[Federal Register Volume 60, Number 190 (Monday, October 2, 1995)]
[Notices]
[Pages 51481-51483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24354]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Advisory Committees; Notice of Meetings
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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:
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. October 20, 1995, 8 a.m., Corporate Bldg.,
ground floor conference room, 9200 Corporate Blvd., Rockville, MD. A
limited number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Hotel, 9751 Washingtonian Blvd.,
Gaithersburg, MD. Attendees requiring overnight accommodations may
contact the hotel at 301-590-0044 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, 8 a.m. to
9 a.m., unless public participation does not last that long; open
committee discussion, 9 a.m. to 3 p.m.; closed committee deliberations,
3 p.m. to 6 p.m.; Mary J. Cornelius, Center for Devices and
Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2194, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area) Gastroenterology and Urology Devices Panel, code
12523.
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 October 13, 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 general
issues related to a premarket approval application for an
electromagnetic device intended to treat benign prostatic hyperplasia
using localized heat.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
regarding medical devices. This portion of the meeting will be closed
to permit discussion of this information (5 U.S.C. 552b(c)(4)).
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee
Date, time, and place. October 23, 1995, 8:30 a.m., and October 24,
1995, 7:30 a.m., DoubleTree Hotel, Ballroom, 1750 Rockville Pike,
Rockville, MD. A limited number of overnight accommodations have been
reserved at the hotel. Attendees requiring overnight accommodations may
contact the hotel
[[Page 51482]]
at 301-468-1100 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, October
23, 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 5 p.m.; closed
committee deliberations, October 24, 1995, 7:30 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
p.m.; Alfred W. Montgomery, Center for Devices and Radiological Health
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1180, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area) Obstetrics and Gynecology Devices Panel, code 12524.
-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 October 4, 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 October 23, 1995, the committee will
consider a list of devices used for in vitro fertilization and other
assisted reproduction technologies. The committee will provide expert
advice on these devices that will be used to develop 510(k) guidance.
On October 24, 1995, the committee will consider a draft guidance
document on the preparation of an investigational device exemption for
thermal endometrial ablation devices. Single copies of the list of in
vitro fertilization devices and the guidance document for thermal
endometrial ablation devices are available to the public after October
1, 1995, by contacting the Division of Small Manufacturers Assistance,
1350 Piccard Dr., Rockville, MD 20851, 1-800-638-2041.
Closed committee deliberations. On October 24, 1995, FDA staff will
present to the committee 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)).
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. October 26 and 27, 1995, 8 a.m., Parklawn
Bldg., conference rooms D and E, 5600 Fishers Lane, Rockville, MD.
Type of meeting and contact person. Open committee discussion,
October 26, 1995, 8 a.m. to 8:15 a.m.; open public hearing, 8:15 a.m.
to 8:45 a.m., unless public participation does not last that long; open
committee discussion, 8:45 a.m. to 1:30 p.m.; closed committee
deliberations, 1:30 p.m. to 2:30 p.m.; open committee discussion, 2:30
p.m. to 6 p.m.; closed committee deliberations, October 27, 1995, 8
a.m. to 12:30 p.m.; open public hearing, 12:30 p.m. to 1 p.m., unless
public participation does not last that long; open committee
discussion, 1 p.m. to 5:15 p.m.; Nancy T. Cherry or Sandy M. Salins,
Center for Biologics Evaluation and Research (HFM-21), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314,
or FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Vaccines and Related Biological
Products Advisory Committee, code 12388.
General function of the committee. The committee reviews and
evaluates data on the safety and effectiveness of vaccines 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 October 18, 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 October 26, 1995, the committee will
hear presentations on recent acellular pertussis trials sponsored by
the Public Health Service, and on a new strategic plan for the year
2004 developed by the Center for Biologics Evaluation and Research. The
committee will also consider whether a single formulation for
pneumococcal conjugate vaccines should be adopted for children in the
United States. On October 27, l995, the committee will discuss a draft
Points to Consider document addressing the evaluation of combination
vaccines. Copies of the document will be available at the meeting.
Closed committee deliberations. On October 26 and 27, l995, the
committee will review trade secret and/or confidential commercial
information relevant to pending investigational new drug applications
or product licensing applications. These portions of the meeting will
be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Medical Imaging Drugs Advisory Committee
Date, time, and place. October 26 and 27, 1995, 8 a.m., Holiday
Inn, Plaza Ballroom, 8777 Georgia Ave., Silver Spring, MD.
-Type of meeting and contact person. Open public hearing, October
26, 1995, 8 a.m. to 9 a.m., unless public participation does not last
that long; closed committee deliberations, 9 a.m. to 11 a.m.; open
committee discussion, 11 a.m. to 4 p.m.; open committee discussion,
October 27, 1995, 8 a.m. to 4 p.m.; Leander B. Madoo (HFD-9), Center
for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4695, or FDA Advisory
Committee Information Hotline, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), Medical Imaging Drugs Advisory Committee, code
12540.
General function of committee. The committee reviews and evaluates
data concerning the safety and effectiveness of marketed and
investigational human drug products for use in diagnostic and
therapeutic procedures using radioactive pharmaceuticals and contrast
media used in diagnostic radiology.
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 October 12, 1995, and submit a brief
statement of the general nature of the evidence or
[[Page 51483]]
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 hold a preliminary
discussion in preparation for drafting of future ``Points to Consider
for Diagnostic Imaging Agents''.
Closed committee deliberations. The committee will be briefed on
confidential commercial information relevant to pending IND's and
NDA's. 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: September 26, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-24354 Filed 9-29-95; 8:45 am]
BILLING CODE 4160-01-F
