Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5887 

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. 2025–01154 Filed 1–16–25; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–25–25CQ; Docket No. CDC–2025– 

0004] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed information collection, as 

required by the Paperwork Reduction 

Act of 1995. This notice invites 

comment on a proposed information 

collection project titled Healthcare 

Prevention and Response Workforce 

Development for Health Departments. 

The proposed workforce development 

evaluations will be used to assess 

whether the CDC-developed workforce 

development activities are reaching the 

intended audience and achieving the 

intended goal of strengthening public 

health workforce capacity to prevent 

and respond to Healthcare-Associated 

Infection and Antibiotic Resistance 

(HAI/AR) outbreaks at the individual 

trainee and program level. 

DATES: CDC must receive written 

comments on or before March 18, 2025. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2025– 

0004 by either of the following methods: 

• Federal eRulemaking Portal: 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS H21–8, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

www.regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(www.regulations.gov) or by U.S. mail to 

the address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffrey M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS 

H21–8, Atlanta, Georgia 30329; 

Telephone: 404–639–7570; Email: omb@

cdc.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), Federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

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, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; 

4. 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 submissions 

of responses; and 

5. Assess information collection costs. 

Proposed Project 

Healthcare-Associated Infections and 

Antimicrobial Resistance (HAI/R) 

Programs Response and Prevention 

Workforce Development Activities— 

New—National Center for Emerging and 

Zoonotic Infectious Diseases (NCEZID), 

Centers for Disease Control and 

Prevention (CDC). 

Background and Brief Description 

CDC funds Healthcare-Associated 

Infection and Antibiotic Resistance 

(HAI/AR) Programs in 65 state, local, 

and territorial health departments. 

Funding is awarded through the 

Epidemiology and Laboratory Capacity 

cooperative agreements (ELC). Funds 

are intended to provide critical 

resources to recipients in support of a 

broad range of healthcare infection 

prevention and control and 

epidemiologic surveillance activities to 

detect, monitor, mitigate, and prevent 

the spread of HAI/AR in healthcare 

settings. 

CDC has developed various workforce 

development activities including highpriority trainings requested by the 

health department programs and CDC 

site visits. The goal of these activities is 

to strengthen public health workforce 

capacity to prevent and respond to HAI/ 

AR outbreaks in healthcare settings and 

prepare for other emerging healthcare 

threats. Additionally, the evaluation 

data collected will be used to improve 

future CDC-developed resources. 

CDC requests OMB approval for an 

estimated 455 annual burden hours. 

There is no cost to respondents other 

than their time to participate. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

Total burden 

hours 

Public Health Participants—Standard Trainings .. Registration .................. 600 2 5/60 100 

Public Health Participants—Standard Trainings .. Pre-test ......................... 600 2 5/60 100 

Public Health Participants—Standard Trainings .. Post-test ....................... 600 2 5/60 100 

Public Health Participants—Training Programs ... Application .................... 30 1 120/60 60 

HAI/AR Program Leads—Training Programs ....... Nomination Letter ......... 30 1 60/60 30 


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5888 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name No. of 

respondents 

No. of 

responses per 

respondent 

Average 

burden per 

response 

Total burden 

hours 

Public Health Participants—Training Programs ... Activity Reports ............ 13 4 45/60 39 

Public Health Participants—Training Programs ... Program Evaluation ...... 13 1 30/60 7 

HAI/AR Program Leads—Site Visits .................... Program Evaluation ...... 12 1 15/60 3 

HAI/AR Program Leads ........................................ Program Impact of 

Workforce Development Activities.

65 1 15/60 16 

Total ............................................................... ....................................... ........................ ........................ ........................ 455 

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. 2025–01153 Filed 1–16–25; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10697] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send 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 

March 18, 2025. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. 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: Document Identifier/OMB 

Control Number:, 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/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10697 Medicare Coverage of 

Items and Services for Coverage with 

Evidence Development 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires Federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collections 

1. Type of Information Collection 

Request: Reinstatement with change of a 

previously approved collection; Title of 

Information Collection: Medicare 

Coverage of Items and Services for 

Coverage with Evidence Development; 

Use: This Paperwork Reduction Act 

(PRA) package is for Coverage with 

Evidence Development (CED). As noted 

above, CMS has utilized the CED 

pathway since 2006 under 1862(a)(1)(E) 

of the Act. Early on, there were only 2 

CED National Coverage Determinations 

(NCDs) that required data collection in 

registries, all of which had publicly 

available data collection forms. 

Currently, there are over 120 approved 

CED studies involving complex data 

collections, most of which are 

proprietary to the study sponsor. 

There is no specific submission form 

required for a CED clinical study 

submission. We note that CMS may 

publish guidance, including templates, 

to provide information to manufacturers 

or other study sponsors to assist them in 

creating study protocols to satisfy CED 

requirements (for example, guidance on 

developing RWD study protocols). Any 

approved CED study submission should 

satisfy each of the criteria ‘‘1–17’’ 

provided in the CMS Coverage with 

Evidence Development guidance 

document. CMS uses the 17 criteria 

listed in the 2024 CED guidance 


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