[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]



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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