[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Proposed Rules]
[Pages 54503-54511]
[FR Doc No: 2023-17074]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2023-1021; Airspace Docket No. 22-AWA-6]

Establishment of Class C Airspace and Removal of Class D
Airspace; Harrisburg International Airport, PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class C airspace, and remove
Class D airspace, at the Harrisburg International Airport (MDT), PA.
The FAA is proposing this action to enhance the efficient management of
air traffic operations and reduce the potential for midair collision in
the MDT terminal area. The Class C airspace would replace the existing
Class D airspace at MDT. In addition, the non-regulatory Terminal Radar
Service Area (TRSA) would be removed.

DATES: Comments must be received on or before October 10, 2023.

ADDRESSES: Send comments identified by FAA Docket No. FAA-2023-1021 and
Airspace Docket No. 22-AWA-6 using any of the following methods:
    * Federal eRulemaking Portal: Go to 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, 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
    * Hand Delivery or Courier: Take comments to 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>.
    Docket: Background documents or comments received may be read at
www.regulations.gov at any time. 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.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Brian Vidis, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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
the 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 would modify the airspace structure as necessary to
enhance the safe and efficient flow of air traffic within the
Harrisburg, PA, terminal area.

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal. The most
helpful comments reference a specific portion of the proposal, explain
the reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should submit only one time if comments are filed electronically, or
commenters should send only one copy of written comments if comments
are filed in writing.
    The FAA will file in the docket all comments it receives, as well
as a report summarizing each substantive public

contact with FAA personnel concerning this proposed rulemaking. Before
acting on this proposal, the FAA will consider all comments it receives
on or before the closing date for comments. The FAA will consider
comments filed after the comment period has closed if it is possible to
do so without incurring expense or delay. The FAA may change this
proposal in light of the comments it receives.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

Availability of Rulemaking Documents

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Operations office (see ADDRESSES section for address, phone number, and
hours of operations). An informal docket may also be examined during
normal business hours at the office of the Eastern Service Center,
Federal Aviation Administration, Room 210, 1701 Columbia Avenue,
College Park, GA 30337.

Incorporation by Reference

    Class C airspace areas and Class D airspace areas are published in
paragraphs 4000 and 5000, respectively, of FAA Order JO 7400.11G,
Airspace Designations and Reporting Points, which is incorporated by
reference in 14 CFR 71.1 on an annual basis. This document proposes to
amend the current version of that order, FAA Order JO 7400.11G, dated
August 19, 2022, and effective September 15, 2022. These updates would
be published in the next update to FAA Order JO 7400.11. That order is
publicly available as listed in the ADDRESSES section of this document.
    FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas,
air traffic service routes, and reporting points.

Background

    Harrisburg International Airport (MDT) is located 8 miles southeast
of the city of Harrisburg, PA. Capital City Airport (CXY) is located
approximately 3.5 miles northwest of MDT. The MDT Airport Traffic
Control Tower (ATCT) consists of a combined tower and Terminal Radar
Approach Control (TRACON) facility operating 24 hours a day. CXY has a
part-time ATCT that operates 0700 to 2100 local time, daily. Class D
airspace, extending from the surface to and including 2,800 feet above
mean sea level (MSL), surrounds both airports. During times when the
CXY ATCT is closed, the CXY Class D airspace reverts to a Class E
surface area.
    A Terminal Radar Service Area (TRSA) overlies the two contiguous
Class D airspace areas and extends approximately 15 nautical miles (NM)
east and west of MDT, within the TRACON's delegated airspace.
    The airspace surrounding MDT and CXY is complex and congested due
to the location and uniqueness of the two airport configurations. There
are five airports with operational ATCTs in and around the MDT terminal
area. There are 11 non-towered satellite airports, and 5 hospital
heliports with instrument approach procedures under the jurisdiction of
MDT ATCT. Restricted Area R-5802 is located approximately 11 NM
northeast of MDT. R-5802 is in use nearly every day, and MDT ATCT
frequently controls military aircraft into and out of that airspace.
    Pilots operating under visual flight rules (VFR) frequently
navigate above the MDT and CXY Class D airspace areas by following very
popular routes created by the Susquehanna River and the various
interstate highways interspersed throughout the area. Due to their
proximity, aircraft operations at MDT and CXY may penetrate the current
Class D airspace boundaries of the other. Consequently, air traffic
control (ATC) must often sequence and separate the aircraft landing and
departing MDT and CXY as if they were a single airport.
    The runway configurations at MDT and CXY, plus the proximity to
other airports, local geography, restricted airspace, flight training,
skydiving, and the mix of jet and propeller aircraft combine to make
the airspace in the MDT terminal area a web of intersecting flight
paths. Additionally, significant numbers of VFR aircraft, which are not
in contact with ATC, operate throughout the MDT and CXY terminal area.
Without such communications, air traffic controllers are unaware of
nonparticipating pilots' intentions. Heading and/or altitude changes
made by nonparticipating VFR aircraft are unpredictable, and this often
requires controllers to take action to avoid possible conflicts with
other aircraft under their control. With the current airspace
configuration, there is no requirement for VFR pilots to contact ATC
when operating beyond the boundaries of the MDT and CXY Class D
airspace areas.

Class C Airspace and Terminal Radar Service Areas (TRSA)

    Class C airspace areas are designated under Title 14, Code of
Federal Regulations (CFR) part 71 rulemaking to improve aviation safety
by reducing the risk of midair collisions in the terminal area and
enhancing the management of air traffic operations therein. Class C
airspace is designed to keep ATC informed of all aircraft operating
within the Class C airspace. Pilots are required to establish two-way
radio communications with ATC prior to entering Class C airspace, and
they must maintain communications while operating in Class C airspace.
In addition, pursuant to 14 CFR part 91, no person may operate an
aircraft in Class C airspace unless the aircraft is equipped with an
operational transponder and Automatic Dependent Surveillance--Broadcast
(ADS-B) Out.
    TRSAs are not officially designated by airspace rulemaking action.
They are not incorporated in 14 CFR part 71, nor are there any TRSA-
specific operating rules in 14 CFR part 91. TRSAs are established
around designated airports where ATC provides radar vectoring,
sequencing, and separation services on a full-time basis for all
instrument flight rules (IFR) and participating VFR aircraft. Pilots
operating under VFR are encouraged to contact ATC to avail themselves
of TRSA services. However, VFR pilot participation in TRSA services is
voluntary. The limitations of the TRSA (e.g., voluntary participation
by VFR pilots) often contributes to nonparticipating VFR aircraft
coming in direct conflict with higher-performance jets landing or
departing MDT or CXY.

Need for Class C Airspace at MDT

    To qualify for Class C airspace, an airport must be served by an
operational ATCT and a radar approach control; and meet one of the
following criteria:
    An annual instrument operations count of 75,000 at the primary
airport; or
    An annual instrument operations count of 100,000 at the primary and
secondary airports; or
    An annual count of 250,000 enplaned passengers at the primary
airport.
    MDT qualifies as a candidate for Class C airspace based on its
annual enplaned passenger count. MDT's enplaned passenger count for
calendar year (CY) 2021 (the latest year for which validated

figures are available) was 512,251. This figure represents a 64.05%
increase over CY 2020 numbers. Other factors considered are traffic
volume, airspace complexity, and the potential for midair collision in
the terminal area.
    The existing TRSA does not adequately support the volume and
diversity of aircraft operating in the congested MDT terminal area.
Currently, there is no requirement for VFR pilots to establish radio
contact with ATC outside of the existing MDT and CXY Class D airspace
areas. Since participation in TRSA services is voluntary on the part of
VFR pilots, the TRSA does not provide ATC with an adequate level of
flight information or control required to segregate IFR and VFR
aircraft operating in this complex airspace environment. VFR aircraft
that are not in contact with ATC routinely operate in the area, and in
so doing they cross MDT and CXY arrival and departure corridors and/or
make unexpected heading and/or altitude changes. These aircraft
frequently operate at altitudes that may conflict with aircraft
arriving or departing MDT. As a result, IFR aircraft must alter their
flight path or altitude thereby disrupting the orderly flow of MDT
arrivals or departures. Additionally, air traffic controller workload
is increased due to the need for additional vectoring or altitude
changes of MDT arrivals and departures to ensure separation from the
unknown VFR aircraft that are not communicating with ATC. Under this
proposal, those VFR aircraft operating in the vicinity of the MDT
arrival and departure corridors would be required to establish contact
with ATC to ensure controllers are aware of pilots' intentions and
promote increased safety and efficiency.

Benefits of Class C Airspace

    All pilots would benefit from the enhanced safety provided by Class
C services, which include separation, traffic advisories, and safety
alerts. In addition, Class C airspace would:

--Enhance safety by lessening the likelihood of MDT arrivals and
departures encountering unknown aircraft that are not in contact with
ATC, thereby reducing the potential for midair collision;
--Reduce air traffic controller workload by lessening the need for
additional vectoring of arrivals and departures to avoid conflicts with
unknown VFR aircraft; and
--Minimize disruptions to the orderly flow of arrivals and departures
to ensure pilots can fly stabilized approaches during a critical phase
of flight.

Pre-NPRM Public Input

    In 2019, the FAA initiated action to form an Ad Hoc Committee
(Committee) to seek input and recommendations from representatives of
affected aviation users for the FAA to consider in designing a proposed
Class C airspace area at MDT. The Committee consisted of a diverse
sampling of local aviation users, including representatives from the
Pennsylvania Bureau of Aviation, Susquehanna Area Regional Airport
Authority (SARAA), local airports and flight schools, Piedmont
Airlines, the Experimental Aircraft Association (EAA), Life Lion
Emergency Medical Services, and Corporate Flight Departments.

Ad Hoc Committee Recommendations

    The Committee met throughout 2020 and submitted its report to the
FAA in February 2021. The committee made a counterproposal to the
traditional circular Class C shape being considered by the FAA. The
Committee's design consists of a surface area generally within a 5 NM
radius of MDT; and a rectangular shape aligned primarily along MDT's
runway 13/31 approach/departure corridors extending 15 NM northwest and
southeast of MDT. The FAA studied the Committee's design and determined
that it would meet the needs of enhanced safety and efficiency in the
MDT terminal area and would actually lessen the impact on satellite
airports as opposed to the preliminary circular design. The FAA
proposes to adopt the Committee's design as described in this proposal.
    The Committee recommended that the CXY ATCT operating hours be
extended from the current 0700 to 2100, local time, to 0600 to 2200,
local time, at least from April through September, to mitigate the
potential for conflicts between CXY traffic and MDT arrivals and
departures. When the CXY ATCT is closed, the CXY Class D airspace
reverts to Class E airspace. MDT Approach Control provides services and
has radio communications coverage with aircraft on the ground at CXY.
Pilots at CXY could contact MDT Approach prior to departure to request
entry into the Class C airspace.
    The decision to change the ATCT operating hours is governed by a
separate, stand-alone process, and is outside the scope of this
rulemaking action. However, the FAA believes that the proposed Class C
airspace would provide adequate space for CXY operations while
enhancing safety for operations into and out of MDT.
    The Committee expressed concern that the current TRSA allows
nonparticipating aircraft to loiter or transition through the MDT
arrival and departure corridors creating conflicts between IFR and
nonparticipating VFR aircraft.
    The proposed Class C airspace would require all aircraft to
establish radio communications with ATC before entering the airspace,
and to maintain communications while operating in the airspace. This
would ensure that controllers are aware of, and would provide Class C
services to, all aircraft operating in the Class C airspace thereby
reducing the potential for conflicts with unknown aircraft.
    The Committee emphasized that the Class C design should minimize
the impact on CXY and other satellite airport operations.
    The proposed design includes a cutout within a 1.5 NM radius
northeast of CXY, and a shelf on the southwest side of the Class C
surface area to accommodate CXY operations beyond the lateral boundary
or beneath Class C airspace. The proposed 2,600-foot Class C floor,
over and southwest of CXY, would allow CXY traffic to arrive and depart
beneath the Class C airspace shelf away from MDT traffic flows. This
design would provide adequate space to permit operations by pilots who
do not wish to receive Class C services, or aircraft not properly
equipped to enter that airspace while providing enhanced safety for
operations into and out of MDT. There were also concerns that the CXY
ATCT may extend aircraft in the runway 30 traffic pattern into the MDT
Class C airspace for spacing. CXY ATCT will adjust the upwind/downwind
traffic pattern legs as needed to keep those aircraft clear of the
Class C. To accommodate non-participating aircraft (including aircraft
not equipped with ADS-B Out) operating to/from CXY runway 08, the
proposed class C design excludes a 1.5 NM radius around CXY from the
Class C surface area northeast of CXY airport. This exclusion would
allow operations to/from runway 08 without entering Class C airspace.
The proposed Class C design would enable operations at CXY to continue
largely unchanged. When the CXY ATCT is closed, pilots departing CXY to
the east who wish to enter Class C airspace may contact MDT Approach
prior to takeoff or establish communications with Approach before
entering the Class C area.
    Regarding the various satellite airports in the vicinity of MDT,
only Donegal Springs airport (N71) lies beneath a Class C shelf (2,100
feet MSL). The shelf also allows non-ADS-B equipped aircraft to operate
into and out of LNS without entering Class C

airspace. MDT will continue supporting the aerobatic box and skydiving
operations at N71. Where necessary, a letter of agreement (LOA) with
the stakeholders will be developed to define the procedures for these
operations in Class C airspace.
    The Committee expressed concern that aircraft operating into and
out of CXY during times when the CXY ATCT closes could conflict with
MDT traffic and VFR nonparticipating traffic.
    The proposed airspace design provides sufficient protection for
existing flight patterns, including the extended downwind and final
flight paths of heavy aircraft that routinely operate to and from MDT.
The flight paths into and out of VFR airports located outside of the
proposed Class C remain accessible to nonparticipating aircraft.
    The Committee suggested that visual landmarks be associated with
the Class C boundaries to assist pilots identifying the boundaries or
maintaining clearance from the Class C airspace.
    The proposed boundaries are situated near a number of visual
landmarks to assist pilots with boundary identification. For example,
the ``S turn'' in the Susquehanna River and the ridgeline identifies
the northwestern airspace boundary. Founders Hall is a notable landmark
used when operating at Reigle Field (58N). It lies just north of the
northern lateral boundary of the Class C airspace. Other boundaries are
configured so that major highways, such as the Pennsylvania Turnpike,
I-81, and Carlisle Pike can be used to reference the airspace
boundaries visually. In addition, bridges over the Susquehanna River,
and other landmarks such as Roundtop Ski Mountain, and Pinchot Lake are
also available to mark the southern boundary of Class C airspace. These
landmarks, in combination with the various Class C shelves, would
assist pilots seeking to avoid the Class C airspace.

Discussion of Informal Airspace Meeting Comments

    As announced in the Federal Register on June 4, 2021, the FAA held
an informal airspace meeting on August 18, 2021 (86 FR 29969). The
meeting was held virtually via the Zoom platform and was simultaneously
broadcast on the FAA's Facebook and YouTube channels. A total of 103
people logged into the Zoom meeting. The meeting was also advertised
through the FAA's Flight Standards FAA Safety Team (FAAST) distribution
list. The purpose of the meeting was to provide interested airspace
users with an opportunity to present their views and offer
recommendations regarding the proposed establishment of Class C
airspace at MDT. The meeting began with a presentation of the proposed
Class C airspace by the MDT Air Traffic Manager. Eight attendees
offered comments at the meeting. Four of the eight speakers expressed
support for the Class C proposal. One of the eight opposed the MDT
Class C establishment based on the aircraft equipage requirements.
Three of the eight asked questions rather than making a presentation.
The following topics were discussed.
    Attendees expressed concern that the requirement to equip aircraft
with ADS-B Out for flight within Class C airspace would exclude many
operators from access to the airspace. Commenters stated that pilots
operating non-ADS-B equipped aircraft should be given reasonable
opportunity to access Class C airspace, such as via LOAs.
    In order to ensure access for all operators, the proposed Class C
configuration accommodates aircraft not equipped with ADS-B by
including various shelves designed to allow pilots to navigate through
the area and access airports, while remaining outside Class C airspace.
The FAA designed the shelves and area boundaries to lessen the impact
on satellite airports. Generally, aircraft not equipped with ADS-B Out
would be required to fly around or below the proposed Class C airspace.
    ADS-B Out is a key component in the FAA's multibillion-dollar Next
Generation Air Transportation System (NextGen) program. NextGen is
designed to modernize the U.S. National Airspace System (NAS) in order
to meet future demand, reduce delays, and improve safety. ADS-B
provides more accurate information to air traffic controllers and
pilots. The FAA mandated the requirement for ABS-B Out equipage in
Class C airspace by rulemaking in 14 CFR part 91.\1\
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    \1\ Automatic Dependent Surveillance-Broadcast (ADS-B) Out
Performance Requirements to Support Air Traffic Control (ATC)
Service, Final Rule, 75 FR 30193 (May 28, 2010).
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    Attendees were also concerned that establishing Class C airspace
may cause a reduction in flight training and loss of business in the
MDT area. Additionally, attendees expressed that the Class C might
discourage pilots from other airports who come to this airspace to gain
experience operating with both ATCTs and approach control facilities.
    The FAA does not agree. For aircraft capable of operating in Class
C airspace, there would be few operational differences, thus no impact.
For aircraft not equipped to fly in Class C airspace, Class C
developers gave special consideration to the dimensions and altitudes
of the proposed airspace to ensure operators can fly the ILS runway 08
approach at CXY, and the ILS runway 08 at LNS without entering Class C
airspace. Area Navigation (RNAV) approaches at Donegal Springs Airpark
(N71) and Carlisle Airport (N94) are also outside of Class C. However,
the RNAV runway 26 at CXY and the RNAV-A approach at Reigle Field (58N)
are in Class C airspace because they conflict with MDT arrivals and
departures. Alternatively, many other nearby airports such as York
(THV), Lancaster (LNS), and Reading (RDG), have instrument approaches
that can be used for flight training or alternates to MDT. Considering
the 2,600-foot Class C shelf over and southwest of CXY, student pilots
should be able to continue receiving similar training at CXY as they do
today without having to enter Class C airspace. The establishment of
Class C airspace at MDT could increase local training possibilities by
providing students with the opportunity to learn and operate in Class C
as well as Class D airspace. This experience could also be beneficial
to pilots planning flights to Class C airports beyond the MDT terminal
area.
    A student pilot was concerned about the impact to flight training
of the 2,100 and 2,600-foot Class C shelves above the Carlisle practice
area, an area heavily used for ground reference maneuvers and flight
training. The pilot was concerned the shelves could cause aircraft
attempting to avoid the Class C airspace to further congest the
training area and potentially force aircraft to fly low over populated
areas.
    The Carlisle practice area has no published or defined boundaries.
It is a locally used, unofficial designation that helps pilots
communicate their intentions to ATC. MDT Approach Control is familiar
with the area and provides services, such as traffic advisories, in the
Carlisle practice area today. ATC typically considers the Carlisle
practice area to be west of Carlisle airport (N94), which is already
west of the proposed Class C airspace. The area west of a straight line
between N94 and the Harrisburg Very High Frequency (VHF)
Omnidirectional Range/Tactical Air Navigation (VORTAC) is beyond the
lateral boundaries of the proposed Class C and is safe for flight
training. Aircraft performing maneuvers in the practice area should
remain west of the proposed Class C airspace to remain safely separated
from aircraft arriving and departing CXY and MDT. Pilots who

wish to operate in the western portion of the proposed Class C would be
permitted to do so when in communication with ATC.
    Several commenters were concerned about the proposed Class C
airspace effects on CXY's traffic pattern operations. They noted that
frequently, CXY ATCT extends the downwind leg for runway 30 beyond the
boundary of CXY's Class D airspace and into MDT's Class D airspace.
Currently, this is coordinated between controllers at CXY and MDT.
However, with the proposed Class C airspace at MDT, pilots might worry
about entering the Class C airspace without the required equipment, and
possibly receive a violation, or pilots could put themselves in an
unsafe position trying to avoid the airspace. Another concern was being
directed to make a right 360-degree turn over elevated terrain and
antennas south of CXY near the 1,500-foot MSL traffic pattern altitude.
    MDT ATCT conducted a study of the CXY runway 30 operation. They
reviewed 100 hours of recordings from a sampling of 7 different days
that were selected due to their high traffic count and likelihood of
congestion. During the study period, more than 250 operations were
conducted to/from runway 30. Of the 250, only 7 aircraft were extended
beyond the CXY Class D boundary. Three of the 7 aircraft performed a
360-degree turn on the downwind leg prior to extending beyond the CXY
Class D airspace. Pilots continue to perform this maneuver in the
airspace today. The FAA does not anticipate that the airspace change
from Class D to Class C will impact the safety of a pilot's ability to
perform that maneuver. MDT and CXY ATCTs have no safety concerns with
the traffic pattern operations for CXY runway 12/30. The traffic
pattern operation will not change nor be affected by the proposed Class
C airspace. Regarding ATC extending an aircraft into the Class C
airspace, as stipulated in 14 CFR part 91, no person may operate an
aircraft contrary to an ATC instruction, except in an emergency. Also,
any pilot who is uncomfortable with flying in proximity to the tall
antennas south of CXY can be provided alternate instructions (e.g.,
extend upwind or downwind).
    Another commenter noted that the published missed approach
procedure for the CXY ILS runway 08 approach would enter the proposed
Class C airspace.
    Currently, during normal operations, ATC does not assign the
published missed approach procedure for the ILS runway 08 approach.
Instead, ATC routinely issues alternate missed approach instructions in
order to de-conflict the CXY runway 08 missed approach segment from
aircraft executing the ILS runway 13 approach at MDT, and MDT runway 13
departures that are turning outbound to the northwest. Pilots can
expect a west or south turn out at the HORVI intersection identical to
the standard procedures used today. ATC will issue these instructions
regardless of whether the CXY ATCT is open or closed. Additionally, VFR
aircraft conducting a practice instrument approach to CXY runway 08 are
not authorized to fly the published missed approach unless approved by
ATC. Other segments of the CXY ILS runway 08 approach remain beyond
Class C airspace; thus, the approach is still available to non-ADS-B
equipped aircraft with the assigned the alternate climb-out
instructions.
    Several commenters believed that the low floors of the proposed
Class C airspace shelves could potentially force aircraft to fly low
over heavily populated areas. They stated that requiring aircraft to
maneuver at low altitudes under the shelves is concerning. Having
additional altitude would provide pilots with more time to make
decisions, especially in emergency situations.
    While the FAA recognizes that flying at higher altitudes increases
the time to respond to an unexpected emergency situation, the FAA
developed the Class C shelf floors in the proposed design as high as
possible to enable the most access to nonparticipating aircraft while
retaining the margin of safety required between participating aircraft
and those transitioning under the Class C airspace. The shelves in the
proposed design permit safe flight in compliance with 14 CFR part 91.
The proposed Class C configuration does not obligate any pilot to fly
at a lower altitude or in an unsafe manner. Ultimately, it is the
pilot's responsibility to evaluate all factors that could affect a
planned flight and determine the safest course of action, whether that
be circumnavigating the Class C, flying beneath the area, or
establishing communication with ATC to enter the Class C and receive
ATC services. The proposed Class C airspace would increase safety by
reducing the risk of midair collision in the terminal area. The change
would also ensure that aircraft choosing not to participate in Class C
services remain safe and segregated from other aircraft operating in
the congested airspace around MDT.
    Two pilots were concerned about the proposed airspace change at MDT
from Class D to Class C. One pilot suggested that the FAA consider
expanding the MDT Class D airspace as an alternative to establishing
Class C airspace. That would provide the required communication with
ATC without imposing the equipment mandates associated with Class C
airspace.
    Class D airspace is designated to provide controlled airspace for
terminal VFR and IFR operations at airports having an operational ATCT.
While Class D airspace does require communication with ATC, Class D
services do not include radar traffic advisories and separation
services that are provided in Class C airspace. A large, expanded Class
D airspace around MDT, as suggested, would be contrary to the criteria
for establishing Class D airspace, and would not facilitate the ATC
services provided in Class C airspace that are essential to reducing
the potential for midair collision in the busy MDT terminal area.
Therefore, the FAA is unable to adopt the suggestion for an expanded
Class D airspace area at MDT.
    Two aviation organizations commended the collaborative approach the
FAA used in this proposal process but stated that many of their members
remain unaware of the proposed establishment of Class C airspace at
MDT. They recommended wider communications to the local community.
    The FAA's outreach efforts regarding the proposed MDT Class C
airspace are described in the Ad Hoc Committee and Informal Airspace
Meeting sections of this notice. A recording of the Informal Airspace
Meeting is available for the public to watch on the FAA's YouTube
channel at www.faa.gov/air_traffic/community_engagement/mdt/.
Additionally, this NPRM establishes a 60-day comment period during
which the public can submit their views about the proposal. The FAA
will continue to publicize the proposal and remains receptive to
feedback.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to establish
Class C airspace at MDT and remove the existing Class D airspace area
at MDT. The latitude/longitude coordinates for the MDT and CXY airport
reference points (ARP) would be updated to reflect the current Airport
Master Records data. Also, the existing MDT TRSA would be removed and
replaced by the Class C airspace area. The FAA is proposing this action
to enhance the safe and efficient use of airspace and reduce the risk
of midair collision in the MDT terminal area (see the attached chart).
    The proposed Class C airspace area would consist of six sub-areas
identified

by the letters A through F, described as follows:
    Area A: Area A would extend from the surface up to 4,400 feet MSL
within a 5 NM radius of MDT, except for that portion described as Area
E, below, and excluding that area within a 1.5 NM radius of CXY,
northeast of the airport. Area A would replace the existing Class D
airspace at MDT.
    Area B: Area B would extend from 1,600 feet MSL up to 4,400 feet
MSL. It would consist of that airspace within 3.5 miles either side of
the 117[deg] bearing from MDT, between the 5 mile and 10-mile radii
from MDT.
    Area C: Area C would extend from 1,600 feet MSL up to 4,400 feet
MSL. It would be located northwest of MDT between the 5- and 10-mile
radii of MDT and bounded on the south side by Area E. Area C would
overlie a portion of the CXY Class D airspace area.
    Area D: Area D would extend from 2,100 feet MSL up to 4,400 feet
MSL. Area D would be bounded as follows: on the northwest end by the
15-mile radius of MDT northwest of MDT; on the northeast side by a line
extending from the intersection of the 15-mile radius of MDT and the
MDT's 325[deg] bearing, direct to the intersection of MDT's 089[deg]
bearing and the 15-mile radius of MDT southeast of MDT; and on the
southwest side, by a line extending from lat. 40[deg]01'45'' N, long.
76[deg]40'43'' W, to lat. 40[deg]05'32'' N, long. 76[deg]50'21'' W,
excluding the airspace contained in Areas A, B, C, E, and F. Area D's
2,100-foot floor would create a shelf in the vicinity of Donegal
Springs Airpark (N71) allowing for operations beneath the Class C
airspace.
    Area E: Area E would extend from 2,600 feet MSL up to 4,400 feet
MSL south and west of CXY. Area E would overlie part of the CXY Class D
airspace area to the south and west of CXY. Area E would allow aircraft
to operate to and from CXY without the need for pilots to enter Class C
airspace.
    Area F: Area F would extend from 2,600 feet MSL up to 4,400 feet
MSL. The proposed Area F floor creates a shelf below which pilots could
fly instrument approaches to Lancaster Airport (LNS) runway 08, without
having to enter Class C airspace.
    Full descriptions of the MDT Class C subareas are listed in the
amendments to part 71 set forth below.
    The FAA believes that all users would benefit from participation in
the proposed Class C services around MDT, which include sequencing of
all aircraft to the primary airport; standard IFR services to IFR
aircraft; separation, traffic advisories, and safety alerts between IFR
and VFR aircraft; and mandatory traffic advisories and safety alerts
between VFR aircraft.
    The FAA strongly recommends that pilots participate in the Class C
airspace and receive ATC services. Communication with ATC is critical
in order to provide controllers with awareness of a pilot's intended
flight path. With that predictability, ATC can issue safe, logical
instructions to ensure the safety of all participating aircraft.
    As previously stated, the MDT Class D airspace area and the MDT
TRSA would be removed under this proposal. Any required amendments to
the CXY Class D airspace and the CXY Class E surface area would be
addressed in a separate rulemaking action.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires
that the FAA consider the impact of paperwork and other information
collection burdens imposed on the public. The FAA has determined that
there is no new information collection requirement associated with this
proposed rule.

Regulatory Notices and Analyses

    Regulatory Notices and Analyses Changes to Federal regulations must
undergo several economic analyses. First, Executive Order 12866 and
Executive Order 13563 direct that each Federal agency shall propose or
adopt a regulation only upon a reasoned determination that the benefits
of the intended regulation justify its costs. Second, the Regulatory
Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze
the economic impact of regulatory changes on small entities. Third, the
Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting
standards that create unnecessary obstacles to the foreign commerce of
the United States. In developing U.S. standards, this Trade Act
requires agencies to consider international standards and, where
appropriate, that they be the basis of U.S. standards. Fourth, the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies
to prepare a written assessment of the costs, benefits, and other
effects of proposed or final rules that include a Federal mandate
likely to result in the expenditure by State, local, or tribal
governments, in the aggregate, or by the private sector, of $100
million or more annually (adjusted for inflation with base year of
1995). The current threshold after adjustment for inflation is $177
million, using the most current (2022) Implicit Price Deflator for the
Gross Domestic Product.
    In conducting these analyses, the FAA has determined that this
proposed rule: (1) is expected to have a minimal cost impact, (2) is
not a ``significant regulatory action'' as defined in section 3(f) of
Executive Order 12866, (3) is not significant under DOT's
administrative procedure rule on rulemaking at 49 CFR 5.13; (4) not
have a significant economic impact on a substantial number of small
entities; (5) does not create unnecessary obstacles to the foreign
commerce of the United States; and (6) does not impose an unfunded
mandate on state, local, or tribal governments, or on the private
sector by exceeding the threshold identified above. These analyses are
summarized below.
    This action proposes to establish Class C airspace at MDT in place
of the existing Class D airspace at MDT. The latitude/longitude
coordinates for the MDT and CXY ARP would be updated to reflect the
current Airport Master Records data. Also, the existing MDT TRSA would
be removed and replaced by the Class C airspace area.
    The airspace surrounding MDT and CXY is heavily trafficked due to
the five airports with operational ATCTs in and around the MDT terminal
area. In addition, 11 non-towered satellite airports, 5 hospital
heliports, and military aircraft nearby contribute to the increasing
traffic. The FAA determined that changes in this proposed rule would
enhance the efficient management of air traffic operations and reduce
the potential for midair collision in the MDT terminal area. The
proposal would reduce air traffic controller workloads by lessening the
need for additional vectoring of arrivals and departures to avoid
conflicts with unknown VFR aircraft and minimize disruptions to the
orderly flow of arrivals and departures to ensure pilots can fly
stabilized approaches during a critical phase of flight. Pilots would
also benefit from the enhanced safety provided by Class C services that
include separation, traffic advisories, and safety alerts.
    The FAA considered and accepted recommendations from an Ad Hoc
Committee and informal airspace meetings from stakeholders. The
committee made a counterproposal to the traditional circular Class C
shape being considered by the FAA. The Committee's design consists of a
surface area generally within a 5 NM radius of MDT; and a rectangular
shape aligned primarily along MDT's runway 13-31 approach/departure
corridors and extending 15 NM northwest and southeast of MDT. The FAA
studied Committee's design and determined that it would meet the needs
of enhanced safety and efficiency in the MDT terminal area and would
lessen the

impact on satellite airports as opposed to the preliminary circular
design.
    Class C airspace areas are designated under 14 CFR part 71
rulemaking to improve aviation safety by reducing the risk of midair
collisions in the terminal area and enhancing the management of air
traffic operations therein. Class C airspace is designed to keep ATC
informed of all aircraft operating within the Class C airspace. Pilots
are required to establish two-way radio communications with ATC prior
to entering Class C airspace, and they must maintain communications
while operating in Class C airspace. In addition, pursuant to 14 CFR
part 91, no person may operate an aircraft in Class C airspace unless
the aircraft is equipped with an operational transponder and ADS-B Out.
VFR operators would only need to make minor adjustments to accommodate
the proposed Class C airspace by flying under or around it. Therefore,
the FAA expects the proposal would result in minimal cost to VFR
operators. The FAA requests comments on the benefits and costs of this
proposal to inform the final rule.

Regulatory Flexibility Determination

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA)
establishes ``as a principle of regulatory issuance that agencies shall
endeavor, consistent with the objectives of the rule and of applicable
statutes, to fit regulatory and informational requirements to the scale
of the businesses, organizations, and governmental jurisdictions
subject to regulation.'' To achieve this principle, agencies are
required to solicit and consider flexible regulatory proposals and to
explain the rationale for their actions to assure that such proposals
are given serious consideration. The RFA covers a wide range of small
entities, including small businesses, not-for-profit organizations, and
small governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will
have a significant economic impact on a substantial number of small
entities. If the agency determines it will, it must prepare a
regulatory flexibility analysis as described in the RFA. However, if an
agency determines that a rule is not expected to have a significant
economic impact on a substantial number of small entities, section
605(b) of the RFA provides that the head of the agency may so certify,
and a regulatory flexibility analysis is not required. The
certification must include a statement providing the factual basis for
this determination, and the reasoning should be clear.
    The proposed rule would replace Class D airspace with Class C
airspace at MDT. The FAA is proposing this action to enhance the
efficient management of air traffic operations and reduce the potential
for midair collision in the MDT terminal area. The change would affect
general aviation operators using the proposed Class C airspace.
Operators flying VFR would need to make small adjustments to their
flight paths to avoid the modified Class C airspace, so pilots could
operate without contacting ATC. Additionally, some VFR operators are
currently doing so to avoid heavy traffic. Therefore, as provided in
section 605(b), the head of the FAA certifies that this rulemaking
would not result in a significant economic impact on a substantial
number of small entities.

International Trade Impact Assessment

    The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the
Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal
agencies from establishing standards or engaging in related activities
that create unnecessary obstacles to the foreign commerce of the United
States. Pursuant to these Acts, the establishment of standards is not
considered an unnecessary obstacle to the foreign commerce of the
United States, so long as the standard has a legitimate domestic
objective, such as the protection of safety, and does not operate in a
manner that excludes imports that meet this objective. The statute also
requires consideration of international standards and, where
appropriate, that they be the basis for U.S. standards. The FAA has
assessed the potential effect of this proposed rule and determined that
it would improve safety and is consistent with the Trade Agreements
Act.

Unfunded Mandates Assessment

    Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-
4) requires each Federal agency to prepare a written statement
assessing the effects of any Federal mandate in a proposed or final
agency rule that may result in an expenditure of $100 million or more
(in 1995 dollars) in any one year by State, local, and tribal
governments, in the aggregate, or by the private sector; such a mandate
is deemed to be a ``significant regulatory action''. The FAA currently
uses an inflation-adjusted value of $177 million in $100 million. This
proposed rule does not contain such a mandate; therefore, the
requirements of Title II of the Act do not apply.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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(f), 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 the Federal
Aviation Administration Order JO 7400.11G, Airspace Designations and
Reporting Points, dated August 19, 2022, and effective September 15,
2022, is amended as follows:

Paragraph 4000 Subpart C-Class C Airspace.

* * * * *

AEA PA C Harrisburg, PA [New]

Harrisburg International Airport, PA
    (Lat. 40[deg]11'35'' N, long. 76[deg]45'45'' W)
Capital City Airport
    (Lat. 40[deg]13'02'' N, long. 76[deg]51'05'' W)

Boundaries

    Area A. That airspace extending upward from the surface to and
including 4,400 feet MSL bounded by a line beginning at lat.
40[deg]12'23'' N, long. 76[deg]48'37'' W, thence direct to the
intersection of the Capital City Airport's 106[deg] bearing and 1.5-
mile radius, thence counterclockwise along the Capital City
Airport's 1.5-mile radius to the Harrisburg International Airport's
5-mile radius, thence clockwise along the Harrisburg International
Airport's 5-mile radius to the intersection of the 5-mile radius and
a line bearing 191[deg] from a point at lat. 40[deg]12'23'' N, long.
76[deg]48'37'' W, thence direct to the point of beginning.
    Area B. That airspace extending upward from 1,600 feet MSL to
and including 4,400 feet MSL extending from the Harrisburg
International Airport's 5-mile radius, and within 3.5 miles each
side of the Harrisburg International Airport's 117[deg] bearing to
the Harrisburg International Airport's 10-mile radius southeast of
the Harrisburg International Airport.

    Area C. That airspace extending upward from 1,600 feet MSL to
and including 4,400 feet MSL bounded by a line beginning at the
intersection of the Capital City Airport's 106[deg] bearing and 1.5-
mile radius direct to lat. 40[deg]14'13'' N, long. 76[deg]53'23'' W
direct to lat. 40[deg]14'12'' N, long. 76[deg]56'05'' W thence
direct to lat. 40[deg]14'12'' N, long. 76[deg]58'22'' W, thence
clockwise along the Harrisburg International Airport's 10-mile
radius to lat. 40[deg]18'58'' N, long. 76[deg]54'35'' W, thence
direct to the Harrisburg International Airport's 341[deg] bearing
and the Harrisburg International Airport's 5-mile radius, thence
counterclockwise along the Harrisburg International Airport's 5-mile
radius to the intersection of the Capital City Airport's 1.5-mile
radius, thence clockwise along the Capital City Airport's 1.5-mile
radius to the point of beginning.
    Area D. That airspace extending upward from 2,100 feet MSL to
and including 4,400 feet MSL, within an area bounded by a line
beginning at lat. 40[deg]14'12'' N, long. 76[deg]58'22'' W, thence
direct to lat. 40[deg]14'11'' N, long. 77[deg]05'03'' W, thence
clockwise along the Harrisburg International Airport's 15-mile
radius to the intersection of the Harrisburg International Airport's
325[deg] bearing, thence direct to the intersection of Harrisburg
International Airport's 089[deg] bearing and the Harrisburg
International Airport's 15-mile radius, thence clockwise along the
airport's 15-mile radius to the intersection of the Harrisburg
International Airport's 113[deg] bearing, thence direct to lat.
40[deg]01'45'' N, long. 76[deg]40'43'' W, thence direct to lat.
40[deg]05'32'' N, long. 76[deg]50'21'' W, thence direct to lat.
40[deg]12'23'' N, long. 76[deg]48'37'' W, thence direct to the point
of beginning; excluding that airspace contained in Areas A, B, and
C.
    Area E. That airspace extending upward from 2,600 feet MSL to
and including 4,400 feet MSL bounded by a line beginning at lat.
40[deg]12'23'' N, long. 76[deg]48'37'' W, thence direct to lat.
40[deg]05'32'' N, long. 76[deg]50'21'' W, thence direct to the
Harrisburg International Airport's 269[deg] bearing and Harrisburg
International Airport's 15-mile radius, thence clockwise along the
Harrisburg International Airport's 15-mile radius to lat.
40[deg]14'11'' N, long. 77[deg]05'03'' W, thence direct to lat.
40[deg]14'12'' N, long. 76[deg]58'22'' W thence direct to lat.
40[deg]14'12'' N, long. 77[deg]56'05'' W, thence direct to lat.
40[deg]14'13'' N, long. 76[deg]53'23'' W, thence direct to lat.
40[deg]12'37'' N, long. 76[deg]49'12'' W, thence direct to the point
of beginning.
    Area F. That airspace extending upward from 2,600 feet MSL to
and including 4,400 feet MSL bounded by a line beginning at the
intersection of the Harrisburg International Airport's 113[deg]
bearing and the airport's 15-mile radius, thence clockwise along the
Harrisburg International Airport's 15-mile radius to the
intersection of the airports 145[deg] bearing and the airport's 15-
mile radius, thence direct to lat. 40[deg]01'45'' N, long.
76[deg]40'43'' W, thence direct to the point of beginning.
* * * * *

Paragraph 5000--Subpart D--Class D Airspace

* * * * *

AEA PA D Harrisburg International Airport, PA [Removed]

* * * * *
BILLING CODE 4910-13-P
[GRAPHIC] [TIFF OMITTED] TP11AU23.000

    Issued in Washington, DC, on August 4, 2023.
Karen L. Chiodini,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2023-17074 Filed 8-10-23; 8:45 am]
BILLING CODE 4910-13-C


[Federal Register Volume 82, Number 32 (Friday, February 17, 2017)]
[Notices]
[Pages 11045-11046]
[FR Doc No: 2017-03172]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1677]

Karis Copper Delong: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is issuing an
order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
debarring Karis Copper Delong for a period of 12 years from providing
services in any capacity to a person that has an approved or pending
drug product application. FDA bases this order on a finding that Ms.
Delong was convicted of four misdemeanor counts under the FD&C Act for
introducing, delivering for introduction, and causing the introduction
and delivery for introduction of a misbranded drug into interstate
commerce, which relates to the regulation of drug products under the
FD&C Act. In addition, FDA determined that the type of conduct that
served as the basis for the conviction undermines the process for the
regulation of drugs. Ms. Delong was given notice of the proposed
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. Ms. Delong failed to request a hearing. Ms.
Delong's failure to request a hearing constitutes a waiver of her right
to a hearing concerning this action.

DATES: This order is effective February 17, 2017.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Enforcement,
Office of Regulatory Affairs (ELEM-4144), Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits debarment of an individual if FDA finds
that the individual has been convicted of a misdemeanor under federal
law for conduct relating to the regulation of drug products under the
FD&C Act, and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
    On June 9, 2015, in the U.S. District Court for the Eastern
District of Washington, judgment was entered against Ms. Delong after
she entered a plea of guilty to four counts of shipment of misbranded
drugs in interstate commerce, in violation of section 301(a) of the
FD&C Act (21 U.S.C. 331(a)), which according to section 303(a)(1) of
the FD&C Act (21 U.S.C. 333(a)(1)) constitutes a misdemeanor.
    FDA's finding that debarment is appropriate is based on the
misdemeanor convictions referenced herein. The factual basis for these
convictions is as follows: Beginning as early as April 2008, Ms. Delong
assisted Louis Daniel Smith and others in the operation of Project
Green Life (PGL). PGL was a Nevada corporation with physical operations
at various locations in Spokane, WA. PGL marketed and sold various
health-related products over the Internet. PGL's flagship product was
the Miracle Mineral Solution (MMS), a mixture of sodium chlorite and
water.
    Although Ms. Delong acted primarily at the direction of Louis
Daniel Smith, she had access to PGL's operations. On various occasions,
she handled shipping for PGL, including the delivery of packages
containing MMS for shipment in interstate commerce to PGL customers
nationwide and internationally. Although at times PGL marketed MMS as a
water purification product, Ms. Delong knew that MMS was also used by
consumers to treat disease. At times, PGL provided instructions to
consumers that directed consumers to mix MMS with a citric acid
solution and consume orally to treat various diseases. Ms. Delong knew
that PGL provided such instructions to consumers.

    At no time did Ms. Delong or anyone else employed by PGL register
their MMS manufacturing facilities with FDA as required under section
510 of the FD&C Act (21 U.S.C. 360). In addition, bottled MMS that PGL
shipped to consumers did not bear labeling that bore the full place of
business of the manufacturer.
    On or about November 1, 2010, November 12, 2010, November 16, 2010,
and June 30, 2011, Ms. Delong or another person involved with PGL,
delivered for introduction into interstate commerce a number of
packages containing bottled MMS. These packages contained MMS that Ms.
Delong knew was primarily intended as a treatment for disease.
    As a result of these convictions, FDA sent Ms. Delong by certified
mail on October 12, 2016, a notice proposing to debar her for 12 years
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Ms.
Delong was convicted of misdemeanors under Federal law for conduct
relating to the regulation of drug products under the FD&C Act, and
that the type of conduct that served as the basis for the conviction
undermines the process for the regulation of drugs.
    The proposal offered Ms. Delong an opportunity to request a
hearing, providing her 30 days from the date of receipt of the letter
in which to file the request, and advised her that failure to request a
hearing constituted a waiver of the opportunity for a hearing and of
any contentions concerning this action. Ms. Delong received the
proposal on October 20, 2016. Ms. Delong did not request a hearing
within the timeframe prescribed by regulation and has, therefore,
waived her opportunity for a hearing and has waived any contentions
concerning her debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement and Import
Operations, Office of Regulatory Affairs, under section
306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to the
Director (Staff Manual Guide 1410.35), finds that Karis Copper Delong
has been convicted of four misdemeanor counts under federal law for
conduct relating to the regulation of drug products under the FD&C Act,
and that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
    Based on consideration of the factors under section 306(c)(3) of
the FD&C Act, FDA finds that each offense be accorded a debarment
period of 3 years. Under section 306(c)(2)(A) of the FD&C Act, in the
case of a person debarred for multiple offenses, FDA shall determine
whether the periods of debarment shall run concurrently or
consecutively. FDA has concluded that the 3-year period of debarment
for each of the four offenses of conviction need to be served
consecutively, resulting in a total debarment period of 12 years.
    As a result of the foregoing finding, Karis Copper Delong is
debarred for a period of 12 years from providing services in any
capacity to a person with an approved or pending drug product
application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C.
355, 360b, or 382), or under section 351 of the Public Health Service
Act (42 U.S.C. 262), effective (see DATES) (see sections 306(c)(1)(B),
(c)(3), and 201(dd) of the FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(3),
and 321(dd))). Any person with an approved or pending drug product
application who knowingly employs or retains as a consultant or
contractor, or otherwise uses the services of Karis Copper Delong, in
any capacity during Ms. Delong's debarment, will be subject to civil
money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C.
335b(a)(6))). If Ms. Delong provides services in any capacity to a
person with an approved or pending drug product application during her
period of debarment she will be subject to civil money penalties
(section 307(a)(7) of the FD&C Act). In addition, FDA will not accept
or review any abbreviated new drug applications submitted by or with
the assistance of Karis Copper Delong during her period of debarment
(section 306(c)(1)(B) of the FD&C Act).
    Any application by Ms. Delong for termination of debarment under
section 306(d)(4) of the FD&C Act should be identified with Docket No.
FDA-2016-N-1677 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions will be placed in the docket, and
will be viewable at https://www.regulations.gov or at the Division of
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: February 13, 2017.
Armando Zamora,
Deputy Director, Office of Enforcement and Import Operations, Office of
Regulatory Affairs.
[FR Doc. 2017-03172 Filed 2-16-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Notices]
[Page 51997]
[FR Doc No: 2014-20763]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL14-93-000]

State Corporation Commission of the State of Kansas v. Westar
Energy, Inc.; Notice of Complaint

    Take notice that on August 20, 2014, pursuant to sections 206 and
306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.206, the State Corporation
Commission of the State of Kansas (Complainant), filed a formal
complaint against Westar Energy, Inc. (Respondent), alleging that the
Return on Equity component of the Respondent's Transmission Formula
Rate is unjust, unreasonable, and unduly discriminatory.
    Richard A. Drom, counsel for the Complainant certifies that copies
of the complaint were served on the contact for the Respondent as
listed on the Commission's list of Corporate Officials.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on September 9, 2014.

    Dated: August 21, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-20763 Filed 8-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Rules and Regulations]
[Page 58394]
[FR Doc No: 2016-20422]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2016-0711]

Special Local Regulation; San Diego Maritime Museum Tall Ship
Festival of Sail; San Diego Bay, CA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the special local regulations on
the waters of San Diego Bay, California during the San Diego Maritime
Museum Tall Ship Festival of Sail from 9:00 a.m. to 7:00 p.m. from
September 2, 2016 to September 4, 2016. These special local regulations
are necessary to provide for the safety of the participants, crew,
spectators, sponsor vessels, and general users of the waterway. During
the enforcement period, persons and vessels are prohibited from
anchoring, blocking, loitering, or impeding this regulated parade route
and mock gun battle area unless authorized by the Captain of the Port,
or his designated representative.

DATES: The regulations in 33 CFR 100.1101 will be enforced from 9 a.m.
through 7 p.m. from September 2, 2016 to September 4, 2016, for Item 15
in Table 1 of Section 100.1101.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
publication of enforcement, call or email Petty Officer Randolph
Pahilanga, Waterways Management, U.S. Coast Guard Sector San Diego, CA;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the special
local regulations in 33 CFR 100.1101 for the San Diego Maritime Museum
Tall Ship Festival of Sail in San Diego Bay, CA in 33 CFR 100.1101,
Table 1, Item 15 of that section from 9 a.m. until 7 p.m. from
September 2, 2016 to September 4, 2016. This enforcement action is
being taken to provide for the safety of life on navigable waterways
during the parade and subsequent mock gun battles. The Coast Guard's
regulation for recurring marine events within the San Diego Captain of
the Port Zone identifies the regulated entities for this event. Under
the provisions of 33 CFR 100.1101, persons and vessels are prohibited
from anchoring, blocking, loitering, or impeding within this regulated
parade route and mock gun battle area unless authorized by the Captain
of the Port, or his designated representative. The Coast Guard may be
assisted by other Federal, State, or local law enforcement agencies in
enforcing this regulation.
    This document is issued under authority of 5 U.S.C. 552(a) and 33
CFR 100.1101. In addition to this document in the Federal Register, the
Coast Guard will provide the maritime community with advance
notification of this enforcement period via the Local Notice to
Mariners, Broadcast Notice to Mariners, and local advertising by the
event sponsor.
    If the Captain of the Port Sector San Diego or his designated
representative determines that the regulated area need not be enforced
for the full duration stated on this document, he or she may use a
Broadcast Notice to Mariners or other communications coordinated with
the event sponsor to grant general permission to enter the regulated
area.

    Dated: August 2, 2016.
J.R. Buzzella,
Captain, U.S. Coast Guard, Captain of the Port San Diego.
[FR Doc. 2016-20422 Filed 8-24-16; 8:45 am]
BILLING CODE 9110-04-P