65346 Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices

Plans, directs and evaluates activities

authorized under Title IV of the OAA.

Conducts activities for the development

of adequate knowledge for improving

the circumstances of older people.

Develops a knowledge base for policy

decisions and program development

and coordination through support of a

wide range of research, demonstration,

and training activities.

Prepares the planning documents for,

and coordinates the development of, the

annual discretionary funds program

announcement. Provides technical input

for Congressional and budget

presentations related to the research and

demonstration program. Evaluates

research, demonstration and training

grant and contract proposals; and

recommends approval/disapproval,

monitors progress, gives technical

guidance to and evaluates the

performance of grantees and contractors.

Analyzes and interprets project results

and recommends technical applications.

Promotes coordination of research and

demonstrations with other national,

field and local programs related to

aging.

Within overall AoA strategy and long

range plans, conducts continuing

studies and periodic reviews of

personnel needs and resources in the

field of aging. Plans and assesses AoA’s

activities to ensure trained staff for

programs serving older Americans.

Develops and monitors a national plan

for increasing these resources, and

prepares reports thereon for AoA, the

Federal Council on the Aging, the

Secretary, the President and Congress.

Administers a program through grants

and contracts for developing curricula

and providing training related to

preparation for professional, teaching,

research, and paraprofessional careers

in the field of aging. Makes grants for

planning, developing, and operating

multi-disciplinary centers of

gerontology designed to serve the

purposes set forth under Title IV of the

OAA, including the monitoring of such

grants on a continuing basis.

Develops standards, optional models,

and ‘‘best practice’’ suggestions on

services to the elderly for use by the

Regional Offices, and State and Area

Agencies on Aging. Develops technical

assistance material and in-service

training curricula concerning these

standards, models, and best practice

suggestions.

Provides technical input on research,

demonstration and training programs to

the AoA planning and policy

development activities, legislative

activities and the annual budget

development cycle. Participates in

Departmental and inter-departmental

activities which concern health and

social services; reviews and comments

on Departmental regulations and

policies regarding health programs and

institutional and non-institutional long

term care services.

Manages a program for the collection,

analysis, and dissemination of

information related to the needs and

problems of older persons. Develops

and coordinates initiatives with other

Federal agencies, national aging

organizations and universities to fill

gaps in information in the field of aging.

Reviews all products from AoA, the

OAA network, and other sources of

information on aging to identify new

findings which will be useful to older

people and professionals operating in

the field of aging. Determines the

relative utility of each product, its

potential users, and the most effective

way to disseminate information to users.

Dated: December 12, 1995.

Fernando M. Torres-Gil,

Assistant Secretary for Aging.

[FR Doc. 95–30732 Filed 12–18–95; 8:45 am]

BILLING CODE 4130–01–P

Agency for Health Care Policy and

Research

Meeting of the National Advisory

Council for Health Care Policy,

Research, and Evaluation

AGENCY: Agency for Health Care Policy

and Research, HHS.

ACTION: Notice of public meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the National Advisory Council for

Health Care Policy, Research, and

Evaluation.

DATES: The meeting will be open to the

public on Friday, January 26, from 8:30

a.m. to 5 p.m.

ADDRESSES: The meeting will be held at

the Madison Hotel, 1177 5th Street,

NW., Washington, DC 2005.

FOR FURTHER INFORMATION CONTACT:

Deborah L. Queenan, Executive

Secretary of the Advisory Council at the

Agency for Health Care Policy and

Research, 2101 East Jefferson Street,

Suite 603, Rockville, Maryland 20852,

(301) 594–1459.

In addition, if sign language

interpretation or other reasonable

accommodation for a disability is

needed, please contact Linda Reeves,

the Assistant Administrator for Equal

Opportunity, AHCPR, or (301) 594–6665

no later than January 19, 1996.

SUPPLEMENTARY INFORMATION:

I. Purpose

Section 921 of the Public Health

Service Act (42 U.S.C. 299c) establishes

the National Advisory Council for

Health Care Policy, Research, and

Evaluation. The Council provides

advice to the Secretary and the

Administrator, Agency for Health Care

Policy and Research (AHCPR), on

matters related to AHCPR activities to

enhance the quality, appropriations, and

effectiveness of health care services and

access to such services through

scientific research and the promotion of

improvements in clinical practice and

in the organization, financing, and

delivery of health care services.

The Council is composed of public

members appointed by the Secretary.

These members are: Robert A. Berenson,

M.D.; F. Marian Bishop, Ph.D.; Linda

Burnes Bolton, Dr. P.H.; John W.

Danaher, M.D.; Helen Darling, M.A.;

Nancy J. Kaufman, M.S.; William S.

Kiser, M.D.; Robert M. Krughoff; Risa J.

Lavizzo-Mourey, M.D.; W. David Leak,

M.D.; Harold S. Luft, Ph.D.; Barbara J.

McNeil, M.D.; Walter J. McNerney,

M.H.A.; Edward B. Perrin, Ph.D.; Louis

F. Rossiter, Ph.D.; Albert L. Sui, M.D.;

and Ellen B. White. M.B.A.

There also are Federal ex-officio

members. These members are:

Administrator, Substance Abuse and

Mental Health Services Administration;

Director, National Institutes of Health;

Director, Centers for Disease Control

and Prevention; Administrator, Health

Care Financing Administration;

Commissioner, Food and Drug

Administration; Assistant Secretary of

Defense (Health Affairs); and Chief

Medical Director, Department of

Veterans Affairs.

II. Agenda

On Friday, January 26, 1996, the

meeting will begin at 8:30 a.m. with the

call to order by the Council Chairman.

The Administrator, AHCPR, will update

the status of current Agency issues and

program initiatives. Council will then

discuss the issues of health services

research work force and education,

public/private sector collaboration, and

the large grant review process. The

meeting will adjourn at 5:00 p.m.

Agenda items are subject to change as

priorities dictate.

Dated: December 7, 1995.

Clifton R. Gaus,

Administrator.

[FR Doc. 95–30742 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–90–M
Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices 65347

Food and Drug Administration

[Docket No. 95M–0397]

Progressive Angioplasty Systems,

Inc.; Premarket Approval of the PAS

LacrosseTM PTCA Catheter

AGENCY:Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Progressive Angioplasty Systems, Inc.,

Menlo Park, CA, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of the PAS

LaCrosseTM PTCA Catheter. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of September 27, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by January 18, 1996.

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:

Veronica Price, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8243.

SUPPLEMENTARY INFORMATION: On April

4, 1994, Progressive Angioplasty

Systems, Inc., Menlo Park, CA 94025–

1516, submitted to CDRH an application

for premarket approval of the PAS

LaCrosseTM PTCA Catheter. The device

is a percutaneous transluminal coronary

angioplasty (PTCA) dilatation catheter

and it is indicated for balloon dilatation

of the stenotic portion of a coronary

artery or bypass graft stenosis for the

purpose of improving myocardial

perfusion.

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

duplicated information previously

reviewed by this panel. On September

27, 1995, 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 part 12 (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

§ 10.33(b) (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 18, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

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: December 4, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30743 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0393]

Bioetica, Inc.; Premarket Approval of

HEMOSTAGENE Absorbable

Collagen Hemostatic Sponge

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Bioetica,

Inc., Westbrook, ME, on behalf of

Coletica, S. A., Lyon, France, for

premarket approval, under the Federal

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

of HEMOSTAGENE Absorbable

Collagen Hemostatic Sponge. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of August 15, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by January 18, 1996.

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:

Frances M. Curtis, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–3090.

SUPPLEMENTARY INFORMATION: On August

30, 1993, the U.S. representative,

Bioetica, Inc., Westbrook, ME 04092, on

behalf of Coletica, S. A., Lyon, France,

submitted to CDRH an application for

premarket approval of

HEMOSTAGENE Absorbable Collagen

Hemostatic Sponge. The device is an

absorbable hemostatic agent and is

indicated for use in surgical procedures

(other than in neurosurgical,

ophthalmic, and urological) as an

adjunct to hemostasis when control of

bleeding by ligature or conventional

procedures is ineffective or impractical.

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 General and

Plastic Surgery Devices Panel of the