Federal Register / Vol. 77, No. 60 / Wednesday, March 28, 2012 / Notices 18829 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807, 

subpart E, have been approved under 

OMB control number 0910–0120; and 

the collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7418 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Gastroenterology and Urology 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: Gastroenterology 

and Urology 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 May 10 and 11, 2012, from 8 

a.m. to 6 p.m. 

Location: Hilton Washington, DC 

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

D, 620 Perry Pkwy., Gaithersburg, MD 

20877. The hotel’s 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, 

Avena.Russell@fda.hhs.gov, 301–796– 

3805, 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 May 10 and 11, 2012, the 

committee will discuss general issues 

related to medical devices intended for 

obese patients. The committee will 

provide recommendations regarding 

trial design for clinical studies to 

evaluate the safety and effectiveness of 

weight loss devices placed either 

endoscopically (balloons and suture 

devices) or laparoscopically (bands, 

space-occupying devices, etc.) and 

contrast those to surgery. Additional 

discussion will include issues 

pertaining to clinically meaningful 

weight loss, when the primary endpoint 

should be measured, length of patient 

followup, and how much risk is 

acceptable for a potentially small 

amount of weight loss. 

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 April 27, 2012. Oral 

presentations from the public will be 

scheduled on May 10, 2012 between 

approximately 12:30 p.m. and 2 p.m. 

and on May 11, 2012 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 April 19, 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 April 20, 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, 

Conference Management Staff, at 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: March 22, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–7406 Filed 3–27–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0001] 

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. 


tkelley on DSK3SPTVN1PROD with NOTICES