66374 Federal Register / Vol. 62, No. 243 / Thursday, December 18, 1997 / Notices

postmarket surveillance order, for

example, might be whether there are

alternative postmarket data collection

mechanisms to obtain the same kind of

information about the device. The

agency could use such criteria to guide

its decision whether to impose tracking

or postmarket surveillance in a

particular case.

The agency requests that comments or

presentations be provided concerning

the statutory requirements for medical

device tracking and postmarket

surveillance and related proposed risk

assessment criteria which may be useful

to the agency to determine whether

tracking orders or postmarket

surveillance orders should be issued for

devices that meet the basic statutory

requirements of section 519(e) or 522 of

the Federal Food, Drug, and Cosmetic

Act (21 U.S.C. 360i(e) or 360l). The

agency would like to encourage

comments, discussion and proposals

from the industry, the professional

community, consumers, and any other

interested parties or organizations.

Written comments may be submitted in

advance of the meeting to the Dockets

Management Branch (address above).

To help focus discussion, FDA

requests answers to the following

questions:

(1) What factors (or criteria) should

lead FDA to order tracking and/or

postmarket surveillance?

(2) What factors (or criteria) should

lead FDA not to order tracking and/or

postmarket surveillance?

(3) Under what circumstances should

FDA order both tracking and postmarket

surveillance for a device?

(4) Under what circumstances should

FDA order tracking but not postmarket

surveillance, or vice versa?

Electronic Access

Additional information regarding the

public meeting may be found on the

Internet on the home page for the Center

for Devices and Radiological Health

under the ‘‘New Items on the Internet’’

section at www.cdrh.fda.gov. This will

be an informal meeting conducted in

accordance with 21 CFR 10.65.

Dated: December 15, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–33090 Filed 12–15–97; 3:02 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0500]

Telectronics Pacing Systems, Inc.;

Premarket Approval of Telectronics

GuardianTM ATP II Model 4211

Implantable Cardioverter Defibrillator

System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Telectronics Pacing Systems, Inc.,

Englewood, CO, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of the

GuardianTM ATP II Model 4211

Implantable Cardioverter Defibrillator

System. FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of July 3, 1997, of

the approval of the application.

DATES: Petitions for administrative

review by January 20, 1998.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Doris J. Terry, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8609.

SUPPLEMENTARY INFORMATION: On July 8,

1994, Telectronics Pacing Systems, Inc.,

Englewood, CO 80112, submitted to

CDRH an application for premarket

approval of the GuardianTM ATP II

Model 4211 Implantable Cardioverter

Defibrillator System. The GuardianTM

ATP II Model 4211 Implantable

Cardioverter Defibrillator System is

indicated for use in patients who are at

high risk of sudden death due to

ventricular fibrillation and/or

ventricular tachyrhythmias and who

have experienced one of the following

situations:

• survival of at least one episode of

cardiac arrest (manifested by a loss of

consciousness) due to a ventricular

tachyrhythmia

• recurrent, poorly tolerated

sustained ventricular tachycardia (VT).

Note: The clinical outcome for

hemodynamically stable, sustained-VT

patients is not fully known. Safety and

effectiveness studies have not been

conducted.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On July 3, 1997, CDRH approved the

application by a letter to the applicant

from the Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under 21 CFR part 12 of FDA’s

administrative practices and procedures

regulations or a review of the

application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

21 CFR 10.33(b). A petitioner shall

identify the form of review requested

(hearing or independent advisory

committee) and shall submit with the

petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of the review

to be used, the persons who may

participate in the review, the time and

place where the review will occur, and

other details.

Petitioners may, at any time on or

before January 20, 1998, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,
Federal Register / Vol. 62, No. 243 / Thursday, December 18, 1997 / Notices 66375

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: October 31, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–32968 Filed 12–17–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–265]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement without change

of a previously approved collection for

which approval has expired; Title of

Information Collection: Independent

Renal Dialysis Facility Cost Report Form

and Supporting Regulations 42 CFR

413.198, 413.20; Form No.: HCFA–265;

Use: The Medicare Independent Renal

Dialysis Facility Cost Report provides

for determinations and allocation of

costs to the components of the Renal

Dialysis facility in order to establish a

proper basis for Medicare payment.

Frequency: Annually; Affected Public:

Business or other for profit; Number of

Respondents: 2,472; Total Annual

Responses: 2,472; Total Annual Hours:

484,512.

2. Type of Information Collection

Request: New Collection; Title of

Information Collection: Evaluation of

the Oregon Medicaid Reform

Demonstration: Phase II Adult

Interview, Phase II Child Interview,

Survey of Agency Providers; Form No.:

HCFA–R–221; Use: These survey

instruments will be used to evaluate the

Oregon Medicaid Reform

Demonstration. The Phase II Adult and

Phase II Child interviews are designed

to collect information on health status,

access to care and past health insurance

status for adults and children

participating in Phase II of the Oregon

Health Plan (OHP). The survey of

Agency providers is designed to collect

information on the experience under

OHP of agencies that traditionally treat

disabled and elderly Medicaid

beneficiaries. Frequency: One Time;

Affected Public: Individuals or

Households, Business or other for-profit,

Not-for-profit institutions, and State,

Local or Tribal Governments; Number of

Respondents: 4,150; Total Annual

Responses: 4,150; Total Annual Hours:

1,730.

3. Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Health

Maintenance Organizations &

Competitive Medical Plans National

Data Reporting Requirements and

Supporting Regulations 42 CFR 417.100,

.940, .126, .478, .162; Form No.: HCFA–

906; Use: This form captures

information which governs qualification

of new Health Maintenance

Organizations (HMOs) and the

eligibility of Competitive Medical Plans

(CMPs), employer compliance, recovery

of Federal loan and loan guarantees,

financial disclosure, and continuing

regulation of qualified HMOs and CMPs

which provide health care services to

beneficiaries for a fixed fee which is

paid on a periodic basis. Frequency:

Other; Annually, Quarterly; Affected

Public: Federal Government, Business or

other for-profit, Not-for-profit

institutions, State, local or Tribal

Government; Number of Respondents:

313; Total Annual Responses: 953; Total

Annual Hours: 3,130.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or any

related forms, E-mail your request,

including your address and phone

number, to Paperwork@hcfa.gov, or call

the Reports Clearance Office on (410)

786–1326. Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Information Technology Investment

Management Group, Division of HCFA

Enterprise Standards, Attention: John

Rudolph, Room C2–26–17, 7500

Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: December 11, 1997.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Health Care

Financing Administration.

[FR Doc. 97–33064 Filed 12–17–97; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Document Identifier: HCFA–179

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Transmittal and

Notice of Approval of State Plan

Material and Supporting Regulations in

42 CFR 430.10–430.20 and 440.167;

Form No.: HCFA–179 (OMB #0938–