[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Notices]
[Pages 48871-48872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20118]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


Immunology 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: Immunology 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 October 14, 2011, 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, salons A, B, 
and C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Shanika Craig, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., 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), and

[[Page 48872]]

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 October 14, 2011, the committee will discuss, make 
recommendations, and vote on a premarket approval application for 
the Progensa PCA3 assay sponsored by Gen-Probe, Inc. The Progensa 
PCA3 assay is indicated for use in conjunction with other patient 
information to aid in the decision for repeat biopsy in men 50 years 
of age or older who have had one or more previous negative prostate 
biopsies and for whom a repeat biopsy would be recommended based on 
current standard of care, before consideration of PCA3 assay 
results. A lower PCA3 score is associated with a decreased 
likelihood of a positive biopsy.
    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 
September 30, 2011. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m., immediately 
following lunch. 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 September 22, 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 September 23, 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 
at 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: August 3, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-20118 Filed 8-8-11; 8:45 am]
BILLING CODE 4160-01-P