[Federal Register Volume 59, Number 157 (Tuesday, August 16, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-19984]
[[Page Unknown]]
[Federal Register: August 16, 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:
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. September 1 and 2, 1994, 8:30 a.m., Parklawn
Bldg., conference rms. G, H, and I, 5600 Fishers Lane, Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Holiday Inn Crowne Plaza, 1750 Rockville Pike, Rockville, MD. Attendees
requiring overnight accommodations may contact the hotel at 301-468-
1100 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, September
1, 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 3:30 p.m.;
closed presentation of data, 3:30 p.m. to 5:30 p.m.; open public
hearing, September 2, 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 4:30 p.m.; Colin M. Pollard, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1180.
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 August 29, 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 September 1, 1994, the committee will
discuss general issues relating to devices to aid breast self exams. On
September 2, 1994, the committee will discuss general issues relating
to home uterine activity monitors.
Closed presentation of data. On September 1, 1994, the committee
will discuss trade secret and/or confidential commercial information
regarding various medical devices used in obstetrics and gynecology
that are currently being evaluated by FDA. This portion of the meeting
will be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Anesthesiology and Respiratory Therapy Devices Panel of the Medical
Devices Advisory Committee
Date, time, and place. September 2, 1994, 10 a.m., Holiday Inn
Crowne Plaza, Plaza III Ballroom, 1750 Rockville Pike, Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Holiday Inn Crowne Plaza. Attendees requiring overnight accommodations
may contact the hotel at 301-468-1100 and reference the FDA Panel
meeting block. Reservations will be confirmed at the group rate based
on availability.
Type of meeting and contact person. Closed committee deliberations,
10 a.m. to 1 p.m.; open public hearing, 1 p.m. to 2:30 p.m., unless
public participation does not last that long; open committee
discussion, 2:30 p.m. to 4:30 p.m.; Michael G. Bazaral, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-2623.
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 August 29, 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 a revision to
the guidance document for clinical data to support premarket
notification for apnea monitors.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding present and
future device applications. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Oncologic Drugs Advisory Committee
Date, time, and place. September 12, 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, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 12 m.; closed committee deliberations,
12 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.
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 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 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: (1) New drug
application (NDA) 20-452, Photofrin (Sterile Porfimer Sodium,
QLT Phototherapeutics, Inc.), ``for the reduction of obstruction and
palliation of dysphagia in patients with completely or partially
obstructing esophageal cancer.''
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information relevant to
investigational new drug applications and pending NDA's. This portion
of the meeting will be closed to permit discussion of this information
(5 U.S.C. 552b(c)(4)).
Neurological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. September 16, 1994, 9:45 a.m., Piccard
Bldg., conference rm. 100, 1390 Piccard Dr., Rockville, MD.
Type of meeting and contact person. Open committee discussion, 9:45
a.m. to 10:15 a.m.; open public hearing, 10:15 a.m. to 11:15 a.m.,
unless public participation does not last that long; open committee
discussion, 11:15 a.m. to 1:30 p.m.; closed committee deliberations,
1:30 p.m. to 4 p.m.; Levering Keely, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1523.
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 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 proposed
guidance for biocompatibility of implanted neurological devices and the
clinical utility of electroencephalograph devices.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding present and
future FDA issues. This portion of the meeting will be closed to permit
discussion of this information (5 U.S.C. 552b(c)(4)).
General and Plastic Surgery Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. September 21, 1994, 8 a.m., Holiday Inn--
Gaithersburg, Whetstone Rm., Two Montgomery Village Ave., Gaithersburg,
MD. A limited number of overnight accommodations have been blocked 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 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 1 p.m.; closed committee deliberations,
1 p.m. to 5 p.m.; Daniel G. Schultz, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-2092.
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 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 the following
draft guidance documents: (1) Electrosurgical devices, (2) medical
lasers, (3) noninteractive wound and burn dressing, (4) interactive
wound and burn dressing, and (5) sun protective clothing. Single copies
of the draft guidance documents are available from the Division of
Small Manufacturers Assistance, Center for Devices and Radiological
Health (HFZ-220), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 800-638-2041 or 301-443-6597.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding issues
related to new technologies currently under review. This portion of the
meeting will be closed to permit discussion of this information (5
U.S.C. 552b(c)(4)).
Joint Meeting of the Clinical Chemistry and Clinical Toxicology Devices
Panel and the Microbiology Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. September 22, 1994, 1 p.m., and September
23, 1994, 9 a.m., Holiday Inn--Gaithersburg, Whetstone/Walker Rms., Two
Montgomery Village Ave., Gaithersburg, MD. A limited number of
overnight accommodations have been blocked 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. Closed committee deliberations,
September 22, 1994, 1 p.m. to 5 p.m.; open public hearing, September
23, 1994, 9 a.m. to 10 a.m., unless public participation does not last
that long; open committee discussion, 10 a.m. to 6 p.m.; Cornelia B.
Rooks or Freddie M. Poole, Center for Devices and Radiological Health
(HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville,
MD 20850, 301-594-1243 or 594-2096.
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 September 8, 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 use of
alternate matrices: saliva, sweat, tears, hair, etc., for in vitro
diagnostic devices, and replacement reagents for devices already
cleared by the 510(k) process or approved by premarket approval
application. In addition, the committee will discuss a draft document:
``Points to Consider for Collection of Data in Support of In Vitro
Diagnostic Device Submissions for 510(k)'s.'' These documents will be
available at the meeting.
Closed committee deliberations. The committee will discuss trade
secret and/or confidential commercial information regarding pending or
future device submissions. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Dermatologic Drugs Advisory Committee
Date, time, and place. September 22 and 23, 1994, 8:30 a.m.,
Parklawn Bldg., conference rms. D and E, 5600 Fishers Lane, Rockville,
MD.
Type of meeting and contact person. Closed committee deliberations,
September 22, 1994, 8:30 a.m. to 12 m.; open committee discussion, 12
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.; open committee discussion, September 23, 1994, 8:30
a.m. to 12 m.; Ermona B. McGoodwin or Valerie M. 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 committee. The committee reviews and
evaluates data on the safety and effectiveness of marketed and
investigational human drugs for use in the treatment of dermatologic
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 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 onychomycosis
and determination of endpoints for clinical trials investigating
treatment of onychomycosis.
Closed committee deliberations. On September 22, 1994, the
committee will discuss trade secret and/or confidential commercial
information relevant to pending investigational new drug applications.
This portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)).
Each public advisory committee meeting listed above 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. The dates and times reserved for the separate 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.
The Commissioner has determined for the reasons stated that those
portions of the advisory committee meetings so designated in this
notice shall be closed. The Federal Advisory Committee Act (FACA) (5
U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings
in certain circumstances. Those portions of a meeting designated as
closed, however, shall be closed for the shortest possible time,
consistent with the intent of the cited statutes.
The FACA, as amended, provides that a portion of a meeting may be
closed where the matter for discussion involves a trade secret;
commercial or financial information that is privileged or confidential;
information of a personal nature, disclosure of which would be a
clearly unwarranted invasion of personal privacy; investigatory files
compiled for law enforcement purposes; information the premature
disclosure of which would be likely to significantly frustrate
implementation of a proposed agency action; and information in certain
other instances not generally relevant to FDA matters.
Examples of portions of FDA advisory committee meetings that
ordinarily may be closed, where necessary and in accordance with FACA
criteria, include the review, discussion, and evaluation of drafts of
regulations or guidelines or similar preexisting internal agency
documents, but only if their premature disclosure is likely to
significantly frustrate implementation of proposed agency action;
review of trade secrets and confidential commercial or financial
information submitted to the agency; consideration of matters involving
investigatory files compiled for law enforcement purposes; and review
of matters, such as personnel records or individual patient records,
where disclosure would constitute a clearly unwarranted invasion of
personal privacy.
Examples of portions of FDA advisory committee meetings that
ordinarily shall not be closed include the review, discussion, and
evaluation of general preclinical and clinical test protocols and
procedures for a class of drugs or devices; consideration of labeling
requirements for a class of marketed drugs or devices; review of data
and information on specific investigational or marketed drugs and
devices that have previously been made public; presentation of any
other data or information that is not exempt from public disclosure
pursuant to the FACA, as amended; and, deliberation to formulate advice
and recommendations to the agency on matters that do not independently
justify closing.
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 10, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-19984 Filed 8-15-94; 8:45 am]
BILLING CODE 4160-01-F
