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:

-Peripheral and Central Nervous System Drugs Advisory Committee

Date, time, and place. June 6, 1996, 8:30 a.m., Holiday Inn--

Bethesda, Versailles Ballrooms III and IV, 8120 Wisconsin Ave.,

Bethesda, MD.

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

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

committee discussion, 9 a.m. to 3 p.m.; open public hearing, 3 p.m. to

3:30 p.m., unless public participation does not last that long; William

Freas or Sheila D. Langford, Center for Biologics Evaluation and

Research (HFM-21), Food and Drug Administration, 1401 Rockville Pike,

Bethesda, MD 20852, 301-827-0314, or FDA Advisory Committee Information

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

Peripheral and Central Nervous System Drugs Advisory Committee, code

12543. Please call the hotline for information concerning any possible

changes.

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 neurological disease.

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, 1996, 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 product

license application 96-0350 for ActivaseTM (alteplase), Genentech,

for the management of acute ischemic stroke.

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Antiviral Drugs Advisory Committee -

-Date, time, and place. June 6 and 7, 1996, 8:30 a.m., Quality

Hotel, Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD.

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

June 6, 1996, 8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. to 12

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

discussion, 12 m. to 5 p.m.; open committee discussion, June 7, 1996,

8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. to 12 m., unless

public participation does not last that long; open committee

discussion, 12 m. to 5 p.m.; Rhonda W. Stover or Liz Ortuzar, Center

for Drug Evaluation and Research (HFD-21), 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), Antiviral Drugs Advisory Committee,

code 12531. Please call the hotline for information concerning any

possible changes.

-General function of the committee. The 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.

-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, 1996, 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 June 6, 1996, the committee will

discuss data relevant to new drug application (NDA) 20-585,

Bravavir (sorivudine), Bristol Myers Squibb, for use in the

treatment of herpes zoster in immunocompromised adults. On June 7,

1996, the committee will discuss data relevant to NDA 20-636,

Viramune (nevirapine), Boehringer Ingelheim, for use in the

treatment of human immunodeficiency virus infection.------

Peripheral and Central Nervous System Drugs Advisory Committee

-Date, time, and place. June 7, 1996, 8:30 a.m., Holiday Inn--

Bethesda, Versailles Ballrooms III and IV, 8120 Wisconsin Ave.,

Bethesda, MD.

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

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; Michael A. Bernstein,

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

Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2775,

or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-

0572 in the Washington, DC area), Peripheral and Central Nervous System

Drugs Advisory Committee, code 12543. Please call the hotline for

information concerning any possible changes.

-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 neurological disease.

-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 June 1, 1996, 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 review data from two

clinical studies which evaluated Myotrophin's utility in

treating patients with amyotrophic lateral sclerosis. Data from these

studies have been submitted to FDA in support of a treatment protocol,

investigational new drug application 39,927, Cephalon, Inc.

-Advisory Committee for Reproductive Health Drugs -(formerly Fertility

and Maternal Health Drugs Advisory Committee)

Date, time, and place. June 28, 1996, 9 a.m., Holiday Inn--

Gaithersburg, Whetstone and Walker Rooms, Two Montgomery Village Ave.,

Gaithersburg, MD.

-Type of meeting and contact person. Open committee discussion, 9

a.m. to 5 p.m.; open public hearing, at the completion of the formal

presentations, at approximately 2 p.m. to 3 p.m., unless public

participation does not last that long; Philip A. Corfman, Center for

Drug Evaluation and Research (HFD-510), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD 20857, 301-443-3510, or FDA Advisory

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

Washington, DC area), Advisory Committee for Reproductive Health Drugs,

code 12537. Please call the hotline for information concerning any

possible changes.

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 obstetrics and

gynecology.

-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 June 17, 1996, 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 efficacy of certain oral contraceptives for postcoital emergency

use. Over the years, there has been increasing interest in this use by

health care professionals and consumers. This use has been approved in

some countries, and physicians have prescribed oral contraceptives for

emergency use in the United States, although contraceptives marketed in

the United States are not labeled for this use. On November 23, 1994,

the Center for Reproductive Law and Policy submitted a citizen's

petition requesting FDA to direct sponsors of certain oral

contraceptives to amend the labeling and patient package inserts to

include information regarding the use of these products for postcoital

emergency contraception (Docket No. 94P-0427). FDA denied the petition

but determined that it would be appropriate to discuss the scientific

issues related to the safety and effectiveness of this use with the

Reproductive Health Drugs Advisory Committee to determine whether the

data support the use under certain conditions.

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.

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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: May 16, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96-12797 Filed 5-21-96; 8:45 am]

BILLING CODE 4160-01-F