[Federal Register Volume 59, Number 97 (Friday, May 20, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12375]
[[Page Unknown]]
[Federal Register: May 20, 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.
MEETINGS: The following advisory committee meetings are announced:
Peripheral and Central Nervous System Drugs Advisory Committee
Date, time, and place. June 6, l994, 9 a.m., and June 7, l994, 8:30
a.m., Potomac Inn, Ballrooms A, B, and C, Three Research Ct.,
Rockville, MD.
Type of meeting and contact person. Open committee discussion, June
6, 1994, 9 a.m. to 5 p.m.; open committee discussion, June 7, l994,
8:30 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.; Michael A. Bernstein, Center for Drug
Evaluation and Research (HFD-120), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2850.
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 neurological disease.
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 June 1, l994, 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
intracerebroventricular (ICV) administration of drugs and biologics for
the treatment of chronic neurologic illness.
Cardiovascular and Renal Drugs Advisory Committee
Date, time, and place. June 9 and 10, 1994, 9 a.m., National
Institutes of Health, Clinical Center, Bldg. 10, Jack Masur Auditorium,
9000 Rockville Pike, Bethesda, MD. 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, June 9,
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, June 10, 1994, 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.
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 May 23, 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 June 9, 1994, the committee will
discuss: (1) New drug application (NDA) 20-364, benazepril HC1/
amlodipine besylate, Ciba-Geigy, to be indicated for hypertension and
(2) product license application (PLA) 93-1057 (abciximab),
CentoRx, Centocor, for high risk angioplasty. On June 10,
1994, the committee will discuss PLA 1048, Supplement #93-0889
(alteplase recombinant), Activase, Genentech, Inc., for new
accelerated dose regimen.
Blood Products Advisory Committee
Date, time, and place. June 21 and 22, 1994, 8 a.m., Holiday Inn--
Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.
Type of meeting and contact person. Open committee discussion, June
21, 1994, 8 a.m. to 8:30 a.m.; 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 5:30 p.m.; open committee
discussion, June 22, 1994, 8 a.m. to 6 p.m.; Linda A. Smallwood, Center
for Biologics Evaluation and Research (HFM-300), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
6700.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness, and appropriate use of
blood products intended for use in the diagnosis, prevention, or
treatment of human 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 June 13, 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 June 21, 1994, the committee will
discuss and provide recommendations on plasma collected by apheresis,
particularly with regard to infrequent donations of different
frequencies, and on autologous blood donation, and in the afternoon,
will discuss and provide recommendations on red cell loss during source
plasma collection and plateletpheresis, and will hear an informational
summary of regulatory issues concerning stem cells. The agenda for June
22, 1994, has not been developed. An amendment to this notice will be
published in the Federal Register at a later date.
Dental Products Panel Plaque Subcommittee (Nonprescription Drugs) of
the Medical Devices Advisory Committee
Date, time, and place. June 28 and 29, 1994, 9 a.m., Parklawn
Bldg., conference rm. E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open committee discussion, June
28, 1994, 9 a.m. to 12 m.; open public hearing 12 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, June 29, 1994,
9 a.m. to 11 a.m.; open public hearing, 11 a.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 A. Mason,
Center for Drug Evaluation and Research (HFD-813), Food and Drug
Administration, 7520 Standish Pl., Rockville, MD 20855, 301-594-1003.
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 subcommittee. Those desiring to make formal
presentations should notify the contact person before June 17, 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 begin a discussion
of the possible relationship of alcohol-containing mouthwashes to the
development of oral and pharyngeal cancers. It will also begin to
discuss general guidelines for determining the safety and effectiveness
of antiplaque and antiplaque-related drug products.
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: May 16, 1994.
Linda A. Suydam,
Interim Dupty Commissioner for Operations.
[FR Doc. 94-12375 Filed 5-19-94; 8:45 am]
BILLING CODE 4160-01-F