Federal Register / Vol. 63, No. 142 / Friday, July 24, 1998 / Notices 39879

Each public meeting will provide an

opportunity for an open comment

session where attendees can express

their views.

IV. Registration and Requests for Oral

Presentations

Send registration information

(including name, title, firm name,

address, telephone, e-mail, and fax

number), and written material and

requests to make oral presentations, to

the appropriate contact person listed in

section III of this document by July 31,

1998.

If you need special accommodations

due to a disability, please contact the

appropriate contact person listed in

section III of this document at least 7

days in advance.

V. Additional Meetings

The public meeting for the Center for

Food Safety and Applied Nutrition

(CFSAN) was held on June 24 and 25,

1998. The comment period associated

with the CFSAN meeting closed on July

15, 1998. A summary of the views

presented at the CFSAN meeting is

available on the CFSAN website ‘‘http:/

/www.cfsan.fda.gov’’. For information

on the CFSAN meeting, contact Tracy S.

Summers, Center for Food Safety and

Applied Nutrition (HFS–1), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–205–4850,

FAX 202–205–5025, e-mail

‘‘tsummers@bangate.fda.gov’’.

An additional public meeting is being

planned for September 15, 1998, to

obtain stakeholder views on potential

recurring themes and the best approach

for consolidating these themes agency

wide. A separate notice of this meeting

will be published in the Federal

Register.

VI. Transcripts

Transcripts of these meetings 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 of the meeting will be

available for public examination at the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday, as well as on

the FDA website ‘‘http://www.fda.gov’’.

Dated: July 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19816 Filed 7–21–98; 3:31 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Dental Products Panel of the Medical

Devices Advisory Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Dental Products

Panel of the Medical Devices Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on August 4, 1998, 10:30 a.m. to

6:30 p.m., and August 5, 1998, 8 a.m. to

3 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Pamela D. Scott,

Center for Devices and Radiological

Health (HFZ–480), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–827–5283, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12518. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On August 4, 1998, the

committee will discuss: (1) Previously

unclassified devices for use in the

diagnosis and/or treatment of

temporomandibular joint dysfunction

and oral-facial pain, (2) devices that

FDA believes may fall within a present

device classification and those devices

that do not fall within a present device

classification and thus remain

unclassified, and (3) classification of the

devices that remain unclassified. On

August 5, 1998, the committee will

continue discussion of the classification

of devices for use in the diagnosis and/

or treatment of temporomandibular joint

dysfunction and oral-facial pain that

remain unclassified. The list of those

devices that FDA believes may fall

within a present device classification

and those devices that do not fall within

a present device classification and thus

remain unclassified will be placed on

the FDA web site at ‘‘http://

www.fda.gov/cdrh/degenint.html’’.

Procedure: On August 4, 1998, from

10:30 a.m. to 5:30 p.m. and on August

5, 1998, from 8 a.m. to 3 p.m., the

meeting is open to the public. Interested

persons may present data, information,

or views, orally or in writing, on issues

pending before the committee. Written

submissions may be made to the contact

person by July 31, 1998. Oral

presentations from the public will be

scheduled between approximately 1:30

p.m. and 2:30 p.m. on August 4, 1998,

and between approximately 8:10 a.m.

and 8:40 a.m. on August 5, 1998. Near

the end of committee deliberations, a

30-minute open public session will be

conducted for interested persons to

address issues specific to the

classification before the committee.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 31, 1998,

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 requested to make

their presentation.

Closed Committee Deliberations: On

August 4, 1998, from 5:30 p.m. to 6:30

p.m., the meeting will be closed to

permit discussion of trade secret and/or

confidential information regarding

dental device issues (5 U.S.C.

552b(c)(4)). The meeting will discuss

classified device issues.

FDA regrets that it was unable to

publish this notice 15 days prior to the

August 4 and 5, 1998, Dental Products

Panel of the Medical Devices Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

these issues to public discussion and

qualified members of the Dental

Products Panel of the Medical Devices

Advisory Committee 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. I11Notice of this meeting

is given under the Federal Advisory

Committee Act (5 U.S.C. app. 2).

Dated: July 21, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19945 Filed 7–22–98; 11:41 am]

BILLING CODE 4160–01–F