[Federal Register Volume 59, Number 161 (Monday, August 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20510]
[[Page Unknown]]
[Federal Register: August 22, 1994]
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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.
MEETINGS: The following advisory committee meetings are announced:
Antiviral Drugs Advisory Committee
Date, time, and place. September 12 and 13, 1994, 8:30 a.m.;
Holiday Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
Type of meeting and contact person. Open committee discussion,
September 12, 1994, 8:30 a.m. to 11:30 a.m.; open public hearing, 11:30
a.m. to 12 m., unless public participation does not last that long;
open committee discussion, 12 m. to 5 p.m.; open committee discussion,
September 13, 1994, 8:30 a.m. to 11:30 a.m.; open public hearing, 11:30
a.m. to 12 m., unless public participation does not last that long;
open committee discussion, 12 m. to 4 p.m.; Lee L. Zwanziger or Valerie
Mealy, Center for Drug Evaluation and Research (HFD-9), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4695.
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 acquired immune deficiency syndrome (AIDS), AIDS-related
complex (ARC), and other viral, fungal, and mycobacterial infections.
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 2, 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 scientific
and medical issues relevant to the validation of surrogate markers for
use as criteria in regulatory decisionmaking.
Anti-Infective Drugs Advisory Committee
Date, time, and place. September 23, 1994, 8 a.m., Holiday Inn,
Plaza Ballroom, 8777 Georgia Ave., Silver Spring, 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 11:30 a.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.
General function of the committee. The Anti-Infective Drugs
Advisory Committee reviews and evaluates data relating to the safety
and effectiveness of marketed and investigational human drugs for use
in infectious and ophthalmic 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 September 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. The committee will discuss surrogate
markers, such as pharmacokinetic parameters and microbiological
inhibitory and cidal data, and whether these parameters can be used
instead of clinical efficacy data to support an alternative dosing
regimen for oral metronidazole in the treatment of Trichomonas
vaginalis vaginitis.
Joint Meeting of the Dermatologic Drugs and Anti-Infective Drugs
Advisory Committees
Date, time, and place. September 23, 1994, 1 p.m., conference rms.
D and E , Parklawn Bldg., 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. 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.; 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.
General function of the committees. The Dermatologic Drugs Advisory
Committee reviews and evaluates data on the safety and effectiveness of
marketed and investigational human drugs for use in the treatment of
dermatologic diseases. The Anti-Infective Drugs Advisory Committee
reviews and evaluates data relating to the safety and effectiveness of
marketed and investigational human drugs for use in infectious and
ophthalmic 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 September 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. The committees will discuss the
potential for development of antibiotic resistance with over-the-
counter use of topical erythromycin in the treatment of acne.
Peripheral and Central Nervous System Drugs Advisory Committee
Date, time, and place. September 26 and 27, 1994, 8:30 a.m.,
conference rms. D and E, Parklawn Bldg., 5600 Fishers Lane, Rockville,
MD.
Type of meeting and contact person. Open public hearing, September
26, 1994, 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, September 27, 1994, 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, 301-594-2775.
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 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 September 19, 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 discussions. On September 26, 1994, the committee
will discuss the safety and effectiveness of Freedox
(tirilazad mesylate), new drug application (NDA) 20-399, The Upjohn
Co., for use in the treatment of subarachnoid hemorrhage. On September
27, 1994, the committee will discuss the safety and effectiveness of
Tegretol (carbamazepine), NDA 18-927, Basel Pharmaceuticals,
for use as an anticonvulsant in children under 6 years old.
Additionally, the committee will reconsider the relative risks and
benefits of Felbatol (felbamate), NDA 20-189, Carter-Wallace,
for use in the treatment of epilepsy.
National Mammography Quality Assurance Advisory Committee
Date, time, and place. September 28, 1994, 10 a.m., and September
29 and 30, 1994, 8:30 a.m., Gaithersburg Hilton Hotel, 620 Perry Pkwy.,
Gaithersburg, MD. A limited number of overnight accommodations have
been reserved at the Gaithersburg Hilton Hotel. Attendees requiring
overnight accommodations may contact the hotel at 301-977-8900 and
reference the FDA committee meeting block. Reservations will be
confirmed at the group rate based on availability.
Type of meeting and contact person. Open public hearing, September
28, 1994, 10 a.m. to 11 a.m., unless public participation does not last
that long; open committee discussion, 11 a.m. to 5 p.m.; open committee
discussion, September 29, 1994, 8:30 a.m. to 5 p.m.; open committee
discussion, September 30, 1994, 8:30 a.m. to 5 p.m.; Charles K.
Showalter, Center for Devices and Radiological Health (HFZ-240), Food
and Drug Administration, 1901 Chapman Ave., Rockville, MD 20857, 301-
594-3311.
General function of the committee. The committee advises on
developing appropriate quality standards and regulations for the use of
mammography facilities.
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 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. The committee will discuss the draft
final standards for accreditation bodies and the draft final standards
for facilities. Specific topics to be discussed include: States as
certifying bodies, mobile units, breast implant imaging, consumer
complaint mechanism, and equipment other than the x-ray unit.
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: August 15, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-20510 Filed 8-19-94; 8:45 am]
BILLING CODE 4160-01-F
