104550 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 

The reorganization will improve 

FDA’s ability to carry out its public 

health mission by realigning and 

dedicating resources within the 

organization to modernize clinical trials. 

The clinical trial innovation work tracks 

will place DCI at the forefront to 

robustly meet policy development, 

implementation, and analysis needs in 

areas such as Artificial Intelligence (AI), 

Digital Health Technologies (DHTs), 

Real-World Evidence (RWE), and other 

rapidly advancing sectors in the 

dynamic clinical trial ecosystem. 

The CDER, OMP, Office of Medical 

Policy Initiatives retitled the Division of 

Clinical Trial Quality to the Division of 

Clinical Innovations. 

The reorganization will enhance the 

office’s ability to attract and retain a 

diverse workforce representative of our 

nation and bring like scientists and 

policy experts together from across the 

organization, thereby facilitating 

collaboration and efficient use of shared 

resources while advancing key 

innovations in drug development. By 

developing responsive policies, the 

Division of Clinical Innovations will 

modernize the policy environment to 

ensure that CDER is providing the 

needed regulatory perspective to guide 

the appropriate use of such tools and 

technologies. 

The FDA’s CDER, OMP has been 

restructured as follows: 

DCDH ORGANIZATION. The CDER 

OMP (DCDH) is headed by the Director, 

OMP and includes the following: 

Office of Medical Policy (DCDH) 

Office of Prescription Drug Promotion 

(DCDHA) 

Division of Advertising and Promotion 

Review II (DCDHAA) 

Division of Advertising and Promotion 

Review I (DCDHAB) 

Division of Promotion Policy, Research 

and Operations (DCDHAC) 

Office of Medical Policy Initiatives 

(DCDHB) 

Division of Medical Policy Development 

(DCDHBA) 

Division of Medical Policy Programs 

(DCDHBB) 

Division of Clinical Innovations 

(DCDHBC) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

This reorganization is reflected in 

FDA’s Staff Manual Guide (SMG). 

Persons interested in seeing the 

complete Staff Manual Guide can find it 

on FDA’s website at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/ 

StaffManualGuides/default.htm. 

Authority: 44 U.S.C. 3101. 

Xavier Becerra, 

Secretary of Health and Human Services. 

[FR Doc. 2024–30333 Filed 12–20–24; 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 (HHS). 

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 Council) 

has scheduled a public meeting. 

Information about ACBSCT and the 

agenda for the meeting can be found on 

the ACBSCT website at https://

bloodstemcell.hrsa.gov/about/advisorycouncil. 

DATES: Thursday, January 23, 2025, 3:00 

p.m.–5:00 p.m. Eastern Standard Time. 

ADDRESSES: This meeting will be held 

virtually by webinar. A link to register 

and join the meeting will be posted at 

least 10 days prior to the meeting at 

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

advisory-council. 

FOR FURTHER INFORMATION CONTACT: 

Shelley Tims Grant, Designated Federal 

Official, Division of Transplantation, 

Health Systems Bureau, HRSA, 5600 

Fishers Lane, 8W–67, Rockville, 

Maryland 20857; 301–443–8036; or 

ACBSCTHRSA@hrsa.gov. 

SUPPLEMENTARY INFORMATION: ACBST 

provides advice and recommendations 

to the Secretary of HHS (Secretary) 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), Public Law 109– 

129, as amended. The 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 January 23, 2025, 

meeting is being finalized and may 

include the following topics: graft 

versus host disease and late effects, 

strategies for selecting cord blood units 

for transplantation, HHS’ approach for 

reviewing the state of the science and 

recommendations on the 

appropriateness of the inclusion of adult 

stem cells and birthing tissues as new 

types of therapies in the C.W. Bill 

Young Cell Transplantation Program, 

and other areas to increase blood stem 

cell donation and transplantation. 

Agenda items are subject to change as 

priorities dictate. Refer to ACBSCT’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 ACBSCT 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 ACBSCT 

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. 2024–30604 Filed 12–20–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60 Day 

Notice for Extension of Fast Track 

Generic Clearance for the Collection of 

Qualitative Feedback on Agency 

Service Delivery: Indian Health Service 

Customer Service Satisfaction and 

Similar Surveys 

AGENCY: Indian Health Service, HHS. 

ACTION: Notice and request for 

comments. Request for extension of 

approval. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

Indian Health Service (IHS) invites the 

general public to take this opportunity 

to comment on the information 

collection Office of Management and 

Budget (OMB) Control Number 0917– 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 104551 

0036, ‘‘Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery.’’ This notice 

announces our intent to submit this 

previously approved information 

collection, which expires February 28, 

2025, to the OMB for approval of an 

extension and solicit comments on 

specific aspects for the proposed 

information collection. 

DATES: Consideration will be given to all 

comments received by February 21, 

2025. 

ADDRESSES: Submit comments to 

Patricia Lawton by email at 

Patricia.Lawton@ihs.gov. 

Comments submitted in response to 

this notice will be made available to the 

public by publishing them in the 30-day 

Federal Register Notice for this 

information collection. For this reason, 

please do not include information of a 

confidential nature, such as sensitive 

personal information or proprietary 

information. If comments are submitted 

via email, the email address will be 

automatically captured and included as 

part of the comment that is placed in the 

public docket and made available on the 

internet. Please note that responses to 

this public comment request containing 

any routine notice about the 

confidentiality of the communication 

will be treated as public comments that 

may be made available to the public 

notwithstanding the inclusion of the 

routine notice. 

A copy of the draft supporting 

statement is available at 

www.regulations.gov (see Docket ID 

IHS_FRDOC_0001). 

SUPPLEMENTARY INFORMATION: The IHS is 

submitting the proposed information 

collection to OMB for review, as 

required by the Paperwork Reduction 

Act of 1995, as amended, and its 

implementing regulations. This notice is 

soliciting comments from members of 

the public and affected agencies as 

required by 44 U.S.C. 3506(c)(2)(A) and 

5 CFR 1320.8(d) concerning the 

proposed collection of information to: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the Agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the Agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) Minimize the 

burden of the collection of information 

on those who are to respond; including 

through the use of appropriate 

automated collection techniques of 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Title: Generic Clearance for the 

Collection of Qualitative Feedback on 

Agency Service Delivery: Indian Health 

Service Customer Service Satisfaction 

and Similar Surveys. 

Type of Information Collection 

Request: Three year extension approval 

of this information collection. 

OMB Control Number: 0917–0036. 

Abstract: The proposed information 

collection activity provides a means to 

garner qualitative customer and 

stakeholder feedback in an efficient, 

timely manner, in accordance with the 

Administration’s commitment to 

improving service delivery. Qualitative 

feedback is information that provides 

useful insights on perceptions and 

opinions, but is not statistical surveys 

that yield quantitative results that can 

be generalized to the population of 

study. This feedback will provide 

insights into customer or stakeholder 

perceptions, experiences and 

expectations, provide an early warning 

of issues with service, or focus attention 

on areas where communication, training 

or changes in operations might improve 

delivery of products or services. These 

collections will allow for ongoing, 

collaborative and actionable 

communications between the Agency 

and its customers and stakeholders. It 

will also allow feedback to contribute 

directly to the improvement of program 

management. 

The solicitation of feedback will target 

areas such as: timeliness, 

appropriateness, accuracy of 

information, courtesy, efficiency of 

service delivery, and resolution of 

issues with service delivery. Responses 

will be assessed to plan and inform 

efforts to improve or maintain the 

quality of service offered to the public. 

If this information is not collected, vital 

feedback from customers and 

stakeholders on the Agency’s services 

will be unavailable. 

The Agency will only submit a 

collection for approval under this 

generic clearance if it meets the 

following conditions: 

• Information gathered will be used 

only internally for general service 

improvement and program management 

purposes and is not intended for release 

outside of the Agency; 

• Information gathered will not be 

used for the purpose of substantially 

informing influential policy decisions; 

• Information gathered will yield 

qualitative information; the collections 

will not be designed or expected to 

yield statistically reliable results or used 

as though the results are generalizable to 

the population of study; 

• The collections are voluntary; 

• The collections are low-burden for 

respondents (based on considerations of 

total burden hours, total number of 

respondents, or burden-hours per 

respondent) and are low-cost for both 

the respondents and the Federal 

Government; 

• The collections are noncontroversial and do not raise issues of 

concern to other Federal agencies; 

• Any collection is targeted to the 

solicitation of opinions from 

respondents who have experience with 

the program or may have experience 

with the program in the near future; and 

• With the exception of information 

needed to provide remuneration for 

participants of focus groups and 

cognitive laboratory studies, personally 

identifiable information (PII) is 

collected only to the extent necessary 

and is not retained. 

Feedback collected under this generic 

clearance provides useful information, 

but it does not yield data that can be 

generalized to the overall population. 

This type of generic clearance for 

qualitative information will not be used 

for quantitative information collections 

that are designed to yield reliably 

actionable results, such as monitoring 

trends over time or documenting 

program performance. Such data uses 

require more rigorous designs that 

address: the target population to which 

generalizations will be made, the 

sampling frame, the sample design 

(including stratification and clustering), 

the precision requirements or power 

calculations that justify the proposed 

sample size, the expected response rate, 

methods for assessing potential nonresponse bias, the protocols for data 

collection, and any testing procedures 

that were or will be undertaken prior to 

fielding the study. Depending on the 

degree of influence the results are likely 

to have, such collections may still be 

eligible for submission for other generic 

mechanisms that are designed to yield 

quantitative results. 

As a general matter, information 

collections will not result in any new 

system of records containing privacy 

information and will not ask questions 

of a sensitive nature, such as sexual 

behavior and attitudes, religious beliefs, 

and other matters that are commonly 

considered private. 

Current Actions: Extension of 

approval for a collection of information. 

Type of Review: Extension. 

Affected Public: Individuals and 

households, businesses and 

organizations, and Tribal governments. 

Estimated Number of Respondents: 

105,000. 


khammond on DSK9W7S144PROD with NOTICES
104552 Federal Register / Vol. 89, No. 246 / Monday, December 23, 2024 / Notices 

Below are projected annual average 

estimates for the next 3 years: 

Average Expected Annual Number of 

activities: 100. 

Average number of Respondents per 

Activity: 1050. 

Annual responses: 105,000. 

Frequency of Response: Once per 

request. 

Average minutes per response: 10. 

Burden hours: 17,500. 

There are no direct costs to 

respondents to report. 

An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless it displays a currently valid OMB 

control number. 

Comment Due Date: Your comments 

regarding this information collection are 

best assured of having full effect if 

received within 60-days of the date of 

this publication. 

Roselyn Tso, 

Director, Indian Health Service. 

[FR Doc. 2024–30541 Filed 12–20–24; 8:45 am] 

BILLING CODE 4165–16–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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 on 

Aging Special Emphasis Panel; Role of tau in 

non-neuronal dysfunction in Alzheimer’s 

Disease (AD) and Related Disorders (RD). 

Date: February 5, 2025. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute on Aging, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Nesar Uddin Akanda, 

M.D., Ph.D., Scientific Review Officer 

National Institute of Aging, National Institute 

of Health, 5601 Fishers Lane, Room 2E405, 

Rockville, MD 20852, (301) 594–8984, 

nesar.akanda@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 17, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–30560 Filed 12–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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 on 

Aging Special Emphasis Panel; Mechanisms 

of the age-related changes in gait 

biomechanics and the impact on the 

increased metabolic cost of walking. 

Date: February 20, 2025. 

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

Agenda: To review and evaluate grant 

applications. 

Address: National Institute on Aging, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Nesar Uddin Akanda, 

M.D., Ph.D., Scientific Review Officer, 

National Institute of Aging, National Institute 

of Health, 5601 Fishers Lane, Room 2E405, 

Rockville, MD 20852, (301) 594–8984, 

nesar.akanda@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 17, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–30558 Filed 12–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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 on 

Aging Special Emphasis Panel; Inequities in 

Digital Health for Older Adults with 

Cognitive Decline and ADRD. 

Date: February 21, 2025. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Address: National Institute on Aging, 5601 

Fishers Lane, Suite 8B, Rockville, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Rajasri Roy, Ph.D., MPH, 

Scientific Review Officer, National Institute 

of Aging, National Institute of Health, 5601 

Fishers Lane, Room 100, Rockville, MD 

20852, (301) 496–9666, rajasri.roy@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: December 17, 2024. 

Miguelina Perez, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–30563 Filed 12–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

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 


khammond on DSK9W7S144PROD with NOTICES