Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 48992-48993 [E9-23257]
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Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices
be scheduled between approximately
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Notice of this meeting is given under
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Dated: September 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23143 Filed 9–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
jlentini on DSKJ8SOYB1PROD with NOTICES
[CMS–3216–N]
Medicare Program; Request for
Nominations for Members for the
Medicare Evidence Development &
Coverage Advisory Committee
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
VerDate Nov<24>2008
18:52 Sep 24, 2009
Jkt 217001
SUMMARY: This notice announces the
request for nominations for
consideration for membership on the
Medicare Evidence Development &
Coverage Advisory Committee
(MEDCAC). Among other things, the
MEDCAC advises the Secretary of the
Department of Health and Human
Services (the Secretary) and the
Administrator of the Centers for
Medicare & Medicaid Services, as
requested by the Secretary, whether
medical items and services are
‘‘reasonable and necessary’’ and
therefore eligible for coverage under
Title XVIII of the Social Security Act.
We are requesting nominations for
both voting and nonvoting members to
serve on the MEDCAC. Nominees are
selected based upon their individual
qualifications and not as representatives
of professional associations or societies.
We have a special interest in ensuring
that women, minority groups, and
physically challenged individuals are
adequately represented on the
MEDCAC. Therefore, we encourage
nominations of qualified candidates
from these groups.
The MEDCAC reviews and evaluates
medical literature, reviews technology
assessments, and examines data and
information on the effectiveness and
appropriateness of medical items and
services that are covered or eligible for
coverage under Medicare.
DATES: Nominations will be considered
if postmarked by Monday, October 26,
2009 and mailed to the address
specified in the ADDRESSES section of
this notice.
ADDRESSES: You may mail nominations
for membership to the following
address: Centers for Medicare &
Medicaid Services, Office of Clinical
Standards and Quality, Attention: Maria
Ellis, 7500 Security Boulevard, Mail
Stop: Central Building 1–09–06,
Baltimore, MD 21244.
FOR FURTHER INFORMATION CONTACT:
Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare &
Medicaid Services, Office of Clinical
Standards and Quality, Coverage and
Analysis Group, C1–09–06, 7500
Security Boulevard, Baltimore, MD
21244 or contact Ms. Ellis by phone
(410–786–0309) or via e-mail at
Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 14, 1998, we published
a notice in the Federal Register (63 FR
68780) announcing establishment of the
Medicare Coverage Advisory Committee
(MCAC). The Secretary signed the initial
charter for the Medicare Coverage
PO 00000
Frm 00092
Fmt 4703
Sfmt 4703
Advisory Committee on November 24,
1998. On January 26, 2007 the Secretary
published a notice in the Federal
Register (72 FR 3853), changing the
Committee’s name to the Medicare
Evidence Development and Coverage
Advisory Committee (MEDCAC). The
charter for the committee was renewed
by the Secretary and will terminate on
November 24, 2010, unless renewed
again by the Secretary.
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).
The MEDCAC consists of a pool of
100 appointed members including: 6
patient advocates, who are standard
voting members, and 6 representatives
of industry interests, who are nonvoting
members. Members are selected from
among authorities in clinical medicine
of all specialties, administrative
medicine, public health, biologic and
physical sciences, health care data and
information management and analysis,
patient advocacy, the economics of
health care, medical ethics, and other
related professions such as
epidemiology and biostatistics, and
methodology of trial design.
The MEDCAC functions on a
committee basis. The committee reviews
and evaluates medical literature,
reviews technology assessments, and
examines data and information on the
effectiveness and appropriateness of
medical items and services that are
covered or eligible for coverage under
Medicare. The Committee works from
an agenda provided by the Designated
Federal Official that lists specific issues,
and develops technical advice to assist
us in determining reasonable and
necessary applications of medical
services and technology when we make
national coverage decisions for
Medicare. The Committee also advises
CMS as part of Medicare’s coverage
evidence development activities.
II. Provisions of the Notice
As of December 2009, there will be 45
terms of membership expiring, 3 of
which are nonvoting industry
representatives.
Accordingly, we are requesting
nominations for both voting and
nonvoting members to serve on the
MEDCAC. Nominees are selected based
upon their individual qualifications and
not as representatives of professional
associations or societies. We have a
special interest in ensuring that women,
E:\FR\FM\25SEN1.SGM
25SEN1
jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices
minority groups, and physically
challenged individuals are adequately
represented on the MEDCAC. Therefore,
we encourage nominations of qualified
candidates from these groups.
All nominations must be
accompanied by curricula vitae.
Nomination packages must be sent to
Maria Ellis at the address listed in the
ADDRESSES section of this notice.
Nominees for voting membership must
also have expertise and experience in
one or more of the following fields:
• Clinical medicine of all specialties.
• Administrative medicine.
• Public health.
• Patient advocacy.
• Biologic and physical sciences.
• Health care data and information
management and analysis.
• The economics of health care.
• Medical ethics.
• Other related professions such as
epidemiology and biostatistics, and
methodology of clinical trial design.
We are looking for experts in a
number of fields. Our most critical
needs are for experts in hematology;
genomics; end of life care; Bayesian
statistics; clinical epidemiology; clinical
trial methodology; knee, hip, and other
joint replacement surgery;
ophthalmology; psychopharmacology;
registries; rheumatology; screening and
diagnostic testing analysis; and stroke.
We also need experts in biostatistics in
clinical settings, cardiovascular
epidemiology, cost effectiveness
analysis, dementia, endocrinology,
geriatrics, gynecology, 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.
• E-mail address.
• List of areas of expertise.
In the nominations letter, we are
requesting that the nominee specify
whether applying for a Voting position
or 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 conflict of
interest.
VerDate Nov<24>2008
18:52 Sep 24, 2009
Jkt 217001
Members are invited to serve for
overlapping 2-year terms. A member
may serve after the expiration of the
member’s term until a successor takes
office. Any interested person may
nominate one or more qualified persons.
Self-nominations are also accepted.
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 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: September 21, 2009.
Barry M. Straube,
CMS Chief Medical Officer, Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. E9–23257 Filed 9–24–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Listing of Members of the
National Institutes of Health’s Senior
Executive Service 2009 Performance
Review Board (PRB)
The National Institutes of Health
(NIH) announces the persons who will
serve on the National Institutes of
Health’s Senior Executive Service 2009
Performance Review Board. This action
is being taken in accordance with Title
5, U.S.C., Section 4314(c)(4), which
requires that members of performance
review boards be appointed in a manner
to ensure consistency, stability, and
objectivity in performance appraisals
and requires that notice of the
appointment of an individual to serve as
a member be published in the Federal
Register.
The following persons will serve on
the NIH Performance Review Board,
which oversees the evaluation of
performance appraisals of NIH Senior
Executive Service (SES) members: Ms.
Colleen Barros (Chair); Dr. Michael
Gottesman; Ms. Lenora Johnson; Ms.
Robin Kawazoe; Dr. Raynard Kington;
Ms. Janis Mullaney; Dr. Sally Rockey.
For further information about the NIH
Performance Review Board, contact the
Office of Human Resources, Workforce
Relations Division, National Institutes of
PO 00000
Frm 00093
Fmt 4703
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48993
Health, Building 31, Room B3C07,
Bethesda, Maryland 20892, telephone
301–402–9203 (not a toll-free number).
Dated: September 20, 2009.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. E9–23265 Filed 9–24–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0026]
Apothecon et al.; Withdrawal of
Approval of 103 New Drug
Applications and 35 Abbreviated New
Drug Applications; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
SUMMARY: The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of February 11, 2009 (74 FR
6896). The document announced the
withdrawal of approval of 103 new drug
applications (NDAs) and 35 abbreviated
new drug applications (ANDAs). The
document published with an error in
the identification of the ANDA for
Amiodarone Hydrochloride Injection,
50 milligrams/milliliter, held by
Hospira, Inc. This document corrects
that error.
DATES:
Effective March 13, 2009.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
In FR Doc.
E9–2901, appearing on page 6896 in the
Federal Register of Wednesday,
February 11, 2009, the following
correction is made:
On page 6900, in the first column of
the table, third item from the bottom of
the page, the entry ‘‘ANDA 75–108’’ is
corrected to read ‘‘ANDA 76–108’’.
SUPPLEMENTARY INFORMATION:
Dated: September 9, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E9–23170 Filed 9–24–09; 8:45 am]
BILLING CODE 4160–01–S
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25SEN1
]]>Agencies
[Federal Register Volume 74, Number 185 (Friday, September 25, 2009)]
[Notices]
[Pages 48992-48993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23257]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3216-N]
Medicare Program; Request for Nominations for Members for the
Medicare Evidence Development & Coverage Advisory Committee
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the request for nominations for
consideration for membership on the Medicare Evidence Development &
Coverage Advisory Committee (MEDCAC). Among other things, the MEDCAC
advises the Secretary of the Department of Health and Human Services
(the Secretary) and the Administrator of the Centers for Medicare &
Medicaid Services, as requested by the Secretary, whether medical items
and services are ``reasonable and necessary'' and therefore eligible
for coverage under Title XVIII of the Social Security Act.
We are requesting nominations for both voting and nonvoting members
to serve on the MEDCAC. Nominees are selected based upon their
individual qualifications and not as representatives of professional
associations or societies. We have a special interest in ensuring that
women, minority groups, and physically challenged individuals are
adequately represented on the MEDCAC. Therefore, we encourage
nominations of qualified candidates from these groups.
The MEDCAC reviews and evaluates medical literature, reviews
technology assessments, and examines data and information on the
effectiveness and appropriateness of medical items and services that
are covered or eligible for coverage under Medicare.
DATES: Nominations will be considered if postmarked by Monday, October
26, 2009 and mailed to the address specified in the ADDRESSES section
of this notice.
ADDRESSES: You may mail nominations for membership to the following
address: Centers for Medicare & Medicaid Services, Office of Clinical
Standards and Quality, Attention: Maria Ellis, 7500 Security Boulevard,
Mail Stop: Central Building 1-09-06, Baltimore, MD 21244.
FOR FURTHER INFORMATION CONTACT: Maria Ellis, Executive Secretary for
MEDCAC, Centers for Medicare & Medicaid Services, Office of Clinical
Standards and Quality, Coverage and Analysis Group, C1-09-06, 7500
Security Boulevard, Baltimore, MD 21244 or contact Ms. Ellis by phone
(410-786-0309) or via e-mail at Maria.Ellis@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 14, 1998, we published a notice in the Federal Register
(63 FR 68780) announcing establishment of the Medicare Coverage
Advisory Committee (MCAC). The Secretary signed the initial charter for
the Medicare Coverage Advisory Committee on November 24, 1998. On
January 26, 2007 the Secretary published a notice in the Federal
Register (72 FR 3853), changing the Committee's name to the Medicare
Evidence Development and Coverage Advisory Committee (MEDCAC). The
charter for the committee was renewed by the Secretary and will
terminate on November 24, 2010, unless renewed again by the Secretary.
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).
The MEDCAC consists of a pool of 100 appointed members including: 6
patient advocates, who are standard voting members, and 6
representatives of industry interests, who are nonvoting members.
Members are selected from among authorities in clinical medicine of all
specialties, administrative medicine, public health, biologic and
physical sciences, health care data and information management and
analysis, patient advocacy, the economics of health care, medical
ethics, and other related professions such as epidemiology and
biostatistics, and methodology of trial design.
The MEDCAC functions on a committee basis. The committee reviews
and evaluates medical literature, reviews technology assessments, and
examines data and information on the effectiveness and appropriateness
of medical items and services that are covered or eligible for coverage
under Medicare. The Committee works from an agenda provided by the
Designated Federal Official that lists specific issues, and develops
technical advice to assist us in determining reasonable and necessary
applications of medical services and technology when we make national
coverage decisions for Medicare. The Committee also advises CMS as part
of Medicare's coverage evidence development activities.
II. Provisions of the Notice
As of December 2009, there will be 45 terms of membership expiring,
3 of which are nonvoting industry representatives.
Accordingly, we are requesting nominations for both voting and
nonvoting members to serve on the MEDCAC. Nominees are selected based
upon their individual qualifications and not as representatives of
professional associations or societies. We have a special interest in
ensuring that women,
[[Page 48993]]
minority groups, and physically challenged individuals are adequately
represented on the MEDCAC. Therefore, we encourage nominations of
qualified candidates from these groups.
All nominations must be accompanied by curricula vitae. Nomination
packages must be sent to Maria Ellis at the address listed in the
ADDRESSES section of this notice. Nominees for voting membership must
also have expertise and experience in one or more of the following
fields:
Clinical medicine of all specialties.
Administrative medicine.
Public health.
Patient advocacy.
Biologic and physical sciences.
Health care data and information management and analysis.
The economics of health care.
Medical ethics.
Other related professions such as epidemiology and
biostatistics, and methodology of clinical trial design.
We are looking for experts in a number of fields. Our most critical
needs are for experts in hematology; genomics; end of life care;
Bayesian statistics; clinical epidemiology; clinical trial methodology;
knee, hip, and other joint replacement surgery; ophthalmology;
psychopharmacology; registries; rheumatology; screening and diagnostic
testing analysis; and stroke. We also need experts in biostatistics in
clinical settings, cardiovascular epidemiology, cost effectiveness
analysis, dementia, endocrinology, geriatrics, gynecology, 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.
E-mail address.
List of areas of expertise.
In the nominations letter, we are requesting that the nominee specify
whether applying for a Voting position or 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 conflict of interest.
Members are invited to serve for overlapping 2-year terms. A member
may serve after the expiration of the member's term until a successor
takes office. Any interested person may nominate one or more qualified
persons. Self-nominations are also accepted.
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 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: September 21, 2009.
Barry M. Straube,
CMS Chief Medical Officer, Director, Office of Clinical Standards and
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. E9-23257 Filed 9-24-09; 8:45 am]
BILLING CODE 4120-01-P
