Federal Register / Vol. 74, No. 199 / Friday, October 16, 2009 / Notices 53273 

Dated: October 8, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–24872 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; ‘‘Population Genetics 

Analysis Program: Immunity to Vaccines/ 

Infections’’. 

Date: November 12, 2009. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate contract 

proposals. 

Place: Renaissance M Street Hotel, 1143 

New Hampshire Avenue, NW., Mount 

Vernon Room, Washington, DC 20037. 

Contact Person: Katrin Eichelberg, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–451–2899, 

keichelberg@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: October 8, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–24870 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group, Acquired Immunodeficiency 

Syndrome Research Review Committee. 

Date: November 13, 2009. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Erica L. Brown, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

National Institutes of Health/NIAID, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892–7616, 301–451–2639, 

ebrown@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: October 8, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–24866 Filed 10–15–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

National Mammography Quality 

Assurance Advisory Committee; 

Notice of Postponement of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is postponing the 

meeting of the National Mammography 

Quality Assurance Advisory Committee 

scheduled for November 2, 2009. This 

meeting was announced in the Federal 

Register of October 1, 2009 (74 FR 

50803). The postponement is due to 

guidance documents planned for 

discussion at the meeting are not yet 

available. A future meeting date will be 

announced in the Federal Register. 

FOR FURTHER INFORMATION CONTACT: 

Normica Facey, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301– 

796–5914, or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), code 3014512397. Please call the 

Information Line for up-to-date 

information on this meeting. 

Dated: October 9, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–24895 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] 

Vaccines and Related Biological 

Products 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). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Vaccines and 

Related Biological Products 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 18, 2009 from 8 a.m. 

to approximately 5:45 p.m. and on 

November 19, 2009 from 8 a.m. to 

approximately 3:15 p.m. 

Location: Bethesda Marriott, 5151 

Pooks Hill Rd., Bethesda, MD. 

Contact Person: Christine Walsh or 

Denise Royster, Center for Biologics 

Evaluation and Research (HFM–71), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 


jlentini on DSKJ8SOYB1PROD with NOTICES
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