Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Notices 17849

ANALYTE: Helicobacter pylori

Antibodies (2513)

TEST SYSTEM, ASSAY,

EXAMINATION:

Quidel QuickVue One-Step H. pylori

Test for Whole Blood (52037)

SPECIALITY/SUBSPECIALITY:

Urinalysis

ANALYTE: Urine Dipstick or Tablet

Analytes, nonautomated (9641)

TEST SYSTEM, ASSAY,

EXAMINATION:

Bayer CHEK-STIX U.T.I. Test Strips

(07790)

Genesis Labs DIA SCREEN 10 Way

Reagent Strips: Urinalysis (22182)

TCPI URI-TEST Glucose in Urine

(61256)

TCPI URI-TEST Nitrite in Urine

(61257)

[FR Doc. 97–9350 Filed 4–10–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Proposed Information Collection

Activity; Comment Request

Proposed Projects

Title: Procedures for Requests To Use

Child Care and Development Fund for

Construction or Major Renovation of

Child Care Facilities.

OMB No: New Collection.

Description; The Personal

Responsibility and Work Opportunity

Reconciliation Act of 1996 (Public Law

104–193) allows tribal grantees to use

Child Care and Development Fund

(CCDF) grant awards for construction

and renovation of child care facilities. A

tribal grantee must first request and

receive approval from the

Administration for Children and

Families (ACF) before using CCDF funds

for construction or major renovation.

This information collection contains the

statutorily-mandated uniform

procedures for the solicitation and

consideration of requests. Respondents

will be CCDF tribal grantees requesting

to use the CCDF funds for construction

or major renovation.

Respondents: Tribal Governments.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses per

respondent

Average

burden hours

per

response

Total

burden hours

Construction and renovation collection ............................................................ 100 1 20 2,000

Estimated Total Annual Burden Hours: 2,000.

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the administration for Children and

Families, Office of Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade, S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. All requests should be

identified by the title of the information

collection.

The Department specifically requests

comments on: (a) whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: April 7, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–9396 Filed 4–10–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 97M–0136]

Thoratec Laboratories Corp.;

Premarket Approval of Thoratec

Ventricular Assist Device System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Thoratec

Laboratories Corp., Berkeley, CA, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of Thoratec Ventricular Assist Device

System. After reviewing the

recommendation of the Circulatory

Systems Devices Panel, FDA’s Center for

Devices and Radiological Health (CDRH)

notified the applicant, by letter of

December 20, 1995, of the approval of

the application.

DATES: Petitions for administrative

review by May 12, 1997.

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: Dina

A. Justice, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8262.

SUPPLEMENTARY INFORMATION: On June

26, 1992, Thoratec Laboratories Corp.,

Berkeley, CA 94710, submitted to CDRH

an application for premarket approval of

Thoratec Ventricular Assist Device

System. The device is a ventricular

assist device and is intended as a bridge

to cardiac transplantation for use in

patients suffering from end-stage heart

failure. The patient should meet all of

the following criteria: (1) Candidate for

cardiac transplantation, (2) imminent

risk of dying before donor heart

procurement, and (3) dependence on, or

incomplete response to, continued

vasopressor support.

On December 5, 1994, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the