Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices 7589 

Center for Biologics Evaluation and 

Research (HFM–71), Food and Drug 

Administration, 1401 Rockville Pike, 

Rockville, MD 20852, Contact 1–301– 

827–1277 or 1–301–827–1281, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

Dated: February 7, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–3199 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Tobacco Products Scientific 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: Tobacco 

Products Scientific Advisory Committee 

(TPSAC). 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

DATES: Date and Time: The meeting will 

be held on March 1, 2012, from 10 a.m. 

to 5 p.m., and on March 2, 2012, from 

8 a.m. to 1 p.m. 

Location: Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373. 

Contact Person: Caryn Cohen, Center 

for Tobacco Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373 

(choose option 4), email: 

TPSAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. 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: As part of the TPSAC’s 

required report to the Secretary of 

Health and Human Services, the 

committee will complete their 

discussion of issues related to the nature 

and impact of the use of dissolvable 

tobacco products on the public health, 

including such use among children. 

Discussion will include such topics as 

the composition and characteristics of 

dissolvable tobacco products, product 

use, potential health effects, and 

marketing. 

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 March 1, 2012, from 1 

p.m. to 5 p.m., and on March 2, 2012, 

from 8 a.m. to 1 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 February 16, 2012. 

Oral presentations from the public will 

be scheduled between approximately 

1:30 p.m. and 2:30 p.m. on March 1, 

2012. Those individuals interested in 

making 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 February 23, 2012. 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 

February 24, 2012. 

Closed Committee Deliberations: On 

March 1, 2012, from 10 a.m. to 12 p.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)). This 

portion of the meeting must be closed 

because the Committee will be 

discussing trade secret and/or 

confidential data regarding products 

provided by the tobacco companies. 

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 Caryn Cohen 

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/ 

AdvisoryCommittees/ 

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: February 8, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–3258 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

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 


erowe on DSK2VPTVN1PROD with NOTICES
7590 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on March 23, 2012, from 8 a.m. to 

7 p.m. 

Location: Hilton Washington, DC 

North/Gaithersburg, Grand Ballroom, 

620 Perry Pkwy., Gaithersburg, MD 

20877. The hotel telephone number is 

301–977–8900. 

Contact Person: Avena Russell, Center 

for Devices and Radiological Health, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

1535, Silver Spring, MD 20993–0002, 

301–796–3805, 

Avena.Russell@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. 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 March 23, 2012, the 

committee will discuss current 

knowledge about the safety and 

effectiveness of the Wingspan Stent 

System with Gateway PTA Balloon 

Catheter for the treatment of intracranial 

arterial stenosis. FDA is convening this 

committee to seek expert scientific and 

clinical opinion on the risks and 

benefits of this device based on the 

available premarket and postmarket 

data. The Wingspan Stent System with 

Gateway PTA Balloon Catheter is a 

neurovascular stent, balloon catheter, 

and delivery system consisting of the 

following components: 

1. Wingspan Stent—This is a selfexpanding, nitinol stent with a tubular 

mesh design. 

2. Gateway PTA Balloon Catheter— 

This balloon catheter is used to 

predilate the lesion prior to introduction 

of the Wingspan Stent System into the 

patient. 

3. Wingspan Delivery System—This 

delivery system is a single lumen, overthe-wire, coaxial microcatheter that is 

used to deliver the stent to the treatment 

site within the patient’s artery. 

The Wingspan Stent System with 

Gateway PTA Balloon Catheter has been 

approved under a humanitarian device 

exemption (HDE) (H050001) for the 

following indications: ‘‘The Wingspan 

Stent System with Gateway PTA 

Balloon Catheter is indicated for use in 

improving cerebral artery lumen 

diameter in patients with intracranial 

atherosclerotic disease, refractory to 

medical therapy, in intracranial vessels 

with ≥ 50% stenosis that are accessible 

to the system.’’ 

Interim results and analyses of data 

from an ongoing randomized clinical 

trial, ‘‘Stenting and Aggressive Medical 

Management for Preventing Recurrent 

Stroke in Intracranial Stenosis’’ 

(SAMMPRIS), published in the New 

England Journal of Medicine 

(2011;365:993–1003), will be presented 

for the Wingspan Stent with Gateway 

PTA Balloon catheter. The committee 

will be asked to discuss the 

comparability of the patient populations 

for the approved HDE and SAMMPRIS 

trial and the relevance of the 

SAMMPRIS trial results to the 

assessment of safety and probable 

benefit for the Wingspan Stent System 

with Gateway PTA Balloon Catheter 

HDE. 

FDA recently received a citizen’s 

petition seeking withdrawal of the HDE 

approval and recall of Wingspan stents 

currently on the market. The petitions 

are available for public review and 

comment at www.regulations.gov under 

docket number FDA–2011–P–0923. 

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: FDA will work with 

affected industry and professional 

organizations that have an interest in 

the Wingspan Stent System and who 

wish to make a presentation separate 

from the general Open Public Hearing; 

time slots between 2 p.m. and 3 p.m. are 

provided. Representatives from industry 

and professionals organizations 

interested in making formal 

presentations to the committee should 

notify the contact person on or before 

March 1, 2012. 

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 

March 9, 2012. Oral presentations from 

the public will be scheduled between 

approximately 11 a.m. and 12 p.m. 

Those individuals interested in making 

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 March 1, 2012. 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 March 2, 2012. 

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 James Clark, 

James.Clark@fda.hhs.gov or 301–796– 

5293 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/ 

AdvisoryCommittees/ 

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: February 8, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–3243 Filed 2–10–12; 8:45 am] 

BILLING CODE 4160–01–P 


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