Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 80729 

SUPPLEMENTARY INFORMATION: 

I. Background 

This public meeting is intended to 

facilitate improvements in the treatment 

of rare diseases and conditions, 

consistent with the requirements under 

section 3202 of the Food and Drug 

Omnibus Reform Act of 2022 (FDORA). 

Section 3202 of FDORA requires FDA to 

conduct a number of activities related to 

improving the treatment of rare diseases 

and conditions, including the convening 

of one or more public meetings to 

address increasing and improving 

engagement with rare disease patients, 

rare disease patient groups, and experts 

on small population studies, in order to 

improve the understanding of patient 

burden, treatment options, and the side 

effects of treatments (see section 

3202(d)(2) of FDORA). 

II. Topics for Discussion at the Public 

Meeting 

The purpose of this public meeting is 

to highlight and build upon existing 

actionable approaches for engaging 

patients, patient groups, and related 

experts when developing necessary 

evidence for rare disease drug 

approvals. The meeting will address 

approaches to increasing and improving 

engagement with rare disease patients, 

groups representing such patients, rare 

disease experts, and experts on small 

population studies, to improve the 

understanding of how to best 

understand patients’ experiences living 

with a rare disease and how to 

incorporate those experiences and 

priorities throughout the drug 

development process. This includes 

understanding patient perspectives on 

the burden of their condition and any 

existing treatment options, as well as 

how their current health status and risk 

of disease progression may impact 

willingness to accept risks from 

treatment side effects. 

Meeting updates, the agenda, and 

background materials (if any) will also 

be made available at https://duke.is/4/ 

7yuu prior to the meeting. 

III. Participating in the Public Meeting 

Registration: To register for the public 

meeting, please visit the following 

website: https://duke.is/4/7yuu. Please 

provide complete contact information 

for each attendee, including name, title, 

affiliation, address, email, and 

telephone. Registration will end at 11:59 

p.m. Eastern Time on December 13, 

2023. 

Registration is free and persons 

interested in attending this public 

meeting must register to receive a link 

to the meeting. Registrants will receive 

a confirmation email after they register. 

If you need special accommodations 

due to a disability, please contact 

Margolisevents@duke.edu no later than 

November 30, 2023. Please note, closed 

captioning will be available 

automatically. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://duke.is/4/7yuu. The transcript 

will also be available at https://

www.regulations.gov and may be 

viewed at the Dockets Management Staff 

(see ADDRESSES). 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25500 Filed 11–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Advisory Committee on 

Blood and Tissue Safety and 

Availability 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: The U.S. Department of 

Health and Human Services is hereby 

giving notice that the Advisory 

Committee on Blood and Tissue Safety 

and Availability (ACBTSA) will hold a 

virtual meeting. The meeting will be 

open to the public via webcast. The 

committee will discuss and vote on 

recommendations related to surge 

capacity for blood and blood products. 

DATES: The meeting will take place 

virtually on January 11, 2024 from 

approximately 9:00 a.m.—5:00 p.m. 

Eastern Time (ET). Meeting times are 

tentative and subject to change. The 

confirmed times and agenda items for 

the meeting will be posted on the 

ACBTSA web page at https://

www.hhs.gov/oidp/advisory-committee/ 

blood-tissue-safety-availability/ 

meetings/2024-01-11/index.html when 

this information becomes available. 

FOR FURTHER INFORMATION CONTACT: 

James Berger, Designated Federal Officer 

for the ACBTSA; Office of Infectious 

Disease and HIV/AIDS Policy, Office of 

the Assistant Secretary for Health, 

Department of Health and Human 

Services, Tower Building, 1101 Wootton 

Parkway, Rockville, MD, 20852. Email: 

ACBTSA@hhs.gov. Phone: 202–795– 

7608. 

SUPPLEMENTARY INFORMATION: On the 

day of the meeting, please go to https:// 

www.hhs.gov/live/index.html to view 

the meeting. The public will have an 

opportunity to present their views to the 

ACBTSA by submitting a written public 

comment. Comments should be 

pertinent to the meeting discussion. 

Persons who wish to provide written 

public comment should review 

instructions at https://www.hhs.gov/ 

oidp/advisory-committee/blood-tissuesafety-availability/meetings/2024-01-11/ 

index.html and respond by midnight 

January 3, 2024, ET. Written public 

comments will be accessible to the 

public on the ACBTSA web page prior 

to the meeting. 

Background and Authority: The 

ACBTSA is a discretionary Federal 

advisory committee and is governed by 

the provisions of the Federal Advisory 

Committee Act (FACA), Public Law 92– 

463, as amended (5 U.S.C. app), which 

sets forth standards for the formation 

and use of advisory committees. The 

ACBTSA functions to provide advice to 

the Secretary through the Assistant 

Secretary for Health on a range of policy 

issues to include: (1) Identification of 

public health issues through 

surveillance of blood and tissue safety 

issues with national survey and data 

tools; (2) identification of public health 

issues that affect availability of blood, 

blood products, and tissues; (3) broad 

public health, ethical, and legal issues 

related to the safety of blood, blood 

products, and tissues; (4) the impact of 

various economic factors (e.g., product 

cost and supply) on safety and 

availability of blood, blood products, 

and tissues; (5) risk communications 

related to blood transfusion and tissue 

transplantation; and (6) identification of 

infectious disease transmission issues 

for blood, organs, blood stem cells and 

tissues. The Committee has met 

regularly since its establishment in 

1997. 

Dated: November 2, 2023. 

James J. Berger, 

Designated Federal Officer, Advisory 

Committee on Blood and Tissue Safety and 

Availability, Office of Infectious Disease and 

HIV/AIDS Policy. 

[FR Doc. 2023–25572 Filed 11–17–23; 8:45 am] 

BILLING CODE 4150–28–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Findings of Research Misconduct 

AGENCY: Office of the Secretary, HHS. 


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