Advisory Committees; Notice of Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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 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:

Endocrinologic and Metabolic Drugs Advisory Committee

Date, time, and place. June 1, 1995, 8 a.m., Holiday Inn--Silver

Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, 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 5 p.m.; Kathleen R. Reedy, Center for

Drug Evaluation and Research (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 May 26, 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 hear presentations

and discuss data submitted regarding the safety and efficacy of

acarbose, new drug application 20-482, (Precose, Bayer

Corp.), for a non-insulin dependent diabetes mellitus indication.

Working Group Meeting of the Food Advisory Committee

Date, time, and place. June 7 and 8, 1995, 8:30 a.m., Days Inn--

Downtown Convention Center, 1201 K St. NW., Washington, DC.

Type of meeting and contact person. Open working group discussion,

June 7, 1995, 8:30 a.m. to 4 p.m.; open public hearing, 4 p.m. to 5:30

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

group discussion, June 8, 1995, 8:30 a.m. to 12 m.; Lynn A. Larsen,

Center for Food Safety and Applied Nutrition (HFS-5), Food and Drug

Administration, 200 C St. SW., Washington, DC 20204, 202-205-4727, or

Catherine M. DeRoever, Advisory Committee Staff (HFS-22), 202-205-4251,

FAX 202-205-4970, or FDA [[Page 26037]] Advisory Committee Information

Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), Food

Advisory Committee, code 10564.

General function of the committee. The committee provides advice

on emerging food safety, food science, and nutrition issues that FDA

considers of primary importance in the next decade.

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 May 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 required to make their comments. If

necessary, comments may be limited to 5 minutes.

Open working group discussion. The working group will consider

whether foods containing substances that may cause serious adverse

gastrointestinal effects, such as laxation, present a significant

concern such that consumer education or special labeling for these

foods would be appropriate options for FDA to pursue. More detailed

information regarding the meeting agenda that may become available

prior to the meeting will be provided to the public via the 800 number

given above.

Food Advisory Committee

Date, time, and place. June 8, 1995, 1 p.m., and June 9, 1995,

8:30 a.m., Days Inn--Downtown Convention Center, 1201 K St. NW.,

Washington, DC.

Type of meeting and contact person. Open committee discussion, June

8, 1995, 1 p.m. to 4 p.m.; open public hearing, 4 p.m. to 5 p.m.,

unless public participation does not last that long; open committee

discussion, June 9, 1995, 8:30 a.m. to 4 p.m.; Lynn A. Larsen, Center

for Food Safety and Applied Nutrition (HFS-5), Food and Drug

Administration, 200 C St. SW., Washington, DC 20204, 202-205-4727, or

Catherine M. DeRoever, Advisory Committee Staff (HFS-22), 202-205-4251,

FAX 202-205-4970, or FDA Advisory Committee Information Hotline, 1-800-

741-8138 (301-443-0572 in the Washington, DC area), Food Advisory

Committee, code 10564.

General function of the committee. The committee provides advice

on emerging food safety, food science, and nutrition issues that FDA

considers of primary importance in the next decade.

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 May 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 required to make their comments. If

necessary, comments may be limited to 5 minutes.

Open committee discussion. The committee will consider the actions

and recommendations of two special working groups regarding: (1) An

educational campaign on Vibrio vulnificus, and (2) certain food

products that may cause unexpected gastrointestinal effects. The

committee will also discuss with FDA staff, future food safety

strategies for the agency. More detailed information regarding the

meeting agenda that may become available prior to the meeting will be

provided to the public via the 800 number given above.

National Task Force on AIDS Drug Development

Date, time, and place. June 29, 1995, 9 a.m., and June 30, 1995,

8:30 a.m., Omni Shoreham Hotel, Diplomat Room, 250 Calvert St. NW.,

Washington, DC.

Type of meeting and contact person. Open task force discussion,

June 29, 1995, 9 a.m. to 4:30 p.m.; open public hearing, 4:30 p.m. to

5:30 p.m., unless public participation does not last that long; open

task force discussion, June 30, 1995, 8:30 a.m. to 11:30 a.m.; Heidi C.

Marchand 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 the 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 task force 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 task force discussion. The task force will meet to discuss

incentives and disincentives for private investment and collaboration

in drug discovery and development for HIV/acquired immune deficiency

syndrome (AIDS).

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 June 5, 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.

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 [[Page 26038]] 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.

Dated: May 10, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95-12019 Filed 5-15-95; 8:45 am]

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