[Federal Register Volume 60, Number 186 (Tuesday, September 26, 1995)]
[Notices]
[Pages 49616-49619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-23738]
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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:
Arthritis Advisory Committee
Date, time, and place. October 11, 1995, 8 a.m., Holiday Inn--
Gaithersburg, Whetstone Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD, and October 12, 1995, 8:30 a.m., Holiday Inn--Silver
Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion,
October 11, 1995, 8 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2
p.m., unless public participation does not last that long; open
committee discussion, 2 p.m. to 5 p.m.; open committee discussion,
October 12, 1995, 8:30 a.m. to 9:30 a.m.; open public hearing, 9:30
a.m. to 10:30 a.m., unless public participation does not last that
long; open committee discussion, 10:30 a.m. to 4:30 p.m.; Isaac F.
Roubein or Kathleen 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), Arthritis
Advisory Committee, code 12532.
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 arthritic conditions.
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 29, 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 October 11, 1995, the committee will
consider issues presented in a citizen petition submitted by the Health
Research Group of Public Citizen (Docket No. 94P-0458/CP1). The
petition requests that FDA remove from the market drug products
containing piroxicam, a nonsteroidal anti-inflammatory drug (NSAID),
stating that the drug presents a significantly higher risk of
gastropathy than other drugs in its class. The committee will examine
safety data for the drug and advise FDA on whether piroxicam should be
withdrawn from the market, whether changes in the drugs' labeling
should be made, or whether no action need be taken. On October 12,
1995, the committee will examine the adequacy of the current
gastropathy warnings in labeling for the class of NSAID's.
Food Advisory Committee
Date, time, and place. October 11 and 12, 1995, 9 a.m., Disabled
American Veterans, Denvel D. Adams National Service and Legislative
Headquarters, 807 Maine Ave. SW., Washington, DC. Seating for this
meeting is limited. If you plan to attend, please call a contact person
listed below to reserve a seat.
Type of meeting and contact person. Open committee discussion,
October 11, 1995, 9 a.m. to 4 p.m.; open public hearing, October 12,
1995, 9 a.m. to 10 a.m., unless public participation does not last that
long; open committee discussion, 10 a.m. to 4 p.m.; Lynn A. Larsen,
Center for Food Safety and Applied Nutrition (HFS-5), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4727, or
Catherine M. DeRoever, Advisory Committee Staff (HFS-22), 202-205-4251,
FAX 202-205-4970, or FDA Advisory Committee Information Hotline, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), Food Advisory
Committee, code 10564.
General function of the committee. The committee provides advice on
emerging food safety, food science, and nutrition issues that FDA
considers of primary importance in the next decade.
Agenda--Open public hearing. Interested persons may present data,
information, or views, orally or in
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writing, on issues pending before the committee. Those desiring to make
formal presentations should notify the contact person by close of
business September 29, 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. If necessary,
comments may be limited to 5 minutes.
Open committee discussion. A working group will consider the
significance and extent of the serious adverse events associated with
the consumption of food products containing a source of ephedrine
alkaloids, including ephedrine, pseudoephedrine, and norpseudoephedrine
from Ephedra sinica Stapf. and other related species (e.g., Ma huang
and Chinese ephedra). More detailed information regarding the meeting
agenda that may become available prior to the meeting and on the
availability of background materials will be provided to the public via
the 800 number given above.
Psychopharmacologic Drugs Advisory Committee
Date, time, and place. October 16, 1995, 8:30 a.m., Parklawn Bldg.,
conference rooms D and E, 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, 301-594-5521,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Psychopharmacologic Drugs Advisory
Committee, code 12544.
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 practice of psychiatry and
related fields.
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 October 9, 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 REMERON (mirtazapine), new drug
application (NDA) 20-415, Organon, Inc., for use in the treatment of
depression.-
Oncologic Drugs Advisory Committee
Date, time, and place. October 16 and 17, 1995, 8 a.m., Quality
Hotel, Maryland Room, 8727 Colesville Rd., Silver Spring, MD.
Type of meeting and contact person. Open public hearing, October
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 5 p.m.; open
public hearing, October 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 5 p.m.; Adele S. Seifried, 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), Oncologic Drugs Advisory Committee, code 12542.
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 treatment of cancer.
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 October 12, 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 October 16, 1995, the committee will
discuss: (1) NDA 20-497, Fareston (toremifene, Orion Corp.)
for treatment of advanced breast cancer in postmenopausal women and (2)
NDA 20-541, Arimidex (anastrozole, Zeneca Pharmaceuticals) as
``a selective aromatase inhibitor for the treatment of postmenopausal
women with advanced breast cancer who develop progressive disease while
receiving tamoxifen.'' On October 17, 1995, the committee will discuss:
(1) NDA 20-449, Taxotere (docetaxel, Rhone-Poulenc Rorer) for
treatment of ``patients with locally advanced or metastatic breast
carcinoma in whom previous therapy has failed; prior therapy should
have included an anthracycline unless clinically contraindicated,'' and
(2) product license application 91-0209, CEA-ScanTM (arcitumomab,
Immunomedics, Inc.) ``for diagnostic imaging in pre-surgical patients
who are being considered for resection of recurrent/metastatic
colorectal cancer and, in combination with standard diagnostic
modalities (SDM), for more accurate localization of carcinoembryonic
antigen (CEA)-producing colorectal cancers.''
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. October 19 and 20, 1995, 8:30 a.m., Holiday
Inn--Gaithersburg, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD. A limited number of overnight accommodations have
been reserved at the Holiday Inn--Gaithersburg. Attendees requiring
overnight accommodations may contact the hotel at 301-948-8900 and
reference the FDA Ophthalmic 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., 8300 Colesville Rd., suite 550, Silver
Spring, MD 20910, 301-608-2151. The availability of appropriate
accommodations cannot be assured unless prior notification is received.
Type of meeting and contact person. Open public hearing, October
19, 1995, 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.; open
public hearing, October 20, 1995, 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.; Sara M. Thornton, Center for Devices and Radiological
Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-2053, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Ophthalmic Devices Panel, code 12396.
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
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committee. Those desiring to make formal presentations should notify
the contact person before September 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. On October 19, 1995, the committee will
discuss general issues relating to premarket approval applications
(PMA's) for retinal tamponades used for the treatment of complicated
retinal detachments. On October 20, 1995, the committee will discuss
general issues relating to a PMA for an excimer laser for
photorefractive keratectomy. General updates will include the redraft
of the myopia refractive laser guidance document.
Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. October 19 and 20, 1995, 9 a.m., National
Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium,
9000 Rockville Pike, Bethesda, MD. Parking in the Clinical Center
visitor area is reserved for Clinical Center patients and their
visitors. If you must drive, please use an outlying lot such as Lot
41B. Free shuttle bus service is provided from Lot 41B to the Clinical
Center every 8 minutes during rush hour and every 15 minutes at other
times.
Type of meeting and contact person. Open public hearing, October
19, 1995, 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.; open committee
discussion, October 20, 1995, 9 a.m. to 5 p.m.; Joan C. Standaert,
Center for Drug Evaluation and Research (HFD-110), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-259-6211,
or Valerie M. Mealy, Advisors and Consultants Staff, 301-443-4695, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Cardiovascular and Renal Drugs
Advisory Committee, code 12533.
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 cardiovascular and renal
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 October 6, 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 October 19, 1995, the committee will
discuss NDA: 20-491, ibutilide (Convert, The Upjohn Co.), for
conversion of atrial flutter and atrial fibrillation, and NDA 20-546,
vasoprost (Alprostadil Schwarz-Pharma Kremers Urban) for
severe peripheral arterial occlusive disease to reduce the incidence of
leg amputations in nondiabetic patients. On October 20, 1995, the
committee will discuss ``Anti-hypertensive Agents; Guidelines for
Therapy.''
Joint Meeting of the Anti-Infective Drugs Advisory Committee and the
Gastrointestinal Drugs Advisory Committee
Date, time, and place. October 26, 1995, 8:30 a.m., Holiday Inn--
Gaithersburg, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, 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.; Ermona B. McGoodwin or
Valerie Mealy, 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), Anti-Infective Drugs
Advisory Committee, code 12530. -
General function of the committees. 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 Gastrointestinal Drugs Advisory Committee reviews and evaluates
data on the safety and effectiveness of marketed and investigational
human drugs for use in gastrointestinal diseases.
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 October 20, 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 meet jointly to
discuss treatment of Helicobacter pylori to reduce peptic ulcer
recurrence and to discuss resistance implications of widespread
Helicobacter pylori treatment.
Anti-Infective Drugs Advisory Committee
Date, time, and place. October 27, 1995, 8:30 a.m., Holiday Inn--
Gaithersburg, Grand Ballroom, Two Montgomery Village Ave.,
Gaithersburg, 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.; Ermona B. McGoodwin or Mary
Elizabeth Donahue, 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), Anti-Infective Drugs
Advisory Committee, code 12530.
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 infectious diseases and 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 October 20, 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 diagnosis
of Helicobacter pylori related gastrointestinal disease and resistance
implications of widespread Helicobacter pylori treatment.
FDA public advisory committee meetings may have as many as four
separable portions: (1) An open public hearing, (2) an open committee
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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.,
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: September 19, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-23738 Filed 9-25-95; 8:45 am]
BILLING CODE 4160-01-F
