80728 Federal Register / Vol. 88, No. 222 / Monday, November 20, 2023 / Notices 

readiness and a stronger and safer drug 

supply chain including the following: 

1. How are you using the stabilization 

period to: 

a. Troubleshoot and mature secure, 

electronic, interoperable systems and 

processes for enhanced drug 

distribution security with upstream 

trading partners? 

b. Troubleshoot and mature secure, 

electronic, interoperable systems and 

processes for enhanced drug 

distribution security with downstream 

trading partners? 

2. What are the most significant 

challenges you have overcome? What 

strategies did you employ to overcome 

those challenges? 

3. What aspects of your systems and 

processes have you successfully 

operationalized? 

4. What are the next steps in your 

strategy to ensure successful 

implementation of the enhanced drug 

distribution security requirements by 

November 27, 2024? 

Dated: November 15, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25609 Filed 11–17–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4718] 

Advancing the Development of 

Therapeutics Through Rare Disease 

Patient Community Engagement 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Advancing the 

Development of Therapeutics Through 

Rare Disease Patient Community 

Engagement.’’ Convened by the DukeRobert J. Margolis, MD Center for Health 

Policy (Duke-Margolis) in collaboration 

with FDA and supported by a 

cooperative agreement between FDA 

and Duke-Margolis, the workshop will 

focus on how best to understand 

patients’ experiences living with a rare 

disease and how to incorporate those 

experiences, as well as patients’ 

priorities for treatment goals, 

throughout the drug development 

process. 

DATES: The public meeting will be held 

virtually on December 14, 2023, from 12 

p.m. to 5 p.m. Eastern Time. Either 

electronic or written comments on this 

public meeting must be submitted by 

February 12, 2024. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held virtually using the Zoom platform. 

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 February 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– 

2023–N–4718 for ‘‘Advancing the 

Development of Therapeutics Through 

Rare Disease Patient Community 

Engagement.’’ 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: 

Stuti Ganatra, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Silver Spring, MD 

20993, 301–796–8112, PatientFocused@

fda.hhs.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1
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. 


ddrumheller on DSK120RN23PROD with NOTICES1