Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 66723-66724 [2014-26699]
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Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
necessary for the proper performance of
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burden of the information collection,
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November 2014.
Federal Deposit Insurance Corporation.
Robert E. Feldman,
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Denise Roth, Deputy Administrator—Chair.
Antonia T. Harris, Chief Human Capital
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Christine J. Harada, Associate Administrator
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Giancarlo Brizzi, Principal Deputy Associate
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Thomas A. Sharpe, Jr., Commissioner,
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Dated: November 3, 2014.
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[FR Doc. 2014–26641 Filed 11–7–14; 8:45 am]
[FR Doc. 2014–26624 Filed 11–7–14; 8:45 am]
BILLING CODE 6714–01–P
BILLING CODE 6820–34–P
GENERAL SERVICES
ADMINISTRATION
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Notice–CX–2014–01; Docket No. 2014–
0002; Sequence 32]
Centers for Medicare & Medicaid
Services
SES Performance Review Board
[CMS–3298–N]
General Services
Administration.
ACTION: Notice.
Medicare Program; Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee
AGENCY:
Notice is hereby given of the
appointment of new members to the
General Services Administration Senior
Executive Service Performance Review
Board. The Performance Review Board
assures consistency, stability, and
objectivity in the performance appraisal
process.
DATES: Effective: November 10, 2014.
FOR FURTHER INFORMATION CONTACT: Ms.
Antonia T. Harris, Chief Human Capital
Officer, Office of Human Resources
Management, General Services
Administration, 1800 F Street NW.,
Washington, DC 20405, 202–501–0398.
SUPPLEMENTARY INFORMATION: Section
4314(c)(1) through (5) of title 5 U.S.C.
requires each agency to establish, in
accordance with regulations prescribed
by the Office of Personnel Management,
one or more SES performance review
board(s). The board is responsible for
making recommendations to the
appointing and awarding authority on
the performance appraisal ratings and
performance awards for the Senior
Executive Service employees.
The following have been designated
as members of the Performance Review
Board of the General Services
Administration:
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:25 Nov 07, 2014
Jkt 235001
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 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.
DATES: Nominations must be received
by Monday, December 8, 2014.
ADDRESSES: You may mail nominations
for membership to the following
address: Centers for Medicare &
Medicaid Services, Center for Clinical
SUMMARY:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
66723
Standards and Quality, Attention: 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:
I. Background
The Secretary signed the initial
charter for the Medicare Coverage
Advisory Committee (MCAC) on
November 24, 1998. A notice in the
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 charter for
the committee can be accessed at https://
www.cms.gov/Regulations-andGuidance/Guidance/FACA/
MEDCAC.html.
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: 94
at-large standing members (6 of whom
are patient advocates), and 6
representatives of industry interests.
Members generally are recognized
authorities in clinical medicine
including subspecialties, administrative
E:\FR\FM\10NON1.SGM
10NON1
66724
Federal Register / Vol. 79, No. 217 / Monday, November 10, 2014 / Notices
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.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
II. Provisions of the Notice
As of June 2015, there will be 16
membership terms expiring. Of the 16
memberships expiring, 2 are industry
representatives, 1 is a patient advocate,
and the remaining 13 membership
openings are for the at-large standing
MEDCAC membership.
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
from these groups.
All nominations must be
accompanied by curricula vitae.
Nomination packages should be sent to
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,
VerDate Sep<11>2014
18:25 Nov 07, 2014
Jkt 235001
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
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Current Good
Manufacturing Practice Regulations for
Finished Pharmaceuticals
AGENCY:
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program.)
Fmt 4703
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[Docket No. FDA–2011–N–0362]
Authority: 5 U.S.C. App. 2, section 10(a)(1)
and (a)(2).
Frm 00042
[FR Doc. 2014–26699 Filed 11–7–14; 8:45 am]
Food and Drug Administration
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. The current
Secretary’s Charter for the MEDCAC is
available on the CMS Web site 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
CONTACT section of this notice.
PO 00000
Dated: November 4, 2014.
Patrick Conway,
Deputy Administrator for Innovation and
Quality and CMS Chief Medical Officer,
Centers for Medicare & Medicaid Services.
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the current good manufacturing practice
(CGMP) regulations for finished
pharmaceuticals.
DATES: Submit either electronic or
written comments on the collection of
information by January 9, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA 305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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
SUMMARY:
E:\FR\FM\10NON1.SGM
10NON1
]]>Agencies
[Federal Register Volume 79, Number 217 (Monday, November 10, 2014)]
[Notices]
[Pages 66723-66724]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-26699]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3298-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 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.
DATES: Nominations must be received by Monday, December 8, 2014.
ADDRESSES: You may mail nominations for membership to the following
address: Centers for Medicare & Medicaid Services, Center for Clinical
Standards and Quality, Attention: 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:
I. Background
The Secretary signed the initial charter for the Medicare Coverage
Advisory Committee (MCAC) on November 24, 1998. A notice in the 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
charter for the committee can be accessed at https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/MEDCAC.html.
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:
94 at-large standing members (6 of whom are patient advocates), and 6
representatives of industry interests. Members generally are recognized
authorities in clinical medicine including subspecialties,
administrative
[[Page 66724]]
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 2015, there will be 16 membership terms expiring. Of the
16 memberships expiring, 2 are industry representatives, 1 is a patient
advocate, and the remaining 13 membership openings are for the at-large
standing MEDCAC membership.
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 from these groups.
All nominations must be accompanied by curricula vitae. Nomination
packages should be sent to 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.
The current Secretary's Charter for the MEDCAC is available on the CMS
Web site 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 CONTACT section of this
notice.
Authority: 5 U.S.C. App. 2, section 10(a)(1) and (a)(2).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program.)
Dated: November 4, 2014.
Patrick Conway,
Deputy Administrator for Innovation and Quality and CMS Chief Medical
Officer, Centers for Medicare & Medicaid Services.
[FR Doc. 2014-26699 Filed 11-7-14; 8:45 am]
BILLING CODE 4120-01-P
