[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 [email protected], 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