Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 61639-61640 [2018-26090]
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Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, 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, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–1326.
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).
amozie on DSK3GDR082PROD with NOTICES1
CMS–10691 Data Request and
Attestation for PDP Sponsors
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 Collection
Type of Information Collection
Request: New collection (request for a
new OMB control number); Title of
Information Collection: Data Request
and Attestation for PDP Sponsors; Use:
Section 50354 of the Bipartisan Budget
Act of 2018 (BBA) provides that the
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17:00 Nov 29, 2018
Jkt 247001
Secretary shall establish a process under
which the sponsor of a Prescription
Drug Plan (PDP) that provide
prescription drug benefits under
Medicare Part D may request, beginning
in plan year 2020, that the Secretary
provide on a periodic basis and in an
electronic format standardized extracts
of Medicare claims about its plan
enrollees. Section 50354 of the BBA
further specifies that PDP sponsors
receiving such Medicare claims data for
their corresponding PDP plan enrollees
may use the data for: (1) Optimizing
therapeutic outcomes through improved
medication use, (2) improving care
coordination so as to prevent adverse
healthcare outcomes, such as
preventable emergency department
visits and hospital readmissions, and (3)
for any other purposes determined
appropriate by the Secretary. Section
50354 also states that the PDP sponsor
may not use the data: (1) To inform
coverage determinations under Part D,
(2) to conduct retroactive review of
medically accepted conditions, (3) to
facilitate enrollment changes to a
different PDP or a MA–PD plan offered
by the same parent organization, (4) to
inform marketing benefits; and (5) for
any other purpose the Secretary
determines is necessary to include in
order to protect the identity of
individuals entitled to or enrolled in
Medicare, and to protect the security of
personal health information. This
proposed information collection request
would allow the PDP sponsor to submit
a request to CMS for claims data for its
enrollees and to attest that it will adhere
to the permitted uses and limitations on
the use of the Medicare claims data that
are listed in 42 CFR 423.153. Form
Number: CMS–10691 (OMB control
number: 0938–TBD); Frequency:
Occasionally; Affected Public: Private
sector; Number of Respondents: 63;
Total Annual Responses: 68; Total
Annual Hours: 1.36. (For policy
questions regarding this collection
contact Kari Gaare at 410–786–8612.)
Dated: November 27, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–26052 Filed 11–29–18; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
61639
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3374–N]
Medicare Program; Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
request for nominations for membership
on the Medicare Evidence Development
& Coverage Advisory Committee
(MEDCAC). Among other duties, the
MEDCAC provides advice and guidance
to the Secretary of the Department of
Health and Human Services (the
Secretary) and the Administrator of the
Centers for Medicare & Medicaid
Services (CMS) concerning the
adequacy of scientific evidence
available to CMS in making coverage
determinations under the Medicare
program.
The MEDCACs fundamental purpose
is to support the principles of an
evidence-based determination process
for Medicare’s coverage policies.
MEDCAC panels provide advice to CMS
on the strength of the evidence available
for specific medical treatments and
technologies through a public,
participatory, and accountable process.
DATES: Nominations must be received
by Monday, January 7, 2019.
ADDRESSES: You may mail nominations
for membership to the following
address: Centers for Medicare &
Medicaid Services, Center for Clinical
Standards and Quality, Attention: Leah
Cromwell or Maria Ellis, 7500 Security
Boulevard, Mail Stop: S3–02–01,
Baltimore, MD 21244 or send via email
to MEDCACnomination@cms.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for the
MEDCAC, Centers for Medicare &
Medicaid Services, Center for Clinical
Standards and Quality, Coverage and
Analysis Group, S3–02–01, 7500
Security Boulevard, Baltimore, MD
21244 or contact Ms. Ellis by phone
(410–786–0309) or via email at
Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Secretary signed the initial
charter for the Medicare Coverage
Advisory Committee (MCAC) on
November 24, 1998. A notice in the
Frm 00041
Fmt 4703
Sfmt 4703
E:\FR\FM\30NON1.SGM
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amozie on DSK3GDR082PROD with NOTICES1
61640
Federal Register / Vol. 83, No. 231 / Friday, November 30, 2018 / Notices
Federal Register (63 FR 68780)
announcing establishment of the MCAC
was published on December 14, 1998.
The MCAC name was updated to more
accurately reflect the purpose of the
committee and on January 26, 2007, the
Secretary published a notice in the
Federal Register (72 FR 3853),
announcing that the Committee’s name
changed to the Medicare Evidence
Development & Coverage Advisory
Committee (MEDCAC). The current
Secretary’s Charter for the MEDCAC is
available on the CMS website at: https://
www.cms.hhs.gov/FACA/Downloads/
medcaccharter.pdf, or you may obtain a
copy of the charter by submitting a
request to the contact listed in the FOR
FURTHER INFORMATION section of this
notice.
The MEDCAC is governed by
provisions of the Federal Advisory
Committee Act, Public Law 92–463, as
amended (5 U.S.C. App. 2), which sets
forth standards for the formulation and
use of advisory committees, and is
authorized by section 222 of the Public
Health Service Act as amended (42
U.S.C. 217A).
We are requesting nominations for
candidates to serve on the MEDCAC.
Nominees are selected based upon their
individual qualifications and not solely
as representatives of professional
associations or societies. We wish to
ensure adequate representation of the
interests of both women and men,
members of all ethnic groups, and
physically challenged individuals.
Therefore, we encourage nominations of
qualified candidates who can represent
these interests.
The MEDCAC consists of a pool of
100 appointed members including: 90
at-large standing members (10 of whom
are patient advocates), and 10
representatives of industry interests.
Members generally are recognized
authorities in clinical medicine
including subspecialties, administrative
medicine, public health, biological and
physical sciences, epidemiology and
biostatistics, clinical trial design, health
care data management and analysis,
patient advocacy, health care
economics, medical ethics or other
relevant professions.
The MEDCAC works from an agenda
provided by the Designated Federal
Official. The MEDCAC reviews and
evaluates medical literature and
technology assessments, and hears
public testimony on the evidence
available to address the impact of
medical items and services on health
outcomes of Medicare beneficiaries. The
MEDCAC may also advise the Centers
for Medicare & Medicaid Services (CMS)
VerDate Sep<11>2014
17:00 Nov 29, 2018
Jkt 247001
as part of Medicare’s ‘‘coverage with
evidence development’’ initiative.
II. Provisions of the Notice
As of June 2019, there will be 20
membership terms expiring. Of the 20
memberships expiring, 1 is an industry
representative and the remaining 19
membership openings are for the atlarge standing MEDCAC membership.
All nominations must be
accompanied by curricula vitae.
Nomination packages should be sent to
Leah Cromwell or Maria Ellis at the
address listed in the ADDRESSES section
of this notice. Nominees are selected
based upon their individual
qualifications. Nominees for
membership must have expertise and
experience in one or more of the
following fields:
• Clinical medicine including
subspecialties
• Administrative medicine
• Public health
• Biological and physical sciences
• Epidemiology and biostatistics
• Clinical trial design
• Health care data management and
analysis
• Patient advocacy
• Health care economics
• Medical ethics
• Other relevant professions
We are looking particularly for
experts in a number of fields. These
include cancer screening, genetic
testing, clinical epidemiology,
psychopharmacology, screening and
diagnostic testing analysis, and vascular
surgery. We also need experts in
biostatistics in clinical settings,
dementia treatment, minority health,
observational research design, stroke
epidemiology, and women’s health.
The nomination letter must include a
statement that the nominee is willing to
serve as a member of the MEDCAC and
appears to have no conflict of interest
that would preclude membership. We
are requesting that all curricula vitae
include the following:
• Date of birth
• Place of birth
• Social security number
• Title and current position
• Professional affiliation
• Home and business address
• Telephone and fax numbers
• Email address
• List of areas of expertise
In the nomination letter, we are
requesting that nominees specify
whether they are applying for a patient
advocate position, for an at-large
standing position, or as an industry
representative. Potential candidates will
be asked to provide detailed information
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
concerning such matters as financial
holdings, consultancies, and research
grants or contracts in order to permit
evaluation of possible sources of
financial conflict of interest. Department
policy prohibits multiple committee
memberships. A federal advisory
committee member may not serve on
more than one committee within an
agency at the same time.
Members are invited to serve for
overlapping 2-year terms. A member
may continue to serve after the
expiration of the member’s term until a
successor is named. Any interested
person may nominate one or more
qualified persons. Self-nominations are
also accepted. Individuals interested in
the representative positions must
include a letter of support from the
organization or interest group they
would represent.
III. Collection of Information
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
Dated: November 21, 2018.
Kate Goodrich,
Director, Center for Clinical Standards and
Quality, Chief Medical Officer, Centers for
Medicare & Medicaid Services.
[FR Doc. 2018–26090 Filed 11–29–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1446]
Self-Monitoring Blood Glucose Test
Systems for Over-the-Counter Use;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance for industry and FDA staff
entitled ‘‘Self-Monitoring Blood Glucose
Test Systems for Over-the-Counter Use.’’
This draft guidance document describes
studies and information that FDA
recommends be used when submitting
premarket notifications (510(k)s) for
self-monitoring blood glucose test
SUMMARY:
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61639-61640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26090]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3374-N]
Medicare Program; Request for Nominations for Members for the
Medicare Evidence Development & Coverage Advisory Committee
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the request for nominations for
membership on the Medicare Evidence Development & Coverage Advisory
Committee (MEDCAC). Among other duties, the MEDCAC provides advice and
guidance to the Secretary of the Department of Health and Human
Services (the Secretary) and the Administrator of the Centers for
Medicare & Medicaid Services (CMS) concerning the adequacy of
scientific evidence available to CMS in making coverage determinations
under the Medicare program.
The MEDCACs fundamental purpose is to support the principles of an
evidence-based determination process for Medicare's coverage policies.
MEDCAC panels provide advice to CMS on the strength of the evidence
available for specific medical treatments and technologies through a
public, participatory, and accountable process.
DATES: Nominations must be received by Monday, January 7, 2019.
ADDRESSES: You may mail nominations for membership to the following
address: Centers for Medicare & Medicaid Services, Center for Clinical
Standards and Quality, Attention: Leah Cromwell or Maria Ellis, 7500
Security Boulevard, Mail Stop: S3-02-01, Baltimore, MD 21244 or send
via email to [email protected].
FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for
the MEDCAC, Centers for Medicare & Medicaid Services, Center for
Clinical Standards and Quality, Coverage and Analysis Group, S3-02-01,
7500 Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by
phone (410-786-0309) or via email at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Secretary signed the initial charter for the Medicare Coverage
Advisory Committee (MCAC) on November 24, 1998. A notice in the
[[Page 61640]]
Federal Register (63 FR 68780) announcing establishment of the MCAC was
published on December 14, 1998. The MCAC name was updated to more
accurately reflect the purpose of the committee and on January 26,
2007, the Secretary published a notice in the Federal Register (72 FR
3853), announcing that the Committee's name changed to the Medicare
Evidence Development & Coverage Advisory Committee (MEDCAC). The
current Secretary's Charter for the MEDCAC is available on the CMS
website at: https://www.cms.hhs.gov/FACA/Downloads/medcaccharter.pdf, or
you may obtain a copy of the charter by submitting a request to the
contact listed in the FOR FURTHER INFORMATION section of this notice.
The MEDCAC is governed by provisions of the Federal Advisory
Committee Act, Public Law 92-463, as amended (5 U.S.C. App. 2), which
sets forth standards for the formulation and use of advisory
committees, and is authorized by section 222 of the Public Health
Service Act as amended (42 U.S.C. 217A).
We are requesting nominations for candidates to serve on the
MEDCAC. Nominees are selected based upon their individual
qualifications and not solely as representatives of professional
associations or societies. We wish to ensure adequate representation of
the interests of both women and men, members of all ethnic groups, and
physically challenged individuals. Therefore, we encourage nominations
of qualified candidates who can represent these interests.
The MEDCAC consists of a pool of 100 appointed members including:
90 at-large standing members (10 of whom are patient advocates), and 10
representatives of industry interests. Members generally are recognized
authorities in clinical medicine including subspecialties,
administrative medicine, public health, biological and physical
sciences, epidemiology and biostatistics, clinical trial design, health
care data management and analysis, patient advocacy, health care
economics, medical ethics or other relevant professions.
The MEDCAC works from an agenda provided by the Designated Federal
Official. The MEDCAC reviews and evaluates medical literature and
technology assessments, and hears public testimony on the evidence
available to address the impact of medical items and services on health
outcomes of Medicare beneficiaries. The MEDCAC may also advise the
Centers for Medicare & Medicaid Services (CMS) as part of Medicare's
``coverage with evidence development'' initiative.
II. Provisions of the Notice
As of June 2019, there will be 20 membership terms expiring. Of the
20 memberships expiring, 1 is an industry representative and the
remaining 19 membership openings are for the at-large standing MEDCAC
membership.
All nominations must be accompanied by curricula vitae. Nomination
packages should be sent to Leah Cromwell or Maria Ellis at the address
listed in the ADDRESSES section of this notice. Nominees are selected
based upon their individual qualifications. Nominees for membership
must have expertise and experience in one or more of the following
fields:
Clinical medicine including subspecialties
Administrative medicine
Public health
Biological and physical sciences
Epidemiology and biostatistics
Clinical trial design
Health care data management and analysis
Patient advocacy
Health care economics
Medical ethics
Other relevant professions
We are looking particularly for experts in a number of fields.
These include cancer screening, genetic testing, clinical epidemiology,
psychopharmacology, screening and diagnostic testing analysis, and
vascular surgery. We also need experts in biostatistics in clinical
settings, dementia treatment, minority health, observational research
design, stroke epidemiology, and women's health.
The nomination letter must include a statement that the nominee is
willing to serve as a member of the MEDCAC and appears to have no
conflict of interest that would preclude membership. We are requesting
that all curricula vitae include the following:
Date of birth
Place of birth
Social security number
Title and current position
Professional affiliation
Home and business address
Telephone and fax numbers
Email address
List of areas of expertise
In the nomination letter, we are requesting that nominees specify
whether they are applying for a patient advocate position, for an at-
large standing position, or as an industry representative. Potential
candidates will be asked to provide detailed information concerning
such matters as financial holdings, consultancies, and research grants
or contracts in order to permit evaluation of possible sources of
financial conflict of interest. Department policy prohibits multiple
committee memberships. A federal advisory committee member may not
serve on more than one committee within an agency at the same time.
Members are invited to serve for overlapping 2-year terms. A member
may continue to serve after the expiration of the member's term until a
successor is named. Any interested person may nominate one or more
qualified persons. Self-nominations are also accepted. Individuals
interested in the representative positions must include a letter of
support from the organization or interest group they would represent.
III. Collection of Information
This document does not impose information collection requirements,
that is, reporting, recordkeeping or third-party disclosure
requirements. Consequently, there is no need for review by the Office
of Management and Budget under the authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
Dated: November 21, 2018.
Kate Goodrich,
Director, Center for Clinical Standards and Quality, Chief Medical
Officer, Centers for Medicare & Medicaid Services.
[FR Doc. 2018-26090 Filed 11-29-18; 8:45 am]
BILLING CODE 4120-01-P
