60900 Federal Register / Vol. 62, No. 219 / Thursday, November 13, 1997 / Notices

Secretary of Health and Human Services

reflect the commitment of the President

and the Secretary to the development of

a sound and consistent regulatory policy

on labeling of dietary supplements.

The Commission is charged with

conducting a study and providing

recommendations for regulation of label

claims and statements for dietary

supplements, including the use of

supplemental literature in connection

with their sale and, in addition,

procedures for evaluation of label

claims. The Commission is evaluating

how best to provide truthful,

scientifically valid, and non-misleading

information to consumers in order that

they may make informed health care

choices for themselves and their

families. The Commission’s report may

include recommendations on

legislation, if appropriate and necessary.

The purpose of Meeting #10 is to

announce the completion and public

availability of the Final Report of the

Commission. The meeting agenda will

include approval of the minutes of the

previous meeting and follow-up

activities to be undertaken by the staff.

The meeting is open to the public;

however seating is limited. If you will

require a sign language interpreter,

please call Sandra Saunders (202) 690–

7102 by 4:30 p.m. E.S.T. on November

14, 1997.

Dated: November 5, 1997.

Susanne A. Stoiber,

Acting Deputy Assistant Secretary for Health

(Disease Prevention and Health Promotion),

U.S. Department of Health and Human

Services.

[FR Doc. 97–29872 Filed 11–12–97; 8:45 am]

BILLING CODE 4160–17–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Advisory Commission on Consumer

Protection and Quality in the Health

Care Industry; Notice of Public Meeting

In accordance with Section 10(a)(2) of

the Federal Advisory Committee Act,

Pub. L. 92–463, notice is hereby given

of the meeting of the Advisory

Commission on Consumer Protection

and Quality in the Health Care Industry.

This two-day meeting will be open to

the public, limited only by the space

available.

Place of Meeting: William Natcher

Conference Center, National Institutes of

Health (Building 45), 45 Center Drive,

Bethesda, MD 20892. Exact locations of

the sessions will be available at the

conference center and on the

Commission’s web site,

‘‘www.hcqualitycommission.gov’’.

Times and Dates: The public meeting

will span two days. On Tuesday,

November 18, 1997, the subcommittee

break-out sessions will take place from

8:30 a.m. until 4:30 p.m. On

Wednesday, November 19, 1997, the

general plenary session will begin at

8:00 a.m. and it will continue until 4:00

p.m.

Purpose/Agenda: To hear testimony

and continue formal proceedings of the

Commission’s three (3) remaining

subcommittees (Subcommittee on

Consumer Rights has completed its

work). Agenda items are subject to

change as priorities dictate.

Contact Person: For more information,

including substantive program

information and summaries of the

meeting, please contact: Edward (Chip)

Malin, Hubert Humphrey Building,

Room 118F, 200 Independence Avenue,

SW., Washington, DC 20201; [202/205–

3333].

Dated: November 5, 1997.

Janet Corrigan,

Executive Director, Advisory Commission on

Consumer Protection and Quality in the

Health Care Industry.

[FR Doc. 97–29873 Filed 11–12–97; 8:45 am]

BILLING CODE 4110–60–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Health Care Policy and

Research

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Agency for Health Care Policy

and Research, HHS.

ACTION: Notice.

SUMMARY: This notice announces that

the Agency for Health Care Policy and

Research (AHCPR) is planning to

request the Office of Management and

Budget (OMB) to allow a proposed

information collection of the ‘‘Medical

Expenditure Panel Survey Household

Component (MEPS–HC)—Panels 3 and

4.’’ In accordance with the Paperwork

Reduction Act of 1995, Public Law 104–

13 (44 U.S.C. 3506(c)(2)(A)), AHCPR

invites the public to comment on this

proposed information collection.

This proposed information collection

was previously published in the Federal

Register on September 8, 1997 and

allowed 60 days for public comment. No

public comments were received. The

purpose of this notice is to allow an

additional 30 days for public comment.

DATES: Comments on this notice must be

received by December 15, 1997.

ADDRESSES: Written comments should

be submitted to the OMB Desk Officer

at the following address: Allison Eydt,

Human Resources and Housing Branch,

Office of Information and Regulatory

Affairs, OMB; New Executive Office

Building, Room 10235; Washington,

20503.

All comments will become a matter of

public record.

FOR FURTHER INFORMATION CONTACT:

Ruth A. Celtnieks, AHCPR Reports

Clearance Officer, (301) 594–1406, ext.

1497.

SUPPLEMENTARY INFORMATION:

Proposed Project

‘‘Medical Expenditure Panel Survey

Household Component (MEPS–HC)—

Panels 3 and 4.’’

The AHCPR is planning to conduct an

annual panel survey of U.S. households

to collect information on a variety of

measures related to health status, health

insurance coverage, health care use and

expenditures, and sources of payment

for health services. Each panel consists

of a nationally representative sample of

U.S. households who remain in MEPS

for two consecutive years of data

collection. The first two panels of MEPS

began in 1996 and 1997. Panels 3 and

4 of the MEPS–HC begin in 1998 and

1999, respectively. The MEPS–HC is

jointly sponsored by the AHCPR and the

National Center for Health Statistics

(NCHS). It will be conducted using a

sample of households selected from

households which responded to the

National Health Interview Survey

(NHIS) sponsored by NCHS. The NHIS

is a household survey which collects

health related data from approximately

50,000 households and 110,000 people.

Due to the Department of Health and

Human Services (HHS) efforts to

integrate survey data collection

activities, the NHIS is used as the

sampling frame for the MEPS and

several other surveys.

Data to be collected from each

household include detailed information

on demographics, health conditions,

current health status, utilization of

health care providers, charges and

payments for health care services,

medications, employment, and health

insurance. Subject to AHCPR and NCHS

confidentiality statutes, data will be

made available through publications,

articles in major journals as well as

public use data files. The data are

intended to be used for purposes such

as:

• Generating national estimates of

individual and family health care use

and expenditures, private and public

health insurance coverage, and the
Federal Register / Vol. 62, No. 219 / Thursday, November 13, 1997 / Notices 60901

availability, costs, and scope of private

health insurance benefits among

Americans;

• Examining the effects of changes in

how chronic care and disability are

managed and financed;

• Evaluating the growing impact of

managed care and of enrollment in

different types of managed care plans;

and

• Examining access to and costs of

health care for common diseases and

conditions, prescription drug use, and

other health issues.

Statisticians and researchers will use

these data to make important

generalizations on the civilian

noninstitutionalized population of the

United States, as well as to conduct

research in which the family is the unit

of analysis.

Method of Collection

The data will be collected using a

combination of modes. For example, the

AHCPR intends to introduce study

participants to the survey through

advance mailings. The first contact will

provide the household with information

regarding the importance and uses of

the information obtained. The AHCPR

will then conduct five (in-person)

interviews with each household to

obtain health care use and expense data.

Lastly, the AHCPR will conduct one

telephone interview with each

household to obtain tax and asset

information. Data will be collected

using a computer-assisted personal

interviewing method (CAPI). In certain

cases, AHCPR will conduct interviews

over the telephone, if necessary. Burden

estimates follow:

Initial Number of Respondents:

10,000.

Panel 3: 4800.

Panel 4: 5200.

Number of Surveys Per Respondent: 6.

Average Burden Per Respondent: 9.0

hours.

Estimated Burden Total: 81,100

hours.

Panel 3: 39,050 hours.

Panel 4: 42,050 hours.

Request for Comments

Comments are invited on: (a) the

necessity of the proposed collection; (b)

the accuracy of the Agency’s estimate of

burden of the proposed collection of

information; (c) ways to enhance 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 the use of

automated collection techniques or

other forms of information technology.

Comments submitted in response to

this notice will be summarized and/or

included in the request for OMB

approval of this information collection.

Copies of these proposed collection

plans and instruments can be obtained

from the AHCPR Reports Clearance

Officer (see above).

Dated: November 4, 1997.

John M. Eisenberg,

Administrator.

[FR Doc. 97–29837 Filed 11–12–97; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Health Care Policy and

Research

Notice of Meetings

In accordance with section 10(a) of

the Federal Advisory Committee Act (5

U.S.C., Appendix 2) announcement is

made of the following advisory

subcommittees scheduled to meet

during November 1997:

Name: Health Services Research

Initial Review Group (Subcommittees:

Health Systems Research, Health Care

quality and Effectiveness Research,

Health Care Technology and Decision

Sciences, and Health Research

Dissemination and Implementation).

Date and Time: November 19, 1997,

8:00 a.m.

Place: Bethesda Hyatt Hotel, One

Metro Plaza, Bethesda, Maryland 20816.

Open November 19, 8:00 a.m. to 8:30

a.m.

Closed for remainder of meetings.

Purpose: The Health Systems

Research Subcommittee is charged with

the initial review of research

applications relating to cost and

financing of health care, health care

markets, organizational and delivery

system issues, and the provider

workforce. The Health Research

Dissemination and Implementation

Subcommittee is charged with the

initial review of research applications

relating to behavior change,

demonstrations and interventions,

consumer decision-making,

dissemination, health professional and

consumer education, and translation of

research findings. The Health Care

Technology and Decision Sciences

Subcommittee is charged with the

initial review of research applications

relating to the development, refinement,

assessment, cost-effectiveness, and

application of health care technologies.

The Health Care Quality and

Effectiveness Research Subcommittee is

charged with the initial review of

research applications relating to clinical

outcomes and effectiveness, quality and

cost-effectiveness of health care,

effectiveness research, evidence-based

medicine, and quality of care research.

Agenda: The open sessions of these

meetings on November 19, from 8:00

a.m. to 8:30 a.m., will be devoted to

business meetings covering

administrative matters and reports.

During the closed sessions, the

Subcommittees will be reviewing

research and demonstration grant

applications relating to the delivery,

organization, and financing of health

services. In accordance with the Federal

Advisory Committee Act, section 10(d)

of 5 U.S.C., Appendix 2 and 5 U.S.C.,

552b(c)(6), the Administrator, AHCPR,

has made a formal determination that

these latter sessions will be closed

because the discussions are likely to

reveal personal information concerning

individuals associated with the

applications. This information is

exempt from mandatory disclosure.

Anyone wishing to obtain rosters of

members, minutes of the meetings, or

other relevant information should

contact Sheila S. Simmons, Committee

Management Officer, Agency for Health

Care Policy and Research, Suite 400,

Executive Office Center, 2101 East

Jefferson Street, Rockville, Maryland

20852, Telephone (301) 594–1452 ext.

1627.

Agenda items for all meetings are

subject to change as priorities dictate.

Dated: November 4, 1997.

John M. Eisenberg,

Administrator.

[FR Doc. 97–29836 Filed 11–12–97; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Exchange of Letters Between the Food

and Drug Administration and the

Australian Therapeutic Goods

Administration

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of an exchange of letters (EOL)

between FDA and the Australian

Therapeutic Goods Administration. The

purpose of the EOL is to facilitate the

exchange of documents and information

concerning a drug or biological

preparation that is considered for

orphan status.

DATES: The agreement became effective

August 12, 1997.