996 Federal Register / Vol. 62, No. 4 / Tuesday, January 7, 1997 / Notices

effectiveness, and reliability, and

display in the labeling and advertising

of certain warnings. Section 814.84

specifies the contents of periodic

reports. Section 814.82 requires the

maintenance of records to trace patients

and the organizing and indexing of

records into identifiable files to enable

FDA to determine whether there is

reasonable assurance of the device’s

continued safety and effectiveness. The

applicant determines what records

should be maintained during product

development to document and/or

substantiate the device’s safety and

effectiveness. Records required by the

current good manufacturing practices

for medical devices regulation (21 CFR

part 820) may be relevant to a PMA

review and may be submitted as part of

an application. In individual instances,

records may be required to be

maintained as conditions of approval to

ensure the device’s continuing safety

and effectiveness.

Respondents to this information

collection are persons filing an

application with the Secretary of Health

and Human Services for approval of a

Class III medical device. Part 814

defines a person as any individual,

partnership, corporation, association,

scientific or academic establishment,

government agency or organizational

unit, or other legal entity. These

respondents include manufacturers of

commercial medical devices in

distribution prior to May 28, 1976 (the

enactment date of the Medical Device

Amendments).

FDA estimates the burden of this

collection of information as follows:

ESTIMATED ANNUAL REPORTING BURDEN

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

814.15, 814.20, and 814.37 545 1 545 837.28 456,320

814.39 545 1 545 73.15 39,865

814.82 545 1 545 9.14 4,983

814.84 545 1 545 18.29 9,966

Total Hours 511,134

There are no capital costs or operating and maintenance costs associated with this collection of information.

ESTIMATED ANNUAL RECORDKEEPING BURDEN

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

814.82(a)(5) and (a)(6) 567 1 567 16.7 9,469

Total 9,469

There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: December 31, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–291 Filed 1–6–97; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; 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

meeting:

Committee Name: National Institute of

Diabetes and Digestive and Kidney Diseases

Special Emphasis Panel (Telephone

Conference Call).

Date: January 6, 1997.

Place: Natcher Building, Room 6AS–25F,

National Institutes of Health, 45, Center

Drive, Bethesda, Maryland 20892-6600.

Contact Person: Lakshmanan Sankaran, Ph.

D., Scientific Review Administrator, Natcher

Building, Room 6AS–25F, National Institutes

of Health, 45 Center Drive, Bethesda,

Maryland 20892-6600; Phone: 301-594-7799.

Agenda/Purpose: To review and evaluate a

research grant application.

This notice is being published less than 15

days prior to the 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.

Application 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. 93.847-849, Diabetes, Endocrine

and Metabolic Diseases; Digestive Diseases

and Nutrition; and Kidney Diseases, Urology

and Hematology Research, National Institutes

of Health.)

Dated: December 26, 1996.

Margery G. Grubb,

Senior Committee Management Specialist,

NIH.

[FR Doc. 97–319 Filed 1–2–97; 4:43 pm]

BILLING CODE 4140–01–M

DEPARTMENT OF THE INTERIOR

Bureau of Indian Affairs

Indian Gaming; Notice of amendment

to Approved Tribal-State Compact

SUMMARY: Pursuant to 25 U.S.C. 2710, of

the Indian Gaming Regulatory Act of

1988 (Pub. L. 100–497), the Secretary of

the Interior shall publish, in the Federal

Register, notice of approved Tribal-State

Compacts for the purpose of engaging in

Class III (casino) gambling on Indian

reservations. The Assistant Secretary—

Indian Affairs, Department of the

Interior, through her delegated

authority, has approved Amendment II

to the Tribal-State Compact for

Regulation of Class III Gaming Between

The Klamath Tribes and the State of

Oregon, which was executed on

November 13, 1996.

DATES: This action is effective January 7,

1997.

FOR FURTHER INFORMATION CONTACT:

George T. Skibine, Director, Indian

Gaming Management Staff, Bureau of

Indian Affairs, Washington, DC 20240

(202) 219–4068.
Federal Register / Vol. 62, No. 4 / Tuesday, January 7, 1997 / Notices 997

Dated: December 26, 1996.

Elizabeth L. Homer,

Assistant Secretary—Indian Affairs.

[FR Doc. 97–245 Filed 1–6–97; 8:45 am]

BILLING CODE 4310–02–P

Indian Gaming; Notice of Approved

Second Amendment to Tribal-State

Compact

AGENCY: Bureau of Indian Affairs,

Interior.

SUMMARY: Pursuant to 25 U.S.C. 2710, of

the Indian Gaming Regulatory Act of

1988 (Pub. L. 100–497), the Secretary of

the Interior shall publish, in the Federal

Register, notice of approved Tribal-State

Compacts for the purpose of engaging in

Class III (casino) gaming on Indian

reservations. The Assistant Secretary—

Indian Affairs, Department of the

Interior, through her delegated

authority, has approved the Second

Amendment to the Tribal-State Gaming

Compact Between the Swinomish

Indian Tribal Community and the State

of Washington executed on October 4,

1996.

DATES: This action is effective January 7,

1997.

FOR FURTHER INFORMATION CONTACT:

George T. Skibine, Director, Indian

Gaming Management Staff, Bureau of

Indian Affairs, Washington, DC 20240

(202) 219–4068.

Dated: December 26, 1996.

Elizabeth L. Homer,

Assistant Secretary—Indian Affairs.

[FR Doc. 97–244 Filed 1–6–97; 8:45 am]

BILLING CODE 4310–02–P

NATIONAL AERONAUTICS AND

SPACE ADMINISTRATION

[Notice (97–001)]

NASA Advisory Council (NAC), Space

Science Advisory Committee (SScAC),

Solar System Exploration Advisory

Subcommittee; Meeting

AGENCY: National Aeronautics and

Space Administration.

ACTION: Notice of meeting.

SUMMARY: In accordance with the

Federal Advisory Committee Act, Public

Law 92–463, as amended, the National

Aeronautics and Space Administration

announces a meeting of the NASA

Advisory Council, Space Science

Advisory Committee, Solar System

Exploration Advisory Subcommittee.

DATES: Wednesday, January 15, 1997,

8:30 a.m. to 5:00 p.m.; Thursday,

January 16, 1997, 8:30 a.m. to 5:00 p.m.;

and Friday, January 17, 1997, 8:30 a.m.,

4:00 p.m.

ADDRESSES: National Aeronautics and

Space Administration, MIC Room 6H46,

300 E Street, SW., Washington, DC

20546.

FOR FURTHER INFORMATION CONTACT:

Jurgen Rahe, Code SA, National

Aeronautics and Space Administration,

Washington, DC 20546, (202) 358–2150.

SUPPLEMENTARY INFORMATION: The

meeting will be open to the public up

to the capacity of the room. The agenda

for the meeting is as follows:

—Office of Space Science Activities

—Board of Directors Overview

—Reserch Program Management

Overview

—Advanced Technology and Mission

Studies Overview

—Mission and Payload Development,

Overview

—Roadmap to the Solar System

—Future Activities

It is imperative that the meeting be

held on these dates to accommodate the

scheduling priorities of the key

participants. Visitors will be requested

to a sign a visitor’s register.

Dated: January 2, 1997.

Leslie M. Nolan,

Advisory Committee Management Officer,

National Aeronautics and Space

Administration.

[FR Doc. 97–289 Filed 1–6–97; 8:45 am]

BILLING CODE 7510–01–M

NATIONAL SCIENCE FOUNDATION

Special Emphasis Panel in Advanced

Scientific Computing; Notice of

Meeting

In accordance with the Federal

Advisory Committee Act (Pub. L. 92–

463, as amended), the National Science

Foundation announces the following

meeting:

Name: Special Emphasis Panel in

Advanced Scientific Computing (#1185)

Date and Time: January 24, 1997, 8:30 am

to 5:00 pm.

Place: National Science Foundation, 4201

Wilson Boulevard, Suite 1150, Arlington, VA

22230.

Type of Meeting: Closed.

Contact Person: Dr. John Van Rosendale,

Program Director, New Technologies

Program, Suite 1122, National Science

Foundation, 4201 Wilson Boulevard,

Arlington, VA 22230, (703) 306–1962.

Purpose of Meeting: To provide

recommendations and advice concerning

proposals submitted NSF for financial

support.

Agenda: Panel review of CISE Postdoctoral

Research Associates in Computational

Science and Engineering proposals as part of

the selection process for awards.

Reason for Closing: The proposals being

reviewed include information of a

proprietary or confidential nature, including

technical information; financial data, such as

salaries; and personal information

concerning individuals associated with the

proposals. These matters are exempt under 5

U.S.C. 552b(c) (4) and (6) of the Government

in the Sunshine Act.

Dated: January 2, 1997.

M. Rebecca Winkler,

Committee Management Officer.

[FR Doc. 97–273 Filed 1–6–97; 8:45 am]

BILLING CODE 7555–01–M

Special Emphasis Panel in

Astronomical Sciences (1186); Notice

of Meetings

In accordance with the Federal

Advisory Committee Act (Pub. L. 92–

463, as amended), the National Science

Foundation announces that the Special

Emphasis Panel in Astronomical

Sciences (1186) will be holding panel

meetings for the purpose of reviewing

proposals submitted to the Career

Program in the area of Astronomical

Sciences. In order to review the large

volume of proposals, panel meetings

will be held on January 30–31, 1997, (2).

All meetings will be closed to the public

and will be held at the National Science

Foundation, 4201 Wilson Boulevard,

Arlington, Virginia, from 8:30 AM to

5:00 PM each day.

Contact Person: Dr. James P. Wright,

Program Director, Education, Human

Resources, and Special Programs,

Division of Astronomical Sciences,

National Science Foundation, Room

1030, 4201 Wilson Boulevard,

Arlington, VA 22230, (703) 306–1819.

Reason for Closing: The proposals

being reviewed include information of a

proprietary or confidential nature,

including technical information,

financial data such as salaries, and

personal information concerning

individuals associated with the

proposals. These matters are exempt

under 5 USC 552(c) (4) and (6) of the

Government in the Sunshine Act.

Dated: January 2, 1997.

M. Rebecca Winkler,

Committee Management Officer.

[FR Doc. 97–271 Filed 1–6–97; 8:45 am]

BILLING CODE 7555–01–M

Special Emphasis Panel in

Bioengineering and Environmental

System; Notice of Meeting

In accordance with the Federal

Advisory Committee Act (Pub. L. 92–

463, as amended), the National Science

Foundation announces the following

meeting: