Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices 15741 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Circulatory System 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: Circulatory 

System 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 April 23, 2009, from 8:30 a.m. 

to 5:30 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, and C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: James Swink, Center 

for Devices and Radiological Health 

(HFZ–450), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 240–276–4050, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512625. 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: The committee will discuss, 

make recommendations, and vote on a 

premarket approval application, 

sponsored by Atritech, Inc., for the 

WATCHMAN® Left Atrial Appendage 

(LAA) Closure Technology. The 

WATCHMAN® device, a 

percutaneously placed permanent 

implant, is intended as an alternative to 

warfarin therapy for patients with nonvalvular atrial fibrillation. The 

WATCHMAN® LAA Closure 

Technology is designed to prevent 

embolization of thrombi that may form 

in the left atrial appendage thereby 

preventing the occurrence of ischemic 

stroke and systemic thromboembolism. 

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/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2009 and 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 April 16, 2009. Oral 

presentations from the public will be 

scheduled approximately 30 minutes at 

the beginning of committee 

deliberations and approximately 30 

minutes near the end of the 

deliberations. 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 April 8, 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 April 9, 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, Conference Management 

Staff, at 240–276–8932, 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/oc/advisory/ 

default.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: March 30, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–7726 Filed 4–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0146] 

Sodium Shale Oil Sulfonate Eligibility 

for Inclusion in Monograph; Over-theCounter Dandruff, Seborrheic 

Dermatitis, and Psoriasis Drug 

Products for Human Use; Request for 

Safety and Effectiveness Data 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of eligibility; request for 

data and information. 

SUMMARY: As part of our ongoing review 

of over-the-counter (OTC) drug 

products, we (Food and Drug 

Administration (FDA)) are announcing a 

call-for-data for safety and effectiveness 

information for sodium shale oil 

sulfonate (SSOS), 0.5 to 2.0 percent, as 

a rinse-off treatment for dandruff. We 

have reviewed a time and extent 

application (TEA) for SSOS and 

determined that it is eligible for 

consideration in our OTC drug 

monograph system. We will evaluate the 

submitted data and information to 

determine whether SSOS can be 

generally recognized as safe and 

effective (GRASE) as an OTC rinse-off 

treatment for dandruff. 

DATES: Submit data, information, and 

general comments by July 6, 2009. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2009–N– 

0146, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

∑ Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

∑ FAX: 301–827–6870. 

∑ Mail/Hand delivery/Courier (For 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, we are no longer accepting