Federal Register / Vol. 62, No. 4 / Tuesday, January 7, 1997 / Notices 995

The Federal Open Market Committee

seeks monetary and financial conditions

that will foster price stability and

promote sustainable growth in output.

In furtherance of these objectives, the

Committee at its meeting in July

reaffirmed the ranges it had established

in January for growth of M2 and M3 of

1 to 5 percent and 2 to 6 percent

respectively, measured from the fourth

quarter of 1995 to the fourth quarter of

1996. The monitoring range for growth

of total domestic nonfinancial debt was

maintained at 3 to 7 percent for the year.

For 1997 the Committee agreed on a

tentative basis to set the same ranges as

in 1996 for growth of the monetary

aggregages and debt, measured from the

fourth quarter of 1996 to the fourth

quarter of 1997. The behavior of the

monetary aggregates will continue to be

evaluated in the light of progress toward

price level stability, movements in their

velocities, and developments in the

economy and financial markets.

In the implementation of policy for

the immediate future, the Committee

seeks to maintain the existing degree of

pressure on reserve positions. In the

context of the Committee’s long-run

objectives for price stability and

sustainable economic growth, and

giving careful consideration to

economic, financial, and monetary

developments, somewhat greater reserve

restraint would or slightly lesser reserve

restraint might be acceptable in the

intermeeting period. The contemplated

reserve conditions are expected to be

consistent with moderate growth in M2

and relatively strong expansion in M3

over coming months.

By order of the Federal Open Market

Committee, December 27, 1996.

Donald L. Kohn,

Secretary, Federal Open Market Committee.

[FR Doc. 97-250 Filed 1-6-97; 8:45 am]

BILLING CODE 6210-01-F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0491]

Agency Information Collection

Activities: Proposed Collection;

Reinstatement

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

notice in the Federal Register

concerning each proposed collection of

information, including each proposed

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

requirements for premarket approval

applications (PMA’s) that are submitted

under part 814 (21 CFR part 814).

DATES: Submit written comments on the

collection of information requirements

by March 10, 1997.

ADDRESSES: Submit written comments

on the collection of information

requirements to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the

Paperwork Reduction Act of 1995 (the

PRA) (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed reinstatement

of an existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Premarket Approval of Medical

Devices—Part 814 (OMB Control

Number 0910–0231—Reinstatement)

Section 515 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

360e) sets forth requirements for

premarket approval of certain medical

devices. Under section 515 of the act, an

application must contain several pieces

of information, including: Full reports

of all information concerning

investigations showing whether the

device is safe and effective; a statement

of components; a full description of the

methods used in, and the facilities and

controls used for, the manufacture and

processing of the device; and labeling

specimens. The implementing

regulations, contained in part 814,

further specify the contents of a PMA

for a medical device and the criteria

FDA will employ in approving, denying,

or withdrawing approval of a PMA. The

purpose of these regulations is to

establish an efficient and thorough

procedure for FDA’s review of PMA’s

for class III (premarket approval)

medical devices, in order to facilitate

the approval of PMA’s for devices that

have been shown to be safe and effective

and otherwise meet the statutory criteria

for approval and to ensure the

disapproval of PMA’s for devices that

have not been show to be safe and

effective and that do not otherwise meet

the statutory criteria for approval.

Under § 814.15, an applicant may

submit in support of a PMA studies

from research conducted outside the

United States, but an applicant must

explain in detail any differences

between standards used in a study to

support the PMA’s and those standards

found in the Declaration of Helsinki.

Section 814.20 provides a list of

information required in the PMA,

including: A summary of information in

the application, a complete description

of the device, technical and scientific

information, and copies of proposed

labeling. Section 814.37 provides

requirements for an applicant who seeks

to amend a pending PMA. Under

§ 814.39, an applicant must submit a

supplement to the PMA before making

a change affecting the safety or

effectiveness of the device. Section

814.82 sets forth postapproval

requirements FDA may propose,

including periodic reporting on safety,
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.