Federal Register / Vol. 62, No. 198 / Tuesday, October 14, 1997 / Notices 53333

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

regulatory issues.

Date and Time: The meeting will be

held on November 3, 1997, 9 a.m. to

5:30 p.m.; November 4, 1997, 8:30 a.m.

to 5:30 p.m.; and November 5, 1997, 8

a.m. to 12 m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, 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 November 3, 1997, the

committee will discuss the previously

unclassified devices for use in the

diagnosis and/or treatment of

temporomandibular joint dysfunction

and oral-facial pain (e.g., muscle

monitor devices, jaw tracking devices,

TENS (transcutaneous electrical nerve

stimulation) devices, EMG

(electromyographic) devices, and

ultrasound devices). The committee will

provide comments on the types of

devices to be included within this

category under these indications, which

will assist FDA in developing a

comprehensive strategy for subsequent

classification efforts. This discussion

will not include previously classified

devices such as temporomandibular

joint implants. The proposed listing of

devices to be included within this

category will be placed on CDRH’s

Internet website at http://www.fda.gov/

cdrh. The topical index may be

consulted for its specific location. On

November 4, 1997, the committee will

discuss and make recommendations to

FDA regarding the reclassification of

subgroups of endosseous dental implant

devices. The following subgroups of

endosseous implants will be included:

Coated and uncoated hollow cylinder

and solid cylinder implants, coated and

uncoated screw type implants (other

than the commercially pure titanium

screw type implant previously proposed

for reclassification), coated and

uncoated blade type implants, implants

with special enhanced retention

mechanisms and transitional implants.

The coated implants may be further

divided into porous coatings (e.g.,

titanium bead coatings), nonporous

coatings (e.g., titanium plasma spray

coatings), metallic coatings and ceramic

coatings (e.g., hydroxylapatite coatings).

The committee will also discuss and

make recommendations regarding the

classification of oral appliances for the

treatment of obstructive sleep apnea and

snoring. On November 5, 1997, the

committee will continue discussion of

the classification of oral appliances for

the treatment of obstructive sleep apnea

and snoring if time does not permit this

issue to be completed on November 4,

1997.

Procedure: On November 3, 1997,

from 9 a.m. to 5:30 p.m.; November 4,

1997, from 8:30 a.m. to 4:30 p.m.; and

on November 5, 1997, from 8 a.m. to 12

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 October

27, 1997. Oral presentations from the

public regarding devices with

indications for use involving the

diagnosis and/or treatment of

temporomandibular joint dysfunction

and oral-facial pain will be scheduled

between approximately 9:30 a.m. and 10

a.m. on November 3, 1997. Oral

presentations from the public regarding

the reclassification of subgroups of

endosseous dental implant devices will

be scheduled between approximately

8:45 a.m. and 9:15 a.m. on November 4,

1997. Oral presentations from the public

regarding the classification of oral

appliances for the treatment of

obstructive sleep apnea and snoring will

be scheduled between approximately

3:15 p.m. and 3:45 p.m. on November 4,

1997. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before October 27, 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

requested to make their presentation.

FDA regrets that it was unable to

publish this notice 15 days prior to the

November 3, 4, and 5, 1997, Dental

Products 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

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.

Closed Committee Deliberations: On

November 4, 1997, from 4:30 p.m. to

5:30 p.m., the meeting will be closed to

permit discussion of trade secret and/or

confidential information (5 U.S.C.

552b(c)(4)) regarding dental device

issues.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: October 8, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–27233 Filed 10–9–97; 10:26 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C Appendix 2), notice

is hereby given of the following Center

for Scientific Review Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Clinical Sciences.

Date: October 15–17, 1997.

Time: 8:00 a.m.

Place: Doubletree Hotel, Rockville,

Maryland.

Contact Person: Dr. Christine Melchior,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4118, Bethesda,

Maryland 20892, (301) 435–1713.

This notice is being published less than 15

days prior to the above meeting due to the

urgent need to meet timing limitations

imposed by the grant review and funding

cycle.

Name of SEP: Biological and Physiological

Sciences.

Date: November 17, 1997.

Time: 11:00 a.m.
53334 Federal Register / Vol. 62, No. 198 / Tuesday, October 14, 1997 / Notices

Place: NIH, Rockledge 2, Room 4202,

Telephone Conference.

Contact Person: Dr. Calbert Laing,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4202, Bethesda,

Maryland 20892, (301) 435–1221.

Name of SEP: Biological and Physiological

Sciences.

Date: November 17–18, 1997.

Time: 8:30 a.m.

Place: George Washington University Inn,

Washington, DC.

Contact Person: Dr. Richard Marcus,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5194, Bethesda,

Maryland 20892, (301) 435–1256.

Name of SEP: Biological and Physiological

Sciences.

Date: November 19, 1997.

Time: 10:15 a.m.

Place: NIH, Rockledge 2, Room 5200,

Telephone Conference.

Contact Person: Dr. Bob Weller, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 5200, Bethesda, Maryland 20892, (301)

435–1259.

Purpose/Agenda: To review Small

Business Innovation Research.

Name of SEP: Clinical Sciences.

Date: October 31, 1997.

Time: 9:00 a.m.

Place: Holiday Inn-Georgetown,

Washington, DC.

Contact Person: Dr. Nancy Shinowara,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5216, Bethesda,

Maryland 20892, (301) 435–1173.

Name of SEP: Biological and Physiological

Sciences.

Date: November 18–19, 1997.

Time: 8:30 a.m.

Place: Wyndham Bristol Hotel,

Washington, DC.

Contact Person: Dr. Camilla Day, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 6152, Bethesda, Maryland 20892, (301)

435–1037.

Name of SEP: Microbiological and

Immunological Sciences.

Date: November 19–20, 1997.

Time: 8:30 a.m.

Place: Ramada Inn, Rockville, Maryland.

Contact Person: Dr. Timothy Henry,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4180, Bethesda,

Maryland 20892, (301) 435–1147.

Name of SEP: Behavioral and

Neurosciences.

Date: November 21, 1997.

Time: 8:30 a.m.

Place: Bethesda Marriott, Bethesda,

Maryland.

Contact Person: Dr. Luigi Giacometti,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5170, Bethesda,

Maryland 20892, (301) 435–1236.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)

Dated: October 6, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27092 Filed 10–10–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Heart, Lung, and Blood

Institute; Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Heart, Lung, and Blood

Institute Special Emphasis Panel (SEP)

meetings:

Name of SEP: Transfusion-Associated

Immunomodulation (TRIM) Telephone

Conference Call.

Date: November 5, 1997.

Time: 1:30 p.m.

Place: Two Rockledge Center, Room 7214,

6701 Rockledge Drive, Bethesda, Maryland

20892.

Contact Person: Louise Corman, Ph.D.,

Two Rockledge Center, Room 7180, 6701

Rockledge Drive, Bethesda, MD 20892–7924,

(301) 435–0270.

Purpose/Agenda: To review and evaluate

contract proposals.

Name of SEP: Lipoprotein Metabolism in

Atherosclerosis.

Date: December 8–9, 1997.

Time: 7:30 p.m.

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Chevy Chase, Maryland

20815.

Contact Person: Ivan Baines, Ph.D., Two

Rockledge Center, Room 7184, 6701

Rockledge Drive, Bethesda, MD 20892–7924,

(301) 435–0277.

Purpose/Agenda: To review and evaluate

grant applications.

These meetings will be closed in

accordance with the provisions set forth in

sections 552b(c)(4) and 552b(c)(6), title 5

U.S.C. Applications and/or contract

proposals and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the applications and/or

proposals, the disclosure of which would

constitute a clearly unwarranted invasion of

personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.837, Heart and Vascular

Diseases Research; 93.838, Lung Diseases

Research; and 93.839, Blood Diseases and

Resources Research, National Institutes of

Health)

Dated: October 6, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27095 Filed 10–10–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meetings of the National Institute of

Mental Health Special Emphasis Panel:

Agenda Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: October 15, 1997.

Time: 11 a.m.

Place: Double Tree Hotel, 1750 Rockville

Pike, Rockville, MD 20852.

Contact Person: Gavin T. Wilkom,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857,

Telephone: 301, 443–4868.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: October 30, 1997.

Time: 1 p.m.

Place: Parklawn Building, Room 9C–18,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Gavin T. Wilkom,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857,

Telephone: 301, 443–4868.

The meetings will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

This notice is being published less than

fifteen days prior to the meetings due to the

urgent need to meet timing limitations

imposed by the review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Numbers 93.242, 93.281, 93.282)

Dated: October 6, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–27094 Filed 10–10–97; 8:45 am]

BILLING CODE 4140–01–M