[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 ActivaseTM (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 (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.
[[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
