74280 Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Notices 

1Coast 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). 

2These 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.’’ 

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/ 

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] 

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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-tomariners?district=7+0&subdistrict=n. 

Sector Jacksonville MSIBs can be 

accessed on their Homeport page at 

https://homeport.uscg.mil/portdirectory/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 

Meredith.D.Overstreet1@uscg.mil. 

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. 

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). 

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] 

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