Notification of Public Meetings on Requirement for Helicopters To Use the New York North Shore Helicopter Route, 55134-55135 [2018-24129]
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Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Proposed Rules
Chart’’). The Rule was promulgated to
maximize use of the route, as published
per the Chart, to secure and improve
upon decreased levels of noise that had
been voluntarily achieved.1 Under the
Rule, pilots are permitted to deviate
from the route and altitude
requirements when necessary for safety,
weather conditions, or transitioning to
or from a destination or point of
landing.
The Rule originally had a two-year
duration and was set to terminate on
August 6, 2014. The FAA limited the
duration of the Rule because, at the time
of promulgation, the FAA did not have
data on the current rate of compliance
with the voluntary route nor the
circumstances surrounding an
operator’s decision not to use the route.
The FAA concluded there would be no
reason to retain the Rule if the FAA
determined helicopter noise along the
North Shore of Long Island did not
improve. Accordingly, the Agency
decided that the Rule would expire in
two years, if it was determined there is
no meaningful improvement in the
effects of helicopter noise on quality of
life or that the Rule was otherwise
unjustified. Specifically, the FAA stated
that should there be such an
improvement, the FAA may, after
appropriate notice and opportunity for
comment, decide to make the Rule
permanent. Likewise, should the FAA
determine that reasonable modification
could be made to the route to better
address noise concerns (and any other
relevant concerns), the FAA may choose
to modify the Rule after notice and
comment.
On June 23, 2014, the FAA issued a
two-year extension of the Rule’s
termination date (79 FR 35488), and on
July 25, 2016 the FAA issued a four-year
extension of the Rule’s termination date
(81 FR 48323). The Rule is scheduled to
expire on August 6, 2020.
As explained in the Rule, helicopters
are generally limited in the distance
they can prudently operate from shore
without being equipped for overwater
operations because they are not able to
glide for any significant distance in the
event of a total loss of power.
At the time of the original rulemaking,
the FAA estimated that two-thirds of
commercial helicopters operating along
the north shore were equipped with
multiple engines. This equipage allowed
for a route to be established a little
farther off shore than what would be
prudent in an area where single-engine
1 The rule is based on a voluntary VFR route that
was developed by the FAA working with the
Eastern Region Helicopter Council. The voluntary
route originally was added to the Chart on May 8,
2008.
VerDate Sep<11>2014
16:35 Nov 01, 2018
Jkt 247001
helicopters are predominantly operated;
however, there are still significant safety
implications with pushing all helicopter
traffic farther over the water. Allowing
helicopters to operate within sight of the
coastline provides pilots with multiple
visual waypoints by which to safely
navigate along the north shore. The
route was designed to avoid the
potential safety implications associated
with helicopters flying in VFR
conditions off the coastline and the
interaction with other traffic at or above
the route’s specified altitude.
The FAA is inviting comments that
may assist the agency in assessing and
understanding the impacts of the Rule
and any potential implications of
modifying the Rule. In particular, we
invite responses to the following
questions:
1. Did implementation of the Rule
result in more or less helicopter noise in
your community compared to levels you
experienced prior to implementation of
the Rule?
2. How and when do helicopter
operators deviate from the Rule?
3. Are there alternative or
supplemental routes that you believe
will reduce the noise impacts without
jeopardizing the safe operation of
aircraft?
4. Should the Rule be extended,
modified, or allowed to expire in 2020?
Issued under authority provided by Public
Law 115–254, 49 U.S.C. 106(f), 44701(a), and
44703 in Washington, DC, on October 29,
2018.
Daniel K. Elwell,
Acting Administrator.
[FR Doc. 2018–24051 Filed 11–1–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 93
RIN 2120–AK39
Notification of Public Meetings on
Requirement for Helicopters To Use
the New York North Shore Helicopter
Route
Federal Aviation
Administration (FAA), DOT.
ACTION: Notification of public meetings.
AGENCY:
The FAA announces three
public meetings to solicit feedback
concerning the New York North Shore
Helicopter Rule (‘‘the Rule’’). These
meetings are being held pursuant to
Section 182 of the FAA Reauthorization
Act of 2018. The Rule requires civil
helicopter pilots operating under Visual
SUMMARY:
PO 00000
Frm 00024
Fmt 4702
Sfmt 4702
Flight Rules (VFR), whose route of flight
takes them over the north shore of Long
Island between the Visual Point Lloyd
Harbor (VPLYD) waypoint and Orient
Point (VPOLT), to use the North Shore
Helicopter Route.
DATES: The public meetings will be held
on November 13, November 14, and
November 15, 2018.
ADDRESSES: The public meetings will be
held at the following sites:
November 13, 2018, 7–9 p.m.—Cradle
of Aviation Museum, Charles Lindbergh
Blvd., Garden City, NY 11530.
November 14, 2018, 7–9 p.m.—
Riverhead Middle School, 600 Harrison
Avenue, Riverhead, NY 11901.
November 15, 2018, 7–9 p.m.—
Vaughn College, 8601 23rd Ave,
Flushing, NY 11369.
FOR FURTHER INFORMATION CONTACT:
Christopher Bailey, Office of
Rulemaking, Federal Aviation
Administration; telephone (202) 267–
4158; email Christopher.bailey@faa.gov.
SUPPLEMENTARY INFORMATION:
Purpose of the Public Meetings
The purpose of the public meetings is
for the FAA to obtain feedback relevant
to the Rule at subpart H of part 93,
which requires civil helicopter pilots
operating under VFR, whose route of
flight takes them over the north shore of
Long Island between the VPLYD
waypoint and VPOLT, to use the North
Shore Helicopter Route. The FAA will
consider comments made at the public
meetings in its review of the Rule.
Public Participation and Meeting
Procedures
The meetings will use a workshop
format. FAA will have several stations
covering a number of relevant aspects of
the Rule. Each station will be staffed by
a representative of the FAA who is able
to answer questions regarding that
subject. There will also be a station
where the public can submit a written
statement or have their oral comment
transcribed. No formal presentations
will be made.
Section 182 of the FAA
Reauthorization Act of 2018 also calls
for a written comment period on the
North Shore Helicopter Rule. See the
document published elsewhere in this
issue of the Federal Register, titled
Request for Comments on Requirement
for Helicopters to Use the New York
North Shore Helicopter Route, under
docket number FAA–2018–0954, for
information regarding submitting
written comments on the Rule to the
Federal Register.
Sign and oral interpretation can be
made available at the meeting, as well
E:\FR\FM\02NOP1.SGM
02NOP1
Federal Register / Vol. 83, No. 213 / Friday, November 2, 2018 / Proposed Rules
as an assistive listening device, if
requested 10 calendar days before the
meeting. The meetings will be open to
all persons on a space-available basis.
There will be no admission fee or other
charge to attend and participate.
Issued in Washington, DC, on October 30,
2018.
Brandon Roberts,
Deputy Executive Director, Office of
Rulemaking.
[FR Doc. 2018–24129 Filed 11–1–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 10
RIN 0906–AB19
340B Drug Pricing Program Ceiling
Price and Manufacturer Civil Monetary
Penalties Regulation
Health Resources and Services
Administration, HHS.
ACTION: Notice of proposed rulemaking;
effective date change.
AGENCY:
The Health Resources and
Services Administration (HRSA)
administers section 340B of the Public
Health Service Act (PHSA), which is
referred to as the ‘‘340B Drug Pricing
Program’’ or the ‘‘340B Program.’’ HRSA
published a final rule on January 5,
2017, that set forth the calculation of the
340B ceiling price and application of
civil monetary penalties.
On June 5, 2018, HRSA published a
final rule that delayed the effective date
of the 340B ceiling price and civil
monetary rule until July 1, 2019, to
allow a more deliberate process of
considering alternative and
supplemental regulatory provisions and
to allow for sufficient time for
additional rulemaking. After further
consideration of the issue, the
Department of Health and Human
Services (HHS or Department) proposes
to cease any further delay of the rule
and change the effective date from July
1, 2019, to January 1, 2019.
DATES: Submit comments on or before
November 23, 2018
ADDRESSES: You may submit comments,
identified by the Regulatory Information
Number (RIN) 0906–AB19, by any of the
following methods. Please submit your
comments in only one of these ways to
minimize the receipt of duplicate
submissions. The first is the preferred
method.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow
instructions for submitting comments.
SUMMARY:
VerDate Sep<11>2014
16:35 Nov 01, 2018
Jkt 247001
This is the preferred method for the
submission of comments.
• Email: 340BCMPNPRM@hrsa.gov.
Include 0906–AB19 in the subject line
of the message.
• Mail: Office of Pharmacy Affairs
(OPA), Healthcare Systems Bureau
(HSB), Health Resources and Services
Administration (HRSA), 5600 Fishers
Lane, Mail Stop 08W05A, Rockville, MD
20857.
All submitted comments will be
available to the public in their entirety.
Please do not submit commercial
confidential information or personal
identifying information that you do not
want in the public domain.
FOR FURTHER INFORMATION CONTACT:
CAPT Krista Pedley, Director, OPA,
HSB, HRSA, 5600 Fishers Lane, Mail
Stop 08W05A, Rockville, MD 20857, or
by telephone at 301–594–4353.
SUPPLEMENTARY INFORMATION:
I. Background
HHS published a notice of proposed
rulemaking (NPRM) in June 2015 to
implement civil monetary penalties
(CMPs) for manufacturers who
knowingly and intentionally charge a
covered entity more than the ceiling
price for a covered outpatient drug; to
provide clarity regarding the
requirement that manufacturers
calculate the 340B ceiling price on a
quarterly basis and how the ceiling
price is to be calculated; and to establish
the requirement that a manufacturer
charge a $.01 (penny pricing policy) for
drugs when the ceiling price calculation
equals zero (80 FR 34583, (June 17,
2015)). The public comment period
closed on August 17, 2015, and HRSA
received 35 comments. After review of
the initial comments, HHS reopened the
comment period (81 FR 22960, (April
19, 2016)) to invite additional comments
on the following areas of the NPRM:
340B ceiling price calculations that
result in a ceiling price that equals zero
(penny pricing); the methodology that
manufacturers use when estimating the
ceiling price for a new covered
outpatient drug; and the definition of
the ‘‘knowing and intentional’’ standard
to be applied when assessing a CMP for
manufacturers that overcharge a covered
entity. The comment period closed May
19, 2016, and HHS received 72
comments.
On January 5, 2017, HHS published a
final rule in the Federal Register (82 FR
1210, (January 5, 2017)). Comments
from both the NPRM and the reopening
notice were considered in the
development of the final rule. The
provisions of that rule were to be
effective March 6, 2017; however,
PO 00000
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Fmt 4702
Sfmt 4702
55135
through a series of rules, HHS delayed
the effective date of the January 5, 2017
final rule until July 1, 2019 (83 FR
25943, June 5, 2018).
II. Proposal To Change the Effective
Date of the Final Rule From July 1,
2019, to January 1, 2019
HHS proposes to cease any further
delay of the January 5, 2017 final rule
and to change the effective date from
July 1, 2019, to January 1, 2019. As the
effective date will be the first day of the
quarter, the implementation date and
the effective date will be the same. In its
most recent rulemaking delaying the
effective date of the January 5, 2017
final rule, HHS stated that it ‘‘is
developing new comprehensive policies
to address the rising costs of
prescription drugs. These policies will
address drug pricing in government
programs, such as Medicare Parts B & D,
Medicaid, and the 340B Program. Due to
the development of these
comprehensive policies, we are delaying
the effective date for the January 5,
2017, final rule to July 1, 2019.’’ (83 FR
25944)
The Department has determined that
the finalization of the 340B ceiling price
and civil monetary penalty rule will not
interfere with the Department’s
development of these comprehensive
policies. Accordingly, the Department
no longer believes a delay in the
effective date is necessary and is
proposing to change the effective date of
the rule from July 1, 2019, to January 1,
2019.
The provisions included in the
January 5, 2017 final rule were subject
to extensive public comment, and have
been delayed several times. As such,
HHS believes that it has considered the
full range of comments on the
substantive issues in the January 5, 2017
final rule.
HHS believes that finalization of this
proposed change to the effective date of
the January 5, 2017 final rule would
satisfy its obligation to implement the
statutory provisions enacted by
Congress in 2010 to create civil
monetary penalties.
HHS seeks public comments
specifically regarding the impact of
ceasing any further delay of the January
5, 2017 final rule, including any
potential disruptions to
implementation, and changing the
effective date from July 1, 2019, to
January 1, 2019.
HHS encourages all stakeholders to
provide comment on this proposed rule.
A comment period of 21 days is
sufficient to provide affected parties the
opportunity to provide their views as
this rule is uncomplicated and simply
E:\FR\FM\02NOP1.SGM
02NOP1
]]>Agencies
[Federal Register Volume 83, Number 213 (Friday, November 2, 2018)]
[Proposed Rules]
[Pages 55134-55135]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24129]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 93
RIN 2120-AK39
Notification of Public Meetings on Requirement for Helicopters To
Use the New York North Shore Helicopter Route
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notification of public meetings.
-----------------------------------------------------------------------
SUMMARY: The FAA announces three public meetings to solicit feedback
concerning the New York North Shore Helicopter Rule (``the Rule'').
These meetings are being held pursuant to Section 182 of the FAA
Reauthorization Act of 2018. The Rule requires civil helicopter pilots
operating under Visual Flight Rules (VFR), whose route of flight takes
them over the north shore of Long Island between the Visual Point Lloyd
Harbor (VPLYD) waypoint and Orient Point (VPOLT), to use the North
Shore Helicopter Route.
DATES: The public meetings will be held on November 13, November 14,
and November 15, 2018.
ADDRESSES: The public meetings will be held at the following sites:
November 13, 2018, 7-9 p.m.--Cradle of Aviation Museum, Charles
Lindbergh Blvd., Garden City, NY 11530.
November 14, 2018, 7-9 p.m.--Riverhead Middle School, 600 Harrison
Avenue, Riverhead, NY 11901.
November 15, 2018, 7-9 p.m.--Vaughn College, 8601 23rd Ave,
Flushing, NY 11369.
FOR FURTHER INFORMATION CONTACT: Christopher Bailey, Office of
Rulemaking, Federal Aviation Administration; telephone (202) 267-4158;
email [email protected].
SUPPLEMENTARY INFORMATION:
Purpose of the Public Meetings
The purpose of the public meetings is for the FAA to obtain
feedback relevant to the Rule at subpart H of part 93, which requires
civil helicopter pilots operating under VFR, whose route of flight
takes them over the north shore of Long Island between the VPLYD
waypoint and VPOLT, to use the North Shore Helicopter Route. The FAA
will consider comments made at the public meetings in its review of the
Rule.
Public Participation and Meeting Procedures
The meetings will use a workshop format. FAA will have several
stations covering a number of relevant aspects of the Rule. Each
station will be staffed by a representative of the FAA who is able to
answer questions regarding that subject. There will also be a station
where the public can submit a written statement or have their oral
comment transcribed. No formal presentations will be made.
Section 182 of the FAA Reauthorization Act of 2018 also calls for a
written comment period on the North Shore Helicopter Rule. See the
document published elsewhere in this issue of the Federal Register,
titled Request for Comments on Requirement for Helicopters to Use the
New York North Shore Helicopter Route, under docket number FAA-2018-
0954, for information regarding submitting written comments on the Rule
to the Federal Register.
Sign and oral interpretation can be made available at the meeting,
as well
[[Page 55135]]
as an assistive listening device, if requested 10 calendar days before
the meeting. The meetings will be open to all persons on a space-
available basis. There will be no admission fee or other charge to
attend and participate.
Issued in Washington, DC, on October 30, 2018.
Brandon Roberts,
Deputy Executive Director, Office of Rulemaking.
[FR Doc. 2018-24129 Filed 11-1-18; 8:45 am]
BILLING CODE 4910-13-P
