48992 Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. Those desiring 

to make formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before October 9, 2009. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 12, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Minh Doan 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

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 

[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, 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 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: http://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 

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. 

SUPPLEMENTARY INFORMATION: 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’’. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES