[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Notices]
[Page 75292]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30692]



[[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