Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices 9199

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:

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
9200 Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices

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-thecounter device for measuring

fructosamine. On March 20 and 21,

1997, the committee will discuss selfmonitoring 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.
Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices 9201

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

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