Document ID: FDA-2011-N-0478-0001
Agency: fda
Document Type: Notice
Title: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2011-07-07T04:00Z

[Federal Register Volume 76, Number 130 (Thursday, July 7, 2011)]
[Notices]
[Pages 39882-39883]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16952]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0478]

General and Plastic Surgery Devices Panel of the Medical Devices 

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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: General and Plastic Surgery 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 August 30 and 31, 2011, 

from 8 a.m. to 6 p.m.

    Addresses: FDA is opening a docket for public comment on this 

document. The docket will open for public comment on July 7, 2011. The 

docket will close on August 26, 2011. Interested persons may submit 

electronic or written comments regarding this document. Submit 

electronic comments to http://www.regulations.gov. Submit written 

comments to the Division of Dockets

[[Page 39883]]

Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 

Rockville, MD 20852. Submit a single copy of electronic comments or two 

paper copies of any mailed comments, except that individuals may submit 

one paper copy. Comments are to be identified 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.

    Location: Hilton Washington DC North/Gaithersburg, Ballroom, 620 

Perry Pkwy., Gaithersburg, MD.

    Contact Person: Margaret McCabe-Janicki, Center for Devices and 

Radiological Health, Food and Drug Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1535, Silver Spring, MD 20993-0002, 301-796-7029, 

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 August 30 and 31, 2011, the committee will discuss and 

make recommendations on postmarketing issues related to silicone gel-

filled breast implants. This meeting is regarding the discussion of 

different innovative methodological approaches to the conduct of 

postmarket studies regarding silicone gel breast implants. 

Additionally, the panel will discuss key long-term safety issues 

associated with silicone gel breast implants in the real-world setting.

    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 

August 24, 2011. Oral presentations from the public will be scheduled 

between approximately 1 p.m. and 3 p.m. on August 30, 2011, and between 

approximately 8 a.m. and 10 a.m. on August 31, 2011. 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 August 15, 2011. 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 August 17, 2011.

    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, 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/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: June 23, 2011.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

[FR Doc. 2011-16952 Filed 7-6-11; 8:45 am]

BILLING CODE 4160-01-P