[Federal Register Volume 60, Number 164 (Thursday, August 24, 1995)]
[Notices]
[Pages 44036-44039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21001]



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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 

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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:
Device Good Manufacturing Practice Advisory Committee
    Date, time, and place. September 13 and 14, 1995, 8:30 a.m., 
Holiday Inn--Gaithersburg, 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 committee meeting block of rooms. Reservations will be confirmed at 
the group rate based on availability. Attendees with a disability 
requiring special accommodations should contact Ed Regenstein, 
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, September 
13, 1995, 8:30 a.m. to 2:30 p.m., unless public participation does not 
last that long; open committee discussion, 2:30 p.m. to 4:30 p.m.; open 
committee discussion, September 14, 1995, 8:30 a.m. to 4:30 p.m.; 
Sharon M. Kalokerinos, Center for Devices and Radiological Health (HFZ-
331), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 
20850, 301-594-4613, ext. 139, or FDA Advisory Committee Information 
Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC area), 
Device Good Manufacturing Practice Advisory Committee, code 12398.
    General function of the committee. The committee reviews proposed 
regulations for good manufacturing practices governing the methods used 
in, and the facilities and controls used for, the manufacture, packing, 
storage, and installation of devices, and makes recommendations on the 
feasibility and reasonableness of the proposed regulations.
    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 August 30, 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. The committee will consider the 
tentative final rule on quality systems which sets forth requirements 
for current good manufacturing practices to include methods used in, 
and the facilities and controls used for the design, purchasing, 
manufacturing, packaging, labeling, storage, installation, and 
servicing of all finished medical devices intended for human use. This 
document was made available through a Notice of Availability published 
on July 24, 1995 (60 FR 37856), and copies can be obtained from the 
Division of Small Manufacturers Assistance (HFZ-220), Food and Drug 
Administration, 1350 Piccard Dr. Rockville, MD 20850. -
Peripheral and Central Nervous System Drugs Advisory Committee
    Date, time, and place. September 18, 1995, 8:30 a.m., Parklawn 
Bldg., conference rooms G through J, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, 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.; 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.-
    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 September 11, 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. The committee will discuss the safety 
and effectiveness of Rilutek (riluzole), new drug application 
(NDA) 20-599, Rhone-Poulenc Rorer Pharmaceuticals, Inc., for use in the 
treatment of Amyotrophic Lateral Sclerosis (ALS).
Pulmonary-Allergy Drugs Advisory Committee
    Date, time, and place. September 25, 1995, 8 a.m., Parklawn Bldg., 
conference rooms G through J, 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.; 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), Pulmonary-Allergy Drugs Advisory Committee, code 
12545.
    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 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 September 25, 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. The committee will discuss two NDA's: 
(1) 

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NDA 20-548, FloventTM Inhalation Aerosol (a metered-dose inhaler 
formulation of fluticasone propionate), and (2) NDA 20-549, 
FloventTM Inhalation via Diskhaler (a dry powder formulation of 
fluticasone propionate). Both NDA's are indicated for the maintenance 
treatment of bronchial asthma and for treatment of patients requiring 
oral corticosteroid therapy for asthma who may be able to significantly 
reduce or eliminate their requirement for oral corticosteroids over 
time. The sponsor for both NDA's is Glaxo Welcome.
Endocrinologic and Metabolic Drugs Advisory Committee
    Date, time, and place. September 28, 1995, 8 a.m., Parklawn Bldg., 
conference rooms G through J, 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.; Kathleen R. Reedy, Center for 
Drug Evaluation and Research, Advisors and Consultants Staff (HFD-9), 
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), Endocrinologic and 
Metabolic Drugs Advisory Committee, code 12536.
    General function of 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 September 21, 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. The committee will hear presentations 
and discuss data submitted regarding the safety and efficacy of 
dexfenfluramine hydrochloride, NDA 20-344, Interneuron Pharmaceuticals, 
Inc., for an obesity indication.
Joint Meeting of the Drug Abuse Advisory Committee and the -
Endocrinologic and Metabolic Drugs Advisory Committee
    Date, time, and place. September 29, 1995, 9 a.m., Parklawn Bldg., 
conference rooms G through J, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, 9 a.m. to 
10 a.m., unless public participation does not last that long; open 
committee discussion, 10 a.m. to 5 p.m.; Stephen P. Pollitt or Kathleen 
R. Reedy, Center for Drug Evaluation and Research (HFD-9), 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), Drug Abuse Advisory 
Committee, code 12535.
    General function of the committee. The Drug Abuse Advisory 
Committee advises on the scientific and medical evaluation of 
information gathered by the Department of Health and Human Services and 
the Department of Justice on the safety, efficacy, and abuse potential 
of drugs, and recommends actions to be taken on the marketing, 
investigation, and control of such drugs. The Endocrinologic and 
Metabolic Drugs Advisory 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 September 18, 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. The committees will discuss the petition 
to remove from the Controlled Substance Act, Fenfluramine and its 
isomers, Fenfluramine, NDA 16-618, Wyeth-Ayerst, and Dexfenfluramine, 
NDA 20-344, Interneuron Pharmaceuticals Inc.
    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 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., 

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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: August 17, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-21001 Filed 8-23-95; 8:45 am]
BILLING CODE 4160-01-F