41400 Federal Register / Vol. 62, No. 148 / Friday, August 1, 1997 / Notices

10. What methods are available to

provide users with more access to

device labeling?

11. Are there other issues with the

labeling regulation or the labeling

procedures used by CDRH that the

agency should address?

12. Relating to FDA’s medical device

reporting system, what are the concerns

if the agency would require

manufacturers to submit periodic

summary reports for common and

anticipated adverse events that are

listed in the device labeling, in lieu of

individual incident reports. The

agency’s interest in requiring summary

reporting for anticipated adverse events

already listed in the labeling is to

improve the signals received in the

medical device reporting system and to

reduce repeat reports of known

problems when further agency action is

unlikely. What adverse events should

still be reported individually, even if the

events are anticipated and listed in the

labeling?

Interested persons who wish to

participate may, on or before August 22,

1997, submit notice of participation to

the Dockets Management Branch

(address above). All notices of

participation submitted should be

identified with the docket number

found in brackets in the heading of this

document and should contain the name,

address, telephone number, business

affiliation of the person requesting to

make a presentation, a brief summary of

the presentation, and the approximate

time requested for the presentation.

Individuals or groups having similar

interests are requested to consolidate

their comments and present them

through a single representative. FDA

may require joint presentations by

persons with common interests. FDA

will allocate the time available for the

meeting among the persons who

properly file a notice of appearance.

Persons who are unable to participate

on the day of the meeting are

encouraged to submit written comments

to the Dockets Management Branch

(address above). Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday.

Dated: July 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–20312 Filed 7-31-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Dental Research;

Notice of Closed Meeting

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 Institute of Dental Research

Special Emphasis Panel (SEP) meeting:

Name of SEP: National Institute of Dental

Research Special Emphasis Panel-Review of

R01s & R29 (97–43).

Date: August 12, 1997.

Time: 9:30 a.m.

Place: Natcher Building, Rm. 4AN–44F,

National Institutes of Health, Bethesda, MD

20892, (teleconference).

Contact Person: Dr. George Hausch, Chief,

Grants Review Section, 4500 Center Drive,

Natcher Building, Room 4AN–44F, Bethesda,

MD 20892, (301) 594–2372.

Purpose/Agenda: To evaluate and review

grant applications and/or contract proposals.

This notice is being published less than

fifteen days prior to the above meeting due

to the urgent need to meet timing limitations

imposed by the review and funding cycle.

The meeting will be closed in accordance

with the provisions set forth in secs.

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 No. 93.121, Oral Diseases and

Disorders Research)

Dated: July 29, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–20324 Filed 7–31–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute on Deafness and

Other Communication Disorders;

Notice of Meeting

Notice is hereby given of a meeting of

the NIDCD Work Group on Peer Review

on August 21–23, 1997 in Conference

Room 10, Building 31, the National

Institutes of Health, 9000 Rockville

Pike, Bethesda, MD 20892. The meeting

will be held to discuss issues involving

the initial review of grant applications

and will be held from 3 to 5 p.m. on

August 21, 8:30 a.m. to 5 p.m. on

August 22, and from 8:30 a.m. to 12

p.m. on August 23.

The entire meeting is open to the

public. Individuals who plan to attend

and need special assistance, such as

sign language interpretation or other

reasonable accommodations, should

contact Craig A. Jordan, Ph.D., Division

of Extramural Activities, NIDCD, EPS

Room 400C, Bethesda, MD 20892, 301–

496–8693 in advance of the meeting.

Dated: July 29, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–20325 Filed 7–31–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Environmental

Health Sciences; Notice of Meeting of

National Advisory Environmental

Health Sciences Council

Pursuant to Pub. L. 92–463, notice is

hereby given of the meeting of the

National Advisory Environmental

Health Sciences Council, September 15–

16, 1997, Building 101 Conference

Room, South Campus, Research

Triangle Park, North Carolina.

This meeting will be open to the

public from 9:00 a.m. to approximately

3:45 p.m. on September 15 for the report

of the Director, NIEHS, and for

discussion of the NIEHS budget,

program policies and issues, recent

legislation, and other items of interest.

Attendance by the public will be limited

to space available.

In accordance with the provisions set

forth in secs. 552b(c)(4) and 552b(c)(6),

Title 5 U.S.C. and sec. 10(d) of Pub. L.

92–463, the meeting will be closed to

the public from approximately 3:45 p.m.

on September 15 to adjournment on

September 16, for the review,

discussion, and evaluation of individual

grant applications. These applications

and the discussions could reveal

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

contact the Executive Secretary in

advance of the meeting.

Dr. Anne Sassaman, Director, Division

of Extramural Research and Training,