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
Federal Register / Vol. 62, No. 168 / Friday, August 29, 1997 / Notices 45823

before the committee. Written

submissions may be made to the contact

person by September 5, 1997. Oral

presentations from the public will be

scheduled between approximately 12:30

p.m. and 1:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before September 5, 1997, 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.

Closed Committee deliberations: On

September 19, 1997, from 9:30 a.m. to

10 a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). FDA staff will

present to the committee confidential

information regarding pending or future

submissions.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: August 22, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–23020 Filed 8–28–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[OPL–016–N]

Medicare Program; September 22,

1997, Meeting of the Practicing

Physicians Advisory Council

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice of meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the Practicing Physicians Advisory

Council. This meeting is open to the

public.

DATES: The meeting is scheduled for

September 22, 1997, from 9:00 a.m.

until 5:00 p.m. e.d.t.

ADDRESSES: The meeting will be held in

Room 800, 8th Floor, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Jeffrey Kang, M.D., Executive Director,

Practicing Physicians Advisory Council,

Room 435–H, Hubert H. Humphrey

Building, 200 Independence Avenue,

S.W., Washington, DC 20201, (202) 690–

7874.

SUPPLEMENTARY INFORMATION: The

Secretary of the Department of Health

and Human Services (the Secretary) is

mandated by section 1868 of the Social

Security Act to appoint a Practicing

Physicians Advisory Council (the

Council) based on nominations

submitted by medical organizations

representing physicians.

The Council meets quarterly to

discuss certain proposed changes in

regulations and carrier manual

instructions related to physicians’

services, as identified by the Secretary.

To the extent feasible and consistent

with statutory deadlines, the

consultation must occur before

publication of the proposed changes.

The Council submits an annual report

on its recommendations to the Secretary

and the Administrator of the Health

Care Financing Administration not later

than December 31 of each year.

The Council consists of 15 physicians,

each of whom has submitted at least 250

claims for physicians’ services under

Medicare or Medicaid in the previous

year. Members of the Council include

both participating and nonparticipating

physicians, and physicians practicing in

rural and underserved urban areas. At

least 11 members must be doctors of

medicine or osteopathy authorized to

practice medicine and surgery by the

States in which they practice. Members

have been invited to serve for

overlapping 4-year terms. In accordance

with section 14 of the Federal Advisory

Committee Act, terms of more than 2

years are contingent upon the renewal

of the Council by appropriate action

before the end of the 2-year term.

The Council held its first meeting on

May 11, 1992.

The current members are: Richard

Bronfman, D.P.M.; Wayne R. Carlsen,

D.O.; Gary C. Dennis, M.D.; Catalina E.

Garcia, M.D.; Mary T. Herald, M.D.;

Ardis Hoven, M.D.; Sandral Hullett,

M.D.; Jerilynn S. Kaibel, D.C.; Marie G.

Kuffner, M.D.; Marc Lowe, M.D.;

Katherine L. Markette, M.D.; Derrick L.

Latos, M.D.; Susan Schooley, M.D.;

Maisie Tam, M.D.; and Kenneth M.

Viste, Jr., M.D. The chairperson is

Kenneth M. Viste, Jr., M.D.

Council members will receive an

update on the Balanced Budget Act of

1997 as it relates to Medicare and

Medicaid. The agenda will provide for

discussion and comment on the

following topic: the Office of the

Inspector General’s Chief Financial

Officer’s Audit of the Health Care

Financing Administration for Fiscal

Year 1996.

Individuals or organizations who

wish to make 5-minute oral

presentations on the agenda issue

should contact the Executive Director by

12:00 noon, September 11, 1997, to be

scheduled. The number of oral

presentations may be limited by the

time available. A written copy of the

oral remarks should be submitted to the

Executive Director no later than 12:00

noon, September 15, 1997. Anyone who

is not scheduled to speak may submit

written comments to the Executive

Director by 12:00 noon, September 17,

1997. The meeting is open to the public,

but attendance is limited to the space

available.

(Section 1868 of the Social Security Act (42

U.S.C. 1395ee) and section 10(a) of Public

Law 92–463 (5 U.S.C. App. 2, section 10(a));

45 CFR Part 11)

(Catalog of Federal Domestic Assistance

Program No. 93.773, Medicare—Hospital

Insurance; and Program No. 93.774,

Medicare—Supplementary Medical

Insurance Program)

Dated: August 22, 1997.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 97–23090 Filed 8–28–97; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Notice Regarding Section 602 of the

Veterans Health Care Act of 1992

Rebate Option

AGENCY: Health Resources and Services

Administration.

ACTION: Notice.

SUMMARY: Section 602 of Pub. L. 102–

585, the ‘‘Veterans Health Care Act of

1992,’’ enacted section 340B of the

Public Health Service (PHS) Act,

‘‘Limitation on Prices of Drugs

Purchased by Covered Entities.’’ Section

340B provides that a manufacturer who

sells covered outpatient drugs to eligible

entities must sign a pharmaceutical

pricing agreement with the Secretary of

HHS in which the manufacturer agrees

to charge a price for covered outpatient

drugs that will not exceed that amount

determined under a statutory formula.

The purpose of this notice is to

request comments on the proposal of a

rebate option for State AIDS Drug

Assistance Programs (ADAPs) receiving

funds under Title XXVI of the PHS Act.

DATES: The public is invited to submit

comments on the proposed rebate