53274 Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512391. Please call the Information 

Line for up-to-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: In open session on November 

18, 2009, the committee will discuss 

and make recommendations on the 

safety and effectiveness of a 

Pneumococcal 13-valent Conjugate 

Vaccine (Diphtheria CRM197 Protein), 

BLA 125324, and will hear an update on 

FDA’s Influenza A (H1N1) 2009 

monovalent vaccine activities; 

Postmarketing surveillance. On 

November 19, 2009, the committee will 

discuss and make recommendations on 

the safety and effectiveness of an 

Influenza Vaccine, Purified 

Recombinant Influenza Hemagglutinin, 

BLA STN125285. 

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: On November 18, 2009, 

from 8 a.m. to approximately 5:45 p.m. 

and on November 19, 2009, from 

approximately 9 a.m. to approximately 

3:15 p.m., the meeting is open to the 

public. 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 

November 16, 2009. Oral presentations 

from the public will be scheduled 

between approximately 1:20 p.m. and 

1:50 p.m. on November 18, 2009, and 

approximately 1:30 p.m. and 2 p.m. on 

November 19, 2009. 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 November 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 

November 10, 2009. 

Closed Committee Deliberations: On 

November 19, 2009, from 8 a.m. to 

approximately 9 a.m., the meeting will 

be closed to permit discussion and 

review of trade secret and/or 

confidential commercial information (5 

U.S.C. 552b(c)(4)). 

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 Christine 

Walsh or Denise Royster 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: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24894 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

The Neurological Devices Panel of the 

Medical Devices 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: Neurological 

Devices Panel of the Medical Devices 

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 November 20, 2009, from 8 a.m. 

to 5 p.m. 

Location: Holiday Inn, Ballroom, Two 

Montgomery Village Ave., Gaithersburg, 

MD. 

Contact Person: Deborah Falls, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Silver Spring, MD 

20993, 301–796–6459, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512513. Please call the Information 

Line for up-to-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: On November 20, 2009, the 

committee will discuss, make 

recommendations and vote on a 

premarket approval application for the 

Deep Brain Stimulation System for 

Epilepsy sponsored by Medtronic, Inc. 

This device is indicated as adjunctive 

therapy for reducing the frequency of 

seizures in individuals diagnosed with 

epilepsy. For this device, a patient’s 

epilepsy should be characterized by 

partial-onset seizures (affecting only a 

part of the brain when they begin), with 

or without secondary generalization, 

that are refractory to antiepileptic 

medications. ‘‘Secondary 

generalization’’ is used to describe a 

partial-onset seizure that later spreads to 

the whole brain. ‘‘Refractory’’ to 

antiepileptic medications means that 

the patient’s epilepsy does not respond 

to approved medications. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53275 

the meeting. Background material is 

available on the FDA Internet under the 

appropriate date 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 November 16, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 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 November 12, 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 

November 13, 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 AnnMarie 

Williams, 301–796–5966, 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: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24893 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Meeting of the National Advisory 

Council for Healthcare Research and 

Quality 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Notice of public meeting. 

SUMMARY: In accordance with section 

10(a) of the Federal Advisory Committee 

Act, 5 U.S.C. app. 2, this notice 

announces a meeting of the National 

Advisory Council for Healthcare 

Research and Quality. 

DATES: The meeting will be held on 

Friday, November 13, 2009, from 9 a.m. 

to 3 p.m. 

ADDRESSES: The meeting will be held at 

the Eisenberg Conference Center, 

Agency for Healthcare Research and 

Quality, 540 Gaither Road, Rockville, 

Maryland 20850. 

FOR FURTHER INFORMATION CONTACT: 

Deborah Queenan, Coordinator of the 

Advisory Council, at the Agency for 

Healthcare Research and Quality, 540 

Gaither Road, Rockville, Maryland 

20850, (301) 427–1330. For press-related 

information, please contact Karen 

Migdail at (301) 427–1855. 

If sign language interpretation or other 

reasonable accommodation for a 

disability is needed, please contact the 

Food and Drug Administration (FDA) 

Office of Equal Employment 

Opportunity and Diversity Management 

on (301) 827–4840, no later than 

October 30, 2009. The agenda, roster, 

and minutes are available from Ms. 

Bonnie Campbell, Committee 

Management Officer, Agency for 

Healthcare Research and Quality, 540 

Gaither Road, Rockville, Maryland 

20850. Ms. Campbell’s phone number is 

(301) 427–1554. 

SUPPLEMENTARY INFORMATION: 

I. Purpose 

The National Advisory Council for 

Healthcare Research and Quality was 

established in accordance with Section 

921 (now Section 931) of the Public 

Health Service Act 42 U.S.C. 299c. In 

accordance with its statutory mandate, 

the Council is to advise the Secretary of 

the Department of Health and Human 

Services and the Director, Agency for 

Healthcare Research and Quality 

(AHRQ), on matters related to actions of 

AHRQ to enhance the quality, improve 

the outcomes, and reduce the costs of 

health care services; improve access to 

such services through scientific 

research; and promote improvements in 

clinical practice and in the organization, 

financing, and delivery of health care 

services. The Council is composed of 

members of the public, appointed by the 

Secretary, and Federal ex-officio 

members. 

II. Agenda 

On Friday, November 13, the Council 

meeting will convene at 9 a.m., with the 

call to order by the Council Chair and 

approval of previous Council summary 

notes. The AHRQ director will present 

her update on current research, 

programs, and initiatives. The agenda 

will include a report from the 

subcommittee of Child Health Insurance 

Program Reauthorization Act (CHIPRA) 

Quality Provisions, and discussion of 

the Patient Safety and Medical Liability 

Reform Demonstration Project. 

The final agenda will be available on 

the AHRQ Web site at http:// 

www.ahrq.gov no later than November 

9, 2009. 

Dated: October 7, 2009. 

Carolyn M. Clancy, 

Director. 

[FR Doc. E9–24885 Filed 10–15–09; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Council on Graduate Medical 

Education; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Council on Graduate Medical 

Education (COGME). 

Dates and Times: November 18, 2009, 8:30 

a.m.–4:45 p.m., November 19, 2009, 7:30 

a.m.–4:15 p.m. 

Place: Hilton Washington DC/Rockville 

Executive Meeting Center, Regency Ballroom, 

1750 Rockville Pike, Rockville, MD 20854, 

Telephone: (301) 468–1100. 

Status: The meeting will be open to the 

public. 

Agenda: On the morning of November 18, 

following the welcoming remarks from the 

COGME Chair and the Executive Secretary of 

COGME, there will be a presentation on the 

AAMC and the Physician Workforce given by 

Darrell G. Kirch, M.D., followed by a panel 

presentation: ‘‘Does the Nation Have the 

Right Number and Mix of GME Slots,’’ given 

by Edward Salsberg, M.P.A.; David 

Sundwall, M.D.; and Fitzhugh Mullan, M.D. 

The Vice Chair of COGME, Robert Phillips, 

Jr., M.D., M.S.P.H., will be the facilitator. 

In the late morning there will be a 

presentation of Bureau of Health Professions 


jlentini on DSKJ8SOYB1PROD with NOTICES