Federal Register / Vol. 89, No. 177 / Thursday, September 12, 2024 / Notices 74279 

Requests for copies of the information 

collection proposal should be sent to 

Mr. Lucas at whs.mc-alex.esd.mbx.dddod-information-collections@mail.mil. 

Dated: September 4, 2024. 

Aaron T. Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2024–20650 Filed 9–11–24; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3945] 

The Food and Drug Administration’s 

Draft Strategy Document on Innovative 

Manufacturing Technologies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the publication of a draft 

Strategy Document for public comment 

outlining specific actions FDA will take 

during fiscal years 2023–2027 to 

facilitate the use of innovative 

manufacturing technologies. As part of 

the Prescription Drug User Fee Act 

(PDUFA) Reauthorization Performance 

Goals and Procedures Fiscal Years 

2023–2027 (PDUFA VII), FDA 

committed to advance the use and 

implementation of innovative 

manufacturing. In connection with this 

effort, on June 8, 2023, FDA participated 

in a public workshop on the use of 

innovative manufacturing technologies 

for products regulated by the Center for 

Drug Evaluation and Research (CDER) 

and the Center for Biologics Evaluation 

and Research (CBER), including barriers 

to their adoption. FDA also committed 

to issuing this draft Strategy Document 

for public comment. The actions 

described in the draft Strategy 

Document are based on lessons learned 

from FDA’s experiences with 

submissions involving advanced 

manufacturing technologies as well as 

feedback from the workshop and other 

public input. 

DATES: Either electronic or written 

comments on the draft Strategy 

Document must be submitted by 

November 12, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 12, 2024.Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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 

do not wish to be made available to the 

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. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–3945 for ‘‘FDA’s Strategy 

Document on Innovative Manufacturing 

Technologies.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions: To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Elisa A. Nickum, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4521, 

Silver Spring, MD 20993, 301–796– 

4226, Elisa.Nickum@fda.hhs.gov; or 

James Myers, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Innovative manufacturing 

technologies—including but not limited 

to continuous manufacturing, 

distributed manufacturing, modern 

aseptic manufacturing equipment, and 


ddrumheller on DSK120RN23PROD with NOTICES1
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] 

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 

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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