Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: This notice announces a forthcoming meeting of a public

advisory committee of the Food and Drug Administration (FDA). This

notice also summarizes the procedures for the meeting and methods by

which interested persons may participate in open public hearings before

FDA's advisory committees.

MEETING: The following advisory committee meeting is announced:

Joint Meeting of the Antiviral Drugs and Nonprescription Drugs Advisory

Committees

Date, time, and place. May 19, 1994, 3:30 p.m., conference rms. D

and E, Parklawn Bldg., 5600 Fishers Lane, Rockville, MD.

Type of meeting and contact person. Open public hearing, 3:30 p.m.

to 4:30 p.m., unless public participation does not last that long; open

committee discussion, 4:30 p.m. to 6 p.m.; Lee L. Zwanziger, Mae

Brooks, or Valerie Mealy, Center for Drug Evaluation and Research (HFD-

9), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-443-4695.

General function of the committees. The Antiviral Drugs Advisory

Committee reviews and evaluates available data concerning the safety

and effectiveness of marketed and investigational human drug products

for use in the treatment of acquired immune deficiency syndrome (AIDS),

AIDS-related complex (ARC), and other viral, fungal, and mycobacterial

infections. The Nonprescription Drugs Advisory Committee reviews and

evaluates available data concerning the safety and effectiveness of

over-the-counter (nonprescription) human drug products for use in the

treatment of a broad spectrum of human symptoms and diseases.

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

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

the committees. Those desiring to make formal presentations should

notify the contact person before May 9, 1994, 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.

Those persons or groups presenting views on this topic at the public

hearing before the Commissioner of Food and Drugs, earlier the same

day, need not make a second presentation because views presented in the

earlier meeting will be taken into consideration in this joint advisory

committee meeting.

Open committee discussion. The committees will discuss jointly the

issues and concerns relating to over-the-counter availability of

acyclovir for the treatment of recurrent genital herpes, taking into

consideration the views expressed at the public hearing scheduled

earlier the same day. (See a notice of public hearing on the proposed

switch of acyclovir from prescription to over-the counter status

published elsewhere in this issue of the Federal Register.)

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.

Dated: March 1, 1994.

Jane E. Henney,

Deputy Commissioner for Operations.

[FR Doc. 94-5129 Filed 3-2-94; 2:55 pm]

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