Federal Register / Vol. 74, No. 185 / Friday, September 25, 2009 / Notices 48991 

the number of registered participants; 

however, written submissions will be 

accepted. Individuals who wish to 

provide written feedback should e-mail 

their feedback to Colette Shatto at 

MFG@cms.hhs.gov. Written feedback 

will be accepted through November 6, 

2009. Consideration will be given to 

feedback received on the topics 

discussed at the meeting, but written 

responses will not be provided. 

Registered participants from the 

meeting will be included as volunteer 

participants in the MPFG and may be 

contacted throughout the year for 

follow-up meetings to solicit additional 

opinions or clarify any issues that may 

arise from the October 29, 2009 meeting. 

III. Registration Instructions 

The Division of Provider Relations 

and Evaluations, Provider 

Communications Group, Center for 

Medicare Management is coordinating 

the meeting registration. While there is 

no registration fee, individuals must 

register to participate both on-site and 

by teleconference. Individuals must 

complete the on-line registration located 

at http://registration.intercall.com/go/ 

cms2. 

The on-line registration system will 

capture contact information and 

practice characteristics (for example, 

names, e-mail addresses, and provider 

and supplier types). Registration will be 

open beginning September 28, 2009 and 

will close on October 23, 2009. 

Registration after 5 p.m. EDT on October 

23, 2009 will not be accepted. 

The on-line registration system will 

generate a confirmation page to indicate 

the completion of your registration. 

Participants should print this page as 

his or her registration receipt. 

Teleconference instructions will be 

issued as part of the confirmation page 

once participants have registered 

through the on-line registration 

instrument. Seating capacity is limited 

to the first 250 registrants. 

If seating capacity has been reached 

for on-site participants, notification will 

be sent that the meeting has reached 

capacity; however, those wishing to 

participate may still do so by 

teleconference. 

IV. Security, Building, and Parking 

Guidelines 

Because this meeting will be located 

on Federal property, for security 

reasons, any persons wishing to attend 

this meeting must register by 5 p.m. 

EDT on October 23, 2009. Individuals 

who have not registered by the 

registration deadline will not be allowed 

to enter the building to attend the 

meeting or attend the meeting by 

teleconference. 

The on-site check-in for visitors will 

be held from 12:30 p.m. to 1:30 p.m 

EDT. Participants should allow 

sufficient time to go through the 

security checkpoints. It is suggested that 

participants arrive at 7500 Security 

Boulevard no later than 1:30 p.m. EDT 

in order to arrive promptly at the 

meeting by 2 p.m. 

Security measures will include 

inspection of vehicles, inside and out, at 

the entrance to the grounds. In addition, 

all persons entering the building must 

pass through a metal detector. All items 

brought to the building, whether 

personal or for the purpose of the 

meeting, are subject to inspection. In 

order to gain access to the building, 

participants will be required to show a 

government-issued photo identification 

(for example, driver’s license or 

passport), and must be listed on an 

approved security list before persons are 

permitted entrance. Persons not 

registered in advance will not be 

permitted into the CMS building and 

will not be permitted to attend the 

meeting. 

We cannot assume responsibility for 

coordinating the receipt, transfer, 

transport, storage, set-up, safety, or 

timely arrival of any personal 

belongings or items used for the purpose 

of presentation. 

Individuals requiring sign language 

interpretation or other special 

accommodation must contact the 

Designated Federal Officer specified in 

the ‘‘FOR FURTHER INFORMATION

CONTACT’’ section of this notice by 

October 23, 2009. 

(Catalog of Federal Domestic Assistance 

Program No. 93.774, Medicare— 

Supplementary Medical Insurance Program) 

Dated: September 3, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E9–22164 Filed 9–24–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Anti-Infective Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Anti-Infective 

Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 27, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Minh Doan, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

minh.doan@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington DC area), code 3014512530. 

Please call the Information Line for upto-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: The committee will discuss 

biologics license application (BLA) 

125349, for raxibacumab injection, 

manufactured by Human Genome 

Sciences, Inc., proposed for the 

treatment of inhalational anthrax 

disease. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before October 16, 2009. 

Oral presentations from the public will 


jlentini on DSKJ8SOYB1PROD with NOTICES
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