[Federal Register Volume 59, Number 220 (Wednesday, November 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-28449]


[[Page Unknown]]

[Federal Register: November 16, 1994]


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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:

Gastrointestinal Drugs Advisory Committee

    Date, time, and place. December 1, 1994, 9 a.m., and December 2, 
1994, 8:30 a.m., Parklawn Bldg., conference rms. D and E, 5600 Fishers 
Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, December 
1, 1994, 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, December 2, 1994, 8:30 a.m. to 4 p.m.; Joan C. Standaert, 
Center for Drug Evaluation and Research (HFD-180), 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), Gastrointestinal Drugs Advisory 
Committee, code 12538.
     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 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 November 16, 1994, 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 December 1, 1994, the committee will 
discuss new drug application (NDA) 20-406, TAP Pharmaceuticals, 
Prevacid (lansoprazole), to be indicated for the treatment of 
reflux esophagitis, maintenance of healing of reflux esophagitis, 
duodenal ulcer and hypersecretory conditions including Zollinger-
Ellison syndrome. On December 2, 1994, the committee will discuss NDA 
19-810, Astra-Merck, Prilosec (omeprazole) for maintenance 
treatment of gastroesophageal reflux disease.

Circulatory System Devices Panel of the Medical Devices Advisory 
Committee

    Date, time, and place. December 5, 1994, 8:30 a.m., Holiday Inn--
Gaithersburg, Goshen and Whetstone Ballrooms, 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 panel meeting block. Reservations will be 
confirmed at the group rate based on availability.
    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 4:30 p.m.; Ramiah Subramanian, 
Center for Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Circulatory System Devices 
Panel of the Medical Devices Advisory Committee, code 12625.
    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 26, 1994, 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 general 
issues relating to the review of two premarket approval applications, 
one for a ventricular assist device and one for a dysrhythmia treatment 
device.

Dental Drug Products Panel Plaque Subcommittee (Nonprescription 
Drugs) of the Medical Devices Advisory Committee

    Date, time, and place. December 5 and 7, 1994, 9 a.m., Renaissance 
Hotel at Tech World, Salons A and B of the Renaissance Ballroom, 999 
Ninth St. NW., Washington, DC.
    Type of meeting and contact person. Open committee discussion, 
December 5, 1994, 9 a.m. to 1 p.m.; open public hearing, 1 p.m. to 3 
p.m., unless public participation does not last that long; open 
committee discussion, 3 p.m. to 5 p.m.; open committee discussion, 
December 7, 1994, 9 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 4 p.m.; Jeanne L. Rippere or Stephanie 
Mason, Center for Drug Evaluation and Research (HFD-813), Food and Drug 
Administration, 7520 Standish Pl., Rockville, MD 20855, 301-594-1003, 
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Dental Products Panel of the Medical 
Devices Advisory Committee, code 12518.
    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.
    The Dental Products Panel of the Medical Devices Advisory Committee 
functions at times as a nonprescription drug advisory panel. As such, 
the panel reviews and evaluates available data concerning the safety 
and effectiveness of active ingredients, and combinations thereof, of 
various currently marketed nonprescription drug products for human use, 
the adequacy of their labeling, and advises the Commissioner of Food 
and Drugs on the promulgation of monographs establishing conditions 
under which these drugs are generally recognized as safe and effective 
and not misbranded.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on the general issues 
pending before the committee. Those desiring to make formal 
presentations should notify the contact person before November 25, 
1994, 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 subcommittee will continue with its 
discussions held during the October 11, 1994, and June 28 and 29, 1994, 
meetings as follows: (1) The possible relationship of alcohol-
containing mouthwashes to the development of oral and pharyngeal 
cancers, (2) the drug/cosmetic status of antiplaque products and 
claims, and (3) work on developing general guidelines for determining 
the safety and effectiveness of antiplaque and antiplaque-related drug 
products. The committee will also work on a draft document to be 
presented at a joint meeting of the Dental Drug Products Panel and the 
Dental Drug Products Panel Plaque Subcommittee on December 6, 1994 (see 
meeting announcement elsewhere in this issue of the Federal Register).
Joint Meeting of the Dental Drug Products Panel and the Dental Drug 
Products Plaque Subcommittee (Nonprescription Drugs) of the Medical 
Devices Advisory Committee
    Date, time, and place. December 6, 1994, 9 a.m., Renaissance Hotel 
at Tech World, Salons A and B of the Renaissance Ballroom, 999 Ninth 
St. NW., Washington, DC.
    Type of meeting and contact person. Open committee discussion, 9 
a.m. to 1 p.m.; open public hearing, 1 p.m. to 3 p.m., unless public 
participation does not last that long; open committee discussion, 3 
p.m. to 5 p.m.; Jeanne L. Rippere or Stephanie Mason, Center for Drug 
Evaluation and Research (HFD-813), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-1003, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), Dental Products Panel of the Medical Devices 
Advisory Committee, code 12518.
    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.
    The Dental Products Panel of the Medical Devices Advisory Committee 
functions at times as a nonprescription drug advisory panel. As such, 
the panel reviews and evaluates available data concerning the safety 
and effectiveness of active ingredients, and combinations thereof, of 
various currently marketed nonprescription drug products for human use, 
the adequacy of their labeling, and advises the Commissioner of Food 
and Drugs on the promulgation of monographs establishing conditions 
under which these drugs are generally recognized as safe and effective 
and not misbranded.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on the general issues 
pending before the committee. Those desiring to make formal 
presentations should notify the contact person before November 25, 
1994, 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 panel and subcommittee will discuss: 
(1) Definitions and general information related to antiplaque and 
antiplaque-related drug products and claims, (2) the possible 
relationship of alcohol-containing mouthwashes to the development of 
oral and pharyngeal cancers, (3) the drug/cosmetic status of antiplaque 
products and claims, and (4) general guidelines for determining the 
safety and effectiveness of antiplaque and antiplaque-related drug 
products.
Oncologic Drugs Advisory Committee
    Date, time, and place. December 12 and 13, 1994, 8 a.m., Parklawn 
Bldg, conference rms. D and E, 5600 Fishers Lane, Rockville, MD.
    Type of meeting and contact person. Open public hearing, December 
12, 1994, 8 a.m. to 8:30 a.m., unless public participation does not 
last that long; open committee discussion, 8:30 a.m. to 4:30 p.m.; open 
public hearing, December 13, 1994, 8 a.m. to 8:30 a.m., unless public 
participation does not last that long; open committee discussion, 8:30 
a.m. to 4:30 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 the 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 December 5, 1994, 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 December 12, 1994, the committee will 
discuss: (1) NDA 20-212, ZinecardTM (dexrazoxane for injection, 
Pharmacia, Inc.) ``for preventing/reducing the incidence and severity 
of cardiomyopathy associated with doxorubicin administration in 
patients who have received potentially cardiotoxic doses of doxorubicin 
and who, in their physician's opinion, would benefit from continuing 
therapy with doxorubicin,'' and (2) NDA 20-221, Ethyol (amifostine 
injection, U.S. Bioscience, Inc.) ``as a cytoprotective agent against 
both the acute and cumulative hematologic and renal toxicities 
associated with alkylating agents such as cyclophosphamide, and 
platinum agents such as cisplatin, in patients with ovarian cancer.'' 
On December 13, 1994, 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 ``patients with 
locally advanced or metastatic non-small cell lung cancer even after 
failure of platinum-based chemotherapy,'' and (2) NDA 20-438, 
VesanoidTM (tretinoin, all-trans retinoic acid, Hoffmann-La Roche, 
Inc.) ``for the treatment of patients with acute promyelocytic leukemia 
(APL)'' * * * ``for induction of remission in patients who are 
resistant to or are contraindicated for anthracycline-based 
chemotherapy or have relapsed after entering remission induced by 
chemotherapy.''
    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., 
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: November 14, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-28449 Filed 11-15-94; 8:45 am]
BILLING CODE 4160-01-F