73420 Federal Register / Vol. 89, No. 175 / Tuesday, September 10, 2024 / Notices 

Average Minutes per Response: 56 

minutes. 

Annual Burden Hours: 4,030 hours. 

Frequency: On occasion. 

Request for Comments: Public 

comment is invited specifically on the 

need for and practical utility of this 

Generic Clearance, the accuracy of 

OGE’s burden estimate, the 

enhancement of quality, utility and 

clarity of the information collected, and 

the minimization of burden (including 

the use of information technology). The 

comments will become a matter of 

public record. 

Approved: September 4, 2024. 

Shelley K. Finlayson, 

Acting Director, U.S. Office of Government 

Ethics. 

[FR Doc. 2024–20352 Filed 9–9–24; 8:45 am] 

BILLING CODE 6345–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–10141, CMS– 

10913, CMS–R–290 and CMS–10443] 

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 

November 12, 2024. 

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–10141 Medicare Prescription 

Drug Benefit Program 

CMS–10913 Medicare Part C 

Utilization Management Annual Data 

Submission and Audit Protocol Data 

Request 

CMS–R–290 Medicare Program: 

Procedures for Making National 

Coverage Decisions 

CMS–10443 Transcatheter Valve 

Therapy (TVT) Registry 

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: Revision of a currently 

approved information collection; Title 

of Information Collection: Medicare 

Prescription Drug Benefit Program; Use: 

CMS will use this information from plan 

sponsors and States to approve contract 

applications, monitor compliance with 

contract requirements, make proper 

payment to plans, and ensure that 

correct information is disclosed to 

potential and current enrollees. Form 

Number: CMS–10141 (OMB control 

number: 0938–0964); Frequency: 

Annually; Affected Public: Private 

Sector, State, Local, or Tribal 

Governments; Number of Respondents: 

4,633,032; Total Annual Responses: 

87,014,803; Total Annual Hours: 

25,409,037. (For policy questions 

regarding this collection contact Chad 

Buskirk at 410–786–1630 or 

chad.buskirk@cms.hhs.gov). 

2. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Medicare Part C 

Utilization Management Annual Data 

Submission and Audit Protocol Data 

Request; Use: Section 1857(d) of the 

Act, added by the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 and implementing 

regulations at 42 CFR 422.503 and 

422.504 state that CMS must oversee an 

MA organization’s continued 

compliance with the requirements for a 

MA organization. Additionally, per 

§ 422.516(a), MA organizations are 

required to compile and report to CMS 

information related to the utilization of 

services, and other matters as CMS may 

require. 

The information gathered during this 

annual data collection and audit will be 

used by the Medicare Parts C and D 

Oversight and Enforcement Group 

(MOEG) within the Center for Medicare 

(CM) to assess Sponsoring 

organizations’ compliance with 

Medicare UM requirements. CMS will 

utilize the data submitted during the 

annual data submission to assess the 

number of items and services that have 

associated internal coverage criteria, 

and to develop a landscape of items and 

services across the nation to assess 


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Federal Register / Vol. 89, No. 175 / Tuesday, September 10, 2024 / Notices 73421 

trends related to the development and 

utilization of internal coverage criteria. 

Additionally, CMS will use the annual 

submission to select a number of 

Sponsoring organizations to undergo 

UM audits each year, and to select 

specific items and services to audit. 

Annual UM data submissions, for all 

Sponsoring organizations, will be due to 

CMS by January 31 of each calendar 

year. Form Number: CMS–10913 (OMB 

control number: 0938–new); Frequency: 

Yearly; Affected Public: Private Sector, 

Business or other for-profits, Not-forprofits institutions; Number of 

Respondents: 179; Total Annual 

Responses: 179; Total Annual Hours: 

19,180. (For policy questions regarding 

this collection contact Caroline Zeman 

at 410–786–1564). 

3. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection; 

Title: Medicare Program: Procedures for 

Making National Coverage Decisions; 

Use: This collection is required by a 

notice (78 FR 48164–69) published on 

August 7, 2013 which delineates the 

process for making a national coverage 

determination (NCD) including 

information for external parties to 

submit a formal request for a new NCD 

or a reconsideration of an existing NCD. 

An NCD is defined in 1862(l) of the 

Social Security Act (the Act) as ‘‘a 

determination by the Secretary with 

respect to whether or not a particular 

item or service is covered nationally 

under this title.’’ This information 

collection will assist us in obtaining the 

information we require to make a 

national coverage determination in a 

timely manner and ensuring that the 

Medicare program continues to meet the 

needs of its beneficiaries. Form Number: 

CMS–R–290 (OMB control number: 

0938–0776); Frequency: Annual; 

Affected Public: Private Sector: Business 

or other for-profits; Number of 

Respondents: 30; Total Annual 

Responses: 30; Total Annual Hours: 

1,200. (For policy questions regarding 

this collection contact Lori M. Ashby at 

410–786–6322.) 

4. Type of Information Collection 

Request: Reinstatement without change 

of a previously approved collection: 

Title of Information Collection: 

Transcatheter Valve Therapy (TVT) 

Registry; Use: The data collection is 

required by the Centers for Medicare 

and Medicaid Services (CMS) National 

Coverage Determination (NCD) entitled, 

‘‘Transcatheter Aortic Valve 

Replacement (TAVR)’’. The TAVR 

device is only covered when specific 

conditions are met including that the 

heart team and hospital are submitting 

data in a prospective, national, audited 

registry. The data includes patient, 

practitioner and facility level variables 

that predict outcomes such as all cause 

mortality and quality of life. CMS finds 

that the Society of Thoracic Surgery/ 

American College of Cardiology 

Transcatheter Valve Therapy (STS/ACC 

TVT) Registry, one registry overseen by 

the National Cardiovascular Data 

Registry, meets the requirements 

specified in the NCD on TAVR. The 

TVT Registry will support a national 

surveillance system to monitor the 

safety and efficacy of the TAVR 

technologies for the treatment of aortic 

stenosis. 

The data will also include the 

variables on the eight item Kansas City 

Cardiomyopathy Questionnaire (KCCQ– 

10) to assess heath status, functioning 

and quality of life. In the KCCQ, an 

overall summary score can be derived 

from the physical function, symptoms 

(frequency and severity), social function 

and quality of life domains. For each 

domain, the validity, reproducibility, 

responsiveness and interpretability have 

been independently established. Scores 

are transformed to a range of 0–100, in 

which higher scores reflect better health 

status. 

The conduct of the STS/ACC TVT 

Registry and the KCCQ–10 is in 

accordance with section 1142 of the 

Social Security Act (the Act) that 

describes the authority of the Agency for 

Healthcare Research and Quality 

(AHRQ). Under section 1142, research 

may be conducted and supported on the 

outcomes, effectiveness, and 

appropriateness of health care services 

and procedures to identify the manner 

in which disease, disorders, and other 

health conditions can be prevented, 

diagnosed, treated, and managed 

clinically. Section 1862(a)(1)(E) of the 

Act allows Medicare to cover under 

coverage with evidence development 

(CED) certain items or services for 

which the evidence is not adequate to 

support coverage under section 

1862(a)(1)(A) and where additional data 

gathered in the context of a clinical 

setting would further clarify the impact 

of these items and services on the health 

of beneficiaries. 

The data collected and analyzed in 

the TVT Registry will be used by CMS 

to determine if the TAVR is reasonable 

and necessary (e.g., improves health 

outcomes) for Medicare beneficiaries 

under section 1862(a)(1)(A) of the Act. 

Furthermore, data from the Registry will 

assist the medical device industry and 

the Food and Drug Administration 

(FDA) in surveillance of the quality, 

safety and efficacy of new medical 

devices to treat aortic stenosis. For 

purposes of the TAVR NCD, the TVT 

Registry has contracted with the Data 

Analytic Centers to conduct the 

analyses. In addition, data will be made 

available for research purposes under 

the terms of a data use agreement that 

only provides de-identified datasets. 

Form Number: CMS–10443 (OMB 

control number: 0938–1202); Frequency: 

Annual; Affected Public: Individuals, 

Households and Private Sector; Number 

of Respondents: 49,704; Total Annual 

Responses: 198,816; Total Annual 

Hours: 63,790. (For policy questions 

regarding this collection contact Nina 

Arya at 667–290–9456). 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–20400 Filed 9–9–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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: Oncology 1-Basic 

Translational Integrated Review Group; 

Cancer Cell Biology Study Section. 

Date: October 8–9, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Alexandria Old 

Town, 1900 Diagonal Road, Alexandria, VA 

22314. 

Contact Person: Charles Morrow, Ph.D., 

M.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6202, 

MSC 7804, Bethesda, MD 20892, 301–408– 

9850, morrowcs@csr.nih.gov. 

Name of Committee: Interdisciplinary 

Molecular Sciences and Training Integrated 

Review Group; Enabling Bioanalytical and 

Imaging Technologies Study Section. 

Date: October 9–10, 2024. 

Time: 8:00 a.m. to 6:00 p.m. 


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