4538 Federal Register / Vol. 62, No. 20 / Thursday, January 30, 1997 / Notices

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.

Dated: January 23, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–2338 Filed 1–29–97; 8:45 am]

BILLING CODE 4160–01–F

Open Meeting for Representatives of

Health Professional, Consumer, and

Patient Advocacy Organizations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public meeting.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public meeting with representatives of

health professional, consumer, and

patient advocacy organizations. The

meeting will be chaired by Sharon

Smith Holston, Deputy Commissioner

for External Affairs. The topic will be

FDA’s final regulation restricting the

sale and distribution of cigarettes and

smokeless tobacco to protect children

and adolescents. The purpose of this

meeting is to provide an opportunity for

representatives of health professional,

consumer, and patient advocacy groups,

and other interested persons to be

briefed by senior FDA staff and to

provide an opportunity for informal

discussion regarding FDA’s final

regulation governing access to and

promotion of cigarettes and smokeless

tobacco to protect children and

adolescents.

DATES: The meeting will be held on

Monday, February 10, 1997, from 9 a.m.

to 12 m.

ADDRESSES: The meeting will be held at

the Hyatt Regency Hotel, One Bethesda

Metro Center, Bethesda, MD.

FOR FURTHER INFORMATION CONTACT:

Betty B. Palsgrove, Office of Health

Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1652.

There is no registration fee for this

meeting, however, space is limited.

Interested persons will be registered in

the order in which calls are received.

Please call the contact person listed

above to register. Registrations also may

be transmitted by FAX at 1–800–344–

3332 or 301–443–2446. Please include

the name and title of the person

attending and the name of the

organization being represented.

Dated: January 24, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–2337 Filed 1–29–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA–644]

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: Intake and

Assessment survey package for the

Community Nursing Organization

Demonstration; Form No.: HCFA–644;

Use: The Omnibus Reconciliation Act of

1987 section 4079 requires the Secretary

of Health and Human Services (HHS) to

conduct a demonstration project, testing

capitated payment for community

nursing and ambulatory care services

(primarily Medicare-covered home

health services, medical devices and

durable medical equipment, and certain

ambulatory care) provided to Medicare

beneficiaries by community nurse

organization sites. This aspect of the

demonstration is aimed at replacing the

multiple payment mechanisms, such as

reasonable cost, predetermined fee

schedules, and usual, customary, and
Federal Register / Vol. 62, No. 20 / Thursday, January 30, 1997 / Notices 4539

prevailing costs, which exist currently;

Frequency: Annually; Affected Public:

Not-for-profit institutions; Number of

Respondents: 11,300; Total Annual

Responses: 11,300; Total Annual Hours:

6385.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, or to

obtain the supporting statement and any

related forms, 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 30 days of this notice directly to

the HCFA Paperwork Clearance Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: January 23, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–2277 Filed 1–29–97; 8:45 am]

BILLING CODE 4120–03–P

Health Resources and Services

Administration

Program Announcement for a

Cooperative Agreement To Initiate an

Interdisciplinary Center for

Community-Based Learning

The Health Resources and Services

Administration (HRSA) announces the

awarding of a sole source cooperative

agreement to the Association of

Academic Health Centers to plan for

and implement an Interdisciplinary

Center for Community-Based Learning.

This activity will be supported under

the authority of Title III, Section 301, of

the Public Health Service Act. A

proposed three-year period of support

beginning in fiscal year 1997 is

anticipated with approximately

$100,000 per year.

The project will (1) strengthen and

institutionalize the academic health

centers commitment to interdisciplinary

community-based learning, particularly

in under served community settings, (2)

provide expertise to academic health

centers in regard to model

interdisciplinary community-based

curricula and training sites, and (3)

support an interdisciplinary network of

health care professionals working to

create and strengthen an

interdisciplinary community-based

curriculum.

The Association of Academic Health

Centers was chosen because it is the

recognized professional association

representing academic health centers,

with a mission that ‘‘seeks to explore

and study issues that relate to greater

coordination of health-related schools

and programs, both within and among

institutions, interdisciplinary and

multiprofessional concerns.’’

It also has previously established

relationships with several

multiprofessional groups and

associations which are actively

developing an agenda for

interdisciplinary community-based

learning and have ready access to

information regarding all

interdisciplinary community-based

training programs at academic health

centers in the country.

Federal Involvement

The Cooperative Agreement

mechanism is being used for this project

to allow for substantial Federal

programmatic involvement with the

planning, development, administration,

and evaluation of the Interdisciplinary

Center for Community-Based Learning.

Requests for Additional Information

Requests for additional information

regarding this sole source cooperative

agreement should be directed to: Sue

Hassmiller, Ph.D., R.N., Bureau of

Health Professions, Room 8–05, Health

Resources and Services Administration,

5600 Fishers Lane, Rockville, Maryland

20857, Telephone: (301)443–6700, Fax:

(301)443–2111, Email:

shassmiller@hrsa.dhhs.gov

Dated: January 23, 1997.

Ciro V. Sumaya,

Administrator.

[FR Doc. 97–2292 Filed 1–29–97; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

Proposed Recommendations of the

Task Force on Genetic Testing; Notice

of Meeting and Request for Comment

AGENCY: National Institutes of Health,

HHS.

ACTION: Notice.

SUMMARY: The Task Force on Genetic

Testing was created by the National

Institutes of Health (NIH)-Department of

Energy (DOE) Working Group on

Ethical, Legal, and Social Implications

of Human Genome Research to make

recommendations to ensure the

development of safe and effective

genetic tests, their delivery in

laboratories of assured quality, and their

appropriate use by health care providers

and consumers. The Task Force

reviewed genetic testing in the United

States, promulgated interim principles

consonant with its goals (‘‘Interim

Principles’’, available at http://

ww2.med.jhu.edu/tfgtelsi), and has

taken public comments into

consideration in revising them. Over the

past eight months the Task Force has

discussed policies to implement several

of its principles. It now submits

proposed recommendations for public

comment. These proposed

recommendations are available at http:/

/ww2.med.jhu.edu/tfgtelsi.

DATES: To assure consideration by the

Task Force, comments must be received

on or before March 10. The Task Force

will meet on March 17 from 8:00 a.m.

to recess and on March 18 from 8:00

a.m. to adjournment at approximately

12:00 noon. The meeting will take place

at the Doubletree Inn at the Colonnade,

4 West University Parkway, Baltimore,

Maryland, (410) 235–5400. Time

permitting, guests will have the

opportunity to speak on comments

already submitted, but no formal time is

being set aside. A final report, including

the principles and recommendations,

together with background information

and comments, will be issued shortly

after the meeting.

ADDRESSES: Written comments should

be sent to Neil A. Holtzman,

M.D.,M.P.H., Genetics and Public Policy

Studies, The Johns Hopkins Medical

Institutions, 550 N. Broadway, Suite

511, Baltimore MD, 21205–2004, faxed

to Dr. Holtzman at 410–955–0241, or emailed to tfgta@welchlink.welch.jhu.edu. Individuals

who plan to attend the March 17–18

meeting and need special assistance,

such as sign language interpretation or

other reasonable accommodations,

should contact Dr. Holtzman in advance

of the meeting.

Background

Scientific breakthroughs have greatly

accelerated the discovery of genes

which, when altered by mutation, result

in disease or in increased risk of

disease. When these mutations occur in

the germline (sperm or egg), they can be

passed from one generation to the next.

These basic research discoveries lead

readily to the development of tests for

inherited mutations. The number of

DNA-based genetic tests and the volume

of testing are increasing steadily. This

has been accomplished in part by the

work of the new biotechnology industry.