Center for Scientific Review; Notice of Closed Meetings, 73421-73422 [2024-20334]
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Federal Register / Vol. 89, No. 175 / Tuesday, September 10, 2024 / Notices
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
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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
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73421
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]
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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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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
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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)
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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]
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[Federal Register Volume 89, Number 175 (Tuesday, September 10, 2024)]
[Notices]
[Pages 73421-73422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-20334]
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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, [email protected].
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.
[[Page 73422]]
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, [email protected].
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, [email protected].
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, [email protected].
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,
[email protected].
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, [email protected].
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, [email protected].
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, [email protected].
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, [email protected].
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,
[email protected].
(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
