62722 Federal Register / Vol. 65, No. 203 / Thursday, October 19, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dermatologic and Ophthalmic Drugs

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: Dermatologic

and Ophthalmic Drugs 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 November 16, 2000, 9 a.m. to

5:30 p.m.

Location: Holiday Inn, Grand

Ballroom, Two Montgomery Village

Ave., Gaithersburg, MD.

Contact: Jaime Henriquez, Center for

Drug Evaluation and Research (HFD–

21), Food and Drug Administration,

5600 Fishers Lane (for express delivery,

5630 Fishers Lane, rm. 1066), Rockville,

MD 20857, 301–827–7001, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 12534.

Please call the Information Line for upto-date information on this meeting.

Agenda: On November 16, 2000, the

committee will discuss new drug

application (NDA) 50–777, Protopic

(tacrolimus) Ointment, Fujisawa

Healthcare, Inc., for short- and longterm treatment of the signs and

symptoms of atopic dermatitis in adult

and pediatric patients 2 years of age or

older.

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 November 6, 2000. Oral

presentations from the public will be

scheduled between approximately 1:30

p.m. and 2:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 6, 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.

Closed Committee Deliberations: On

November 16, 2000, from 9 a.m. to 10

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

regarding NDA issues (5 U.S.C.

552b(c)(4)).

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 11, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–26787 Filed 10–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Radiological 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: Radiological

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 November 6, 2000, 10 a.m. to

4:30 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Robert J. Doyle,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1212, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12526. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will discuss,

make recommendations, and vote on a

premarket approval application for an

embolic radiation therapy device.

Procedure: On November 6, 2000,

from 10 a.m. to 12:30 p.m., and from 1

p.m. to 4:30 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 October 26, 2000. Oral

presentations from the public will be

scheduled between approximately 10:15

a.m. and 10:45 a.m., and for an

additional 30 minutes near the end of

the committee deliberations. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before October 26, 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.

Closed Committee Deliberations: On

November 6, 2000, from 12:30 p.m. to 1

p.m., the meeting will be closed to the

public to permit discussion and review

of trade secret and/or confidential

commercial information (5 U.S.C.

552b(c)(4)) regarding pending and future

agency issues.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 13, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–26899 Filed 10–18–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Joint Meeting of the Advisory

Committee for Pharmaceutical Science

and the Dermatologic and Ophthalmic

Drugs 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: Advisory

Committee for Pharmaceutical Science

and the Dermatologic and Ophthalmic

Drugs 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 November 17, 2000, from 8:30

a.m. to 12:30 p.m.