[Federal Register Volume 61, Number 100 (Wednesday, May 22, 1996)]
[Notices]
[Pages 25682-25684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12797]



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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 Activase<SUP>TM (alteplase), Genentech, 
for the management of acute ischemic stroke.

[[Page 25683]]

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<Register> (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<Register> (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<Register>'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.

[[Page 25684]]

    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