Federal Register / Vol. 66, No. 106 / Friday, June 1, 2001 / Notices 29823

such approach satisfies the applicable

statute and regulations.

The agency has adopted good

guidance practices (GGPs), 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 document is issued as a Level

1 guidance in accordance with the GGP

regulations.

III. Electronic Access

In order to receive ‘‘Premarket

Guidance: Reprocessing and Reuse of

Single-Use Devices’’ via your fax

machine, call the CDRH Facts-OnDemand 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 (1331) 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of the draft guidance may also do so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 access to the

Internet. 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 Internet

site at http://www.fda.gov/ohrms/

dockets/default.htm.

IV. Comments

Interested persons may submit to

Dockets Management Branch (address

above) written comments regarding this

draft guidance by August 30, 2001.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 The draft guidance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: May 22, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–13731 Filed 5–31–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–906]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Health Care Financing

Administration, DHHS.

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: Revision of a Currently

Approved Collection; Title of

Information Collection: The National

Data Reporting Requirements (NDRR).

We are requesting the name of the

collection be changed to the Fiscal

Soundness Reporting Requirements

(FSRR). and Supporting Regulations in

42 CFR 417., .126.478,. 162; Form No.:

HCFA–906 (OMB# 0938–0469); Use:

HCFA needs this information to

establish an on-going fiscal soundness

of the Managed Care Organizations in

the Medicare+Choice Program;

Frequency: Quarterly; Affected Public:

Business or other for-profit; Number of

Respondents: 300; Total Annual

Responses: 300; Total Annual Hours:

301.

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: May 17, 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. 01–13762 Filed 5–31–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10008]

Agency Information Collection

Activities: Submission For OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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: Reinstatement, without change,

of a previously approved collection for

which approval has expired;

Title of Information Collection:

Medical Equipment and Supplies

Consumer Survey;

29824 Federal Register / Vol. 66, No. 106 / Friday, June 1, 2001 / Notices

Form No.: 10008 (OMB# 0938–0807).

Use: This survey is necessary to

collect access, quality, and diversity of

product selection information from

beneficiaries. These key elements of the

evaluation cannot be thoroughly

evaluated without a beneficiary survey.

The information will be presented to

HCFA and to Congress, who will use the

results to determine whether the

demonstration should be extended to

other sites.

Frequency: Annually;

Affected Public: Individuals or

households;

Number of Respondents: 2,500;

Total Annual Responses: 2,500;

Total Annual Hours: 725.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, 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 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 17, 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. 01–13760 Filed 5–31–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–2728]

Agency Information Collection

Activities: Submission For OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the 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 previously

approved collection;

Title of Information Collection: End

Stage Renal Disease Medical Evidence

Report Medicare Entitlement and/or

Patient Registration and Supporting

Regulations in 42 CFR, 405.2133;

Form No.: HCFA–2728 (OMB# 0938–

0046);

Use: To capture the necessary medical

information required to determine

Medicare eligibility of an end stage

renal disease claimant. It also captures

the specific medical data required for

research and policy decisions on this

population as required by law;

Frequency: weekly, monthly,

quarterly, semi-annually, and annually;

Affected Public: Individuals or

households, business or other for profit,

not-for-profit institutions;

Number of Respondents: 60,000;

Total Annual Responses: 60,000;

Total Annual Hours: 25,000.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov/regs/prdact95.htm, or Email your request, including your

address and phone number, 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 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 17, 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. 01–13761 Filed 5–31–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–3071–N]

Medicare Program; Meeting of the

Drugs, Biologics, and Therapeutics

Panel of the Medicare Coverage

Advisory Committee—June 20, 2001

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: This notice announces a

public meeting of the Drugs, Biologics,

and Therapeutics Panel (the Panel) of

the Medicare Coverage Advisory

Committee. The Panel provides advice

and recommendations to us about

clinical issues. The Panel will hear and

discuss presentations from interested

persons regarding the use of levocarnitine in end stage renal disease

patients.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. App. 2, section 10(a)(1) and

(a)(2)).

DATES: The Meeting: June 20, 2001 from

8 a.m. until 4:30 p.m. E.D.T.

Deadline for Presentations and

Comments: June 13, 2001, 5 p.m., E.D.T.

Special Accommodations: Persons

attending the meeting who are hearing

or visually impaired, or have a

condition that requires other special

assistance or accommodations, are

asked to notify the Executive Secretary

by June 6, 2001 (see FOR FURTHER

INFORMATION CONTACT).

ADDRESSES: The Meeting: The meeting

will be held at The Baltimore

Convention Center, Rooms 321 and 322,

One West Pratt Street, Baltimore, MD

21201.

Presentations and Comments: Submit

formal presentations and written

comments to Kimberly A. Long,

Executive Secretary; Office of Clinical

Standards and Quality; Health Care

Financing Administration; 7500

Security Boulevard; Mail Stop S3–02–

01; Baltimore, MD 21244.

Website: You may access up-to-date

information about this meeting at

www.hcfa.gov/coverage.

Hotline: You may access up-to-date

information about this meeting on the

HCFA Advisory Committee Information

Hotline, 1–877–449–5659 (toll free) or

in the Baltimore area (410) 786–9379.

FOR FURTHER INFORMATION CONTACT:

Kimberly A. Long, Executive Secretary,

410–786–5702.

SUPPLEMENTARY INFORMATION: On August

13, 1999, we published a notice (64 FR