[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
