Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 8982-8983 [2010-4019]
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‘‘Adenosine derivatives, method of
synthesis thereof, and the
pharmaceutical compositions for the
prevention and treatment of the
inflammatory diseases containing the
same as an active ingredient,’’ filed
March 7, 2007, [HHS Ref. No. E–109–
2006/0–PCT–01] to Acorn Biomedical,
Inc., having an office in at 612 SE. 5th
Avenue, Suite #3, Fort Lauderdale, FL
33301 U.S.A. The patent rights in these
inventions have been assigned to the
United States of America.
The prospective exclusive license
territory may be worldwide, and the
field of use may be limited to the use
of adenosine A3 antagonists for
treatment of glaucoma and intraocular
pressure.
DATES: Only written comments and/or
applications for a license which are
received by the NIH Office of
Technology Transfer on or before March
29, 2010 will be considered.
ADDRESSES: Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive license should
be directed to: Steven Standley, Ph.D.,
Licensing and Patenting Manager, Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville, MD
20852–3804; Telephone: (301) 435–
4074; Facsimile: (301) 402–0220; E-mail:
sstand@od.nih.gov.
SUPPLEMENTARY INFORMATION: Adenosine
a3 antagonists applied topically to the
cornea have been shown to cause a
reduction in intraocular pressure, which
is a means of treating glaucoma.
The invention relates to several
structurally different pharmacophores
that have been shown to antagonize
adenosine a3 receptors. Molecules are to
be tested to optimize for the treatment
of glaucoma and intraocular pressure in
humans.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR part 404.7. The
prospective exclusive license may be
granted unless within thirty (30) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR part 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
VerDate Nov<24>2008
16:39 Feb 25, 2010
Jkt 220001
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: February 16, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2010–3907 Filed 2–25–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3224–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 the interests of both women and
men, members of all racial and ethnic
groups, and physically challenged
individuals are adequately represented
on the MEDCAC. Therefore, we
encourage nominations of qualified
candidates who can represent these
interests.
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, March 29,
2010 and mailed to the address
PO 00000
Frm 00088
Fmt 4703
Sfmt 4703
specified in the ADDRESSES section of
this notice.
ADDRESSES: You may mail nominations
for membership to the following:
Centers for Medicare & Medicaid
Services, Office of Clinical Standards
and Quality, Attention: Maria Ellis, 7500
Security Boulevard, Mail Stop: C1–09–
06, Baltimore, MD 21244–1850.
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
E:\FR\FM\26FEN1.SGM
26FEN1
Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices
sroberts on DSKD5P82C1PROD with NOTICES
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
with evidence development’’ activities.
II. Provisions of the Notice
As of June 2010, there will be 34
terms of membership expiring, 1 of
which is a nonvoting industry
representative and 4 are voting patient
advocates.
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 the
interests of both women and men,
members of all racial and ethnic 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
VerDate Nov<24>2008
16:39 Feb 25, 2010
Jkt 220001
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 nomination letter, we are
requesting that the nominee specify
whether they are applying for a voting
patient advocate position, for another
voting position, or as a nonvoting
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: February 23, 2010.
Barry M. Straube,
CMS Chief Medical Officer, Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. 2010–4019 Filed 2–25–10; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
Frm 00089
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8983
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–5382–N–03]
Notice of Proposed Information
Collection for Public Comment:
Housing Counseling Outcomes Study
AGENCY: Office of Policy Development
and Research, HUD.
ACTION: Notice.
SUMMARY: The proposed information
collection requirement described below
will be submitted to the Office of
Management and Budget (OMB) for
review, as required by the Paperwork
Reduction Act. The Department is
soliciting public comments on the
subject proposal.
DATES: Comments Due Date: April 27,
2010.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control number and should be sent to:
Reports Liaison Officer, Office of Policy
Development and Research, Department
of Housing and Urban Development,
451 7th Street, SW., Room 8226,
Washington, DC 20410–5000.
FOR FURTHER INFORMATION CONTACT:
Marina L. Myhre, (202) 708–3700,
extension 5705 for copies of the
proposed forms and other available
documents. (This is not a toll-free
number.)
The
Department will submit the proposed
information collection to OMB for
review, as required by the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35, as amended). This Notice is
soliciting comments from members of
the public and affected agencies
concerning the proposed collection of
information to: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information; (3) Enhance the quality,
utility, and clarity of the information to
be collected; and (4) Minimize the
burden of the collection of information
on those who are to respond, including
through the use of appropriate
automated collection techniques or
other forms of information technology
(e.g., permitting electronic submission
of responses).
This Notice also lists the following
information:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\26FEN1.SGM
26FEN1
Agencies
[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8982-8983]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4019]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3224-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
the interests of both women and men, members of all racial and ethnic
groups, and physically challenged individuals are adequately
represented on the MEDCAC. Therefore, we encourage nominations of
qualified candidates who can represent these interests.
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, March
29, 2010 and mailed to the address specified in the ADDRESSES section
of this notice.
ADDRESSES: You may mail nominations for membership to the following:
Centers for Medicare & Medicaid Services, Office of Clinical Standards
and Quality, Attention: Maria Ellis, 7500 Security Boulevard, Mail
Stop: C1-09-06, Baltimore, MD 21244-1850.
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
[[Page 8983]]
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 with evidence development'' activities.
II. Provisions of the Notice
As of June 2010, there will be 34 terms of membership expiring, 1
of which is a nonvoting industry representative and 4 are voting
patient advocates.
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 the interests of both women and men, members of all
racial and ethnic 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 nomination letter, we are requesting that the nominee
specify whether they are applying for a voting patient advocate
position, for another voting position, or as a nonvoting 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: February 23, 2010.
Barry M. Straube,
CMS Chief Medical Officer, Director, Office of Clinical Standards and
Quality, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-4019 Filed 2-25-10; 8:45 am]
BILLING CODE 4120-01-P