[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