[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Notices]
[Pages 67560-67562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32427]
[[Page 67560]]
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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:
Ophthalmic Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. January 13, 1997, 9:30 a.m., and January 14,
1997, 9 a.m., Holiday Inn--Gaithersburg, Walker and Whetstone Rooms,
Two Montgomery Village Ave., Gaithersburg, MD. A limited number of
overnight accommodations have been reserved at the hotel. Attendees
requiring overnight accommodations may contact the hotel at 301-948-
8900 or 1-800-465-4329 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 Sue Bae, KRA Corp. at 301-495-1591, ext. 227. The availability
of appropriate accommodations cannot be assured unless prior
notification is received.
Type of meeting and contact person. Open public hearing, January
13, 1997, 9:30 a.m. to 10:30 a.m., unless public participation does not
last that long; open committee discussion, 10:30 a.m. to 1:30 p.m.;
closed committee deliberations, 1:30 p.m. to 5:30 p.m.; open public
hearing, January 14, 1997, 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.; Sara M. Thornton, Center for Devices and Radiological
Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-2053, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Ophthalmic Devices Panel, code 12396. Please call the hotline
for information concerning any possible changes.
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 January 6, 1997, 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 January 13, 1997, the committee will
discuss general issues relating to a premarket approval application
(PMA) for a retinal tamponade used for the treatment of complicated
retinal detachments. On January 14, 1997, the committee will discuss
general issues relating to a PMA supplement for an excimer laser for
photorefractive keratectomy to correct low to moderate myopia with
astigmatism.
Closed committee deliberations. FDA staff will present to the
committee trade secret and/or confidential commercial information
relevant to investigational device exemption applications and PMA's for
vitreo-retinal, surgical and diagnostic devices, intraocular and
corneal implants, and contact lenses. This portion of the meeting will
be closed to permit discussion of this information (5 U.S.C.
552b(c)(4)).
Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. January 16, 1997, 8 a.m., Corporate Bldg.,
conference room 020B, 9200 Corporate Blvd., Rockville, MD. A limited
number of overnight accommodations have been reserved at the
Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Blvd.,
Gaithersburg, MD. Attendees requiring overnight accommodations may
contact the hotel at 800-228-9290 or 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 Alice Hall Hayes, KRA Corp. at 301-495-
1591, ext. 223. The availability of appropriate accommodations cannot
be assured unless prior written notification is received.
Type of meeting and contact person. Closed committee deliberations,
8 a.m. to 9 a.m.; open public hearing, 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.; 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. Please
call the hotline for information concerning any possible changes.
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 January 9, 1997, 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 hear a presentation
on the revisions made in the Draft Guidance on Penile Rigidity Implants
(November 1996). The committee will discuss general issues related to a
PMA for a metallic mesh stent intended to relieve prostatic obstruction
secondary to benign prostatic hyperplasia (BPH) or bladder neck
contracture.
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)).
[[Page 67561]]
Vaccines and Related Biological Products Advisory Committee
Date, time, and place. January 30, 1997, 8 a.m., Holiday Inn--
Bethesda, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda,
MD.
Type of meeting and contact person. Open committee discussion, 8
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 4:30 p.m.; open public
hearing, 4:30 p.m. to 5:30 p.m., unless public participation does not
last that long; Nancy T. Cherry or Denise H. Royster, 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. Please call the hotline for
information concerning any possible changes.
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 January 23, 1997, 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 influenza
virus vaccine formulation for 1997-1998. The committee will also hear
briefings on a research program in the Division of Bacterial Products
and on recent activities in the Center for Biologics Evaluation and
Research.
Closed committee deliberations. The committee will review data of a
personal nature where disclosure would constitute a clearly unwarranted
invasion of personal privacy. This portion of the meeting will be
closed to permit discussion of this information (5 U.S.C. 552b(c)(6)).
Biological Response Modifiers Advisory Committee
Date, time, and place. January 30, 1997, 3 p.m., Rockwall 1 Bldg.,
conference room 4108, fourth floor, 11400 Rockville Pike, Rockville,
MD.
Type of meeting and contact person. This meeting will be held by a
telephone conference call. A speaker telephone will be provided in the
conference room to allow public participation in the meeting. Open
public hearing, 3 p.m. to 4 p.m., unless public participation does not
last that long; open committee discussion, 4 p.m. to 4:30 p.m.; closed
committee deliberations, 4:30 p.m. to 5:30 p.m.; William Freas, Sheila
D. Langford, or Pearline K. Muckelvene, 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), Biological Response Modifiers Advisory Committee, code 12388.
Please call the hotline for information concerning any possible
changes.
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 January 23, 1997, 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
intramural research program for the Laboratory of Cell Biology,
Division of Cytokine Biology.
Closed committee deliberations. The committee will discuss the
intramural scientific program. This portion of the meeting will be
closed to prevent disclosure of personal information concerning
individuals associated with the research program, disclosure of which
would constitute a clearly unwarranted invasion of personal privacy (5
U.S.C. 552b(c)(6)).
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 the meeting(s) 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, 5600 Fishers Lane, rm. 12A-16, 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, 12420 Parklawn Dr., rm. 1-23,
[[Page 67562]]
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 (a)(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: December 16, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-32427 Filed 12-20-96; 8:45 am]
BILLING CODE 4160-01-F
