[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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