however, could result in an inconvenience to the occupants, excluding
the flight crew.
    2. Minor. Failure conditions which would not significantly reduce
rotorcraft safety, and which would involve crew actions that are well
within their capabilities. Minor failure conditions would include, for
example, a slight reduction in safety margins or functional
capabilities, a slight increase in crew workload such as routine flight
plan changes or result in some physical discomfort to occupants.
    3. Major. Failure conditions which would reduce the capability of
the rotorcraft or the ability of the crew to cope with adverse
operating conditions to the extent that there would be, for example, a
significant reduction in safety margins or functional capabilities, a
significant increase in crew workload or result in impairing crew
efficiency, physical distress to occupants, including injuries, or
physical discomfort to the flight crew.
    4. Hazardous/Severe-Major.
    a. Failure conditions which would reduce the capability of the
rotorcraft or the ability of the crew to cope with adverse operating
conditions to the extent that there would be:
    (1) A large reduction in safety margins or functional capabilities;
    (2) physical distress or excessive workload that would impair the
flight crew's ability to the extent that they could not be relied on to
perform their tasks accurately or completely; or
    (3) possible serious or fatal injury to a passenger or a cabin
crewmember, excluding the flight crew.
    b. ``Hazardous/severe-major'' failure conditions can include events
that are manageable by the crew by the use of proper procedures, which,
if not implemented correctly or in a timely manner, may result in a
catastrophic event.
    5. Catastrophic--Failure conditions which would result in multiple
fatalities to occupants, fatalities or incapacitation to the flight
crew, or result in loss of the rotorcraft.
    Radio Technical Commission for Aeronautics, Inc. (RTCA) Document
DO-178C (Software Considerations in Airborne Systems And Equipment
Certification) provides software design assurance levels most commonly
used for the major, hazardous/severe-major, and catastrophic failure
condition categories. The HeliSAS AP/SAS system equipment must be
qualified for the expected installation environment. The test
procedures prescribed in RTCA Document DO-160G (Environmental
Conditions and Test Procedures for Airborne Equipment) are recognized
by the FAA as acceptable methodologies for finding compliance with the
environmental requirements. Equivalent environment test standards may
also be acceptable. This is to show that the HeliSAS AP/SAS system
performs its intended function under any foreseeable operating
condition, which includes the expected environment in which the HeliSAS
AP/SAS is intended to operate. Some of the main considerations for
environmental concerns are installation locations and the resulting
exposure to environmental conditions for the HeliSAS AP/SAS system
equipment, including considerations for other equipment that may be
affected environmentally by the HeliSAS AP/SAS equipment installation.
The level of environmental qualification must be related to the
severity of the considered failure conditions and effects on the
rotorcraft.

Applicability

    These special conditions are applicable to the HeliSAS AP/SAS
installed as an amended TC approval in Robinson Helicopter Company
model R44 and R44 II helicopters, TC Number H11NM.

Conclusion

    This action affects only certain novel or unusual design features
for a HeliSAS AP/SAS amended TC installed on two model helicopters. It
is not a rule of general applicability and affects only the applicant
who applied to the FAA for approval of these features.

List of Subjects in 14 CFR Part 27

    Aircraft, Aviation safety.
    The authority citation for these special conditions is as follows:

    Authority:  42 U.S.C. 7572, 49 U.S.C. 106(g), 40105, 40113,
44701-44702, 44704, 44709, 44711, 44713, 44715, 45303.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the Robinson Helicopter Company amended type certificate basis for the
installation of a HeliSAS helicopter autopilot/stabilization
augmentation system (AP/SAS) on model R44 and R44 II helicopters, Type
Certificate Number H11NM. In addition to the requirements of Sec.
27.1309(c), HeliSAS AP/SAS installations on Robinson Helicopter company
model R44 and R44 II helicopters must be designed and installed so that
the failure conditions identified in the functional hazard assessment
(FHA) and verified by the system safety assessment (SSA), after design
completion, are adequately addressed in accordance with the following
requirements.

Requirements

    The Robinson Helicopter Company must comply with the existing
requirements of Sec.  27.1309 for all applicable design and operational
aspects of the HeliSAS AP/SAS with the failure condition categories of
``no effect,'' and ``minor,'' and for non-complex systems whose failure
condition category is classified as ``major.'' The Robinson Helicopter
Company must comply with the requirements of these special conditions
for all applicable design and operational aspects of the HeliSAS AP/SAS
with the failure condition categories of ``catastrophic'' and
``hazardous severe/major,'' and for complex systems whose failure
condition category is classified as ``major.'' A complex system is a
system whose operations, failure conditions, or failure effects are
difficult to comprehend without the aid of analytical methods (for
example, FTA, Failure Modes and Effect Analysis, FHA).

System Design Integrity Requirements

    Each of the failure condition categories defined in these special
conditions relate to the corresponding aircraft system integrity
requirements. The system design integrity requirements for the HeliSAS
AP/SAS, as they relate to the allowed probability of occurrence for
each failure condition category and the proposed software design
assurance level, are as follows:
    1. ``Major''--For systems with ``major'' failure conditions,
failures resulting in these major effects must be shown to be remote, a
probability of occurrence on the order of between 1 x 10-5
to 1 x 10-7 failures/hour, and

associated software must be developed, at a minimum, to the Level C
software design assurance level.
    2. ``Hazardous/Severe-Major''--For systems with ``hazardous/severe-
major'' failure conditions, failures resulting in these hazardous/
severe-major effects must be shown to be extremely remote, a
probability of occurrence on the order of between 1 x 10-7
to 1 x 10-9 failures/hour, and associated software must be
developed, at a minimum, to the Level B software design assurance
level.
    3. ``Catastrophic''--For systems with ``catastrophic'' failure
conditions, failures resulting in these catastrophic effects must be
shown to be extremely improbable, a probability of occurrence on the
order of 1 x 10-9 failures/hour or less, and associated
software must be developed, at a minimum, to the Level A design
assurance level.

System Design Environmental Requirements

    The HeliSAS AP/SAS system equipment must be qualified to the
appropriate environmental level for all relevant aspects to show that
it performs its intended function under any foreseeable operating
condition, including the expected environment in which the HeliSAS AP/
SAS is intended to operate. Some of the main considerations for
environmental concerns are installation locations and the resulting
exposure to environmental conditions for the HeliSAS AP/SAS system
equipment, including considerations for other equipment that may be
affected environmentally by the HeliSAS AP/SAS equipment installation.
The level of environmental qualification must be related to the
severity of the considered failure conditions and effects on the
rotorcraft.

Test & Analysis Requirements

    Compliance with the requirements of these special conditions may be
shown by a variety of methods, which typically consist of analysis,
flight tests, ground tests, and simulation, as a minimum. Compliance
methodology is related to the associated failure condition category. If
the HeliSAS AP/SAS is a complex system, compliance with the
requirements for failure conditions classified as ``major'' may be
shown by analysis, in combination with appropriate testing to validate
the analysis. Compliance with the requirements for failure conditions
classified as ``hazardous/severe-major'' may be shown by flight-testing
in combination with analysis and simulation, and the appropriate
testing to validate the analysis. Flight tests may be limited for
``hazardous/severe-major'' failure conditions and effects due to safety
considerations. Compliance with the requirements for failure conditions
classified as ``catastrophic'' may be shown by analysis, and
appropriate testing in combination with simulation to validate the
analysis. Very limited flight tests in combination with simulation are
used as a part of a showing of compliance for ``catastrophic'' failure
conditions. Flight tests are performed only in circumstances that use
operational variations, or extrapolations from other flight performance
aspects to address flight safety.
    These special conditions require that the HeliSAS AP/SAS system
installed on a Robinson Helicopter Company model R44 or R44 II
helicopter, Type Certificate Number H11NM, meet these requirements to
adequately address the failure effects identified by the FHA, and
subsequently verified by the SSA, within the defined design system
integrity requirements.

    Issued in Fort Worth, Texas on August 4, 2014.
Lance T. Gant,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2014-19211 Filed 8-13-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Pages 24374-24377]
[FR Doc No: 2017-10179]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2017-0002; Internal Agency Docket No. FEMA-B-1712]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

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.

DATES: These flood hazard determinations will become effective 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 www.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 Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Flood Insurance Rate Maps (FIRMs), and
where applicable, portions of the Flood Insurance Study (FIS) report,
have been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR part 65). 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.
    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 www.msc.fema.gov for comparison.

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

    Dated: April 25, 2017.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

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

--------------------------------------------------------------------------------------------------------------------------------------------------------
Arizona:
    Maricopa...................  City of Glendale    The Honorable Jerry      City Hall, 5850     http://             June 16, 2017........       040045
                                  (16-09-2447P).      Weiers, Mayor, City of   West Glendale       www.msc.fema.gov/
                                                      Glendale, City Hall,     Avenue, Glendale,   lomc.
                                                      5850 West Glendale       AZ 85301.
                                                      Avenue, Glendale, AZ
                                                      85301.
    Maricopa...................  City of Litchfield  The Honorable Thomas L.  City Hall, 214      http://             June 15, 2017........       040128
                                  Park (16-09-        Schoaf, Mayor, City of   West Wigwam         www.msc.fema.gov/
                                  3089P).             Litchfield Park, City    Boulevard,          lomc.
                                                      Hall, 214 West Wigwam    Litchfield Park,
                                                      Boulevard, Litchfield    AZ 85340.
                                                      Park, AZ 85340.
    Maricopa...................  City of Peoria (16- The Honorable Cathy      City Hall, 8401     http://             June 16, 2017........       040050
                                  09-2447P).          Carlat, Mayor, City of   West Monroe         www.msc.fema.gov/
                                                      Peoria, 8401 West        Street, Peoria,     lomc.
                                                      Monroe Street, Peoria,   AZ 85345.
                                                      AZ 85345.
    Maricopa...................  City of Phoenix     The Honorable Greg       Street              http://             June 2, 2017.........       040051
                                  (16-09-2155P).      Stanton, Mayor, City     Transportation      www.msc.fema.gov/
                                                      of Phoenix, 200 West     Department, 200     lomc.
                                                      Washington Street,       West Washington
                                                      11th Floor, Phoenix,     Street, 5th
                                                      AZ 85003.                Floor, Phoenix,
                                                                               AZ 85003.

    Maricopa...................  Unincorporated      The Honorable Denny      Flood Control       http://             June 16, 2017........       040037
                                  Areas of Maricopa   Barney, Chairman,        District of         www.msc.fema.gov/
                                  County (16-09-      Board of Supervisors,    Maricopa County,    lomc.
                                  2447P).             Maricopa County, 301     2801 West Durango
                                                      West Jefferson Street,   Street, Phoenix,
                                                      10th Floor, Phoenix,     AZ 85009.
                                                      AZ 85003.
    Pima.......................  City of Tucson (16- The Honorable Jonathan   Planning and        http://             June 2, 2017.........       040076
                                  09-1226P).          Rothschild, Mayor,       Development         www.msc.fema.gov/
                                                      City of Tucson, 255      Services, 201       lomc.
                                                      West Alameda Street,     North Stone
                                                      10th Floor, Tucson, AZ   Avenue, 1st
                                                      85701.                   Floor, Tucson, AZ
                                                                               85701.
    Pima.......................  Unincorporated      The Honorable Sharon     Pima County Flood   http://             June 2, 2017.........       040073
                                  Areas of Pima       Bronson, Chair, Board    Control District,   www.msc.fema.gov/
                                  County (16-09-      of Supervisors, Pima     201 North Stone     lomc..
                                  1226P).             County, 130 West         Avenue, 9th
                                                      Congress Street, 11th    Floor, Tucson, AZ
                                                      Floor, Tucson, AZ        85701.
                                                      85701.
California:
    Contra Costa...............  City of Brentwood   The Honorable Robert     Planning            http://             June 19, 2017........       060439
                                  (17-09-0675P).      Taylor, Mayor, City of   Department, 150     www.msc.fema.gov/
                                                      Brentwood, 150 City      City Park Way,      lomc.
                                                      Park Way, Brentwood,     Brentwood, CA
                                                      CA 94513.                94513.
    Contra Costa...............  Unincorporated      The Honorable Federal    Public Works        http://             June 19, 2017........       060025
                                  Areas of Contra     D. Glover, Chairman,     Department, 255     www.msc.fema.gov/
                                  Costa County 17-    Board of Supervisors,    Glacier Drive,      lomc.
                                  09-0675P).          Contra Costa County,     Martinez, CA
                                                      651 Pine Street,         94553.
                                                      Martinez, CA 94553.
    Madera.....................  Unincorporated      The Honorable Max        Resource            http://             June 15, 2017........       060170
                                  Areas of Madera     Rodriguez, Chairman,     Management          www.msc.fema.gov/
                                  County (16-09-      Board of Supervisors,    Agency, 2037 West   lomc..
                                  2575P).             Madera County, 200       Cleveland Avenue,
                                                      West 4th Street,         Madera, CA 93637.
                                                      Madera, CA 93637.
    Riverside..................  City of Menifee     The Honorable Scott      Engineering &       http://             June 16, 2017........       060176
                                  (16-09-1612P).      Mann, Mayor, City of     Public Works        www.msc.fema.gov/
                                                      Menifee, 29714 Haun      Departments,        lomc.
                                                      Road, Menifee, CA        29714 Haun Road,
                                                      92586.                   Menifee, CA 92586.
    San Diego..................  City of San Diego   The Honorable Kevin L    Public Works        http://             May 30, 2017.........       060295
                                  (16-09-1178P).      Faulconer, Mayor, City   Department, 525 B   www.msc.fema.gov/
                                                      of San Diego, 202 C      Street, Suite       lomc.
                                                      Street, 11th Floor,      750, MS 908A, San
                                                      San Diego, CA 92101.     Diego, CA 92101.
    San Joaquin................  City of Stockton    The Honorable Michael    Community           http://             June 23, 2017........       060302
                                  (16-09-2351P).      D. Tubbs, Mayor, City    Development         www.msc.fema.gov/
                                                      of Stockton, 425 North   Department, 345     lomc.
                                                      El Dorado Street ,       North El Dorado
                                                      Stockton, CA 95202.      Street, Stockton,
                                                                               CA 95202.
Idaho: Ada.....................  Unincorporated      The Honorable Dave       Ada County          http://             June 23, 2017........       160001
                                  Areas of Ada        Case, Chairman, Ada      Courthouse, 200     www.msc.fema.gov/
                                  County (16-10-      County Board of          West Front          lomc.
                                  1385P).             Commissioners, 200       Street, Boise, ID
                                                      West Front Street, 3rd   83702.
                                                      Floor, Boise, ID 83702.
Indiana:
    Boone......................  City of Lebanon     The Honorable Matt       Municipal           http://             June 23, 2017........       180013
                                  (16-05-5075P).      Gentry, Mayor, City of   Building, 401       www.msc.fema.gov/
                                                      Lebanon, City of         South Meridian      lomc.
                                                      Lebanon Municipal        Street, Lebanon,
                                                      Building, 401 South      IN 46052.
                                                      Meridian Street,
                                                      Lebanon, IN 46052.
    Boone......................  Unincorporated      The Honorable Jeff       Boone County Area   http://             June 23, 2017........       180011
                                  Areas of Boone      Wolfe, Boone County      Plan Commission,    www.msc.fema.gov/
                                  County (16-05-      Commissioner, 201        116 West            lomc.
                                  5075P).             Courthouse Square,       Washington
                                                      Lebanon, IN 46052.       Street, Lebanon,
                                                                               IN 46052.
Kentucky:
    Pike.......................  Unincorporated      The Honorable William    Pike County         http://             June 29, 2017........       210298
                                  Areas of Pike       M. Deskins, Judge        Courthouse, 146     www.msc.fema.gov/
                                  County (17-04-      Executive, Pike          Main Street,        lomc.
                                  1490P).             County, 146 Main         Pikeville, KY
                                                      Street, Pikeville, KY    41501.
                                                      41501.
    Pike.......................  Unincorporated      The Honorable William    Pike County         http://             June 29, 2017........       210298
                                  Areas of Pike       M. Deskins, Judge        Courthouse, 146     www.msc.fema.gov/
                                  County (17-04-      Executive, Pike          Main Street,        lomc.
                                  1672P).             County, 146 Main         Pikeville, KY
                                                      Street, Pikeville, KY    41501.
                                                      41501.
Michigan: Wayne................  City of Northville  The Honorable Ken Roth,  City Hall, 215      http://             June 2, 2017.........       260235
                                  (16-05-6404P).      Mayor, City of           West Main Street,   www.msc.fema.gov/
                                                      Northville, City Hall,   Northville, MI      lomc.
                                                      215 West Main Street,    48167.
                                                      Northville, MI 48167.
Missouri:
    St. Charles................  City of             The Honorable Jim        City Hall, 5490     http://             June 29, 2017........       290898
                                  Cottleville (16-    Hennessey, Mayor, City   5th Street,         www.msc.fema.gov/
                                  07-1877P).          of Cottleville, 5490     Cottleville, MO     lomc.
                                                      5th Street,              63304.
                                                      Cottleville, MO 63304.
    St. Charles................  City of St. Peters  The Honorable Len        City Hall, 1 Saint  http://             June 29, 2017........       290319
                                  (16-07-1877P).      Pagano, Mayor, City of   Peters Centre       www.msc.fema.gov/
                                                      St. Peters, 1 St.        Boulevard, St.      lomc.
                                                      Peters Centre            Peters, MO 63376.
                                                      Boulevard, St. Peters,
                                                      MO 63376.
    St. Charles................  Unincorporated      Mr. Steve Ehlmann, St.   County              http://             June 29, 2017........       290315
                                  Areas of St.        Charles County           Administration      www.msc.fema.gov/
                                  Charles County      Executive, 100 North     Building, 201       lomc.
                                  (16-07-1877P).      3rd Street Suite 318,    North 2nd Street,
                                                      St. Charles, MO 63301.   Suite 420, St.
                                                                               Charles, MO 63301.

Nebraska:
    Howard.....................  Unincorporated      The Honorable Kathy      Howard County       http://             June 8, 2017.........       310446
                                  Areas of Howard     Hirschman, Chairman,     Courthouse, 612     www.msc.fema.gov/
                                  County (16-07-      Howard County Board of   Indian Street,      lomc.
                                  2344P).             Commissioners, 830       St. Paul, NE
                                                      Hardy Road, St Paul,     68873.
                                                      NE 68873.
    Howard.....................  Village of          The Honorable Carol      Village Hall, 102   http://             June 8, 2017.........       310118
                                  Dannebrog (16-07-   Schroeder,               South Mill          www.msc.fema.gov/
                                  2344P).             Chairperson, Village     Street,             lomc.
                                                      of Dannebrog, 104        Dannebrog, NE
                                                      South Mill Street,       68831.
                                                      Dannebrog, NE 68831.
Nevada:
    Carson.....................  City of Carson      The Honorable Robert     Carson City Permit  http://             June 5, 2017.........       320001
                                  City (16-09-        Crowell, Mayor, City     Center, 108 East    www.msc.fema.gov/
                                  1192P).             of Carson City, City     Proctor Street,     lomc.
                                                      Hall, 201 North Carson   Carson City, NV
                                                      Street, Suite 2,         89701.
                                                      Carson City, NV 89701.
    Clark......................  City of Las Vegas   The Honorable Carolyn    Public Works        http://             June 21, 2017........       325276
                                  (16-09-0698P).      G. Goodman, Mayor,       Department, 400     www.msc.fema.gov/
                                                      City of Las Vegas,       Stewart Avenue,     lomc.
                                                      City Hall, 495 South     4th Floor, Las
                                                      Main Street, Las         Vegas, NV 89101.
                                                      Vegas, NV 89101.
    Clark......................  City of North Las   The Honorable John J.    Public Works        http://             May 30, 2017.........       320007
                                  Vegas (16-09-       Lee, Mayor, City of      Department, 2200    www.msc.fema.gov/
                                  2150P).             North Las Vegas, 2250    Civic Center        lomc.
                                                      Las Vegas Boulevard      Drive, North Las
                                                      North, North Las         Vegas, NV 89030.
                                                      Vegas, NV 89030.
    Clark......................  City of North Las   The Honorable John J.    Public Works        http://             May 30, 2017.........       320007
                                  Vegas (16-09-       Lee, Mayor, City of      Department, 2200    www.msc.fema.gov/
                                  2540P).             North Las Vegas, 2250    Civic Center        lomc.
                                                      Las Vegas Boulevard      Drive, North Las
                                                      North, North Las         Vegas, NV 89030.
                                                      Vegas, NV 89030.
    Clark......................  City of North Las   The Honorable John J.    Public Works        http://             June 29, 2017........       320007
                                  Vegas (16-09-       Lee, Mayor, City of      Department, 2200    www.msc.fema.gov/
                                  3212P).             North Las Vegas, 2250    Civic Center        lomc.
                                                      Las Vegas Boulevard      Drive, North Las
                                                      North, North Las         Vegas, NV 89030.
                                                      Vegas, NV 89030.
New Jersey: Ocean..............  Township of Brick   The Honorable John G.    Township Hall       http://             May 30, 2017.........       345285
                                  (16-02-1649P).      Ducey, Mayor, Township   Municipal           www.msc.fema.gov/
                                                      of Brick, 401            Building, 401       lomc.
                                                      Chambersbridge Road,     Chambersbridge
                                                      Brick, NJ 08723.         Road, Brick, NJ
                                                                               08723.
Oregon: Deschutes..............  Unincorporated      Ms. Tammy Baney, Chair,  Deschutes County    http://             June 23, 2017........       410055
                                  Areas of            Deschutes County Board   Board of            www.msc.fema.gov/
                                  Deschutes County    of Commissioners, P.O.   Commissioners,      lomc.
                                  (17-10-0456P).      Box 6005, Bend, OR       1164 Northwest
                                                      97708.                   Bond Street,
                                                                               Bend, OR 97701.
Texas:
    Dallas.....................  City of Balch       The Honorable Carrie     Public Works        http://             July 5, 2017.........       480166
                                  Springs (16-06-     Marshall, Mayor, City    Department, 3117    www.msc.fema.gov/
                                  3086P).             of Balch Springs,        Hickory Tree        lomc.
                                                      13503 Alexander Road,    Road, Balch
                                                      Balch Springs, TX        Springs, TX 75180.
                                                      75181.
    Dallas.....................  City of Dallas (16- The Honorable Michael    Department of       http://             July 5, 2017.........       480171
                                  06-3086P).          S. Rawlings, Mayor,      Public Works, 320   www.msc.fema.gov/
                                                      City of Dallas, 1500     East Jefferson      lomc.
                                                      Marilla Street, Suite    Boulevard,
                                                      5EN, Dallas, TX 75201.   Dallas, TX 75203.
    Dallas.....................  City of Grand       The Honorable Ron        City Development    http://             June 8, 2017.........       485472
                                  Prairie (17-06-     Jensen, Mayor, City of   Center, 206 West    www.msc.fema.gov/
                                  0542P).             Grand Prairie, 317       Church Street,      lomc.
                                                      West College Street,     Grand Prairie, TX
                                                      Grand Prairie, TX        75050.
                                                      75050.
Washington: Wahkiakum..........  Unincorporated      Mr. Blair H. Brady,      Wahkiakum County    http://             June 23, 2017........       530193
                                  Areas of            Chairman, Wahkiakum      Courthouse, 64      www.msc.fema.gov/
                                  Wahkiakum County    County, Board of         Main Street,        lomc.
                                  (16-10-0856P).      Commissioners, 64 Main   Cathlamet, WA
                                                      Street, Cathlamet, WA    98612.
                                                      98612.
Wisconsin:
    Marathon...................  Unincorporated      The Honorable Kurt       Conservation        http://             June 22, 2017........       550245
                                  Areas of Marathon   Gibbs, Chairperson,      Planning and        www.msc.fema.gov/
                                  County (17-05-      Marathon County, 500     Zoning Office,      lomc.
                                  1790X).             Forest Street, Wausau,   210 River Drive,
                                                      WI 54403.                Wausau, WI 54403.
    Marathon...................  Village of Hatley   The Honorable David      Village Hall, 435   http://             June 22, 2017........       550251
                                  (17-05-1790X).      Narloch, President,      Curtis Avenue,      www.msc.fema.gov/
                                                      Village of Hatley, 115   Hatley, WI 54440.   lomc.
                                                      Kuhlman Avenue,
                                                      Hatley, WI 54440.
    Milwaukee..................  City of Milwaukee   The Honorable Tom        City Hall, 200      http://             June 23, 2017........       550278
                                  (16-05-7247P).      Barrett, Mayor, City     East Wells          www.msc.fema.gov/
                                                      of Milwaukee, 200 East   Street,             lomc.
                                                      Wells Street, Room       Milwaukee, WI
                                                      201, Milwaukee, WI       53202.
                                                      53202.
    Milwaukee..................  Village of Brown    The Honorable Carl       Village Hall, 4800  http://             June 23, 2017........       550271
                                  Deer (16-05-        Krueger, Village         West Green Brook    www.msc.fema.gov/
                                  7247P).             President, Village of    Drive, Brown        lomc.
                                                      Brown Deer, 4800 West    Deer, WI 53223.
                                                      Green Brook Drive,
                                                      Brown Deer, WI 53223.
    Waukesha...................  Unincorporated      The Honorable Paul L.    Waukesha County     http://             June 23, 2017........       550476
                                  Areas of Waukesha   Decker, Waukesha         Administration      www.msc.fema.gov/
                                  County (16-05-      County, Board Chair,     Section, 515 West   lomc.
                                  6562P).             County Courthouse, 515   Mooreland
                                                      West Moreland            Boulevard,
                                                      Boulevard, Room C170,    Waukesha, WI
                                                      Waukesha, WI 53188.      53188.

    Waukesha...................  Village of Sussex   The Honorable Gregory    Village Hall,       http://             June 23, 2017........       550490
                                  (16-05-6562P).      L. Goetz, President,     N64W23760 Main      www.msc.fema.gov/
                                                      Village Board,           Street, Sussex,     lomc.
                                                      N61W24222 Oak Court,     WI 53089.
                                                      Sussex, WI 53089.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2017-10179 Filed 5-25-17; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Rules and Regulations]
[Page 20780-20781]
[DOCID:fr17ap08-2]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-0334; Airspace Docket No. 08-ASO-11]

Removal of Class E Airspace; Hawesville, KY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action removes the Class E5 Airspace at Hancock Airfield
Airport, Hawesville, KY, as there is no longer a Standard Instrument
Approach Procedure (SIAP) for Hancock Airfield Airport requiring Class
E5 airspace.

DATES: Effective 0901 UTC, July 31, 2008. The Director of the Federal
Register approves this incorporation by reference action under title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Melinda Giddens, System Support Group,
Eastern Service Center, Federal Aviation Administration, P.O. Box
20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The Hancock Airfield Airport has closed and a new airport,
Lewisport-Hancock County, has been built in the area. As a result, the
associated Standard Instrument Approach Procedures (SIAPs) were
withdrawn and cancelled removing the Class E5 airspace requirement at
Hancock Airfield. New SIAPs are being developed for the new Lewisport/
Hancock County Airport, however, the procedures and associated airspace
are not scheduled for publication until September of 2009. This rule
will become effective on the date specified in the DATES section. Since
this action eliminates the impact of controlled airspace on users of
the National Airspace System in the vicinity of the Hancock County
Airport, notice and public procedure under 5 U.S.C. 553(b) are
unnecessary. Class E airspace designations for airspace areas extending
upward from 700 feet or more above the surface of the earth are
published in Paragraph 6005 of FAA Order 7400.9R, signed August 15,
2007, and effective September 15, 2007, which is incorporated by
reference in 14 CFR 71.1. The Class E designation listed in this
document will be removed from publication subsequently in the Order.

The Rule

    This amendment to Part 71 of the Federal Aviation Regulations (14
CFR part 71) removes Class E5 airspace at Hancock Airfield Airport,
Hawesville, KY.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
noncontroversial and unlikely to result in adverse or negative
comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it removes controlled airspace at Hancock Airfield Airport,
Hawesville, KY.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (Air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., P. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace Designations and Reporting
Points, signed August 15, 2007, effective September 15, 2007, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO KY E5 Hawesville, KY [Remove]

* * * * *

    Issued in College Park, Georgia, on March 31, 2008.
Mark D. Ward,
Acting Manager, System Support Group, Eastern Service Center, Air
Traffic Organization (ATO).
 [FR Doc. E8-8061 Filed 4-16-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Page 80654]
[FR Doc No: 2016-27449]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP16-1299-000]

Kinetica Energy Express, LLC; Notice of Technical Conference

    The Commission's October 31, 2016 order in the above-captioned
proceeding \1\ directed that a technical conference be held to address
the effect of the tariff changes proposed by Kinetica Energy Express,
LLC in its September 30, 2016 filing in this docket.
---------------------------------------------------------------------------

    \1\ Kinetica Energy Express, LLC, 157 FERC ] 61,072 (2016).
---------------------------------------------------------------------------

    Take notice that a technical conference will be held on Thursday
December 1, 2016 at 10:00 a.m., in a room to be designated at the
offices of the Federal Energy Regulatory Commission, 888 First Street
NE., Washington, DC 20426.
    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an email to<EMAIL_ADDRESS>or call toll free (866) 208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER>
with the required accommodations.
    All interested persons and staff are permitted to attend. For
further information please contact Omar Bustami at<PHONE_NUMBER> or
email Omar Bustami at<EMAIL_ADDRESS>
    Dated: November 8, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-27449 Filed 11-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Page 66479]
[FR Doc No: 2023-21022]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4723-DR; Docket ID FEMA-2023-0001]

New York; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4723-DR), dated July 22, 2023, and
related determinations.

DATES: This amendment was issued August 3, 2023.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of July 22, 2023.

    Franklin County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2023-21022 Filed 9-26-23; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16639-16640]
[FR Doc No: 2023-05570]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-1941]

Determination of Regulatory Review Period for Purposes of Patent
Extension; JIVI

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for JIVI and is publishing this
notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological product.

DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by May 19, 2023.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 18, 2023. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 19, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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-2019-E-1941 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; JIVI.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with section 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological product becomes effective and runs
until the approval phase begins. The approval phase starts with the
initial submission of an application to market the human biological
product and continues until FDA grants permission to market the
biological product. Although only a portion of a regulatory review
period may count toward the actual amount of extension that the
Director of USPTO may award (for example, half the testing phase must
be subtracted as well as any time that may have occurred before the
patent was issued), FDA's determination of the length of a regulatory
review period for a human biological product will include all of the
testing phase and approval phase as specified in 35 U.S.C.
156(g)(1)(B).
    FDA has approved for marketing the human biologic product JIVI
(antihemophilic factor (recombinant), PEGylated-aucl). JIVI is
indicated for use in previously treated adults and adolescents (12
years of age and older) with hemophilia A (congenital Factor VIII
deficiency) for: (1) on-demand treatment and control of bleeding
episodes; (2) perioperative management of bleeding; and (3) routine
prophylaxis to reduce the frequency of bleeding episodes. Subsequent to
this approval, the USPTO received a patent term restoration application
for JIVI (U.S. Patent No. 7,632,921) from Bayer HealthCare LLC, and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated September
12, 2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of JIVI
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
JIVI is 2,991 days. Of this time, 2,626 days occurred during the
testing phase of the regulatory review period, while 365 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: June 23,
2010. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 23,
2010.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): August 30, 2017. FDA has verified the
applicant's claim that the biologics license application (BLA) for JIVI
(BLA 125661) was initially submitted on August 30, 2017.
    3. The date the application was approved: August 29, 2018. FDA has
verified the applicant's claim that BLA 125661 was approved on August
29, 2018.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 1,677 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in section 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of section 60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with section 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05570 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31959-31961]
[FR Doc No: 2019-14165]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86225; File No. SR-NYSEAMER-2019-15]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Delete
Provisions in Section 141 of the NYSE American Company Guide That Grant
the Board Authority to Defer, Waive or Rebate Annual Fees for Listed
Equity Securities and Bonds and To Eliminate Obsolete Provisions

June 27, 2019.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on June 18, 2019, NYSE American LLC (``NYSE American'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I,
II, and III 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.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 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 amend Section 141 of the NYSE American
Company Guide (the ``Company Guide'') to delete: (i) Provisions
granting the board of directors of the Exchange, or its designee,
discretion to defer, waive or rebate all or any part of the applicable
annual listing fee payable with respect to a listed class of equity
securities or a listed series of bonds; and (ii) references to fee
provisions that are no longer applicable, as those fees were superseded
as of January 1, 2019. The proposed rule change is available on the
Exchange's website at www.nyse.com, at the principal office of the
Exchange, and at the Commission's Public Reference Room.

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 those statements may be examined at the places specified in Item IV
below. The Exchange has prepared summaries, set forth in sections A, B,
and C below, of the most significant parts of such statements.

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

1. Purpose
    Section 141 of the Company Guide includes provisions granting the
board of directors of the Exchange, or its designee, discretion to
defer, waive or rebate all or any part of the applicable annual listing
fee payable with respect to a listed class of equity securities or
listed bonds under that section. The Exchange has not exercised this
discretion since it was acquired by NYSE Euronext On October 1, 2008,
and does not believe that it is possible to do so in a manner that
would be transparent and fair to all listed companies. In the absence
of this possible exercise of discretion, all similarly situated listed
companies will be treated the same with respect to the annual listing
fees they are charged. For these reasons, the Exchange proposes to
delete these provisions from Section 141.
    The Exchange also proposes to make non-substantive updates to the
text of Section 141 to remove references to the annual fees for equity
securities that were in effect prior to January 1, 2019, as those fees
are no longer applicable.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\4\ in general, and furthers the
objectives of Section 6(b)(4) \5\ of the Act, in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges. The Exchange also believes that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\6\ in that
it is designed to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism of a free and open market and a national market
system, and, in general, to protect investors and the public interest
and is not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(4).
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that it represents an equitable allocation of
reasonable fees and is not unfairly discriminatory to eliminate its
discretion to defer, waive or rebate all or any part of the applicable
annual fee owed by an issuer under Section 141. In that regard, the
Exchange does not believe that it is possible to utilize this
discretion in a manner that would be transparent and fair to all listed
companies.
    The proposed removal of text relating to fees that are no longer
applicable is ministerial in nature and has no substantive effect.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The market for listing
services is extremely competitive. Each listing exchange has a
different fee schedule that applies to issuers seeking to list
securities on its exchange. Issuers have the option to list their
securities on these alternative venues based on the fees charged and
the value provided by each listing. Because issuers have a choice to
list their securities on a different national securities exchange, the
Exchange does not believe that the proposed amendment imposes a burden
on competition. Furthermore, removing the Exchange's authority to waive
annual fees will ensure that the costs of listing on the Exchange will
be transparent and consistent, which will facilitate price competition
among listing venues and therefore will not impose any burden on
competition.
    The proposed removal of text relating to fees that are no longer
applicable is ministerial in nature and has no substantive effect and
therefore imposes no burden on competition.

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

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \7\ and Rule 19b-4(f)(6) thereunder.\8\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \9\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. 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 email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAMER-2019-15 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2019-15. This
file number should be included on the subject line if email 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 website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, 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 website 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 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2019-15 and should be submitted
on or before July 24, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-14165 Filed 7-2-19; 8:45 am]
 BILLING CODE 8011-01-P