12064 Federal Register / Vol. 77, No. 39 / Tuesday, February 28, 2012 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–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 April 11 and 12, 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: Shanika Craig, 

Shanika.Craig@fda.hhs.gov, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 1613, 

Silver Spring, MD 20993, 301–796– 

6639, 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 April 11, 2012, the 

committee will discuss, make 

recommendations, and vote on 

information related to a premarket 

approval application for the Automated 

Breast Ultrasound (ABUS) scanning 

device, sponsored by U–Systems, Inc. 

The ABUS scanning device is intended 

to increase breast cancer detection in 

asymptomatic dense-breasted women 

following a negative screening 

mammogram. 

On April 12, 2012, during session I, 

the committee will discuss and make 

recommendations regarding the 515(i) 

order issued by FDA on April 9, 2009 

(74 FR 16214), for breast 

transilluminators, one of the remaining 

preamendments class III devices. On 

July 18, 1995 (60 FR 36639), FDA 

published a Final Rule that misbranded 

breast transilluminators and effectively 

placed them in class III based on the 

recommendation of the Obstetrics and 

Gynecology Devices Panel, which 

concluded there were no published 

studies or clinical data demonstrating 

the safety and effectiveness of this 

device. The committee discussion will 

include a review of the present 

literature to assess the current 

knowledge of breast transilluminators 

and determine if sufficient safety and 

effectiveness data are available to 

support reclassification of breast 

transilluminators. 

During session II on April 12, 2012, 

the committee will discuss and make 

recommendations regarding the 

classification of blood irradiators. Blood 

irradiators have been found to be 

substantially equivalent to predicate 

devices marketed in interstate 

commerce prior to May 28, 1976, and 

are subject to the general controls 

provisions of the Federal Food, Drug 

and Cosmetic Act. These devices have 

never been formally classified. There is 

an agreement between the Center for 

Devices and Radiological Health (CDRH) 

and the Center for Biologics Evaluation 

and Research (CBER) that outlines 

which FDA center will regulate these 

devices. CDRH regulates irradiators 

intended for use in the immunologically 

active cells in blood and other tissues 

and CBER regulates irradiators intended 

for use in the in-process inactivation of 

HIV viruses or other pathogens. The 

committee discussion will focus on 

whether these devices should be 

classified in class I, II, or III. 

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 3, 2012. On 

April 11, 2012, oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m.; on 

April 12, 2012, oral presentations will 

be scheduled between approximately 9 

a.m. and 10 a.m. for session I and 

between 1:30 p.m. and 2:30 p.m. for 

session II. 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 appropriate 

meeting topic, the names and addresses 

of proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 26, 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 27, 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, 

Committee Management Staff, 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 23, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–4670 Filed 2–27–12; 8:45 am] 

BILLING CODE 4160–01–P 


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