[Federal Register Volume 61, Number 211 (Wednesday, October 30, 1996)]
[Notices]
[Pages 55990-55991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27854]
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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:
Joint Meeting of the Nonprescription Drugs Advisory Committee, the
Advisory Committee for Reproductive Health Drugs, the Anti-Infective
Drugs Advisory Committee, and the Antiviral Drugs Advisory Committee
Date, time, and place. November 20, 1996, 1 p.m., and November 21
and 22, 1996, 8:30 a.m., Holiday Inn--Gaithersburg, Ballroom, Two
Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open committee discussion,
November 20, 1996, 1 p.m. to 3 p.m.; open public hearing, 3 p.m. to 4
p.m., unless public participation does not last that long; open
committee discussion, 4 p.m. to 5:30 p.m.; open committee discussion,
November 21, 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 public hearing, November
22, 1996, 8:30 a.m. to 9:30 a.m., unless public participation does not
last that long; open committee discussion, 9:30 a.m. to 5 p.m.;
Kennerly K. Chapman, Center for Drug Evaluation and Research (HFD-21),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
301-443-5455, or e-mail chapmank@cder.fda.gov, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Nonprescription Drugs Advisory Committee, code
12541. Please call the hotline for information concerning any possible
changes.
General function of the committees. The Nonprescription Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (OTC) (nonprescription)
human drug products for use in the treatment of a broad spectrum of
human symptoms and diseases. The Advisory Committee for Reproductive
Health Drugs reviews and evaluates data on the safety and effectiveness
of marketed and investigational human drugs for use in the practice of
obstetrics, gynecology, and related specialties. The Anti-Infective
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 infectious diseases and
disorders. 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.
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 November 6, 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 committees discussion. On November 20, 1996, the committees
will jointly discuss issues relevant to the use of microbicidal topical
vaginal agents against infection with sexually transmitted Chlamydia
trachomatis (CT) and Neisseria gonorrhoeae (GC). In light of the
significant public health impact of these sexually transmitted
diseases, and the difficulties related to the evaluation and promotion
of topical vaginal agents as prophylaxis against CT and GC, FDA is
soliciting opinions and advice from the advisory committees regarding
the development of policy for topical vaginal bacteriocidal agents.
Issues for discussion include: (1) The quality and type of data that
are available to support the use of such agents as prophylaxis against
CT and GC, (2) what additional data would be required by the agency to
create a label for such agents, and (3) whom would the appropriate
target audience be for such agents. The agency encourages
investigators, academicians, and members of the pharmaceutical industry
with information about the use of such agents as prophylaxis against
infection with CT and GC to respond to this notice. On November 21,
1996, the committees will discuss guidelines for the development of
vaginal products for preventing the transmission of the human
immunodeficiency virus (HIV). On November 22, 1996, the committees will
discuss proposals and guidances for clinical efficacy studies on
marketed OTC vaginal spermicides. Issues for discussion will include
the type of data and quality of both in vitro and in vivo data needed
to support and ensure spermicidal efficacy in final formulation.
Antiviral Drugs Advisory Committee
Date, time, and place. November 22, 1996, 8:30 a.m., Gaithersburg
Hilton, Ballroom, 620 Perry Pkwy., Gaithersburg, MD.
[[Page 55991]]
Type of meeting and contact person. Open committee discussion,
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 4:30 p.m.; Rhonda W. Stover, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, 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 November 15, 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 data
relevant to new drug application (NDA) 20-705, Rescriptor,
(delavirdine, Pharmacia and Upjohn Co.) for use in the treatment of HIV
infection.
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 the meeting(s) 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 (a)(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: October 22, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-27854 Filed 10-29-96; 8:45 am]
BILLING CODE 4160-01-F
