Advisory Committees; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Advisory Committees; Notice of Meetings

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces forthcoming meetings of public advisory

committees of the Food and Drug Administration (FDA). This notice also

summarizes the procedures for the meetings and methods by which

interested persons may participate in open public hearings before FDA's

advisory committees.

FDA has established an Advisory Committee Information Hotline (the

hotline) using a voice-mail telephone system. The hotline provides the

public with access to the most current information on FDA advisory

committee meetings. The advisory committee hotline, which will

disseminate current information and information updates, can be

accessed by dialing 1-800-741-8138 or 301-443-0572. Each advisory

committee is assigned a 5-digit number. This 5-digit number will appear

in each individual notice of meeting. The [[Page 4174]] hotline will

enable the public to obtain information about a particular advisory

committee by using the committee's 5-digit number. Information in the

hotline is preliminary and may change before a meeting is actually

held. The hotline will be updated when such changes are made.

MEETINGS: The following advisory committee meetings are announced:

Psychopharmacologic Drugs Advisory Committee

Date, time, and place. February 6, 1995, 8:30 a.m., Parklawn Bldg.,

conference rooms D and E, 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open public hearing, 8:30 a.m.

to 9:30 a.m., unless public participation does not last that long; open

committee discussion, 9:30 a.m. to 5 p.m.; Michael A. Bernstein, Center

for Drug Evaluation and Research (HFD-120), Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5521,

or FDA Advisory Committee Information Hotline, l-800-741-8l38 (301-443-

0572 in the Washington, DC area), Psychopharmacologic Drugs Advisory

Committee, code 12544.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness of marketed and

investigational human drugs for use in the practice of psychiatry and

related fields.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committee. Those desiring to make formal presentations should

notify the contact person before January 30, 1995, 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 required to make their comments.

Open committee discussion. The committee will discuss the safety

and effectiveness of Depakote tablets (divalproex sodium

tablet), new drug application (NDA) 20-320, Abbott Laboratories, for

use in the treatment of manic episodes associated with bipolar

disorder.

Subcommittee Meeting of the National Task Force on Aids Drug

Development/Drug Discovery Issues

Date, time, and place. February 6, 1995, 8:30 a.m., National

Institutes of Health, Bldg. 31, rm. 6C-8, 9000 Rockville Pike,

Bethesda, MD; and February 7, 1995, 8:30 a.m., Executive Plaza North,

conference room G, 6130 Executive Plaza Blvd., Bethesda, MD.

Type of meeting and contact person. Open subcommittee discussion,

February 6, 1995, 8:30 a.m. to 4 p.m.; open public hearing, 4 p.m. to 5

p.m., unless public participation does not last that long; open

subcommittee discussion, February 7, 1995, 8:30 a.m. to 4 p.m.; open

public hearing, 4 p.m. to 5 p.m., unless public participation does not

last that long; Jean H. McKay or Kimberley M. Miles, Office of AIDS and

Special Health Issues (HF-12), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-443-0104, or FDA Advisory

Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), National Task Force on AIDS Drug Development,

code 12602.

General function of the task force. The National Task Force on

AIDS Drug Development shall identify any barriers and provide creative

options for the rapid development and evaluation of treatments for

human immunodeficiency virus (HIV) infection and its sequelae. It also

advises on issues related to such barriers, and provides options for

the elimination of these barriers.

Open subcommittee discussion. On February 6, 1995, the subcommittee

will present, hear, and discuss issues on the use of and access to

available animal models in the drug discovery/development process and

examine the prospects for the development of new models for such

purposes. On February 7, 1995, the subcommittee will identify

mechanisms for rapid development and sharing of screening assays and to

determine the feasibility of an expanded drug-screening effort, related

to the identification of potential therapies for HIV disease.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the task force. Those desiring to make formal presentations should

notify the contact person before February 1, 1995, 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 required to make their comments.

Advisory Committee on Special Studies Relating to the Possible Long-

Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand

Advisory Committee)

Date, time, and place. February 13 and 14, 1995, 9 a.m., Holiday

Inn, 400 Arch St., Philadelphia, PA.

Type of meeting and contact person. Open committee discussion,

February 13, 1995, 9 a.m. to 5:30 p.m.; open public hearing, February

14, 1995, 9 a.m. to 10 a.m., unless public participation does not last

that long; open committee discussion, 10 a.m. to 5:30 p.m.; Ronald F.

Coene, National Center for Toxicological Research (HFT-10), Food and

Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-

3155, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Ranch Hand Advisory

Committee, code 12560.

General function of the committee. The committee shall advise the

Secretary and the Assistant Secretary for Health concerning its

oversight of the conduct of the Ranch Hand Study by the Air Force and

other studies in which the Secretary or the Assistant Secretary for

Health believes involvement by the advisory committee is desirable.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committee. Those desiring to make formal presentations should

notify the contact person before January 31, 1995, 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 comments.

Open committee discussion. The committee will continue the review

of the chapters of the draft report presenting the results of the 1992

health examination of participants in the Air Force Health Study

entitled ``An Epidemiologic Investigation of Health Effects in Air

Force Personnel Following Exposure to Herbicides.'' This review will

include chapters on: Neoplasia, neurology, psychology,

gastrointestinal, cardiovascular, hematologic, endocrinologic, and

immunologic data, as well as information on quality control,

statistical methods, and covariate associations and the summary chapter

on conclusions and future directions. A final agenda will be available

February 6, 1995, from the contact person. [[Page 4175]]

Oncologic Drugs Advisory Committee

Date, time, and place. February 14, 1995, 8 a.m., Parklawn Bldg.,

conference rooms D and E, 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open public hearing, 8 a.m. to

9 a.m., unless public participation does not last that long; open

committee discussion, 9 a.m. to 4:30 p.m.; Adele S. Seifried, Center

for Drug Evaluation and Research (HFD-9), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory

Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), Oncologic Drugs Advisory Committee, code 12542.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness of marketed and

investigational human drugs for use in the treatment of cancer.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committee. Those desiring to make formal presentations should

notify the contact person before February 10, 1995, 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 required to make their comments.

Open committee discussion. The committee will discuss in the order

listed: (1) NDA 50-718, Dox-SL (pegylated liposomal doxorubicin

hydrochloride, Liposome Technology, Inc.) for AIDS-related Kaposi's

Sarcoma in patients who have failed prior systemic combination

chemotherapy either due to progression of disease or unacceptable

toxicity; and (2) NDA 20-515, Zoladex (goserelin acetate

implant, Zeneca Pharmaceuticals Group) for palliative treatment of

advanced breast cancer in pre- and perimenopausal women.

Cardiovascular and Renal Drugs Advisory Committee

Date, time, and place. February 23 and 24, 1995, 8:30 a.m.,

National Institutes of Health, Clinical Center, Bldg. 10, Jack Masur

Auditorium, 9000 Rockville Pike, Bethesda, MD. Parking in the Clinical

Center visitor area is reserved for clinical center patients and their

visitors. If you must drive, please use an outlying lot such as Lot

41B. Free shuttle bus service is provided from Lot 41B to the Clinical

Center every 8 minutes during rush hour and every 15 minutes at other

times.

Type of meeting and contact person. Open public hearing, February

23, 1995, 8:30 a.m. to 9:30 a.m., unless public participation does not

last that long; open committee discussion, 9:30 a.m. to 5:30 p.m.; open

committee discussion, February 24, 1995, 8:30 a.m. to 5:30 p.m.; Joan

C. Standaert, Center for Drug Evaluation and Research (HFD-110), Food

and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-

259-6211, Valerie M. Mealy, Advisors and Consultants Staff, 301-443-

4695, or FDA Advisory Committee Information Hotline, 1-800-741-8138

(301-443-0572 in the Washington, DC area), Cardiovascular and Renal

Drugs Advisory Committee, code 12533.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness of marketed and

investigational human drugs for use in cardiovascular and renal

disorders.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committee. Those desiring to make formal presentations should

notify the contact person before February 6, 1995, 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 required to make their comments.

Open committee discussion. On February 23, 1995, the committee will

discuss: (1) NDA 09-218, S-76, Dupont Merck, Coumadin

(warfarin), for prevention of death, recurrent myocardial infarction,

and thromboembolic events, such as stroke after myocardial infarction;

and (2) NDA 20-444, Burroughs Wellcome Co., Flolan

(epoprostenol), for treatment of primary pulmonary hypertension. On

February 24, 1995, the committee will discuss antianginal guidelines.

Endocrinologic and Metabolic Drugs Advisory Committee

Date, time, and place. February 23 and 24, 1995, 8:30 a.m., Holiday

Inn Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring,

MD.

Type of meeting and contact person. Open public hearing, February

23, 1995, 8:30 a.m. to 9 a.m., unless public participation does not

last that long; open committee discussion, 9 a.m. to 5 p.m.; open

public hearing, February 24, 1995, 8:30 a.m. to 9 a.m., unless public

participation does not last that long; open committee discussion, 9

a.m. to 4 p.m.; Kathleen R. Reedy, Center for Drug Evaluation and

Research, Advisors and Consultants Staff, HFD-9, Food and Drug

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455,

FAX (301-443-0699), or FDA Advisory Committee Information Hotline, 1-

800-741-8138 (301-443-0572 in the Washington, DC area), Endocrinologic

and Metabolic Drugs Advisory Committee, code 12536.

General function of the committee. The committee reviews and

evaluates data on the safety and effectiveness of marketed and

investigational human drugs for use in endocrine and metabolic

disorders.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committee. Those desiring to make formal presentations should

notify the contact person before February 16, 1995, 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 required to make their comments.

Open committee discussion. On February 23, 1995, the committee will

hear presentations and discuss data submitted regarding the safety and

efficacy of sermorelin acetate, NDA 20-443 (Geref, Serono),

for a growth hormone insufficiency indication. On February 24, 1995,

the committee will discuss nilutamide, NDA 20-169 (Anandron,

Roussel Uclaf), for a prostate cancer indication.

Board of Tea Experts

Date, time, and place. February 27 and 28, 1995, 10 a.m., New York

Regional Laboratory, rm. 700, 850 Third Ave., Brooklyn, NY.

Type of meeting and contact person. Open public hearing, February

27, 1995, 10 a.m. to 11 a.m., unless public participation does not last

that long; open committee discussion, 11 a.m. to 4:30 p.m.; open

committee discussion, February 28, 1995, 10 a.m. to 4:30 p.m.; Faith F.

Lim, New York Regional Laboratory, Food and Drug Administration, 850

Third Ave., Brooklyn, NY 11232, 718-965-5730, or FDA Advisory Committee

Information Hotline, 1-800-8138 (301-443-0572 in the Washington, DC

area), Board of Tea Experts, code 12601.

General function of the board. The board advises on establishment

of uniform standards of purity, quality, and fitness for consumption of

all tea [[Page 4176]] imported into the United States under 21 U.S.C.

42.

Agenda--Open public hearing. Interested persons may present data,

information, or views, orally or in writing, on issues pending before

the committee.

Open board discussion. The board will discuss and select tea

standards.

FDA public advisory committee meetings may have as many as four

separable portions: (1) An open public hearing, (2) an open committee

discussion, (3) a closed presentation of data, and (4) a closed

committee deliberation. Every advisory committee meeting shall have an

open public hearing portion. Whether or not it also includes any of the

other three portions will depend upon the specific meeting involved.

There are no closed portions for the meetings announced in this notice.

The dates and times reserved for the open portions of each committee

meeting are listed above.

The open public hearing portion of each meeting shall be at least 1

hour long unless public participation does not last that long. It is

emphasized, however, that the 1 hour time limit for an open public

hearing represents a minimum rather than a maximum time for public

participation, and an open public hearing may last for whatever longer

period the committee chairperson determines will facilitate the

committee's work.

Public hearings are subject to FDA's guideline (subpart C of 21 CFR

part 10) concerning the policy and procedures for electronic media

coverage of FDA's public administrative proceedings, including hearings

before public advisory committees under 21 CFR part 14. Under 21 CFR

10.205, representatives of the electronic media may be permitted,

subject to certain limitations, to videotape, film, or otherwise record

FDA's public administrative proceedings, including presentations by

participants.

Meetings of advisory committees shall be conducted, insofar as is

practical, in accordance with the agenda published in this Federal

Register notice. Changes in the agenda will be announced at the

beginning of the open portion of a meeting.

Any interested person who wishes to be assured of the right to make

an oral presentation at the open public hearing portion of a meeting

shall inform the contact person listed above, either orally or in

writing, prior to the meeting. Any person attending the hearing who

does not in advance of the meeting request an opportunity to speak will

be allowed to make an oral presentation at the hearing's conclusion, if

time permits, at the chairperson's discretion.

The agenda, the questions to be addressed by the committee, and a

current list of committee members will be available at the meeting

location on the day of the meeting.

Transcripts of the open portion of the meeting may be requested in

writing from the Freedom of Information Office (HFI-35), Food and Drug

Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the meeting, at a cost of 10 cents

per page. The transcript may be viewed at the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15 working days after the meeting,

between the hours of 9 a.m. and 4 p.m., Monday through Friday. Summary

minutes of the open portion of the meeting may be requested in writing

from the Freedom of Information Office (address above) beginning

approximately 90 days after the meeting.

This notice is issued under section 10(a)(1) and (2) of the Federal

Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR

part 14) on advisory committees.

The Commissioner approves the scheduling of meetings at locations

outside of the Washington, DC, area on the basis of the criteria of 21

CFR 14.22 of FDA's regulations relating to public advisory committees.

Dated: January 13, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-1552 Filed 1-19-95; 8:45 am]

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