81422 Federal Register / Vol. 88, No. 224 / Wednesday, November 22, 2023 / Notices 

Transcripts: Please be advised that 

transcripts of the public meeting will 

not be available. 

Dated: November 16, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25816 Filed 11–21–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4965] 

Advancing the Use of Complex 

Innovative Designs in Clinical Trials: 

From Pilot to Practice; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the following public 

workshop entitled ‘‘Advancing the Use 

of Complex Innovative Designs in 

Clinical Trials: From Pilot to Practice.’’ 

The purpose of the public workshop is 

to discuss aspects of complex adaptive, 

Bayesian, and other novel clinical trial 

designs. This workshop is being 

conducted to meet the performance goal 

of convening a public workshop on 

complex innovative design (CID) 

included in the seventh authorization of 

the Prescription Drug User Fee Act 

(PDUFA VII). The workshop may also 

inform a draft guidance on the use of 

Bayesian methodology in clinical trials 

of drugs and biological products. In 

conjunction with the workshop, FDA is 

seeking comments on the use of CID to 

inform regulatory decision making, 

including high-level case examples of 

CIDs and approaches that can advance 

the use of these designs. The public 

workshop will be held on March 5, 

2024, from 9 a.m. to 3:30 p.m. Eastern 

Time. 

DATES: Either electronic or written 

comments on this public workshop 

must be submitted by April 5, 2024. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room, 

Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/about-fda/visitorinformation. The public workshop will 

use an online platform for the webcast. 

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 April 5, 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– 

2023–N–4965 for ‘‘Advancing the Use of 

Complex Innovative Designs in Clinical 

Trials: From Pilot to Practice; Public 

Workshop; Request for Comments.’’ 

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: 

Tuan Pham, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., Bldg. 21, Rm. 3670, 

Silver Spring, MD 20993–0002, 301– 

348–1595, CID.Meetings@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 


khammond on DSKJM1Z7X2PROD with NOTICES
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