38838 Federal Register / Vol. 63, No. 138 / Monday, July 20, 1998 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Gastroenterology and Urology Devices

Panel of the Medical Devices 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). The meeting will be open to the

public.

Name of Committee: Gastroenterology

and Urology 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 July 30, 1998, 9:30 a.m. to 5

p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Mary J. Cornelius,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–2194,

ext. 118, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12523. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: The committee will discuss:

(1) Reclassification of extracorporeal

shock wave lithotriptors indicated for

the fragmentation of kidney and ureteral

calculi, (2) revised clinical and

preclinical performance testing

requirements, and (3) labeling.

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 23, 1998. Oral

presentations from the public will be

scheduled between approximately 9:30

a.m. and 10 a.m. Near the end of the

committee deliberations, a 30-minute

open public session will be conducted

for interested persons to address issues

specific to the FDA proposed

reclassification before the committee.

Time allotted for each presentation may

be limited. Those desiring to make

formal oral presentations should notify

the contact person before July 23, 1998,

and submit a brief statement of the

general nature of the evidence or

arguments they wish to present, the

names and addresses of proposed

participants, and an indication of the

approximate time requested to make

their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

FDA regrets that it was unable to

publish this notice 15 days prior to the

Gastroenterology and Urology Devices

Panel of the Medical Devices Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

these issues to public discussion and

qualified members of the

Gastroenterology and Urology Devices

Panel of the Medical Devices Advisory

Committee were available at this time,

the Commissioner concluded that it was

in the public interest to hold this

meeting even if there was not sufficient

time for the customary 15-day public

notice.

Dated: July 10, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–19175 Filed 7–17–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–P0015S]

Agency Information Collection

Activities: Proposed Collection;

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, is publishing the

following summary of proposed

collections for public comment.

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: Revision of a currently

approved collection; Title of

Information Collection: Medicare

Current Beneficiary Survey: National

Baseline Medicare Beneficiary

Knowledge Supplement; Form No.:

HCFA–P–0015S; Use: This survey will

establish baseline measures of Medicare

beneficiary knowledge/understanding of

the Medicare program, their new

choices legislated under the Balanced

Budget Act (BBA) which will allow

HCFA to quantify current knowledge

and attribute future changes in their

understanding and knowledge to HCFA

information and education initiatives.

Frequency: Biennially; Affected Public:

Business or other for-profit; Number of

Respondents: 16,000; Total Annual

Responses: 16,000; Total Annual Hours:

2,667.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

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 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: John Rudolph, Room C2–26–

17, 7500 Security Boulevard, Baltimore,

Maryland 21244–1850.

Dated: July 9, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, Division of

HCFA Enterprise Standards, Security and

Standards Group, Health Care Financing

Administration.

[FR Doc. 98–19255 Filed 7–17–98; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–21, 21B, 21P,

21.11A, 21E]

Agency Information Collection

Activities: Proposed Collection;

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, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding the burden

estimate or any other aspect of this