[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 

[[Page 54235]]
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]
BILLING CODE 4160-01-F