Port Access Route Study: Approaches to the Port of Cape Canaveral and Vessel Transit Offshore Jacksonville, Daytona, and Canaveral, Florida, 74280 [2024-20746]
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Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Notices
novel analytical methods—can increase
product development speed, bolster
supply chains, and prevent drug
shortages. On June 8, 2023, FDA
cosponsored and participated in a
public workshop hosted by the DukeMargolis Center for Health Policy on
‘‘Advancing the Utilization and
Supporting the Implementation of
Innovative Manufacturing Approaches.’’
At this workshop, interested parties
from industry shared feedback on their
interactions with FDA’s CDER Emerging
Technology Program (ETP) and CBER
Advanced Technologies Team (CATT)
to guide submissions from persons or
organizations using innovative
manufacturing technologies. Regulators,
academic researchers, and industry
representatives discussed the current
barriers to using these technologies and
shared ideas on how initiatives such as
the newly created Advanced
Manufacturing Technologies
Designation Program (AMTDP) could
alleviate these barriers. The workshop
fulfilled a PDUFA VII commitment
related to advancing utilization and
implementation of innovative
manufacturing, as well as section
506L(e)(1) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 356L(e)(1)),
as amended by section 3213 of the Food
and Drug Omnibus Reform Act of 2022
regarding the AMTDP.
Based on lessons learned from the
Agency’s experience with submissions
involving advanced manufacturing, the
topics discussed during the June 8,
2023, workshop, and other public input,
FDA developed the draft Strategy
Document on Innovative Manufacturing
Technologies, which outlines the
specific activities FDA intends to
undertake to facilitate the use of
innovative manufacturing technologies.
Specifically, under the draft strategic
plan FDA intends to undertake the
following activities: continue to
enhance the ETP and CATT as a
mechanism to support innovation;
implement the AMTDP in a manner that
reflects feedback on eligibility criteria;
continue to identify opportunities for
international harmonization in support
of advanced manufacturing; support and
utilize ongoing initiatives for advanced
manufacturing to address potential
barriers; and support training in
advanced manufacturing for FDA
assessment staff.
II. Requested Information and
Comments
The draft Strategy Document on
Innovative Manufacturing Technologies
is available on FDA’s website for
Completed PDUFA VII Deliverables
(https://www.fda.gov/industry/
VerDate Sep<11>2014
20:43 Sep 11, 2024
Jkt 262001
prescription-drug-user-fee-amendments/
completed-pdufa-vii-deliverables).
Interested persons are invited to provide
detailed comments on all aspects of the
draft Strategy Document. FDA
encourages interested parties to provide
the specific rationale and basis for their
comments, including any available
supporting data and information.
Dated: September 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–20665 Filed 9–11–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2023–0822]
Port Access Route Study: Approaches
to the Port of Cape Canaveral and
Vessel Transit Offshore Jacksonville,
Daytona, and Canaveral, Florida
Coast Guard, DHS.
Notice of public meeting.
AGENCY:
ACTION:
A meeting will be held on
September 19, 2024, to support public
interest in the Coast Guard’s Port Access
Route Study (PARS) for the Approaches
to the Port of Cape Canaveral and Vessel
Transit Offshore Jacksonville, Daytona,
and Canaveral, Florida. The Coast Guard
will discuss the PARS notice of study
that was published on April 17, 2024,
and next steps for public engagement.
This meeting is open to the public, and
the Coast Guard invites those attending
to bring additional comments that
support the goals of the PARS.
Public Meeting: The meeting will be
held at the Maritime Center
(Commission Room), 445 Challenger
Rd., Cape Canaveral, FL 32920 on
Thursday, September 19, 2024, from 11
a.m. to 12:30 p.m., Eastern Daylight
Time. Closer to the meeting date,
guidance on how to join virtually will
be published in the Local Notice to
Mariners (LNM) for Coast Guard District
Seven (D7) and the Sector Jacksonville
Marine Safety Information Bulletin
(MSIB). If the meeting date or time
needs to be adjusted due to unforeseen
circumstances, an updated date and
time will be communicated via the LNM
and MSIB. D7 LNMs can be accessed on
the Coast Guard Navigation Center’s
website at https://
www.navcen.uscg.gov/local-notices-tomariners?district=7+0&subdistrict=n.
Sector Jacksonville MSIBs can be
accessed on their Homeport page at
SUMMARY:
PO 00000
Frm 00081
Fmt 4703
Sfmt 9990
https://homeport.uscg.mil/portdirectory/jacksonville.
If
you have questions about this notice of
public meeting or the PARS notice of
study, call or email Lieutenant Meredith
Overstreet, Seventh Coast Guard District
(dpw), U.S. Coast Guard; telephone
206–815–5857, email
Meredith.D.Overstreet1@uscg.mil.
FOR FURTHER INFORMATION CONTACT:
On April
17, 2024, the Coast Guard published a
notice in the Federal Register
announcing we were conducting a
PARS to evaluate safe routes for vessel
traffic transiting to and from the Port of
Cape Canaveral and within the offshore
waters of Jacksonville, Daytona, and
Canaveral, Florida.1 In the notice, we
requested public comments on the
PARS that closed on July 16, 2024.
Additionally, we asked the public to
inform us if they wanted a public
meeting regarding the study area. We
received two public comments
requesting a public meeting.2 We are
scheduling a public meeting. The details
on the meeting are located in the
‘‘Public Meeting’’ section of this
document.
To access the original notice of study,
refer to docket number USCG–2023–
0822 in the Federal Register by utilizing
the search box at https://
www.federalregister.gov/ or by following
the direct link: https://
www.federalregister.gov/documents/
2024/04/17/2024-08191/port-accessroute-study-approaches-to-the-port-ofcape-canaveral-and-vessel-transitoffshore.
This notice is published under the
authority of 46 U.S.C. 70003(c)(1).
SUPPLEMENTARY INFORMATION:
Dated: September 9, 2024.
Douglas M. Schofield,
Rear Admiral, U.S. Coast Guard, Commander,
Seventh Coast Guard District.
[FR Doc. 2024–20746 Filed 9–11–24; 8:45 am]
BILLING CODE 9110–04–P
1 Coast Guard Notice of study; request for
comments document titled, Port Access Route
Study: ‘‘Approaches to the Port of Cape Canaveral
and Vessel Transit Offshore Jacksonville, Daytona,
and Canaveral, Florida’’ (89 FR 27435).
2 These comments can be viewed on
regulations.gov at: Regulations.gov. Insert ‘‘USCG–
2023–0822’’ in the ‘‘search box.’’ Click on the PARS
Study Notice document. Then click on the tab
‘‘Document Comments.’’
E:\FR\FM\12SEN1.SGM
12SEN1
Agencies
[Federal Register Volume 89, Number 177 (Thursday, September 12, 2024)]
[Notices]
[Page 74280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20746]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
[Docket No. USCG-2023-0822]
Port Access Route Study: Approaches to the Port of Cape Canaveral
and Vessel Transit Offshore Jacksonville, Daytona, and Canaveral,
Florida
AGENCY: Coast Guard, DHS.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: A meeting will be held on September 19, 2024, to support
public interest in the Coast Guard's Port Access Route Study (PARS) for
the Approaches to the Port of Cape Canaveral and Vessel Transit
Offshore Jacksonville, Daytona, and Canaveral, Florida. The Coast Guard
will discuss the PARS notice of study that was published on April 17,
2024, and next steps for public engagement. This meeting is open to the
public, and the Coast Guard invites those attending to bring additional
comments that support the goals of the PARS.
Public Meeting: The meeting will be held at the Maritime Center
(Commission Room), 445 Challenger Rd., Cape Canaveral, FL 32920 on
Thursday, September 19, 2024, from 11 a.m. to 12:30 p.m., Eastern
Daylight Time. Closer to the meeting date, guidance on how to join
virtually will be published in the Local Notice to Mariners (LNM) for
Coast Guard District Seven (D7) and the Sector Jacksonville Marine
Safety Information Bulletin (MSIB). If the meeting date or time needs
to be adjusted due to unforeseen circumstances, an updated date and
time will be communicated via the LNM and MSIB. D7 LNMs can be accessed
on the Coast Guard Navigation Center's website at https://www.navcen.uscg.gov/local-notices-to-mariners?district=7+0&subdistrict=n. Sector Jacksonville MSIBs can be
accessed on their Homeport page at https://homeport.uscg.mil/port-directory/jacksonville.
FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of public meeting or the PARS notice of study, call or email
Lieutenant Meredith Overstreet, Seventh Coast Guard District (dpw),
U.S. Coast Guard; telephone 206-815-5857, email
[email protected].
SUPPLEMENTARY INFORMATION: On April 17, 2024, the Coast Guard published
a notice in the Federal Register announcing we were conducting a PARS
to evaluate safe routes for vessel traffic transiting to and from the
Port of Cape Canaveral and within the offshore waters of Jacksonville,
Daytona, and Canaveral, Florida.\1\ In the notice, we requested public
comments on the PARS that closed on July 16, 2024. Additionally, we
asked the public to inform us if they wanted a public meeting regarding
the study area. We received two public comments requesting a public
meeting.\2\ We are scheduling a public meeting. The details on the
meeting are located in the ``Public Meeting'' section of this document.
---------------------------------------------------------------------------
\1\ Coast Guard Notice of study; request for comments document
titled, Port Access Route Study: ``Approaches to the Port of Cape
Canaveral and Vessel Transit Offshore Jacksonville, Daytona, and
Canaveral, Florida'' (89 FR 27435).
\2\ These comments can be viewed on regulations.gov at:
Regulations.gov. Insert ``USCG-2023-0822'' in the ``search box.''
Click on the PARS Study Notice document. Then click on the tab
``Document Comments.''
---------------------------------------------------------------------------
To access the original notice of study, refer to docket number
USCG-2023-0822 in the Federal Register by utilizing the search box at
https://www.federalregister.gov/ or by following the direct link:
https://www.federalregister.gov/documents/2024/04/17/2024-08191/port-access-route-study-approaches-to-the-port-of-cape-canaveral-and-vessel-transit-offshore.
This notice is published under the authority of 46 U.S.C.
70003(c)(1).
Dated: September 9, 2024.
Douglas M. Schofield,
Rear Admiral, U.S. Coast Guard, Commander, Seventh Coast Guard
District.
[FR Doc. 2024-20746 Filed 9-11-24; 8:45 am]
BILLING CODE 9110-04-P