75292 Federal Register / Vol. 65, No. 232 / Friday, December 1, 2000 / Notices

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.

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

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4557–N–48]

Federal Property Suitable as Facilities

to Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

EFFECTIVE DATE: December 1, 2000.

FOR FURTHER INFORMATION CONTACT:

Clifford Taffet, Department of Housing

and Urban Development, Room 7262,

451 Seventh Street SW, Washington, DC

20410; telephone (202) 708–1234; TTY

number for the hearing- and speechimpaired (202) 708–2565, (these

telephone numbers are not toll-free), or

call the toll-free Title V information line

at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with the December 12, 1988

court order in National Coalition for the

Homeless v. Veterans Administration,

No. 88–2503–OG (D.D.C.), HUD

publishes a Notice, on a weekly basis,

identifying unutilized, underutilized,

excess and surplus Federal buildings

and real property that HUD has

reviewed for suitability for use to assist

the homeless. Today’s Notice is for the

purpose of announcing that no

additional properties have been

determined suitable or unsuitable this

week.

Dated: November 21, 2000.

Fred Karnas, Jr.,

Deputy Assistant Secretary for Special Needs

Assistance Programs.

[FR Doc. 00–30216 Filed 11–30–00; 8:45 am]

BILLING CODE 4210–29–M