[Federal Register Volume 73, Number 214 (Tuesday, November 4, 2008)]
[Notices]
[Page 65608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26243]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


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 December 3, 2008, from 
8:30 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Dai J. Li, Center for Devices and Radiological 
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 240-276-0997, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512516. 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: The committee will discuss and make recommendations on the 
premarket notification application for the Fujirebio HE4 EIA kit and 
associated Risk of Malignancy algorithm (ROMA\TM\) Test. The HE4 EIA is 
an enzyme immunometric assay for the quantitative determination of HE4 
in human serum. The HE4 EIA, used in conjunction with the ARCHITECT CA 
125 II assay, creates a predictive probability of epithelial ovarian 
cancer using a mathematical function referred to as the ROMA\TM\, for 
use in premenopausal and postmenopausal women presenting with an 
adnexal mass who have already been referred to an oncologic specialist 
and are scheduled for surgery. Subjects categorized as low risk for 
epithelial ovarian cancer using the ROMA\TM\ value may have surgical 
intervention performed by a non-oncology specialist. The results must 
be interpreted in conjunction with other clinical findings in 
accordance with standard clinical management guidelines. The assay is 
not indicated as an aid in a decision to proceed to surgery.
    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/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and 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 
November 19, 2008. Oral presentations from the public will be scheduled 
for approximately 30 minutes at the beginning of committee 
deliberations and for approximately 30 minutes near the end of the 
deliberations. 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 
November 11, 2008. 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 November 12, 
2008.
    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 
240-276-8932 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/oc/advisory/default.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: October 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26243 Filed 11-3-08; 8:45 am]
BILLING CODE 4160-01-S