[Federal Register Volume 60, Number 13 (Friday, January 20, 1995)]
[Notices]
[Pages 4173-4176]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1552]



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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 [[Page 4174]] 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:
Psychopharmacologic Drugs Advisory Committee
    Date, time, and place. February 6, 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, l-800-741-8l38 (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 January 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 discuss the safety 
and effectiveness of Depakote tablets (divalproex sodium 
tablet), new drug application (NDA) 20-320, Abbott Laboratories, for 
use in the treatment of manic episodes associated with bipolar 
disorder.
Subcommittee Meeting of the National Task Force on Aids Drug 
Development/Drug Discovery Issues
    Date, time, and place. February 6, 1995, 8:30 a.m., National 
Institutes of Health, Bldg. 31, rm. 6C-8, 9000 Rockville Pike, 
Bethesda, MD; and February 7, 1995, 8:30 a.m., Executive Plaza North, 
conference room G, 6130 Executive Plaza Blvd., Bethesda, MD.
    Type of meeting and contact person. Open subcommittee discussion, 
February 6, 1995, 8:30 a.m. to 4 p.m.; open public hearing, 4 p.m. to 5 
p.m., unless public participation does not last that long; open 
subcommittee discussion, February 7, 1995, 8:30 a.m. to 4 p.m.; open 
public hearing, 4 p.m. to 5 p.m., unless public participation does not 
last that long; Jean H. McKay or Kimberley M. Miles, Office of AIDS and 
Special Health Issues (HF-12), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-0104, or FDA Advisory 
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), National Task Force on AIDS Drug Development, 
code 12602.
    General function of the task force.  The National Task Force on 
AIDS Drug Development shall identify any barriers and provide creative 
options for the rapid development and evaluation of treatments for 
human immunodeficiency virus (HIV) infection and its sequelae. It also 
advises on issues related to such barriers, and provides options for 
the elimination of these barriers.
    Open subcommittee discussion. On February 6, 1995, the subcommittee 
will present, hear, and discuss issues on the use of and access to 
available animal models in the drug discovery/development process and 
examine the prospects for the development of new models for such 
purposes. On February 7, 1995, the subcommittee will identify 
mechanisms for rapid development and sharing of screening assays and to 
determine the feasibility of an expanded drug-screening effort, related 
to the identification of potential therapies for HIV disease.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the task force. Those desiring to make formal presentations should 
notify the contact person before February 1, 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.
Advisory Committee on Special Studies Relating to the Possible Long-
Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand 
Advisory Committee)
    Date, time, and place. February 13 and 14, 1995, 9 a.m., Holiday 
Inn, 400 Arch St., Philadelphia, PA.
    Type of meeting and contact person. Open committee discussion, 
February 13, 1995, 9 a.m. to 5:30 p.m.; open public hearing, February 
14, 1995, 9 a.m. to 10 a.m., unless public participation does not last 
that long; open committee discussion, 10 a.m. to 5:30 p.m.; Ronald F. 
Coene, National Center for Toxicological Research (HFT-10), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-
3155, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Ranch Hand Advisory 
Committee, code 12560.
    General function of the committee. The committee shall advise the 
Secretary and the Assistant Secretary for Health concerning its 
oversight of the conduct of the Ranch Hand Study by the Air Force and 
other studies in which the Secretary or the Assistant Secretary for 
Health believes involvement by the advisory committee is desirable.
    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 January 31, 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 requested to make their comments.
    Open committee discussion. The committee will continue the review 
of the chapters of the draft report presenting the results of the 1992 
health examination of participants in the Air Force Health Study 
entitled ``An Epidemiologic Investigation of Health Effects in Air 
Force Personnel Following Exposure to Herbicides.'' This review will 
include chapters on: Neoplasia, neurology, psychology, 
gastrointestinal, cardiovascular, hematologic, endocrinologic, and 
immunologic data, as well as information on quality control, 
statistical methods, and covariate associations and the summary chapter 
on conclusions and future directions. A final agenda will be available 
February 6, 1995, from the contact person. [[Page 4175]] 
Oncologic Drugs Advisory Committee
    Date, time, and place. February 14, 1995, 8 a.m., Parklawn Bldg., 
conference rooms D and E, 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 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 February 10, 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 in the order 
listed: (1) NDA 50-718, Dox-SL (pegylated liposomal doxorubicin 
hydrochloride, Liposome Technology, Inc.) for AIDS-related Kaposi's 
Sarcoma in patients who have failed prior systemic combination 
chemotherapy either due to progression of disease or unacceptable 
toxicity; and (2) NDA 20-515, Zoladex (goserelin acetate 
implant, Zeneca Pharmaceuticals Group) for palliative treatment of 
advanced breast cancer in pre- and perimenopausal women.
Cardiovascular and Renal Drugs Advisory Committee
    Date, time, and place. February 23 and 24, 1995, 8:30 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, February 
23, 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 5:30 p.m.; open 
committee discussion, February 24, 1995, 8:30 a.m. to 5:30 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, 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 February 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 February 23, 1995, the committee will 
discuss: (1) NDA 09-218, S-76, Dupont Merck, Coumadin 
(warfarin), for prevention of death, recurrent myocardial infarction, 
and thromboembolic events, such as stroke after myocardial infarction; 
and (2) NDA 20-444, Burroughs Wellcome Co., Flolan 
(epoprostenol), for treatment of primary pulmonary hypertension. On 
February 24, 1995, the committee will discuss antianginal guidelines.
Endocrinologic and Metabolic Drugs Advisory Committee
    Date, time, and place. February 23 and 24, 1995, 8:30 a.m., Holiday 
Inn Silver Spring, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, 
MD.
    Type of meeting and contact person. Open public hearing, February 
23, 1995, 8:30 a.m. to 9 a.m., unless public participation does not 
last that long; open committee discussion, 9 a.m. to 5 p.m.; open 
public hearing, February 24, 1995, 8:30 a.m. to 9 a.m., unless public 
participation does not last that long; open committee discussion, 9 
a.m. to 4 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, 
FAX (301-443-0699), 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 the 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 February 16, 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 February 23, 1995, the committee will 
hear presentations and discuss data submitted regarding the safety and 
efficacy of sermorelin acetate, NDA 20-443 (Geref, Serono), 
for a growth hormone insufficiency indication. On February 24, 1995, 
the committee will discuss nilutamide, NDA 20-169 (Anandron, 
Roussel Uclaf), for a prostate cancer indication.
Board of Tea Experts
    Date, time, and place. February 27 and 28, 1995, 10 a.m., New York 
Regional Laboratory, rm. 700, 850 Third Ave., Brooklyn, NY.
    Type of meeting and contact person. Open public hearing, February 
27, 1995, 10 a.m. to 11 a.m., unless public participation does not last 
that long; open committee discussion, 11 a.m. to 4:30 p.m.; open 
committee discussion, February 28, 1995, 10 a.m. to 4:30 p.m.; Faith F. 
Lim, New York Regional Laboratory, Food and Drug Administration, 850 
Third Ave., Brooklyn, NY 11232, 718-965-5730, or FDA Advisory Committee 
Information Hotline, 1-800-8138 (301-443-0572 in the Washington, DC 
area), Board of Tea Experts, code 12601.
    General function of the board. The board advises on establishment 
of uniform standards of purity, quality, and fitness for consumption of 
all tea [[Page 4176]] imported into the United States under 21 U.S.C. 
42.
    Agenda--Open public hearing. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee.
    Open board discussion. The board will discuss and select tea 
standards.
    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.
    The Commissioner approves the scheduling of meetings at locations 
outside of the Washington, DC, area on the basis of the criteria of 21 
CFR 14.22 of FDA's regulations relating to public advisory committees.

    Dated: January 13, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-1552 Filed 1-19-95; 8:45 am]
BILLING CODE 4160-01-F