[Federal Register: March 1, 2002 (Volume 67, Number 41)]
[Notices]               
[Page 9456-9457]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01mr02-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Microbiology 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: Microbiology 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 March 7, 2002, from 
10:30 a.m. to 3:30 p.m., and on March 8, 2002, from 8:30 a.m. to 
3:30 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact Person: Freddie M. Poole, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-2096, ext. 111, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 12517. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: On March 7, 2002, the committee will discuss and make 
recommendations on the classification of preamendments in vitro 
diagnostic products to identify Bacillus anthracis and Yersinia 
pestis. No applications will be reviewed at this meeting. On March 
8, 2002, the committee will discuss, make recommendations, and vote 
on a supplement to a premarket approval application for a nucleic 
acid hybridization in vitro diagnostic device for the detection of 
13 high-risk types of human papilloma virus DNA in cervical 
specimens. The test is indicated for use as a general population 
screening test in conjunction with the Papanicolaou smear for women 
30 years of age and older, as an aid to determine the absence of 
high-grade cervical disease or cancer. The test is not intended for 
use as a screening test in the general population for women under 30 
years of age.
    Background information for each day's topic, including the 
agenda and questions for the committee, will be available to the 
public 1 business day before the meeting, on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. Material for the March 7 session 
will be posted on March 6, 2002; material for the March 8 session 
will be posted on March 7, 2002.
    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 by March 4, 
2002. On March 7, 2002, formal oral presentations from the public 
will be scheduled between approximately 11:30 a.m. and 12:15 p.m., 
and between approximately 2:30 p.m. and 2:45 p.m. On March 8, 2002, 
formal oral presentations from the public will be scheduled between 
approximately 11 a.m. and 11:45 a.m., and between approximately 3 
p.m. and 3:15 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should 
notify the contact person before March 4, 2002, and submit a brief 
statement of the

[[Page 9457]]

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.
    FDA regrets that it was unable to publish this notice 15 days 
prior to the March 8, 2002, Microbiology Devices Panel of the 
Medical Devices Advisory Committee meeting. Because the agency 
believes there is some urgency to bring this issue to public 
discussion and qualified members of the Microbiology Devices Panel 
of the Medical Devices Advisory Committee were available at this 
time, the Commissioner of Food and Drugs concluded that it was in 
the public interest to hold this meeting even if there was not 
sufficient time for the customary 15-day public notice.
    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 Shirley Meeks, 
Conference Management Staff, 301-594-1283, ext. 105, at least 7 days 
in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 26, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
Relations.
[FR Doc. 02-5044 Filed 2-27-02; 11:19 am]
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