Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices 45821

market. In an effort to distribute costs

more equitably among the various types

and sizes of laboratories, while

generating sufficient revenue, we now

rely more heavily on average annual test

volumes to determine certificate fees.

The fees for certificate of waiver or PPM

procedures have been, and will

continue to be, a flat fee irrespective of

volume of testing performed. The $50

fee increase for these laboratories is

based on expenditures related to these

types of certificates. These costs

include: reviewing test systems for

categorization as waived or PPM

procedures; maintaining and updating

the data systems; issuing certificates;

issuing test categorization notices;

collecting fees; and analyzing data.

For other certificate types, instead of

using the three-tiered fee schedule

based on general ranges of test volume,

we are maintaining the 11 laboratory

schedules, LVA through J, previously

established on February 28, 1992. The

new biennial certificate fees for each

schedule are computed using a

decreasing per test rate as the volume of

tests increases. This per-test rate is

multiplied by the average annual test

volume performed in each schedule,

with the exception of the smallest

laboratories, LVA through B, being

charged a certificate fee of $150.

Laboratories in Schedules C through G,

which encompass test volumes up to

100,000, each will pay a certificate fee

based on the per-test rate. (See Table III)

Between Schedules G and H

laboratories, the per-test rate is being

reduced by almost one half, because of

the dramatic increase in volume for

Schedule H laboratories. These test

volumes range from more than 100,000

to 500,000. Another very large increase

in volume occurs for Schedule J

laboratories, which perform over 1

million tests annually. Between

Schedules I and J laboratories, the pertest rate is being reduced by

approximately three-fourths, in

recognition of the large increase in the

test volume of these laboratories.

The revisions to the CLIA certificate

fees will significantly alter the biennial

certificate fees for some laboratories.

Table III presents the approximate

number of laboratories in each

laboratory type and their new biennial

certificate fees.

The effect of this new fee schedule

will vary widely among clinical

laboratories. Nearly 62 percent of the

laboratories now hold certificate of

waiver or certificate for PPM procedures

and pay a flat certificate fee. For

certificates of waiver, laboratories will

pay $150 biennially and for certificates

for PPM procedures, the biennial fee

will be $200. These $50 biennial

increases amount to less than $0.07 per

day per laboratory. The new fees take

into account the increased number of

tests that may be performed under these

types of certificates.

Laboratories with a change in name,

location or in any of the conditions

specified in § 493.639 of our regulations

will find the fee for a revised certificate

increased by $25, from $50 to $75.

As previously stated, we are required

by statute to establish fees to support

the CLIA program. Although certificate

fees increase proportionately, we

believe that by relating the fee more

precisely to the number of tests a

laboratory performs each year, the costs

of administering CLIA will be

distributed more equitably across all

laboratories. The laboratories bearing

the largest increase in certificate fees,

Schedules C through J, account for more

than 90 percent of the annual test

volume in this country. Because of their

large test volumes we have applied the

lowest possible per-test rates to those

laboratories, consistent with generating

sufficient revenues. We concluded that

basing certificate fees on the average

annual test volume for each schedule

and a decreasing per-test rate was the

most equitable and practical method for

constructing the fee schedule. (See

Table III) This approach has the merit of

charging larger laboratories less per test

performed, while still basing the overall

fees directly on the volume of testing.

These fees will result in large increases

in certificate fees for the laboratories

with the highest test volumes. These

differences are directly proportional to

test volumes, resulting in laboratories

with similar volumes paying similar

fees.

For the reasons given above, we

certify that this proposed fee schedule

would not have a significant effect on a

substantial number of small entities and

that a regulatory flexibility analysis is

not needed.

B. Rural Hospital Impact Statement

Section 1102(b) of the Act requires us

to prepare a regulatory impact analysis

if a rule may have a significant impact

on the operations of a substantial

number of small rural hospitals. This

analysis must conform to the provisions

of section 604 of the RFA. For purposes

of section 1102(b) of the Act, we define

a small rural hospital as a hospital that

is located outside of a Metropolitan

Statistical Area and has fewer than 50

beds. We are not preparing a rural

impact statement since we have

determined, and certify, that this notice

would not have a significant impact on

the operations of a substantial number

of small rural hospitals.

In accordance with the provisions of

Executive Order 12866, this notice was

reviewed by the Office of Management

and Budget.

(Catalog of Federal Domestic Assistance

Program No. 93–778, Medical Assistance

Program; No. 93.773 Medicare—Hospital

Insurance Program; and No. 93–774,

Medicare—Supplementary Medical

Insurance Program)

Dated: December 20, 1996.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

Dated: December 11, 1996.

David A. Satcher,

Director, Centers for Disease Control and

Prevention.

Dated: March 26, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–23084 Filed 8–28–97; 8:45 am]

BILLING CODE 4210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Translation Advisory Committee for

Diabetes Prevention and Control

Programs: Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), the Centers for Disease

Control and Prevention (CDC)

announces the following committee

meeting.

Name: Translation Advisory Committee for

Diabetes Prevention and Control Programs.

Times and Dates: 9 a.m.–6 p.m., September

16, 1997. 9 a.m.–12 noon, September 17,

1997.

Place: Crown Plaza Ravinia, 4355 AshfordDunwoody Road, Atlanta, Georgia 30346,

telephone 770/395-7700.

Status: Open to the public, limited only by

the space available. The meeting room

accommodates approximately 50 people.

Purpose: This committee is charged with

advising the Director, CDC, regarding policy

issues and broad strategies for diabetes

translation activities and control programs

designed to reduce risk factors, health

services utilization, costs, morbidity, and

mortality associated with diabetes and its

complications. The Committee identifies

research advances and technologies ready for

translation into widespread community

practice; recommends broad public health

strategies to be implemented through public

health interventions; identifies opportunities

for surveillance and epidemiologic

assessment of diabetes and related

complications; and for the purpose of

assuring the most effective use and
45822 Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices

organization of resources, maintains liaison

and coordination of programs within the

Federal, voluntary, and private sectors

involved in the provision of services to

people with diabetes.

Matters to be Discussed: Agenda items

include a discussion of public health issues

pertinent to the role of economic analysis in

the Division of Diabetes Translation (DDT)

priorities, as well as, the challenges of

diabetes in Latino/Hispanic communities.

Agenda items are subject to change as

priorities dictate.

Contact Person for More Information:

Margaret Hurd, Committee Management

Specialist, DDT, National Center for Chronic

Disease Prevention and Health Promotion,

CDC, 4770 Buford Highway, NE, M/S K–10,

Atlanta, Georgia 30341–3724, telephone 770/

488–5505.

Dated: August 25, 1997.

Carolyn J. Russell,

Director, Management Analysis and Services

Office Centers for Disease Control and

Prevention (CDC).

[FR Doc. 97–23189 Filed 8–28–97; 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: Request for

State Data to Determine the Tribal

Family Assistance Grant Amount.

OMB No: New Request.

Description: This information

collection will be used to request data

from States that will be used to

determine the amount of Tribal Family

Assistance Grants. The data requested is

the data required to be used by Section

412(a)(1)(B) of the Social Security Act,

as amended by the Personal

Responsibility and Work Opportunity

Reconciliation Act of 1996.

Respondents: State Govts.

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

Request ............................................................................................................ 18 1 42 756.

Estimated Total Annual Burden

Hours: 756

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: August 25, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–23088 Filed 8–28–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Immunology

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on September 19, 1997, 9:30 a.m.

to 5 p.m.

Location: Parklawn Bldg., conference

rooms D and E, 5600 Fishers Lane,

Rockville, MD.

Contact Person: Peter E. Maxim,

Center for Devices and Radiological

Health (HFZ–440), Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–1293, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12516. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The committee will hear

presentations from FDA staff regarding

new review initiatives pertinent to types

of submissions generally reviewed by

the committee. FDA will also present a

first year summary of activities

associated with the down classification

of tumor markers used for monitoring

cancer patients. FDA seeks to obtain

committee input on the data

requirements for class II submissions of

tumor markers with the intent of

modifying the guidance document that

serves as a special control for these class

II products. Single copies of the

guidance document entitled ‘‘Guidance

For Submission Of Tumor Marker

Premarket Notifications’’ can be

obtained by contacting the Division of

Small Manufacturers Assistance, 1350

Piccard Dr., Rockville, MD 20851, 1–

800–638–2041 or 301–443–6597, or on

the Internet using the World Wide Web

(WWW) (http://www.fda.gov/cdrh/

draftgui.html).

Procedure: On September 19, 1997,

from 10 a.m. to 5 p.m., the meeting is

open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending