Medicare Program; Request for Nominations for Members for the Medicare Evidence Development & Coverage Advisory Committee, 8982-8983 [2010-4019]

Download as PDF sroberts on DSKD5P82C1PROD with NOTICES 8982 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices ‘‘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 Fmt 4703 Sfmt 4703 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]


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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
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