Federal Register / Vol. 60, No. 241 / Friday, December 15, 1995 / Notices 64439

September 29, 1995, of the approval of

the application.

DATES: Petitions for administrative

review by January 16, 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:

Christopher M. Sloan, Center for

Devices and Radiological Health (HFZ–

450), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–443–8243.

SUPPLEMENTARY INFORMATION: On

February 3, 1992, Datascope Corp.,

Montvale, NJ 07645, submitted to CDRH

an application for premarket approval of

the VasoSeal Vascular Hemostasis

Device. The device is a vascular

hemostasis device and is indicated for

use in reducing time to hemostasis at

the femoral arterial puncture site in

patients who have undergone diagnostic

angiography or percutaneous

transluminal coronary angioplasty

(PTCA) procedures using an 8 French or

smaller procedural sheath. The

VasoSeal VHD is also indicated for use

in PTCA patients when immediate

sheath removal is desired.

On May 8, 1995, the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application.

On September 29, 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 (21 U.S.C.

360e(d)(3)) 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 16, 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: November 29, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30610 Filed 12–14–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0396]

Karl Storz Endoscopy-America, Inc.;

Premarket Approval of Storz Modulith

Lithotripter, Model SL20

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Karl

Storz Endoscopy-America, Inc.,

Kennesaw, GA, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of the Storz

Modulith Lithotripter, Model SL20.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of February 17, 1995,

of the approval of the application.

DATES: Petitions for administrative

review by January 16, 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: John

H. Baxley, Center for Devices and

Radiological Health (HFZ–472), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2194.

SUPPLEMENTARY INFORMATION: On

November 24, 1993, Karl Storz

Endoscopy-America, Inc., Kennesaw,

GA 30144, submitted to CDRH an

application for premarket approval of

the Storz Modulith Lithotripter, Model

SL20. The device is an extracorporeal

shock wave lithotripter and is indicated

for use in the noninvasive fragmentation

of urinary calculi in the kidney and

upper ureter.

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 Gastroenterology

and Urology 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 February 17, 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 (21 U.S.C.

360e(d)(3)) 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
64440 Federal Register / Vol. 60, No. 241 / Friday, December 15, 1995 / Notices

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 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 16, 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. 95–30611 Filed 12–14–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[ORD–082–N]

New and Pending Demonstration

Project Proposals Submitted Pursuant

to Section 1115(a) of the Social

Security Act

October 1995.

AGENCY: Health Care Financing

Administration (HCFA, HHS).

ACTION: Notice.

SUMMARY: This notice lists new

proposals for Medicaid demonstration

projects submitted to the Department of

Health and Human Services during the

month of October 1995 under the

authority of section 1115 of the Social

Security Act. This notice also lists

proposals that were approved,

disapproved, pending, or withdrawn

during this time period. (This notice can

be accessed on the Internet at HTTP://

WWW.SSA.GOV/HCFA/

HCFAHP2.HTML.)

COMMENTS: We will accept written

comments on these proposals. We will,

if feasible, acknowledge receipt of all

comments, but we will not provide

written responses to comments. We

will, however, neither approve nor

disapprove any new proposal for at least

30 days after the date of this notice to

allow time to receive and consider

comments. Direct comments as

indicated below.

ADDRESSES: Mail correspondence to:

Susan Anderson, Office of Research and

Demonstrations, Health Care Financing

Administration, Mail Stop C3–11–07,

7500 Security Boulevard, Baltimore, MD

21244–1850.

FOR FURTHER INFORMATION CONTACT:

Susan Anderson, (410) 786–3996.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 1115 of the Social

Security Act (the Act), the Department

of Health and Human Services (HHS)

may consider and approve research and

demonstration proposals with a broad

range of policy objectives. These

demonstrations can lead to

improvements in achieving the

purposes of the Act.

In exercising her discretionary

authority, the Secretary has developed a

number of policies and procedures for

reviewing proposals. On September 27,

1994, we published a notice in the

Federal Register (59 FR 49249) that

specified (1) the principles that we

ordinarily will consider when

approving or disapproving

demonstration projects under the

authority in section 1115(a) of the Act;

(2) the procedures we expect States to

use in involving the public in the

development of proposed demonstration

projects under section 1115; and (3) the

procedures we ordinarily will follow in

reviewing demonstration proposals. We

are committed to a thorough and

expeditious review of State requests to

conduct such demonstrations.

As part of our procedures, we publish

a notice in the Federal Register with a

monthly listing of all new submissions,

pending proposals, approvals,

disapprovals, and withdrawn proposals.

Proposals submitted in response to a

grant solicitation or other competitive

process are reported as received during

the month that such grant or bid is

awarded, so as to prevent interference

with the awards process.

II. Listing of New, Pending, Approved,

and Withdrawn Proposals for the

Month of October 1995

A. Comprehensive Health Reform

Programs

1. New Proposals

No new proposals were received

during the month of October.

2. Pending Proposals

Demonstration Title/State: Better

Access for You (BAY) Health Plan

Demonstration—Alabama.

Description: Alabama proposes to

create a mandatory managed care

delivery system in Mobile County for

non-institutionalized Medicaid

beneficiaries and an expansion

population of low-income women and

children. The network, called the Bay

Health Network, would be administered

by the PrimeHealth Organization, which

is owned by the University of South

Alabama Foundation. The State also

proposes to expand family planning

benefits for pregnant women whose

income is less than 133 percent of the

Federal poverty level.

Date Received: July 10, 1995.

State Contact: Vicki Huff, Director,

Managed Care Division, Alabama

Medicaid Agency, P.O. Box 5624,

Montgomery, AL 36103–5624, (334)

242–5011.

Federal Project Officer: Maria

Boulmetis, Health Care Financing

Administration, Office of Research and

Demonstrations, Mail Stop C3–18–26,

7500 Security Boulevard, Baltimore, MD

21244–1850.

Demonstration Title/State: Arizona

Health Care Cost Containment System

(AHCCCS)—Arizona.

Description: Arizona proposes to

expand eligibility under its current

section 1115 AHCCCS program to

individuals with incomes up to 100

percent of the Federal poverty level.

Date Received: March 17, 1995

State Contact: Mabel Chen, M.D.,

Director, Arizona Health Care Cost

Containment System, 801 East Jefferson,

Phoenix, AZ 85034, (602) 271–4422.

Federal Project Officer: Joan Peterson,

Health Care Financing Administration,

Office of Research and Demonstrations,

Mail Stop C3–18–26, 7500 Security

Boulevard, Baltimore, MD 21244–1850.

Demonstration Title/State: The

Georgia Behavioral Health Plan—

Georgia.

Description: Georgia proposes to

provide behavioral health services

under a managed care system through a