Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Notices 12939

Dated: February 22, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–4966 Filed 2–28–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0044]

Medical Devices Draft Guidance for

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) Criteria

for Waiver; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the draft guidance

entitled ‘‘Guidance for Clinical

Laboratory Improvement Amendments

of 1988 (CLIA) Criteria for Waiver.’’

FDA is issuing this draft guidance to

propose alternative criteria for obtaining

CLIA waiver to the criteria proposed by

the Health Care Financing

Administration (HCFA) and the Centers

for Disease Control and Prevention

(CDC). This draft guidance is neither

final nor in effect at this time.

DATES: Submit written comments on the

draft guidance by May 30, 2001.

ADDRESSES: Submit written requests for

single copies on a 3.5′′ diskette of the

draft guidance entitled ‘‘Guidance for

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) Criteria for

Waiver’’ to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. Submit written comments on the

draft guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

Comments should be identified with the

docket number found in brackets in the

heading of this document. See the

SUPPLEMENTARY INFORMATION section for

information on electronic access to the

draft guidance.

FOR FURTHER INFORMATION CONTACT:

Joseph L. Hackett, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1243.

SUPPLEMENTARY INFORMATION:

I. Background

FDA assumes primary responsibility

for performing the CLIA complexity

categorization functions that includes

requests for waiver. Responsibility for

determining whether a particular device

is waived was transferred from the CDC

to FDA on January 21, 2000. At the same

time, HCFA is responsible for financial

management operations of the CLIA

program. In the Federal Register of

September 13, 1995 (60 FR 47534),

HCFA and CDC published a notice of

proposed rulemaking that proposed

criteria for obtaining CLIA waiver (the

1995 proposed rule). FDA believes,

based on its interpretation of the

legislative history and the changes to

the CLIA statute enacted by Congress on

November 21, 1997, as part of the Food

and Drug Administration Modernization

Act of 1997 (FDAMA), that alternative

criteria to the criteria proposed by

HCFA and CDC can be used to

determine whether a device can be

waived. HCFA, CDC, and FDA are

continuing to discuss whether the

criteria contained in this guidance

appropriately reflect the intent of the

statute. In an effort to get additional

perspective on these criteria, this draft

guidance will be discussed at the

Clinical Laboratory Improvement

Advisory Committee (CLIAC) meeting to

obtain their advice and

recommendations. FDA is publishing

this draft guidance so that it can be

presented and discussed at the February

7 and 8, 2001, CLIAC meeting. FDA

remains committed to ensuring an open,

consistent, reliable process that all

parties can understand and comment on

as we take steps to finalize a rule.

Because FDA believes the agency will

have to repropose a regulation to clarify

waiver criteria, we think it will be some

time before a final rule is codified. If

this draft guidance is made final, the

agency would propose alternative

waiver criteria that may continue in the

interim (based on comments received on

this draft guidance) until a reproposal of

the regulation to clarify waiver criteria

is published.

II. Significance of Guidance

FDA bases the recommendations in

this draft guidance document on our

interpretation of the law, our review

experience with CLIA complexity

reviews, and our interactions with

stakeholders throughout the transition

of this program from CDC to FDA. One

of the interactions with stakeholders

was in the form of an open public

workshop on August 14 and 15, 2000.

We are still evaluating the comments

from this workshop. We intend to

reevaluate and revise this draft

guidance, as circumstances warrant,

based on these and future comments.

The recommendations in this draft

guidance are different from the

recommendations made by HCFA and

CDC in their 1995 proposed rule. As

stated in this draft guidance, FDA will

continue to review requests for waiver

that follow the criteria contained in the

1995 proposed rule; however, we will

also review requests for waiver that

follow the criteria contained in this

draft guidance document. The most

significant difference between the

criteria proposed by CDC and HCFA,

and the criteria outlined in this draft

guidance, is that this draft guidance

allows studies that compare the

performance of the device in the hands

of untrained users with the performance

of the device in the hands of laboratory

professionals to demonstrate accuracy.

This draft guidance represents the

agency’s current thinking on criteria for

obtaining CLIA waiver. It does not

create or confer any rights for or on any

person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statutes and

regulations.

The agency has adopted good

guidance practices regulations (GGP’s),

which set forth the agency’s policies

and procedures for the development,

issuance, and use of guidance

documents (21 CFR 10.115; 65 FR

56468, September 19, 2000). This draft

guidance is issued as a Level 1 draft

guidance consistent with the GGP

regulations.

III. Electronic Access

In order to receive the draft guidance

entitled ‘‘Guidance for Clinical

Laboratory Improvement Amendments

of 1988 (CLIA) Criteria for Waiver’’ via

your fax machine, call the CDRH FactsOn-Demand system at 800–899–0381 or

301–827–0111 from a touch-tone

telephone. Press 1 to enter the system.

At the second voice prompt press 1 to

order a document. Enter the document

number (1147) followed by the pound

sign (#). Follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with Internet access.

Updated on a regular basis, the CDRH

home page includes the draft document

entitled ‘‘Guidance for Clinical

Laboratory Improvement Amendments

12940 Federal Register / Vol. 66, No. 41 / Thursday, March 1, 2001 / Notices

of 1988 (CLCIA) Criteria for Waiver,’’

device safety alerts, Federal Register

reprints, information on premarket

submissions (including lists of approved

applications and manufacturers’

addresses), small manufacturers’

assistance, information on video

conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Guidance

for Clinical Laboratory Improvement

Amendments of 1988 (CLIA) Criteria for

Waiver’’ is available at http://

www.fda.gov/cdrh.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by May 30, 2001. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The draft guidance and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: February 14, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–4963 Filed 2–28–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–265]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Extension of a currently

approved collection;

Title of Information Collection:

Independent Renal Dialysis Facility

Cost Report Form and Supporting

Regulations 42 CFR 413.24, 413.20;

Form No.: HCFA–265 (OMB# 0938–

0236);

Use: The Medicare Independent Renal

Dialysis Facility Cost Report provides

for determinations and allocation of

costs to the components of the Renal

Dialysis facility in order to establish a

proper basis for Medicare payment;

Frequency: Annually;

Affected Public: Business or other forprofit, not-for-profit institutions, and

State, Local, or Tribal Government;

Number of Respondents: 3,085;

Total Annual Responses: 3,085;

Total Annual Hours: 604,660.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 60 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

HCFA, Office of Information Services,

Security and Standards Group, Division

of HCFA Enterprise Standards,

Attention: Melissa Musotto, Room N2–

14–26, 7500 Security Boulevard,

Baltimore, Maryland 21244–1850.

Dated: February 14, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–4987 Filed 2–28–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Children’s Hospitals Graduate Medical

Education (CHGME) Payment Program:

Final Eligibility and Funding Criteria

and List of Eligible Hospitals and

Proposed Methodology for

Determining FTE Resident Count,

Treatment of New Children’s Teaching

Hospitals, and Calculating Indirect

Medical Education Payment

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Final notice and additional

provisions proposed for comment.

SUMMARY: This notice sets forth final

eligibility, funding criteria, payment

methodology and performance measures

for the Children’s Hospitals Graduate

Medical Education Payment (CHGME)

program, authorized by section 340E of

the Public Health Service Act (42 U.S.C.

256e), amended by Pub. L. 106–310, The

Children’s Health Act, 2000. It includes

a list of hospitals potentially eligible for

the CHGME program. The notice also

requests comments on proposed criteria

for: determining FTE resident count, the

treatment of new children’s teaching

hospitals, and the methodology for

indirect medical education (IME)

payments. In compliance with the

Paperwork Reduction Act of 1995, the

Department obtained Office of

Management and Budget (OMB)

approval on an emergency clearance to

any data collections imposed on the

public (OMB No. 0915–0247). The

Department has requested approval for

extension of OMB clearance to any data

collections imposed on the public by

this notice. Any changes to this

collection will not become effective

until approved by OMB.

DATES: Interested persons are invited to

comment by April 2, 2001. All

comments received on or before April 2,

2001 will be considered in the

development of the final notice

concerning the proposed methodology.

The Department will address comments

individually or by group and publish a

final notice on these comments in the

Federal Register.

ADDRESSES: Submit all written

comments concerning this notice to

Barbara Brookmyer, Division of

Medicine and Dentistry, Bureau of

Health Professions, Health Resources

and Services Administration, Room 9A–

27, Parklawn Building, 5600 Fishers

Lane, Rockville, Maryland 20857; or by