[Federal Register Volume 62, Number 40 (Friday, February 28, 1997)]
[Notices]
[Pages 9199-9201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5129]
[[Page 9199]]
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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:
Orthopedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee
Date, time, and place. March 6, 1997, 8:30 a.m., and March 7,
1997, 9 a.m., Holiday Inn--Gaithersburg, Ballroom, 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 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 Soo Bae, KRA Corp.,
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, March 6,
1997, 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 2 p.m.; closed
presentation of data, 2 p.m. to 2:30 p.m.; open committee discussion,
2:30 p.m. to 5:30 p.m.; open public hearing, March 7, 1997, 9 a.m. to
10 a.m., unless public participation does not last that long; open
committee discussion, 10 a.m. to 2 p.m.; William Freas or Sheila D.
Langford, Center for Biologics Evaluation and Research (HFM-21), Food
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-
827-1289, or Jodi H. Nashman, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-2036, or FDA Advisory Committee
Information Hotline, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), Orthopedic and Rehabilitation Devices Panel, code 12521. 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 March 3, 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 March 6, 1997, at the request of,
and in conjunction with the Center for Biologics Evaluation and
Research, the committee will discuss CARTICEL (autologous chondrocytes
manipulated ex-vivo for structural repair, Genzyme Corp.) intended for
treatment and repair of clinically significant, articular cartilage
defects in the knee. On March 7, 1997, the committee will have a
general discussion of study design and efficacy endpoints for clinical
trials utilizing bone void fillers.
Closed presentation of data. On March 6, 1997, the sponsor will
present to the committee trade secret and/or confidential commercial
information relevant to the pending biologics licensing application
(BLA). This portion of the meeting will be closed to permit discussion
of this information (5 U.S.C. 552b(c)(4)).
FDA regrets that it was unable to publish this notice 15 days prior
to the March 6 and 7, 1997, Orthopedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee meeting. Because the agency
believes there is some urgency to bring this issue to public discussion
and qualified members of the Orthopedic and Rehabilitation Devices
Panel were available at this time, the Commissioner concluded that it
was in the public interest to hold this meeting even if there was not
sufficient time for the customary 15-day public notice.
Neurological Devices Panel of the Medical Devices Advisory Committee
Date, time, and place. March 14, 1997, 9:30 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 Soo Bae, KRA Corp., 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, 9:30 a.m.
to 10:45 a.m., unless public participation does not last that long;
open committee discussion, 10:45 a.m. to 3:30 p.m.; closed committee
deliberations, 3:30 p.m. to 4:30 p.m.; G. Levering Keely, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8517, or FDA Advisory Committee Information Hotline, 1-800-741-8138
(301-443-0572 in the Washington, DC area), Neurological Devices Panel,
code 12513. 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 March 3, 1997, and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the
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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 and vote on a
premarket approval application for a deep brain stimulator for the
treatment of tremor due to Parkinson's disease and Essential Tremor.
Closed committee deliberations. FDA staff will present to the
committee 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)).
FDA regrets that it was unable to publish this notice 15 days prior
to the March 14, 1997, Neurological Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring this issue to public discussion and qualified
members of the Neurological Devices Panel were available at this time,
the Commissioner concluded that it was in the public interest to hold
this meeting even if there was not sufficient time for the customary
15-day public notice.
Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical
Devices Advisory Committee
Date, time, and place. March 20 and 21, 1997, 8 a.m., Holiday Inn--
Gaithersburg, Ballroom, 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 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 Christie Wyatt, KRA Corp., 301-495-1591, ext. 267. The
availability of appropriate accommodations cannot be assured unless
prior notification is received.
Type of meeting and contact person. Open public hearing, March 20,
1997, 8 a.m. to 8:30 a.m., unless public participation does not last
that long; open committee discussion, 8:30 a.m. to 9 a.m; closed
presentation of data, 9 a.m. to 9:30 a.m.; open committee discussion,
9:30 a.m. to 1:30 p.m.; open public hearing, 1:30 p.m. to 2:30 p.m.,
unless public participation does not last that long; open committee
discussion, 2:30 p.m. to 6 p.m.; open public hearing, March 21, 1997, 8
a.m. to 9:15 a.m., unless public participation does not last that long;
open committee discussion, 9:15 a.m. to 6 p.m.; Sharon K. Lappalainen,
Center for Devices and Radiological Health (HFZ-440), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1243, or
FDA Advisory Committee Information Hotline, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), Clinical Chemistry and Clinical
Toxicology Devices Panel, code 12514. 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.
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 March 7, 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. The
Docket will remain open until April 3, 1997, to allow written comment
from the public.
Open committee discussion. On March 20, 1997, the committee will
discuss a premarket notification submission, 510(k), for an over-the-
counter device for measuring fructosamine. On March 20 and 21, 1997,
the committee will discuss self-monitoring and management by diabetic
patients including noninvasive and invasive self-monitoring blood
glucose (SMBG) systems, glucose meters and test strips. The invasive
systems have revolutionized modern diabetic management. Improvements in
technology and increased understanding of the benefits of tight control
have been substantial during the past few years. FDA is interested in
identifying mechanisms to help minimize problems associated with SMBG
systems. The goal of the meeting is to solicit information and
suggestions from the FDA advisory panel, professional organizations,
industry, and consumers that will help: (1) Identify how patients are
currently being managed; (2) determine what goals are appropriate for
different groups of patients and different treatment regimens; (3)
determine what device performance is needed for support of these goals;
(4) discuss current technology and its performance capabilities and
limitations; and (5) identify areas in which the agency, professional
groups, patients, and manufacturers can work together to help achieve
the various goals of glucose monitoring and contribute to increased
quality patient outcomes.
Invasive SMBG systems are used by individuals to monitor their own
blood glucose levels. These devices allow individuals to monitor their
status on a daily basis and, if necessary, modify therapy to obtain
near normal glucose homeostasis. The use of SMBG systems has,
therefore, become a cornerstone for modern diabetic therapy of
significant importance to many of the 13 million diabetics in the
United States. Reports in the medical literature have suggested that
meter and strip performance claims made by manufacturers based on
premarket testing may not reflect actual use by consumers. Topics of
discussion will include:
(1) Improvements which can be made in the premarket review of these
products including changes, if warranted, in review criteria and their
application;
(2) Identification of realistic expectations for the physician and
user of these devices based on current technology, and determination of
testing needed to assure product quality. Discussion will include
consideration of both existing technical limitations and the potentials
for changes in glucose measuring technology in the future;
(3) Improvements which could be made in premarket product testing
to provide a more realistic evaluation of actual performance in the
field;
(4) Possible improvements in the labeling of these devices to
better reflect the expected performance in the home setting;
(5) Steps that could be taken to improve the use of quality control
measures in the home setting; and
(6) Other mechanisms available to FDA or other organizations to
improve the practice of blood glucose monitoring in the home.
(7) Improvements that could be made to FDA's existing guidance
document entitled ``Review Criteria for Assessment of Portable Blood
Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase,
Dehydrogenase, or Hexokinase Methodology''--Draft 2/14/96. This
guidance document is available through the Division of Small
Manufacturer's Assistance (DSMA) at 301-443-6597, its toll free number
800-638-2041, or through DSMA Facts on Demand at 800-899-0381, DSMA
Shelf Number 604.
FDA welcomes other input that will contribute to minimizing SMBG
related problems.
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Closed presentation of data. On March 20, 1997, the sponsor may
present to the committee trade secret and/or confidential commercial
information regarding the premarket notification submission. 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 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,
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: February 25, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-5129 Filed 2-26-97; 11:04 am]
BILLING CODE 4160-01-F