9434 Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Notices

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: February 25, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–5147 Filed 2–28–97; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 97M–0052]

Surgical Dynamics, Inc., a Division of

United States Surgical Corp.;

Premarket Approval of Ray Threaded

Fusion Cage (TFC)TM With

Instrumentation

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Surgical

Dynamics, Inc., a division of United

States Surgical Corp., Norwalk, CT, for

premarket approval, under the Federal

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

of the Ray Threaded Fusion Cage

(TFC)TM with instrumentation. After

reviewing the recommendation of the

Orthopedic and Rehabilitation Devices

Panel, FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of October 29, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by April 2, 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:

Samie M. Niver, Center for Devices and

Radiological Health (HFZ-410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On June

14, 1995, Surgical Dynamics, Inc., a

division of United States Surgical Corp.,

Norwalk, CT 06856, submitted to CDRH

an application for premarket approval of

the Ray TFCTM with instrumentation.

This device is an intervertebral body

fusion device. It is indicated for use

with autogenous bone graft in patients

with degenerative disc disease (DDD) at

one or two levels from L2 to S1. These

DDD patients may also have up to Grade

I spondylolisthesis at the involved

level(s). The Ray TFCTM is to be

implanted via an open posterior surgical

approach. DDD is defined as back pain

of discogenic origin with degeneration

of the disc confirmed by history and

radiographic studies. These patients

should be skeletally mature and have

had 6 months of nonoperative therapy.

On May 23, 1996, the Orthopedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On October 29, 1996, 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 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 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 April 2, 1997, 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: January 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–5076 Filed 2–28–97; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Public Law 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of December 1996:

Name: National Advisory Council on

Nurse Education and Practice

Date and Time: April 17–18, 1997, 8:30

a.m.
Federal Register / Vol. 62, No. 41 / Monday, March 3, 1997 / Notices 9435

Place: Spring Room, Silver Spring Holiday

Inn, 8777 Georgia Avenue, Silver Spring,

Maryland 20910.

The meeting is open to the public with the

exception of the period from approximately

8:30 a.m. until 9:30 a.m. on April 18, when

grant applications will be reviewed.

Agenda: Updates on and discussion of

Agency, Bureau and Division activities, and

the legislative and budget status of programs;

overview of the national nursing workforce;

review of nurse practitioner workforce

trends, implications and options for the

future; review of nursing informatics

workgroup recommendations for a national

agenda.

Anyone wishing to obtain a roster of

members, minutes of meeting or other

relevant information should write or contact

Ms. Elaine G. Cohen, Acting Executive

Secretary, National Advisory Council on

Nurse Education and Practice, Health

Resources and Services Administration,

Parklawn Building, Room 9–36, 5600 Fishers

Lane, Rockville, Maryland 20857, Telephone

(301) 443–5786.

Agenda Items are subject to change as

priorities dictate.

Dated: February 25, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination, HRSA.

[FR Doc. 97–5071 Filed 2–28–97; 8:45 am]

BILLING CODE 4160–15–P

Office of Inspector General

Publication of the OIG Model

Compliance Plan for Clinical

Laboratories

AGENCY: Office of Inspector General

(OIG), HHS.

ACTION: Notice.

SUMMARY: This Federal Register notice

sets forth the recently issued model

compliance plan for clinical laboratories

developed by the Office of Inspector

General in cooperation with, and input

from, several provider groups and

industry representatives. Many

providers and provider organizations

have expressed an interest in better

protecting their operations from fraud

through the adoption of compliance

plans. We believe the development of

this initial model compliance plan for

clinical laboratories will serve as a

positive step towards promoting a

higher level of ethical and lawful

conduct throughout the health care

industry.

FOR FURTHER INFORMATION CONTACT: Joel

J. Schaer, Office of Counsel to the

Inspector General, (202) 619–0089.

SUPPLEMENTARY INFORMATION: The

creation of model compliance plans has

become a major initiative of the Office

of Inspector General (OIG) in its effort

to engage the private health care

community in the fight to combat fraud

and abuse. In developing these

compliance plans, the OIG continues to

work closely with the Health Care

Financing Administration and various

sectors of the health care industry.

The clinical laboratory model

compliance plan represents the OIG’s

initial effort to develop such a plan for

use by the industry. The plan considers

elements of the Federal Sentencing

Guidelines and policy guidance given to

major independent laboratories through

corporate integrity agreements.

Specifically, this model plan

recommends that clinical laboratories

implement a number of substantive

changes, such as developing better

requisition forms and policies that

promote the physician’s right to order

only medically necessary tests.

Adoption of the clinical laboratory

model compliance plan set forth below,

and future model compliance plans for

other health care providers, will be

voluntary. All future models will be

similarly structured, that is, substantive

policy recommendations resulting from

our investigations and civil settlements

combined with the elements of the

Federal Sentencing Guidelines.

A reprint of the OIG model

compliance plan follows.

MODEL COMPLIANCE PLAN FOR CLINICAL

LABORATORIES

Introduction

The Office of Inspector General (OIG)

of the Department of Health and Human

Services (HHS) and other Federal

agencies charged with responsibility for

enforcement of Federal law have

emphasized the importance of

voluntarily developed and implemented

compliance plans. In recent years, the

OIG has been asked to supply guidance

as to the elements of a model

compliance plan. The purpose of this

issuance, therefore, is to respond to

those requests by providing some

guidance to health care providers that

supply clinical laboratory testing

services for Medicare and Medicaid

beneficiaries. Like other compliance

plan models that will be issued for other

areas of the health care community, this

guidance is based upon the OIG’s

experience in fraud investigations of

clinical laboratories, the Health Care

Financing Administration’s (HCFA)

regulations and guidelines,

requirements imposed on clinical

laboratories in corporate integrity

agreements negotiated by the OIG, and

input from the clinical laboratory

industry.

The government, especially the OIG,

has a zero tolerance policy towards

fraud and abuse and will use its

extensive statutory authorities to reduce

fraud in Medicare and other federally

funded health care programs.

Compliance plans offer the health care

provider an opportunity to participate

in a nationwide effort to reduce fraud

and abuse in our national health care

programs. The OIG believes that through

a partnership with the private sector,

significant reductions in fraud and

abuse can be accomplished. Compliance

plans offer a vehicle to achieve that

goal.

This information is being supplied to

assist laboratory providers in crafting

and refining their own compliance

plans. Elements of these guidelines can

be used by all laboratories, regardless of

size, to establish a compliance program.

We are not suggesting that all

laboratories must implement all of the

compliance elements discussed in this

document, nor do we suggest that a

laboratory that does not incorporate all

of these elements will be at a

disadvantage when under the scrutiny

of the OIG or other governmental

agency. Rather, these guidelines

represent the government’s suggestions

on how to correct and prevent

fraudulent activity, and they can be

tailored to fit the individual needs and

financial realities of any clinical

laboratory, be it an independent

national laboratory, a hospital

laboratory, or a small, regional

laboratory. We expect variations

reflecting the specific factual context in

which each individual laboratory

operates.

This model compliance plan focuses

on topic areas recently addressed in

corporate integrity agreements with

several players in the laboratory

industry. Consequently, this model

laboratory compliance plan is not all

inclusive as to subject matter. We

recognize that laboratories are

accountable for complying with far

more laws, regulations and guidelines

than we have tried to cover in this

model, and we believe that laboratories

implementing compliance plans should

address any and all areas where abuse

may be prevalent in the industry. For

example, the OIG suggests that

laboratory compliance programs should

include training on topics such as, the

anti-kickback act, Stark self-referral

issues and CLIA requirements.

Depending on the nature of its business,

a laboratory also may need to add

specific measures covering areas such as

ESRD testing and billing, which is

governed by rules and regulations and

which has been subject to abuse by

many companies. Ultimately, each

company bears the responsibility for