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[Federal Register Volume 90, Number 11 (Friday, January 17, 2025)]
[Notices]
[Pages 5888-5889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-01242]

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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.

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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/PRA-Listing.

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

[[Page 5889]]

document to ensure that the submitted CED study has a high degree of 
likelihood to generate the data and evidence needed to support Medicare 
coverage. Form Number: CMS-10697 (OMB control number 0938-1387); 
Frequency: Annually; Affected Public: Private sector--Not-for-profit 
institutions and Businesses or other for-profits; Number of 
Respondents: 13; Total Annual Responses: 13; Total Annual Hours: 1,300. 
(For policy questions regarding this collection, contact Andrew Ward at 
4107-786-1794.)

William N. Parham, III,
Director, Division of Information Collections and Regulatory Impacts, 
Office of Strategic Operations and Regulatory Affairs.
[FR Doc. 2025-01242 Filed 1-16-25; 8:45 am]
BILLING CODE 4120-01-P
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