19948 Federal Register / Vol. 60, No. 77 / Friday, April 21, 1995 / Notices

Application Submission and Deadline

On or before July 3, 1995, submit the

original and two copies of the

application (Form PHS 5161–1—OMB

Number 0937–0189) and one electronic

copy on disk to: Henry S. Cassell III,

Grants Management Officer,

Procurement and Grants Office, Grants

Management Branch, Centers for

Disease Control and Prevention (CDC),

255 East Paces Ferry Road, NE., Room

300, Mailstop E–16, Atlanta, GA 30305.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are:

A. Received on or before the deadline

or

B. Sent on or before the deadline date

and received in time for submission to

the independent review committee.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks will

not be acceptable proof of timely

mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.A. or

1.B. are considered late applications and

will not be considered in the current

competition and will be returned to the

applicant.

Where to Obtain Additional

Information

A complete program description,

information on application procedures,

an application package, and business

management technical assistance may

be obtained from: Manuel Lambrinos,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–16, Atlanta, GA 30305,

telephone (404) 842–6777.

Programmatic technical assistance may

be obtained from: Sevgi Aral, Ph.D.,

Division of STD/HIV Prevention,

National Center for Prevention Services,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Mailstop E–02, Atlanta, GA 30333,

telephone (404) 639–8259.

Please refer to Announcement 523

when requesting information and

submitting an application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: April 14, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–9879 Filed 4–20–95; 8:45 am]

BILLING CODE 4163–18–P

Disease, Disability, and Injury

Prevention and Control Special

Emphasis Panel (SEP): Cooperative

Agreements for National/Regional

Minority Organization Human

Immunodeficiency Virus/Sexually

Transmitted Diseases Prevention,

Immunization, and Tuberculosis

Projects—Program Announcement

305b: Amendment of Time and Date

Federal Register Citation of Previous

Announcement 60 FR 13728—dated

March 14, 1995.

This notice announces an amendment

in the time and date of a previously

announced meeting.

Previously Announced Time and

Date: 8:30 a.m.–4:30 p.m., April 18,

1995.

Amendment in Meeting Time and

Date: 8:30 a.m.–4:30 p.m., April 18,

1995. 8:30 a.m.–4:30 p.m., April 19,

1995.

Dated: April 18, 1995.

Carolyn J. Russell,

Director, Management Analysis and Services

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 95–10009 Filed 4–19–95; 10:14 am]

BILLING CODE 4163–18–M

Food and Drug Administration

[Docket No. 95M–0072]

Cardiac Pacemakers, Inc., Premarket

Approval of VENTAK P2 AICDTM

System: Model 1625 VENTAK P2

Pulse Generator, Model 2835 Software

Module, and Model 2815 VENTAK

ECD External Cardioverter Defibrillator

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Cardiac

Pacemakers, Inc., St. Paul, MN, for

premarket approval, under the Federal

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

of the VENTAK P2 AICDTM System.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of March 10, 1995,

of the approval of the application.

DATES: Petitions for administrative

review by May 22, 1995.

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, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Carole C. Carey, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8609.

SUPPLEMENTARY INFORMATION: On August

30, 1993, Cardiac Pacemakers, Inc., St.

Paul, MN 55112, submitted to CDRH an

application for premarket approval of

VENTAK P2 AICDTM System consists

of the following: Model 1625 VENTAK

P2 pulse generator; Model 2835

Software Module to be used with

commercially available Cardiac

Pacemakers, Inc., (CPI) Model 2035

Handheld Programmer and Model 6575

or 6577 Telemetry Wand; Model 2815

VENTAK ECD External Cardioverter

Defibrillator (which includes the Model

6873 High Voltage Cable with Model

6838 Thumbscrew, Model 6843 Bipolar

Cable with Model 6838 Thumbscrew,

Model 6874 Bipolar Cable, and related

CPI commercially available

accessories); commercially available

CPI ENDOTAK 60–Series Lead

System and accessories; commercially

available CPI epicardial defibrillation

leads and accessories; and commercially

available pace/sense leads and

accessories. The device is an automatic

implantable cardioverter defibrillator

system and is indicated for the

treatment of patients with ventricular

fibrillation and/or ventricular

tachyarrhythmias who are at high risk of

sudden cardiac death. Such patients are

defined as having experienced the

following situations: (1) The survival of

at least one episode of cardiac arrest

presumably due to hemodynamically

unstable ventricular tachyarrhythmia

not associated with acute myocardial

infarction, and/or (2) a poorly tolerated,

sustained ventricular tachycardia (VT)

and/or ventricular fibrillation (VF)

which recurs spontaneously or can be

induced despite the best antiarrhythmic

drug therapy. Note: The clinical

outcome of hemodynamically stable,

sustained VT patients is not fully

known. A study of the safety and

effectiveness of the VENTAK P2

system on this selected subgroup of VT

patients has 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