22242 Federal Register / Vol. 66, No. 86 / Thursday, May 3, 2001 / Notices

the system. At the second voice prompt

press 1 to order a document. Enter the

document number (1332) 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of the draft guidance may also do so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 civil money

penalty guidance documents package,

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

documents are also available on the

Dockets Management Branch Web site at

http://www.fda.gov/ohrms/ dockets/

default.htm.

IV. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

draft guidance by August 1, 2001.

Submit two copies of any comments,

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 guidance document and

received comments may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: April 30, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11231 Filed 5–1–01; 12:40 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–116]

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: Clinical

Laboratory Improvement Amendments

(CLIA) Application Form and

Supporting Regulations in 42 CFR

493.1—.2001; Form No.: HCFA–116

(OMB# 0938–0581); Use: Certification

requirements have been established for

any entity that performs testing on

human beings for diagnostic or

treatment purposes. Laboratories must

apply for and obtain a certificate in

order to perform this testing; Frequency:

Biennially; Affected Public: Business or

other for profit, Not for profit

institutions, Federal Government, and

State, local or tribal government;

Number of Respondents: 16,000; Total

Annual Responses: 16,000; Total

Annual Hours: 20,000.

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: Julie Brown, Room N2–14–

26, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: April 23, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Standards and

Support Group, Division of HCFA Enterprise

Standards.

[FR Doc. 01–11044 Filed 5–2–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–18]

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 curently

approved collection; Title of

Information Collection Application for

Hospital Insurance in 42 CFR 406.7;

Form No.: HCFA–18 (OMB# 0938–

0251); Use: The HCFA–18F5 is used to

establish entitlement to hospital

insurance and supplementary medical

insurance for beneficiaries entitled

under title XVIII of the Social Security

Act; Frequency: On occasion; Affected

Public: Individuals or households;

Number of Respondents: 50,000; Total

Annual Responses: 50,000; Total

Annual Hours: 12,500.

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