Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 / Notices 62777

development, and (5) delineation of the

key features of informed consent for

patients who have received a porcine

xenograft and who undergo screening

for porcine endogenous retrovirus. Procedure: On December 17, 1997,

from 9 a.m. to 11:30 a.m., and 12 m. to

6 p.m., the meeting is open to the

public. 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

10, 1997. Oral presentations from the

public will be scheduled between

approximately 9 a.m. and 10 a.m. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before December 10,

1997, 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.

Closed Committee Deliberations: On

December 17, 1997, from 11:30 a.m. to

12 m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). The meeting will

be closed to discuss current

investigational new drug application

submissions under FDA review.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30910 Filed 11–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Orthopaedic and Rehabilitation

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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Orthopaedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 11, 1997, 9 a.m. to 8

p.m., and December 12, 1997, 8 a.m. to

2 p.m.

Location: Holiday Inn, Versailles

Ballrooms III and IV, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Jodi H. Nashman,

Center for Devices and Radiological

Health (HFZ–410), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2036, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12521. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On December 11, 1997, the

committee will discuss, make

recommendations, and vote on one

premarket approval application (PMA)

for a spinal intervertebral fusion device.

Additionally, there will be a general

discussion of the minimum acceptable

length of patient followup for marketing

approval of spinal implant devices. On

December 12, 1997, the committee will

discuss, make recommendations, and

vote on a PMA for an anti-adhesion

barrier gel.

Procedure: On December 11, 1997,

from 9 a.m. to 8 p.m., and on December

12, 1997, from 9 a.m. to 2 p.m., the

meeting is open to the public. 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 3, 1997. Oral

presentations from the public regarding

spinal intervertebral fusion systems and

devices will be scheduled between

approximately 9 a.m. and 10 a.m., on

December 11, 1997. Oral presentations

from the public regarding anti-adhesion

barrier gels will be scheduled between

9 a.m. and 10 a.m., on December 12,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 3, 1997, 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.

Closed Committee Deliberations: On

December 12, 1997, from 8 a.m. to 9

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)) regarding present

and future FDA issues.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 18, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30914 Filed 11-24-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System 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). At least one portion of the

meeting will be closed to the public.

Name of Committee: Circulatory

System Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 4, 1997, 8 a.m. to 5

p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: John E. Stuhlmuller,

Center for Devices and Radiological

Health (HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8243,

ext. 157, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12625. Please call the

Information Line for up-to-date

information on this meeting.

Procedure: On December 4, 1997,

from 8 a.m. to 9 a.m., the meeting is

open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues

appropriate for the committee. Written

submissions may be made to the contact

person by December 3, 1997. Oral

presentations from the public will be

scheduled between 8 a.m. and 9 a.m.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before December 3,

1997, 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.