[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37655-37657]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17977]
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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 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:
Hematology and Pathology Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. August 7 and 8, 1995, 9 a.m., Gaithersburg
Hilton Hotel, Ballroom Salons C, D, and E, 620 Perry Pkwy.,
Gaithersburg, MD. A limited number of overnight accommodations have
been reserved at the hotel. Attendees requiring overnight
accommodations may contact the hotel at 301-977-8900, and reference the
FDA Panel meeting block. Reservations will be confirmed at the group
rate based on availability. Attendees with a disability requiring
special accommodations should contact Ed Rugenstein, Sociometrics,
Inc., 301-608-2151. The availability of appropriate accommodations
cannot be assured unless prior written notification is received.
Type of meeting and contact person. Closed committee deliberations,
August 7, 1995, 9 a.m. to 10 a.m.; open public hearing, 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 public hearing, August 8,
1995, 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.; Djuana Blagmon,
Center for Devices and Radiological Health (HFZ-440), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-2096, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Hematology and Pathology Devices
Panel, code 12515.
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,
[[Page 37656]]
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 July 28, 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 two premarket
approval applications for automated cervical cytology readers intended
for use in the quality control and rescreening of previously read
Papanicolaou smears.
Closed committee deliberations. FDA staff will present to the
committee 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)).
Dental Products Panel of the Medical Devices Advisory Committee
Date, time, and place. August 8 and 9, 1995, 8:30 a.m., Bethesda
Marriott Hotel, Grand Ballroom Salons A, B, and C, 5151 Pooks Hill Rd.,
Bethesda, MD. A limited number of overnight accommodations have been
reserved at the hotel. Attendees requiring overnight accommodations may
contact the hotel at 301-897-9400 and reference the FDA Panel meeting
block. Reservations will be confirmed at the group rate based on
availability. Attendees with a disability requiring special
accommodations should contact Ed Rugenstein, Sociometrics, Inc., 301-
608-2151. The availability of appropriate accommodations cannot be
assured unless prior written notification is received.
Type of meeting and contact person. Closed presentation of data,
August 8, 1995, 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 6 p.m.; open public hearing, August 9,
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 6 p.m.; Carolyn A.
Tylenda, Center for Devices and Radiological Health (HFZ-410), Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-
594-8897, or FDA Advisory Committee Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Dental Products Panel, code 12518.
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 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.
Open committee discussion. The Dental Products Panel began the
process of classification of bone filling and augmentation devices on
February 11, 1993. On August 8, 1995, the committee will continue the
discussion of the proposed classification status for bone filling and
augmentation devices. The discussion will focus on streamlining the
groupings and descriptions of materials before making final
classification recommendations, which are expected to be completed at
this meeting. On August 9, 1995, the committee will continue the
discussion of bone filling and augmentation devices for oral use, if
necessary, and will discuss and vote on dental device recommendations
for ingredient labeling, and will discuss a guidance document for
dental handpieces.
Closed presentation of data. On August 8, 1995, a sponsor will
present to the committee trade secret and/or confidential commercial
information regarding a dental product. This portion of the meeting
will be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Circulatory System Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. August 21, 1995, 8:30 a.m., and August 22,
1995, 9 a.m., Holiday Inn--Gaithersburg, Ballroom, Two Montgomery
Village Ave., Gaithersburg, MD. A limited number of overnight
accommodations have been reserved at the Holiday Inn--Gaithersburg.
Attendees requiring overnight accommodations may contact the hotel at
301-984-8900 and reference the FDA Panel meeting block. Reservations
will be confirmed at the group rate based on availability. Attendees
with a disability requiring special accommodations should contact Ed
Rugenstein, Sociometrics, Inc., 301-608-2151. The availability of
appropriate accommodations cannot be assured unless prior written
notification is received.
Type of meeting and contact person. Open public hearing, August 21,
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 1:30 p.m.; closed
presentation of data, 1:30 p.m. to 4:30 p.m.; open public hearing,
August 22, 1995, 9 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.;
Ramiah Subramanian, Center for Devices and Radiological Health (HFZ-
450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD
20850, 301-443-8320, or FDA Advisory Committee Information Hotline, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), Circulatory
System Devices Panel, code 12625.
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 15, 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 August 21, 1995, the committee will
discuss general issues related to a premarket approval application
(PMA) for an automatic cardiac defibrillator. On August 22, 1995, the
committee will review and recommend: (1) The reclassification status
for human heart valve allografts; and (2) the reclassification status
of nonroller type cardiopulmonary bypass blood pumps (i.e., centrifugal
pump) for short-term (6 hours or less) use.
Closed presentation of data. On August 21, 1995, FDA staff will
present to the committee trade secret and/or confidential commercial
information relevant to investigational device exemption applications
and PMA's for cardiovascular system devices. This portion of the
meeting will be closed to permit discussion of this information (5
U.S.C. 552b(c)(4)).
[[Page 37657]]
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: July 17, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-17977 Filed 7-20-95; 8:45 am]
BILLING CODE 4160-01-F
