Notification of Replacement Public Meeting on Requirement for Helicopters To Use the New York North Shore Helicopter Route, 63817 [2018-26934]
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Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Proposed Rules
consider comments made at the public
meeting in its review of the Rule.
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2020.
Model Number: HI–STORM 100.
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Dated at Rockville, Maryland, this 29th day
of November 2018.
For the Nuclear Regulatory Commission.
Margaret M. Doane,
Executive Director for Operations.
[FR Doc. 2018–26878 Filed 12–11–18; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 93
RIN 2120–AK39
Notification of Replacement Public
Meeting on Requirement for
Helicopters To Use the New York North
Shore Helicopter Route
Federal Aviation
Administration (FAA), DOT.
ACTION: Notification of public meeting.
AGENCY:
Due to inclement weather on
November 15, 2018, the FAA announces
a replacement public meeting to solicit
feedback concerning the New York
North Shore Helicopter Rule (‘‘the
Rule’’). This meeting is 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 meeting will be held
on Thursday, December 13, 2018.
ADDRESSES: The public meeting will be
held at Vaugh College, 8601 23rd
Avenue, Flushing NY 11369. The
meeting is 7:00 p.m.–9:00 p.m. EST.
FOR FURTHER INFORMATION CONTACT:
Christopher Bailey, Office of
Rulemaking, Federal Aviation
Administration; telephone (202) 267–
4158; email Christopher.Bailey@faa.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Purpose of the Public Meeting
The purpose of the public meeting 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
VerDate Sep<11>2014
17:18 Dec 11, 2018
Jkt 247001
Public Participation and Meeting
Procedures
The meeting 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
an FAA representative 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 docket
number FAA–2018–0954 to submit
written comments.
Sign and oral interpretation can be
made available at the meeting, as well
as an assistive listening device, if
requested 3 calendar days before the
meeting. The meeting 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 December 7,
2018.
Brandon Roberts,
Deputy Executive Director, Office of
Rulemaking.
[FR Doc. 2018–26934 Filed 12–10–18; 4:15 pm]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 600
[Docket No. FDA–2018–N–2732]
RIN 0910–AH57
Definition of the Term ‘‘Biological
Product’’
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA or the Agency) is
proposing to amend its regulation that
defines ‘‘biological product’’ to
incorporate changes made by the
Biologics Price Competition and
Innovation Act of 2009 (BPCI Act), and
to provide its interpretation of the
statutory terms ‘‘protein’’ and
‘‘chemically synthesized polypeptide.’’
Under that interpretation, the term
protein would mean any alpha amino
acid polymer with a specific, defined
sequence that is greater than 40 amino
SUMMARY:
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63817
acids in size. A chemically synthesized
polypeptide would mean any alpha
amino acid polymer that is made
entirely by chemical synthesis and is
greater than 40 amino acids but less
than 100 amino acids in size. This
proposed rule is intended to clarify the
statutory framework under which such
products are regulated.
DATES: Submit either electronic or
written comments on the proposed rule
by February 25, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 25,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of February 25, 2019.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
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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.
E:\FR\FM\12DEP1.SGM
12DEP1
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[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Proposed Rules]
[Page 63817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26934]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 93
RIN 2120-AK39
Notification of Replacement Public Meeting on Requirement for
Helicopters To Use the New York North Shore Helicopter Route
AGENCY: Federal Aviation Administration (FAA), DOT.
ACTION: Notification of public meeting.
-----------------------------------------------------------------------
SUMMARY: Due to inclement weather on November 15, 2018, the FAA
announces a replacement public meeting to solicit feedback concerning
the New York North Shore Helicopter Rule (``the Rule''). This meeting
is 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 meeting will be held on Thursday, December 13, 2018.
ADDRESSES: The public meeting will be held at Vaugh College, 8601 23rd
Avenue, Flushing NY 11369. The meeting is 7:00 p.m.-9:00 p.m. EST.
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 Meeting
The purpose of the public meeting 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 meeting in its review of the Rule.
Public Participation and Meeting Procedures
The meeting 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 an FAA representative 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 docket
number FAA-2018-0954 to submit written comments.
Sign and oral interpretation can be made available at the meeting,
as well as an assistive listening device, if requested 3 calendar days
before the meeting. The meeting 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 December 7, 2018.
Brandon Roberts,
Deputy Executive Director, Office of Rulemaking.
[FR Doc. 2018-26934 Filed 12-10-18; 4:15 pm]
BILLING CODE 4910-13-P