[Federal Register Volume 59, Number 73 (Friday, April 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9242]
[[Page Unknown]]
[Federal Register: April 15, 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.
FDA is in the process of implementing a voice mail telephone system
which will allow the public to obtain information regarding advisory
committee meetings. The public will be able to access the use of this
information system by calling 1-800-741-8138. The project
implementation date is May 1, 1994.
MEETINGS: The following advisory committee meetings are announced:
Circulatory System Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. May 2, 1994, 8:30 a.m., and May 3, 1994, 8
a.m., Holiday Inn--Bethesda, Versailles Ballroom I, 8120 Wisconsin
Ave., Bethesda, MD. A limited number of overnight accommodations have
been reserved at the Holiday Inn--Bethesda. Attendees requiring
overnight accommodations must contact the hotel at 301-652-2000 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, May 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 3 p.m.; closed
committee deliberations, 3 p.m. to 5 p.m.; open public hearing, May 3,
1994, 8 a.m. to 9:30 a.m., unless public participation does not last
that long; open committee discussion, 9:30 a.m. to 1 p.m.; Ramiah
Subramanian, 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 April 27, 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 coronary
interventional device and a dysrhythmia treatment device.
Closed committee deliberations. The committee may discuss trade
secret and/or confidential commercial information. This portion of the
meeting will be closed to permit discussion of this information (5
U.S.C. 552b(c)(4)).
General Hospital and Personal Use Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. May 10, 1994, 1 p.m., and May 11, 1994, 8
a.m., Bethesda Ramada Hotel and Conference Center, Ambassador Ballrooms
I and II, 8400 Wisconsin Ave., Bethesda, MD.
Type of meeting and contact person. Closed committee deliberations,
May 10, 1994, 1 p.m. to 5 p.m.; open public hearing, May 11, 1994, 8
a.m. to 10 a.m., unless public participation does not last that long;
open committee discussion, 10 a.m. to 5 p.m.; Janet L. Scudiero, Center
for Devices and Radiological Health (HFZ-410), Food and Drug
Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-1307.
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 May 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. On May 11, 1994, the committee will
discuss the: (1) Draft Supplementary Guidance on the Content of
Premarket Submissions (510(k)) for Medical Devices with Sharps Injury
Prevention Features, and (2) Reclassification of the Infant Radiant
Warmer. A copy of the draft guidance is 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. On May 10, 1994, the committee will
discuss trade secret and/or confidential commercial information. This
portion of the meeting will be closed to permit discussion of this
information (5 U.S.C. 552b(c)(4)).
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. May 20, 1994, 8:30 a.m., Bethesda Ramada
Hotel and Conference Center, Embassy Ballrooms II and III, 8400
Wisconsin Ave., Bethesda, MD. A limited number of overnight
accommodations have been reserved at the Bethesda Ramada Hotel and
Conference Center. Attendees requiring overnight accommodations must
contact the hotel at 301-654-1000 and reference the FDA Ophthalmic
Panel meeting block. Reservations will be confirmed at the group rate
based on availability.
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 4:30 p.m.; closed committee
deliberations, 4:30 p.m. to 5 p.m.; Daniel W. C. Brown, Center for
Devices and Radiological Health (HFZ-460), Food and Drug
Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-1744.
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 May 6, 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 general
issues relating to premarket approval applications for: (1) A retinal
tamponade used for the treatment of complicated retinal detachments,
and (2) an intraocular lens. There will be an update presented to the
panel on the policy initiatives in the contact lens area to include the
current status of the November 1993 ``Premarket Notification (510(k))
Guidance Document for Daily Wear Contact Lenses.'' Updates on any
intraocular implants issues are tentatively planned.
Closed committee deliberations. The committee may discuss trade
secret and/or confidential commercial information relevant to premarket
approval applications for surgical and diagnostic devices or
intraocular implants. This portion of the meeting will be closed to
permit discussion of this information (5 U.S.C. 552b(c)(4)).
Biological Response Modifiers Advisory Committee
Date, time, and place. May 25, 1994, 10:30 a.m., and May 26, 1994,
8 a.m., Bethesda Ramada Hotel and Conference Center, Embassy Ballrooms
I, II, and III, 8400 Wisconsin Ave., Bethesda, MD.
Type of meeting and contact person. Open public hearing, May 25,
1994, 10:30 a.m. to 11:15 a.m., unless public participation does not
last that long; open committee discussion, 11:15 a.m. to 5:30 p.m.;
open public hearing, May 26, 1994, 8 a.m. to 8:45 a.m., unless public
participation does not last that long; open committee discussion, 8:45
a.m. to 4 p.m.; closed committee deliberations, 4 p.m. to 5 p.m.; open
committee discussion, 5 p.m. to 6 p.m.; William Freas or Pearline
Muckelvene, Center for Biologics Evaluation and Research (HFM-21), Food
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
594-1054.
General function of the committee. The committee reviews and
evaluates data relating to the safety, effectiveness, and appropriate
use of biological response modifiers which are intended for use in the
prevention and treatment of a broad spectrum 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 May 18, 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 May 25 and 26, 1994, the committee
will discuss issues related to the safety and efficacy of hematopoietic
support regimens in the setting of myelotoxic chemotherapy. On May 26,
1994, the committee will receive an update on issues related to
myoblast transfer for the treatment of muscular dystrophy.
Closed committee deliberations. 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: April 13, 1994.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 94-9242 Filed 4-14-94; 8:45 am]
BILLING CODE 4160-01-F
