62096 Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 

orally or in writing, on issues pending 

before the Committee. All electronic and 

written submissions to the Docket (see 

ADDRESSES) on or before November 2, 

2023, will be provided to the 

Committee. Oral presentations from the 

public will be scheduled between 

approximately 1:30 p.m. and 2:30 p.m. 

Eastern Time. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before October 

25, 2023. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 26, 2023. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Takyiah 

Stevenson (see FOR FURTHER

INFORMATION CONTACT) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and that the ends of justice 

will be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19407 Filed 9–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3137] 

Endpoints and Trial Designs To 

Advance Drug Development in Kidney 

Transplantation; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the following public 

meeting on ‘‘Endpoints and Trial 

Designs To Advance Drug Development 

in Kidney Transplantation.’’ 

DATES: The public meeting will be held 

on November 9, 2023, from 8 a.m. to 

4:30 p.m. Eastern Time. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

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. 

FOR FURTHER INFORMATION CONTACT: 

Ozlem Belen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Bldg. 22, Rm. 6118, 

Silver Spring, MD 20993–0002, 301– 

796–0676. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The goal of this public meeting is to 

facilitate discussion among FDA, 

academicians, and industry 

representatives on endpoint and trial 

designs to promote drug development in 

kidney transplantation. The last drug 

FDA approved for use in prophylaxis of 

organ rejection in kidney transplant was 

belatacept in 2011. It is well established 

that kidney transplantation offers a clear 

survival and quality-of-life advantage to 

patients with end-stage kidney disease. 

The current treatment options have 

resulted in excellent short-term graft 

and patient survival but not without 

long-term side effects. FDA recognizes 

the importance of offering safe and 

effective drugs with a tolerable adverse 

effect profile to preserve kidney 

allografts for patients. This public 

meeting aims to discuss current and 

future potential endpoints and trial 

designs that can promote development 

in this area of unmet need. 

II. Topics for Discussion at the Public 

Meeting 

The topics of discussion include: 

• Efficacy endpoints for prophylaxis 

of kidney transplant rejection trials: 

current state of primary endpoints and 

future potential endpoints. 

• Biopsy proven acute rejection 

efficacy failure: long-term impact, 

impact of treatment, and grade of 

rejection. 

• Noninferiority trials: identifying 

clinically important noninferiority 

margin, safety, and secondary efficacy 

endpoints. 

• Enrichment as a tool in trial design: 

identifying target populations. 

III. Attending the Public Meeting 

Registration: If you wish to attend the 

public meeting (either in person or via 

Zoom), please register by October 26, 

2023, at 4 p.m. Eastern Time. Visit the 

registration page here: https://kidneytransplantationworkshop.eventbrite.com. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. If time and space permit, 

onsite registration on the day of the 

public meeting will be provided 

beginning at 7:30 a.m. Eastern Time. We 

will let registrants know if registration 

closes before the day of the public 

meeting/public workshop. 

If you need special accommodations 

due to a disability, please contact 

ONDPublicMTGSupport@fda.hhs.gov 

no later than October 18, 2023. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be virtual via Zoom. Zoom links will be 

sent using the email provided by 

persons who register. We will post a 

link to the archived recording on http:// 

wcms-internet.fda.gov/drugs/newsevents-human-drugs/endpoints-andtrial-designs-advance-drugdevelopment-kidney-transplantation11092023?check_logged_in=1 


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Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 62097 

approximately 1 week after the public 

meeting. 

FDA has verified the website 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. A link to 

the transcript will also be available at 

https://www.fda.gov/about-fda/officeimmunology-and-inflammationdivision-rheumatology-and-transplantmedicine-drtm. 

Dated: September 1, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19405 Filed 9–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Council on Blood Stem Cell 

Transplantation 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

Advisory Council on Blood Stem Cell 

Transplantation (ACBSCT or Advisory 

Council) has scheduled public meetings. 

Information about the Advisory Council 

and the agenda for these meetings can 

be found on the ACBSCT website at: 

https://bloodstemcell.hrsa.gov/about/ 

advisory-council. 

DATES: Thursday, September 28, 2023, 

2:00 p.m.–6:00 p.m. Eastern Standard 

Time; and Thursday, October 26, 2023, 

2:00 p.m.–6:00 p.m. Eastern Standard 

Time. 

ADDRESSES: Both meetings will be held 

virtually by webinar. A link to register 

and join each meeting will be posted at 

least 10 days prior to the meeting date 

at: https://bloodstemcell.hrsa.gov/ 

about/advisory-council. 

FOR FURTHER INFORMATION CONTACT: 

Shelley Tims Grant, Designated Federal 

Official, at the HRSA Health Systems 

Bureau, Division of Transplantation, 

5600 Fishers Lane, 8W–67, Rockville, 

MD 20857; 301–443–8036; or 

ACBSCTHRSA@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

Advisory Council provides advice and 

recommendations to the Secretary of 

Health and Human Services on policy, 

program development, and other 

matters of significance concerning the 

activities under the authority of 42 

U.S.C. 274k (section 379 of the Public 

Health Service Act), as amended, and 

Public Law 109–129, as amended. The 

Advisory Council may transmit its 

recommendations through the 

Administrator of HRSA on matters 

related to the activities of the C.W. Bill 

Young Cell Transplantation Program 

and National Cord Blood Inventory. 

The agenda for the September 28, 

2023, meeting is being finalized and 

may include the following topics: the 

Department of Health and Human 

Services’ periodic review of the state of 

the science of using adult stem cells and 

birthing tissues to develop new types of 

therapies for patients, for the purpose of 

considering potential inclusion of such 

new therapies in the C.W. Bill Young 

Cell Transplantation Program; criteria 

for defining a high-quality cord blood 

unit for banking specifications; the 

unmet needs in blood stem cell 

transplantation and cellular therapy; 

strategies to improve rates of donation 

for adult blood stem cell donors; and 

other areas to increase blood stem cell 

donation and transplantation. The 

agenda for the October 26, 2023, 

meeting will be determined based on 

discussion, priorities, and/or action 

items from the September 28, 2023 

meeting. All agenda items will be 

posted on the Advisory Council’s 

website no later than 10 days prior to 

the respective meeting dates. Agenda 

items are subject to change as priorities 

dictate. Refer to the Advisory Council’s 

website for any updated information 

concerning the meeting. Members of the 

public will have the opportunity to 

provide comments. Public participants 

may submit written statements in 

advance of the scheduled meetings; oral 

comments will be honored in the order 

they are requested and may be limited 

as time allows. Requests to submit a 

written statement or make oral 

comments to the Advisory Council 

should be sent to Shelley Tims Grant, 

using the contact information above at 

least 3 business days prior to the 

meeting. Individuals who plan to attend 

and need special assistance or other 

reasonable accommodations should 

notify the Advisory Council at the 

address and phone number listed above 

at least 10 business days prior to the 

meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2023–19398 Filed 9–7–23; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Drug Abuse; 

Amended Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the National Advisory 

Council on Drug Abuse, September 12, 

2023, 10:30 a.m. to September 12, 2023, 

05:00 p.m., National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 which 

was published in the Federal Register 

on August 21, 2023, FR Doc 2023– 

17889, 88 FR 56847. 

This notice is being amended to 

change the open session start time from 

12:45 p.m. to 1:00 p.m. The open 

session will now be held from 1:00 p.m. 

to 5:00 p.m. on September 12, 2023. The 

meeting is partially closed to the public. 

Dated: September 1, 2023. 

Tyeshia M. Roberson-Curtis, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2023–19406 Filed 9–7–23; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Notice of Meeting for the 

Interdepartmental Serious Mental 

Illness Coordinating Committee 

(ISMICC) 

AGENCY: Substance Abuse and Mental 

Health Services Administration, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: The Secretary of Health and 

Human Services announces a meeting of 

the Interdepartmental Serious Mental 

Illness Coordinating Committee 

(ISMICC). 

The meeting will provide information 

on federal efforts related to serious 

mental illness (SMI) and serious 

emotional disturbance (SED). 

DATES: October 18, 2023, 10:00 a.m. to 

4:00 p.m. (EDT)/Open. 

ADDRESSES: The meeting is open to the 

public and can be accessed virtually 

only by accessing: https://

www.zoomgov.com/j/1608742409?

pwd=NjdoRlpGU2NoOH

paTzZVWXR3N0k4UT09, or by dialing 

646–828–7666, webinar ID: 160 874 

2409, passcode: 446018. Agenda with 

call-in information will be posted on the 


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