Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 90703 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Cities ....................................................... Annual ..................................................... 2 1 75 150 

Cities ....................................................... One-time Addition of Diseases and Data 

Elements.

2 1 3 6 

Total ................................................. ................................................................. .................... ........................ .................... 18,414 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–26778 Filed 11–15–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–25–24HQ] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled ‘‘Division of 

Diabetes Translation Programmatic & 

Participant User Experience Data 

Collection (DDTDC)’’ to the Office of 

Management and Budget (OMB) for 

review and approval. CDC previously 

published a ‘‘Proposed Data Collection 

Submitted for Public Comment and 

Recommendations’’ notice on July 26, 

2024 to obtain comments from the 

public and affected agencies. CDC 

received zero comments related to the 

previous notice. This notice serves to 

allow an additional 30 days for public 

and affected agency comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) 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; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) Minimize the burden of the 

collection of information on those who 

are to respond, including, through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570. 

Comments and recommendations for the 

proposed information collection should 

be sent within 30 days of publication of 

this notice to www.reginfo.gov/public/ 

do/PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. Direct written 

comments and/or suggestions regarding 

the items contained in this notice to the 

Attention: CDC Desk Officer, Office of 

Management and Budget, 725 17th 

Street NW, Washington, DC 20503 or by 

fax to (202) 395–5806. Provide written 

comments within 30 days of notice 

publication. 

Proposed Project 

Division of Diabetes Translation 

Programmatic & Participant User 

Experience Data Collection (DDTDC)— 

New—National Center for Chronic 

Disease Prevention and Health 

Promotion (NCCDPHP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The Division of Diabetes Translation 

(DDT) plays a crucial role in helping 

prevent Type 2 diabetes, reducing 

diabetes complications and disability, 

and reducing diabetes-related 

disparities across the United States. 

DDT accomplishes this by providing 

education, training, technical assistance 

(TA), and engaging in communication/ 

marketing activities for various key 

audiences. These customers include 

national, state, and local partners, 

grantees, providers (e.g., lifestyle 

coaches, diabetes educators, healthcare 

providers, health/medical and 

community-based organizations), people 

with prediabetes, diabetes and their 

family, friends, and caregivers, and 

other consumers of DDT products and 

programs. 

For DDT to be able to efficiently and 

effectively do this work and fulfill its 

mission, it needs to be able to collect 

information and feedback from intended 

audiences in a timely manner and with 

enough frequency to ensure DDT can 

deliver clear, effective, efficient, and 

appropriate customer service. This 

includes, for instance, collecting data on 

key audiences’ needs and on the reach, 

uptake, use, customer experience and 

satisfaction with DDT’s services, 

products, and related programs, 

including its education, training, TA 

and communications services and 

products. 

However, in the interest of timely 

provision of services, DDT often forgoes 

the important step of getting input from 

its key audiences on the clarity, 

efficiency, effectiveness, and 

appropriateness of the services and 

resources it develops and provides for 

them. Skipping this information 

collection step, or doing so with less 

frequency, avoids the delay involved in 

the standard OMB review process, but 

increases the risk of DDT wasting both 

time and money developing and 

providing education, training, TA, and 

communication/marketing that will not 

achieve the intended objectives and will 

be unclear, irrelevant, or not fully meet 

the needs of DDT’s audiences. It can 

also have other unintended 

consequences, such as jeopardizing the 

credibility of Federal health officials. 

The Division of Diabetes Translation 

Programmatic & Participant User 

Experience Data Collection (DDTDC) 

will enable DDT to collect the 

information they require in a timely 

manner to: 

• Provide clear, effective, efficient, 

appropriate, and timely education, 

communication, training, and technical 


lotter on DSK11XQN23PROD with NOTICES1
90704 Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 

assistance to key audiences and other 

interested groups, including consumer 

audiences (e.g., people with prediabetes, 

diabetes, and their family, friends, and 

caregivers), providers (e.g., lifestyle 

coaches, diabetes care and education 

specialists, healthcare and other 

providers, health/medical and 

community-based organizations); and 

partners (national, state, and local 

partners). 

• Ensure quality and prevent 

duplication in the development and 

dissemination of prevention and health 

information and program activities by 

DDT to consumers, providers, and state 

and local partners. 

• Conduct exploratory/formative 

assessments to inform DDT’s 

development of education, 

communication/marketing, training, and 

programmatic materials, tools, and 

resources to support and improve the 

prevention and management of diabetes. 

For example, identifying key audiences’ 

knowledge, attitudes, behaviors, 

motivators, and information needs. 

• Assess the impact of programs, 

messages, educational and training 

materials among recipients and 

determine to what extent they meet 

relevant service-related DDT objectives 

and goals. 

The following are examples of the 

areas of focus that the data collection 

activities under this generic information 

collection mechanism may include: 

• Reach, uptake, use, customer 

experience, and satisfaction with the 

CDC-recognized lifestyle change 

programs for type 2 diabetes prevention, 

as well as related outcomes (e.g., 

participant retention and recruitment 

rates). 

• Satisfaction with CDC-recognized 

lifestyle change programs toolkits, such 

as the Personal Success Tool and 

Champion toolkits. 

• Reach, uptake, use, customer 

experience, and satisfaction with 

diabetes education, type 2 prevention, 

and diabetes management innovations 

(such as the Diabetes Self-Management 

Education and Support services 

promotion initiative) and related shortterm effects on knowledge, awareness, 

practices (such as information seeking), 

and outcomes (such as enrollment of 

people with diabetes or prediabetes). 

• Reach, uptake, satisfaction, 

customer experience, and short-term 

outcomes of CDC’s training and 

technical assistance resources (such as a 

webinar or online toolkit). 

• Needs assessments for customer 

experience with, utilization of, and 

short-term outcomes of technical 

assistance and trainings for diabetes 

prevention and management. 

• Understandability, ease of use, and 

appropriateness of diabetes education 

messages, toolkits, programs, and 

marketing materials. 

• Exploratory assessments of 

knowledge, attitudes, behaviors, beliefs, 

barriers, and facilitators to uptake and 

use of lifestyle change programs for 

diabetes type 2 prevention and diabetes 

management services and related 

innovations, resources, tools, and 

materials. 

Data collection methods proposed 

include, but are not limited to in-depth 

individual interviews, cognitive 

interviews, intercept interviews, groupbased discussions (including focus 

groups and dyads/triads), surveys or 

questionnaires, knowledge assessments, 

observational assessments, and 

implementation and utilization data 

reporting. Respondents would include 

key audiences and stakeholders of 

CDC’s work, including representatives 

of state and local DDT-funded 

organizations; national, state, and local 

DDT partners (not CDC-funded); 

providers of type 2 diabetes prevention 

and diabetes management programs and 

services, including lifestyle coaches, 

diabetes care and educations specialists, 

healthcare and other providers; heath/ 

medical and community-based 

organizations implementing programs 

and services related to type 2 diabetes 

prevention and diabetes management; 

people with—and at risk for—diabetes 

or with prediabetes; family, friends, and 

caregivers of people with—and at risk 

for—diabetes or with prediabetes. 

As the methods for data collection 

and audiences may vary with each 

request submitted under this proposed 

generic clearance, for each data 

collection request unique instruments 

(e.g., surveys, interview guides) will be 

developed to address the specific topics 

that information will be collected on. 

Questions to be asked may focus, for 

example, on collecting data on the 

audiences’ needs and on the reach, 

uptake, use, customer experience and 

satisfaction with DDT’s services, 

products, and programs. Such 

information will enable DDT to identify 

ways to improve its services, products, 

and programs to better meet its 

audiences’ needs and achieve its 

mission of supporting the prevention of 

diabetes and reducing diabetes-related 

complications and disparities across the 

United States. 

CDC requests a three-year approval for 

6,000 burden hours for this proposed 

Generic package. Based on projections, 

the estimated annualized hourly burden 

anticipated for all data collection 

methods would total 2,000 hours and 

include eight to ten data collection 

activities over the course of a year. 

There is no cost to the respondents 

other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Data collection methods 

Number of 

respondents 

across 

methods 

Number 

responses per 

respondent 

Average 

burden per 

response 

Representatives of state and local DDT-funded organizations; national, state, and local DDT partners (not CDCfunded); providers of type 2 diabetes prevention and diabetes management programs and services; heath/medical 

and community-based organizations implementing programs and services related to type 2 diabetes prevention 

and diabetes management; people with—and at risk for— 

diabetes or with prediabetes; family, friends, and caregivers of people with—and at risk for—diabetes or with 

prediabetes.

Interviews; surveys or questionnaires; knowledge assessments; motivation assessments, observational 

assessments; implementation and utilization data reporting.

4,000 1 30/60 


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Federal Register / Vol. 89, No. 222 / Monday, November 18, 2024 / Notices 90705 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Public Health Ethics and 

Regulations, Office of Science, Centers for 

Disease Control and Prevention. 

[FR Doc. 2024–26780 Filed 11–15–24; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10398 #85] 

Medicaid and Children’s Health 

Insurance Program (CHIP) Generic 

Information Collection Activities: 

Proposed Collection; Comment 

Request 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Health and 

Human Services (HHS). 

ACTION: Notice. 

SUMMARY: On May 28, 2010, the Office 

of Management and Budget (OMB) 

issued Paperwork Reduction Act (PRA) 

guidance related to the ‘‘generic’’ 

clearance process. Generally, this is an 

expedited process by which agencies 

may obtain OMB’s approval of 

collection of information requests that 

are ‘‘usually voluntary, low-burden, and 

uncontroversial collections,’’ do not 

raise any substantive or policy issues, 

and do not require policy or 

methodological review. The process 

requires the submission of an 

overarching plan that defines the scope 

of the individual collections that would 

fall under its umbrella. This Federal 

Register notice seeks public comment 

on one or more of our collection of 

information requests that we believe are 

generic and fall within the scope of the 

umbrella. Interested persons are invited 

to submit comments regarding our 

burden estimates or any other aspect of 

this collection of information, 

including: the necessity and utility of 

the proposed information collection for 

the proper performance of the agency’s 

functions, the accuracy of the estimated 

burden, ways to enhance the quality, 

utility and clarity of the information to 

be collected, and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

December 2, 2024. 

ADDRESSES: When commenting, please 

reference the applicable form number 

(CMS–10398 #85) and the OMB control 

number (0938–1148). To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: CMS–10398 #85/OMB 

control number: 0938–1148, Room C4– 

26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, please access the CMS PRA 

website by copying and pasting the 

following web address into your web 

browser: https://www.cms.gov/ 

medicare/regulations-guidance/ 

legislation/paperwork-reduction-act1995/pra-listing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at 410–786–4669. 

SUPPLEMENTARY INFORMATION: Following 

is a summary of the use and burden 

associated with the subject information 

collection(s). More detailed information 

can be found in the collection’s 

supporting statement and associated 

materials (see ADDRESSES). 

Generic Information Collection 

1. Title of Information Collection: 3.1– 

M State Plan Amendment (SPA) 

Templates for Eligible Juveniles Who 

are Inmates of a Public Institution; Type 

of Information Collection Request: New 

information collection request 

information request; Use: Section 5121 

of the Consolidated Appropriation Act 

of 2023 (CAA, 2023) creates a new 

mandate for states by amending section 

1902(a)(84) of the Social Security Act 

(the Act) (42 U.S.C. 1396a) to require 

states to provide specific screening and 

diagnostic services and targeted case 

management (including referrals) in the 

30 days prior to release from 

incarceration, and targeted case 

management (TCM) (including referrals) 

for at least 30 days post release for 

eligible juveniles who are inmates of a 

public institution, post adjudication. 

The requirements are effective January 

1, 2025. 

To comply with the amendments 

states must submit a Medicaid SPA 

attesting that the state has developed an 

internal operation plan, and in 

accordance with such plan, will provide 

coverage during the statutory pre- and 

post-release period of screening, 

diagnostic, and TCM services for 

eligible juveniles who are within 30 

days of release post adjudication. 

States have the option to lift the 

Medicaid inmate payment and CHIP 

eligibility exclusions and provide 

coverage of pre-release Medicaid and 

CHIP services (for electing states) and 

makes available federal matching funds 

for the full breadth of Medicaid and 

CHIP benefits to eligible juveniles who 

are incarcerated and pending 

disposition of charges. States selecting 

this state plan option must provide to 

eligible juveniles all mandatory and 

optional services to which they are 

otherwise entitled under the state plan. 

During the period when an eligible 

juvenile is incarcerated and pending 

disposition of charges, this is essentially 

a full lifting of the Medicaid inmate 

payment exclusion and CHIP eligibility 

exclusion. States cannot choose to 

provide a limited array of state plan 

services under this option. An 

operational plan is not required for this 

state option. 

For states that wish to elect the option 

in section 5122 of the CAA, 2023, states 

should submit a SPA attesting to CMS 

that they are also electing coverage for 

any Medicaid or CHIP state plan 

services for eligible juveniles pending 

disposition of charges to which the 

beneficiary would otherwise be entitled, 

if not for their incarceration status. 

Form Number: CMS–10398 #85 (OMB 

control number: 0938–1148); Frequency: 

Once and on occasion; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 56; Total 

Annual Responses: 168; Total Annual 

Hours: 4,872. (For policy questions 

regarding this collection contact: 

Marlana Thieler at 410–786–6274.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–26713 Filed 11–15–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–4467] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Prescription Drug 

User Fee Program 

AGENCY: Food and Drug Administration, 

HHS. 


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