[Federal Register: December 1, 2000 (Volume 65, Number 232)]
[Notices]
[Page 75292]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de00-79]
[[Page 75292]]
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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 December 8, 2000, 9:30
a.m. to 4:30 p.m.
Location: Marriott Washingtonian Center, Salons A, B, C, and D,
9751 Washingtonian Blvd., 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, 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: The committee will discuss and make recommendations on
issues concerning the types of information necessary to determine the
effectiveness of in vitro diagnostic devices that detect human
papilloma virus (HPV) in women 30 years or older when these devices are
used: (1) In conjunction with Pap smear to increase the effectiveness
of Pap smear screening for cervical cancer, and (2) without Pap smear
to determine a woman's risk of cervical cancer. Additionally, the
committee will discuss and make recommendations on issues concerning
the use of self-collection and alternative specimen sources for the
above indications.
The following draft questions are proposed for discussion and may
be subject to changes prior to the committee meeting:
1. What criteria should be developed to support the safety and
effectiveness of HPV assays used in conjunction with Pap smears and
without Pap smears, in women 30 years or older, for predicting risk for
cervical cancer?
2. What would be the appropriate interpretation of results from HPV
assays used in conjunction with Pap smear in women 30 years or older
intended for use as predictors of risk for cervical cancer?
3. What type(s) of clinical studies would be appropriate to
establish the safety and effectiveness of human papilloma virus testing
used in conjunction with Pap smear and without Pap smear, in women 30
years or older, for the determination of risk for cervical cancer in
the U.S. population?
4. What types of studies would be appropriate to establish
performance characteristics for alternate specimen sources, e.g., urine
or home collected cervical swabs, when used to test for HPV as an
indication of risk for cervical cancer?
FDA will consider these recommendations in the future development
of review criteria for in vitro diagnostic devices, for the detection
of HPV as valid scientific evidence to determine whether there is
reasonable assurance that these devices are safe and effective for
their intended uses.
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 December 1,
2000. On December 8, 2000, oral presentations from the public will be
scheduled between approximately 11:30 a.m. and 12:30 p.m., and between
approximately 3:30 p.m. and 4 p.m. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should
notify the contact person before December 1, 2000, 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.
FDA regrets that it was unable to publish this notice 15 days prior
to the December 8, 2000, 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.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 22, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-30692 Filed 11-28-00; 4:29 pm]
BILLING CODE 4160-01-F