[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
