[Federal Register Volume 60, Number 203 (Friday, October 20, 1995)]
[Notices]
[Pages 54233-54235]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26053]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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:
Endocrinologic and Metabolic Drugs Advisory Committee
Date, time, and place. November 16 and 17, 1995, 8 a.m., Holiday
Inn--Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring,
MD.
Type of meeting and contact person. Open public hearing, November
16, 1995, 8 a.m. to 8:30 a.m., unless public participation does not
last that long; open committee discussion, 8:30 a.m. to 6 p.m.; open
public hearing, November 17, 1995, 8 a.m. to 8:30 a.m., unless public
participation does not last that long; open committee discussion, 8:30
a.m. to 4 p.m.; Kathleen R. Reedy, Center for Drug Evaluation and
Research (HFD-9), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-5455, FAX 301-443-0699, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area) Endocrinologic and Metabolic Drugs Advisory
Committee, code 12536.
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 endocrine and metabolic
disorders.
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 10, 1995, 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 November 16, 1995, in the morning,
the committee will hear presentations and discuss data submitted
regarding the safety and efficacy of dexfenfluramine hydrochloride, new
drug application (NDA) 20-344 (Interneuron Pharmaceuticals, Inc.), for
an obesity indication, as followup to the meeting of September 28,
1995. In the afternoon, the committee will hear presentations and
discuss data submitted regarding the safety and efficacy of sodium
fluoride USP, NDA 19-975 (Slow Fluoride, Texas Southwest Medical
Center), for an osteoporosis indication. On November 17, 1995, the
committee will discuss data regarding the safety and efficacy of
probucol, NDA 17-535 (Lorelco, Hoechst Marion Roussel), for a
lipid altering indication and whether the drug should be withdrawn from
the market.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the
Pulmonary-Allergy Drugs Advisory Committee
-Date, time, and place. November 16, 1995, 8 a.m., Parklawn Bldg.,
conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
-Type of meeting and contact person. Open public hearing, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 5 p.m.; Lee L. Zwanziger, Liz L.
Ortuzar, or Leander B. Madoo, Center for Drug Evaluation and Research
(HFD-9), 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), Nonprescription
Drugs Advisory Committee, code 12541.
-General function of the committees. The Nonprescription Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products for use in the treatment of a broad spectrum of human
symptoms and diseases. The Pulmonary-Allergy Drugs Advisory Committee
reviews and evaluates data on the safety and effectiveness of marketed
and investigational human drugs for use in the treatment of pulmonary
disease and diseases with allergic and/or immunologic mechanisms.
-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 10, 1995, 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 requested to make their comments.
-Open committee discussion. The committees will first discuss data
relevant to investigational new drug (IND) 41,743, sponsored by Sandoz
Pharmaceuticals Corp., on the efficacy of clemastine fumarate in the
common cold. The committees will then discuss a meta-analysis of data
on antihistamines and the common cold to address the inclusion of the
common cold indication for the over-the-counter antihistamines, which
is currently in the tentative final monograph, in the final monograph.
Joint Meeting of the Nonprescription Drugs Advisory Committee and the
Dermatologic and Ophthalmic Drugs Advisory Committee
-Date, time, and place. November 17, 1995, 8 a.m., Parklawn Bldg.,
conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
-Type of meeting and contact person. Open public hearing, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 4 p.m.; Lee L. Zwanziger, Liz L.
Ortuzar, or Ermona McGoodwin, Center
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for Drug Evaluation and Research (HFD-9), 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), Nonprescription Drugs Advisory Committee, code
12541.
-General function of the committees. The Nonprescription Drugs
Advisory Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (nonprescription) human
drug products for use in the treatment of a broad spectrum of human
symptoms and diseases. The Dermatologic and Ophthalmic 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 dermatologic and ophthalmic disorders.
-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 10, 1995, 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 requested to make their comments.
-Open committee discussion. The committees will discuss data
relevant to NDA 19-501 to switch Rogaine (minoxidil 2%
topical solution, The Upjohn Co.), for use as a hair regrowth treatment
for persons with androgenetic alopecia, from prescription to over-the-
counter marketing status.
National Task Force on AIDS Drug Development
Date, time, and place. November 20, 1995, 8:30 a.m.; Hubert H.
Humphrey Bldg., rm. 800, 200 C St. NW., Washington, DC.
Type of meeting and contact person. Open task force discussion,
8:30 a.m. to 4:30 p.m.; open public hearing, 4:30 p.m. to 5:30 p.m.,
unless public participation does not last that long; Heidi C. Marchand
or Kimberley M. Thornton, Office of AIDS and Special Health Issues (HF-
12), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-443-0104, or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), National Task
Force on AIDS Drug Development, code 12602.
General function of the task force. The task force shall identify
any barriers and provide creative options for the rapid development and
evaluation of treatments for the human immunodeficiency virus (HIV)
infection and its sequelae. The task force also advises on issues
related to such barriers, and it provides options for the elimination
of these barriers.
Open task force discussion. The task force will present, hear, and
discuss recommendations made at previous meetings and discuss the
future of the task force.
Agenda--Open public hearing. Interested persons may present
information or views, orally or in writing, on issues pending before
the task force. Those desiring to make formal presentations should
notify the contact person before November 15, 1995, 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.
Immunology Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. November 30 and December 1, 1995, 8 a.m.,
Holiday Inn--Gaithersburg, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD. A limited number of overnight accommodations have
been reserved at the hotel. Attendees requiring overnight
accommodations may contact the hotel at 301-948-8900 and reference the
FDA Panel meeting block. Reservations will be confirmed at the group
rate based on availability. Attendees with a disability requiring
special accommodations should contact Ed Rugenstein, Sociometrics,
Inc., 301-608-2151. The availability of appropriate accommodations
cannot be assured unless prior written notification is received.
Type of meeting and contact person. Open public hearing, November
30, 1995, 8 a.m. to 9 a.m., unless public participation does not last
that long; open committee discussion, 9 a.m. to 6 p.m.; open public
hearing, December 1, 1995, 8 a.m. to 9 a.m., unless public
participation does not last that long; open committee discussion, 9
a.m. to 5 p.m.; Peter E. Maxim, Center for Devices and Radiological
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd.,
Rockville, MD 20850, 301-594-1293, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Immunology Devices Panel, code 12516.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness of marketed and
investigational devices and makes recommendations for their regulation.
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, 1995, 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 November 30, 1995, the committee will
discuss general issues relating to the review of two premarket approval
applications for: (1) An in situ hybridization assay to measure a
prognostic marker in breast tumor tissues; and (2) an assay to measure
a urinary marker to aid in the detection of recurrence in bladder
cancer patients. On December 1, 1995, the committee will discuss a
citizen's petition to reclassify from Class III to Class II all serum
tumor markers that are intended for monitoring recurrence in previously
treated cancer patients.
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 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
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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: October 16, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-26053 Filed 10-19-95; 8:45 am]
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