Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 81423 

I. Background 

This public workshop is intended to 

meet a performance goal FDA agreed to 

under the FDA User Fee 

Reauthorization Act of 2022, in 

accordance with the PDUFA 

Reauthorization Performance Goals and 

Procedures Fiscal Years 2023 Through 

2027 letter (PDUFA VII letter), which is 

available at https://www.fda.gov/media/ 

151712/download. Specifically, section 

I.4.e of the PDUFA VII letter outlines 

goals to enhance FDA’s capacity to 

review complex innovative designs and 

convene a public workshop to discuss 

aspects of complex adaptive, Bayesian, 

and other novel clinical trial designs. 

II. Topics for Discussion at the Public 

Workshop 

The purpose of this public workshop 

is to facilitate discussion on the use of 

external data sources, Bayesian 

statistical methods, and simulations in 

complex innovative trial designs as well 

as trial implementation (e.g., examples 

of defining and mitigating bias when 

using select trial design methods). 

Discussion topics will include 

considerations for external data sources, 

Bayesian statistical methods, 

simulations, and clinical trial 

implementation and will be based on 

FDA accumulated experience both 

within and outside of the Complex 

Innovative Trial Design Meeting 

Program (https://www.fda.gov/drugs/ 

development-resources/complexinnovative-trial-design-meetingprogram). 

The workshop will consist of two 

sessions. The first session will focus on 

case studies that will illustrate various 

aspects of complex innovative designs 

and implementation. The second 

session will consist of panel discussions 

motivated by the case studies. There 

will be an opportunity for public 

comment. 

Workshop updates, agenda, and 

background materials (if any) will be 

made available at https://www.fda.gov/ 

news-events/advancing-use-complexinnovative-designs-clinical-trials-pilotpractice-03052024 prior to the 

workshop. 

III. Participating in the Public 

Workshop 

Registration: To register for the public 

workshop, please visit https://

ComplexInnovativeDesignsWorkshop.

eventbrite.com by February 27, 2024, 

11:59 p.m. Eastern Time. Registration 

will be available starting January 16, 

2024. Please provide complete contact 

information for each attendee, including 

name, affiliation, and email. If you are 

unable to attend the workshop in 

person, you can register to view a live 

webcast of the workshop. You will be 

asked to indicate in your registration if 

you plan to attend in person or via the 

webcast. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by February 27, 2024, 11:59 

p.m. Eastern Time. Early registration is 

recommended because onsite seating is 

limited; therefore, FDA may limit the 

number of in-person participants from 

each organization. Registrants will 

receive a confirmation email after they 

register. 

If you need special accommodations 

due to a disability, please contact Tuan 

Pham (see FOR FURTHER INFORMATION

CONTACT) at least 14 days before the 

workshop. 

Streaming Webcast of the Public 

Workshop: This public workshop will 

also be available on webcast. To register 

for the webcast of this public workshop, 

visit https://ComplexInnovative

DesignsWorkshop.eventbrite.com by 

February 27, 2024, 11:59 p.m. Eastern 

Time. Please provide complete contact 

information for each attendee, including 

name, affiliation, and email. A link to 

the webcast will be provided following 

registration. Although FDA verified the 

website addresses in this document, 

please note that websites are subject to 

change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/news-events/ 

advancing-use-complex-innovativedesigns-clinical-trials-pilot-practice03052024. 

Dated: November 17, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25854 Filed 11–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Biomedical 

Imaging and Bioengineering; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting of the National 

Institute of Biomedical Imaging and 

Bioengineering Special Emphasis Panel. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Biomedical Imaging and Bioengineering 

Special Emphasis Panel; Brain Initiative RFA 

(EB–22–003) Review SEP. 

Date: February 2, 2024. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Democracy II, Suite 920, 6707 Democracy 

Blvd., Bethesda, MD 20817 (Virtual Meeting). 

Contact Person: Yoon-Young Jang, M.D., 

Ph.D., Scientific Review Officer, National 

Institute of Biomedical Imaging and 

Bioengineering, National Institutes of Health, 

6707 Democracy Blvd., Bethesda, MD 20892, 

(301) 451–3397, yoon-young.jang@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, National Institute of 

Biomedical Imaging and Bioengineering, 

National Institutes of Health.) 

Dated: November 16, 2023. 

Patricia B. Hansberger, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–25847 Filed 11–21–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2023–0041] 

Establishment of Homeland Security 

Academic Partnership Council 

Subcommittees 

AGENCY: The Office of Partnership and 

Engagement (OPE), The Department of 

Homeland Security (DHS). 


khammond on DSKJM1Z7X2PROD with NOTICES
81424 Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 

ACTION: Notice of new taskings for the 

Homeland Security Academic 

Partnership Council (HSAPC). 

SUMMARY: On November 14, 2023, the 

Secretary of DHS, Alejandro N. 

Mayorkas, issued three memoranda 

tasking the Homeland Security 

Academic Partnership Council (HSAPC) 

to establish three subcommittees further 

outlined below. This notice is not a 

solicitation for membership. 

FOR FURTHER INFORMATION CONTACT: 

Zarinah ‘‘Traci’’ Silas, Executive 

Director of the Office of Academic 

Engagement and Designated Federal 

Officer, Homeland Security Academic 

Partnership Council, Department of 

Homeland Security at HSAPC@

hq.dhs.gov or 202–891–2876. 

SUPPLEMENTARY INFORMATION: The 

HSAPC provides organizationally 

independent, strategic, timely, specific, 

and actionable recommendations to the 

Secretary on key issues at the 

intersection of education, academia, and 

the DHS mission. 

The Secretary has requested that the 

HSAPC form new subcommittees to 

study and provide recommendations in 

three critical areas for the Department: 

1. Supporting K–12 school and higher 

education communities in fostering 

safety and inclusivity in schools and on 

campuses and supporting campus law 

enforcement professionals and others 

charged with keeping academic 

communities safe. 

2. Combatting online child sexual 

exploitation and abuse (CSEA), 

including development of guidelines 

and best practices for educators and 

academic institutions to understand and 

reduce the risk of CSEA; establish 

processes and protocols to detect and 

report online CSEA and; partner with 

law enforcement and support 

communities to support investigations 

and victims. Additionally, the review 

and recommendation should include an 

assessment of DHS educational, 

awareness, and school safety resources 

to prevent, detect, and report CSEA. 

This should include best practices for 

content delivery, how it is delivered, 

who is delivering, and audience 

prioritization. 

3. Foreign malign influence in higher 

education, including guidelines and 

best practices for higher education 

institutions to reduce the risk of and 

counter foreign malign influence; 

consideration of a public-private 

partnership to enhance collaboration 

and information sharing on foreign 

malign influence; and an assessment of 

how the U.S. Government can enhance 

its internal operations and posture to 

effectively coordinate and address 

foreign malign influence-related 

national security risks posed to higher 

education institutions. 

Schedule: The subcommittees’ 

findings and recommendations will be 

submitted to the HSAPC for its 

deliberation and vote during a public 

meeting on December 13, 2023 and a 

public meeting in Spring 2024. 

Zarinah T. Silas, 

Designated Federal Officer, Homeland 

Security Academic Partnership Council, U.S. 

Department of Homeland Security. 

[FR Doc. 2023–25781 Filed 11–21–23; 8:45 am] 

BILLING CODE 9112–FN–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2023–0046] 

Establishment of Faith-Based Security 

Advisory Council Subcommittee 

AGENCY: The Office of Partnership and 

Engagement (OPE), The Department of 

Homeland Security (DHS). 

ACTION: Notice of a new tasking for the 

Faith-Based Security Advisory Council 

(FBSAC). 

SUMMARY: On November 14, 2023, the 

Secretary of DHS, Alejandro N. 

Mayorkas, issued a memorandum 

tasking the Faith-Based Security 

Advisory Council (FBSAC) to establish 

a subcommittee further outlined below. 

This notice is not a solicitation for 

membership. 

FOR FURTHER INFORMATION CONTACT: 

Sameer Hossain, Designated Federal 

Officer, Faith-Based Security Advisory 

Council of Department of Homeland 

Security, at FBSAC@hq.dhs.gov or 202– 

891–2876. 

SUPPLEMENTARY INFORMATION: The 

FBSAC provides organizationally 

independent, strategic, timely, specific, 

and actionable advice to the Secretary 

through the OPE Assistant Secretary, 

who serves as the DHS Faith-Based 

Organizations Security Coordinator on 

security and preparedness matters 

related to places of worship, faith 

communities, and faith-based 

organizations. The Council consists of 

members who are: faith-based 

organization security officials; faithbased organization leaders; faith leaders; 

State and local public safety, law 

enforcement, and emergency 

management leaders; and a 

representative from the Department of 

Justice or Federal Bureau of 

Investigation. 

The Secretary has requested that the 

FBSAC form a new subcommittee to 

study and provide recommendations in 

the following critical area for the 

Department: 

1. Combatting online child sexual 

exploitation and abuse (CSEA), 

providing recommendations on how 

DHS can partner with faith-based 

organizations to inform faith-based 

leaders and communities about how to 

recognize and respond appropriately to 

incidents of online CSEA; and an 

assessment to gauge the strengths, gaps, 

and opportunities in faith-based 

community awareness, engagement, and 

whole-of-community involvement. This 

assessment should include 

recommendations for faith-based 

organization collaboration to raise 

public awareness of online CSEA. 

Schedule: The subcommittees 

findings and recommendations will be 

submitted to the FBSAC for its 

deliberation and vote during a public 

meeting within 150 days of November 

14, 2023. 

Dated: November 16, 2023. 

Sameer Hossain, 

Designated Federal Officer, Faith-Based 

Security Advisory Council, U.S. Department 

of Homeland Security. 

[FR Doc. 2023–25774 Filed 11–21–23; 8:45 am] 

BILLING CODE 9112–FN–P 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2023–0043] 

Establishment of Homeland Security 

Advisory Council Subcommittee 

AGENCY: Office of Partnership and 

Engagement (OPE), Department of 

Homeland Security (DHS). 

ACTION: Notice of new tasking for the 

Homeland Security Advisory Council 

(HSAC). 

SUMMARY: On November 14, 2023, DHS 

Secretary Alejandro Mayorkas issued a 

memorandum tasking the HSAC with 

establishing a subcommittee to provide 

recommendations to the Department to 

combat online child sexual exploitation 

and abuse. Details of the tasking are 

included below. This notice is not a 

solicitation for membership. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Sternhell, Principal Deputy 

Assistant Secretary & Acting Executive 

Director, Homeland Security Advisory 

Council, Office of Partnership and 

Engagement, U.S. Department of 

Homeland Security at HSAC@

hq.dhs.gov or 202–891–2876. 

SUPPLEMENTARY INFORMATION: The 

Homeland Security Advisory Council 

provides organizationally independent, 

strategic, timely, specific, and 


khammond on DSKJM1Z7X2PROD with NOTICES