[Federal Register: July 28, 2010 (Volume 75, Number 144)]


[Page 44273]

From the Federal Register Online via GPO Access []


Page 44273



Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Radiological 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: Radiological 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 September 24, 2010, 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.

Contact Person: Shanika Craig, Food and Drug Administration, Center

for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg 66,

rm. 1613, Silver Spring, MD 20993-0002, 301-796-6639, or FDA Advisory

Committee Information Line, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), code 3014512526. 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


Agenda: On September 24, 2010, the committee will discuss, make

recommendations, and vote on a premarket approval application for the

Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic,

Inc. The Selenia C Digital Breast Tomosynthesis System is intended for

use in the same clinical applications as traditional mammographic


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

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

September 16, 2010. Oral presentations from the public will be

scheduled between approximately 1 p.m. and 2 p.m., immediately

following lunch. 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

September 9, 2010. 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 September 10,


Persons attending FDA's advisory committee meetings are advised

that the agency is not responsible for providing access to electrical


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

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: July 22, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

[FR Doc. 2010-18416 Filed 7-27-10; 8:45 am]