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. 


khammond on DSKJM1Z7X2PROD with NOTICES
73422 Federal Register / Vol. 89, No. 175 / Tuesday, September 10, 2024 / Notices 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Marriott Georgetown, 

1221 22nd Street NW, Washington, DC 

20037. 

Contact Person: Kenneth Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3218, 

MSC 7717, Bethesda, MD 20892, 301–435– 

0229, kenneth.ryan@nih.hhs.gov. 

Name of Committee: Endocrinology, 

Metabolism, Nutrition and Reproductive 

Sciences Integrated Review Group; Basic 

Mechanisms of Diabetes and Metabolism 

Study Section. 

Date: October 9–10, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Westin Alexandria, 400 Courthouse 

Square, Alexandria, VA 22314. 

Contact Person: Baskaran Thyagarajan, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 800B, 

Bethesda, MD 20892, (301) 594–0331, 

Baski.thyagarajan@nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Surgery, 

Anesthesiology and Trauma Study Section. 

Date: October 9–10, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Weihua Luo, M.D., Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5114, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

1170, luow@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Innovations in Nanosystems and 

Nanotechnology Study Section. 

Date: October 9–10, 2024. 

Time: 9:00 a.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Yingli Fu, Ph.D., Scientific 

Review Officer, Center for Scientific Review, 

National Institutes of Health, 6701 Rockledge 

Drive, Bethesda, MD 20892, (301) 594–0840, 

yingli.fu@nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Bioengineering, 

Technology and Surgical Sciences Study 

Section. 

Date: October 10–11, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Khalid Masood, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5120, 

MSC 7854, Bethesda, MD 20892, 301–435– 

2392, masoodk@csr.nih.gov. 

Name of Committee: Digestive, Kidney and 

Urological Systems Integrated Review Group; 

Kidney and Urological Systems Function and 

Dysfunction Study Section. 

Date: October 10–11, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Bethesda North, 5701 

Martinelli Road, North Bethesda, MD 20852. 

Contact Person: Santanu Banerjee, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2106, 

Bethesda, MD 20892, (301) 435–5947, 

banerjees5@mail.nih.gov. 

Name of Committee: Surgical Sciences, 

Biomedical Imaging and Bioengineering 

Integrated Review Group; Imaging Probes and 

Contrast Agents Study Section. 

Date: October 10–11, 2024. 

Time: 9:00 a.m. to 9:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Donald Scott Wright, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5108, 

MSC 7854, Bethesda, MD 20892, (301) 435– 

8363, wrightds@csr.nih.gov. 

Name of Committee: Emerging 

Technologies and Training Neurosciences 

Integrated Review Group; Molecular 

Neurogenetics Study Section. 

Date: October 10–11, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Mary G Schueler, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5214, 

MSC 7846, Bethesda, MD 20892, 301–915– 

6301, marygs@csr.nih.gov. 

Name of Committee: Healthcare Delivery 

and Methodologies Integrated Review Group; 

Interdisciplinary Clinical Care in Specialty 

Care Settings Study Section. 

Date: October 10–11, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Westin Georgetown, 2350 M 

Street NW, Washington, DC 20037. 

Contact Person: Abu Saleh Mohammad 

Abdullah, Ph.D., Scientific Review Officer, 

Center for Scientific Review, National 

Institutes of Health, 6701 Rockledge Drive, 

Bethesda, MD 20892, (301) 827–4043, 

abuabdullah.abdullah@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 4, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–20334 Filed 9–9–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Advancing 

Translational Sciences; 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 Center for 

Advancing Translational Sciences Special 

Emphasis Panel; Review of Limited 

Competition CTSA R03 Applications. 

Date: October 21, 2024. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, 

Rockville, MD 20892. 

Contact Person: Victor Henriquez, Ph.D., 

Scientific Review Officer, Office of Scientific 

Review, National Center for Advancing 

Translational Sciences, National Institutes of 

Health, 9609 Medical Center Drive, Suite 

1E504, Bethesda, MD 20892, (301) 435–0813, 

henriquv@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.350, B—Cooperative 

Agreements; 93.859, Biomedical Research 

and Research Training, National Institutes of 

Health, HHS) 

Dated: September 4, 2024. 

David W. Freeman, 

Supervisory Program Analyst, Office of 

Federal Advisory Committee Policy. 

[FR Doc. 2024–20369 Filed 9–9–24; 8:45 am] 

BILLING CODE 4140–01–P 


khammond on DSKJM1Z7X2PROD with NOTICES