65350 Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices

August 11, 1995, the following

corrections are made:

1. On page 41556, in footnote 89,

‘‘1588’’ is corrected to read ‘‘1558,’’ and

on the same page, in footnote 90, in line

1, ‘‘MDG’’ is corrected to read ‘‘MDB’’.

2. On page 41557, in footnote 91, in

line 1, the phrase ‘‘of behavioral

dependence’’ is corrected to read ‘‘of

and behavioral dependence’’.

3. On page 41558, in footnote 93, in

line 4, ‘‘Parmacol. Biochem. Behav.’’ is

corrected to read ‘‘Pharmacol.

Biochemistry & Behav.’’

4. On page 41560, in footnote 101, in

line 4, ‘‘Page 50’’ is corrected to read

‘‘Pages 50–51.’’

5. On page 41561, in footnote 105, in

line 2, ‘‘231–234’’ is corrected to read

‘‘231–241.’’

6. On page 41588, in footnote 172, in

line 8, ‘‘12641–46’’ is corrected to read

‘‘02641–02646’’.

7. On page 41621, in footnote 240a, in

line 13, ‘‘July 25, 2995’’ is corrected to

read ‘‘July 25, 1995).’’

Dated: December 12, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–30745 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

Public Health Service

Food and Drug Administration

Statement of Organization, Functions,

and Delegations of Authority

Part H, Chapter HF (Food and Drug

Administration) of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (35 FR 3685, February 25,

1970, and 56 FR 29484, June 27, 1991,

as amended most recently in pertinent

part at 59 FR 17106, April 11, 1994) is

amended to reflect the following

reorganization within the Center for

Devices and Radiological Health

(CDRH), Office of Operations, Food and

Drug Administration (FDA).

The Center for Devices and

Radiological Health is abolishing the

Office of Health Physics (OHP), the

Office of Health Affairs (OHA), and the

Office of Standards and Regulations

(OSR) and realigning their functions

into existing line and staff offices within

the Center. The goal of this realignment

is to more effectively manage the

resources invested in these functional

areas, consolidate similar functions,

realign medical expertise closer to

program needs, and streamline the

current organizational structure.

Under section HF-B, Organization:

1. Delete subparagraphs Office of

Health Physics (HFW12), the Office of

Health Affairs (HFW13), and the Office

of Standards and Regulations (HFW14)

under paragraph Center for Devices and

Radiological Health (HFW), in their

entirety.

2. Insert the following new

subparagraphs under paragraph Office

of Operations (HFA9), Center for

Devices and Radiological Health (HFW)

reading as follows:

Office of Systems and Management

(HFW11). Advises the Center Director

regarding all administrative

management matters.

Plans, develops, and implements

Center management policies and

programs concerning financial and

human resource management, contracts

and grants management, conference

management, occupational safety,

organizational, and general office

services support.

Develops and implements the Center’s

long-range, strategic, and operational

plans.

Develops and applies evaluation

techniques to measure the effectiveness

of Center programs.

Provides general information and

technical publication services to the

Center.

Plans, conducts, and coordinates

Center committee management

activities.

Determines and implements Center

strategy and utilization of information

management resources.

Designs administrative, scientific, and

technical information systems in

support of Center programs.

Provides assistance to Center staff in

accessing information necessary to carry

out the Center’s mission.

Coordinates requests and Center

activities pertaining to the Freedom of

Information and Privacy Acts.

Office of Health and Industry

Programs (HFWG). Analyzes medical

device and radiation-emitting product

user-related problems and conducts

research, applying systems analysis and

human factors to problem identification

and solution strategies. Implements and

evaluates user-related solution

strategies.

Conducts and evaluates programs to

provide technical and other

nonfinancial assistance to small

manufacturers of medical devices to

promote their understanding of

compliance with the medical device

amendments and regulations.

Provides, maintains, and applies

expertise in communications technology

in support of Center and FDA programs.

Develops and implements strategies

for obtaining, analyzing, and

incorporating the views and needs of

health professionals, lay device users,

and industry into the Center policy and

decision-making processes as well as in

problem analysis, resolution strategy

development, implementation, and

evaluation processes.

Establishes and operates a program to

implement the Mammography Quality

Standards Act of 1992.

Provides leadership and technical

expertise to the Center and other

Departmental components in applying

health physics procedures and radiation

protection principles.

Advises the Center Director and

appropriate Agency officials on FDA

regulation development responsibilities

relating to medical devices and

radiological health activities. Serves as

the Center focal point for liaison on

regulations development activities with

the Office of General Counsel.

Coordinates the development, review

and submission of Federal Register

publications for the Center. Prepares

position statements for the Center on

standards promulgated by other

organizations.

Coordinates international relations

activities as required by the Safe

Medical Devices Act of 1990.

Office of Science and Technology

(HFWE). Provides scientific support and

laboratory analyses in response to the

program needs of other Center and

Agency components.

Plans, develops, and implements an

intramural science program covering

key areas of engineering, physics, and

biology; develops, modifies, and

validates test methods and measurement

techniques, risk assessments and hazard

analyses, and generic techniques to

enhance product safety and usefulness.

Provides scientific and engineering

support in the review of regulatory

documents, the development of

regulatory decisions, and the analysis of

postmarket surveillance issues.

Plans, conducts, or stimulates

research on the human health effects of

radiation and medical devices.

Participates in the development of

national and international consensus

standards and voluntary guidelines

through interaction with appropriate

standards committees; coordinates with

other standards-setting groups

representing national and international

standards-setting organizations;

conducts the review and analysis of

performance standards, guides and

documents related to the Center’s

mission.

Establishes official liaisons with

Standards Development Organizations.

Coordinates the liaison within the

Center. Establishes and maintains
Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices 65351

records on committee participation and

status of medical device standards used

by the Center.

3. Prior Delegations of Authority.

Pending further delegations, directives,

or orders by the Commissioner of Food

and Drugs, all delegations of authority

to positions of the affected organizations

in effect prior to this date shall continue

in effect in them or their successors.

Dated: November 28, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95–30813 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

Food and Drug Administration

Statement of Organization, Functions,

and Delegations of Authority

Part H, Chapter HF (Food and Drug

Administration) of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (35 FR 3685, February 25,

1970, and 56 FR 29484, June 27, 1991,

as amended most recently in pertinent

part at 60 FR 53382, October 13, 1995)

is amended to reflect the change in title

of the International Affairs Staff to the

Office of International Affairs, Office of

External Affairs (OEA), in the Food and

Drug Administration (FDA).

The Office of International Affairs

will continue to serve as the Agency

focal point for developing and

maintaining international

communications and programs. FDA

believes that the increase in

international activity with regard to

FDA regulated products and activities

necessitates the elevation of the

International Affairs Staff to office level

status within OEA and that this action

further enhances the management and

coordination of Agency international

activities.

Under section HF-B, Organization:

1. Delete the subparagraph,

International Affairs Staff (HFAQA),

under the Office of External Affairs

(HFAQ), in its entirety and insert a new

subparagraph, Office of International

Affairs (HFAQA), under the Office of

External Affairs (HFAQ), reading as

follows:

Office of International Affairs

(HFAQA). Serves as the Agency focal

point for developing and maintaining

international communications and

programs.

Establishes and provides an Agency

liaison on international activities with

the Department, Public Health Service

(PHS), and other Federal agencies,

foreign governments, including foreign

embassies, and international

organizations.

Represents the Agency at meetings,

conferences, and symposia relating to

international obligations; briefs Agency

participants in such international

activities.

Establishes, identifies, interprets, and

clarifies, in cooperation with

appropriate Agency components, the

Agency’s international obligations and

needs, including those associated with

bilateral programs which involve extra

budgetary support.

Establishes and maintains an

international information exchange

program concerning Agency policies

and programs to provide interchange

between FDA and counterpart agencies

in foreign countries and international

organizations.

Assists in the development,

negotiation, and monitoring of

agreements with foreign governments

and international organizations in

cooperation with appropriate Agency

components; and acts as the Agency

focal point for intergovernmental

conferences.

Negotiates the preparation and

implementation of technical assistance

programs (including formal training

programs and surveys) with foreign

governments and international

organizations in areas relating to the

Agency mission. Coordinates ongoing

technical assistance operations with

appropriate components within the

Department, PHS, and the Agency.

Directs the Agency’s International

Visitors Program, providing participants

with policy briefings, technical training,

and/or assistance in response to specific

needs

2. Prior Delegations of Authority.

Pending further delegations, directives,

or orders by the Commissioner of Food

and Drugs, all delegations of authority

to positions of the affected organizations

in effect prior to this date shall continue

in effect in them or their successors.

Dated: December 5, 1995.

David A. Kessler,

Commissioner of Food and Drugs.

[FR Doc. 95–30744 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

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

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of January 1996.

Name: Council on Graduate Medical

Education

Date and Time: January 9, 1996, 1:00 p.m.–

5:00 p.m., January 10, 1996, 8:30 a.m.–4:00

p.m.

Place: Governor’s House Hotel, 17th Street

at Rhode Island Avenue, N.W., Washington,

D.C. 20036

The meeting is open to the public.

Purpose: Provides advice and

recommendations to the Secretary and to the

Committees on Labor and Human Resources,

and Finance of the Senate and the

Committees on Energy and Commerce and

Ways and Means of the House of

Representatives, with respect to (A) the

supply and distribution of physicians in the

United States; (B) current and future

shortages of physicians in medical and

surgical specialties and subspecialties; (C)

issues relating to international medical

graduates; (D) appropriate Federal policies

regarding (A), (B), and (C) above; (E)

appropriate efforts to be carried out by

medical and osteopathic schools, public and

private hospitals and accrediting bodies

regarding matters in (A), (B), and (C) above;

(F) deficiencies in the needs for

improvements in, existing data bases

concerning supply and distribution of, and

training programs for physicians in the

United States.

Agenda: The Agenda will include a panel

to discuss International Medical Graduates,

entry and participation in the U.S. physician

workforce. A panel to discuss Legislation and

GME Reform, House Ways and Means

Committee. Report on transition funding

issues; Report and updates on the work

groups, Minorities in Medicine; Geographic

Distribution/Medical Education Consortia;

Physician Competencies in a Managed Care

World; and IMG Entry and Participation in

the Physician Workforce.

Anyone requiring information

regarding the meeting should contact F.

Lawrence Clare, M.D., M.P.H., Deputy

Executive Secretary, Telephone 301–

443–6326, Council on Graduate Medical

Education, Division of Medicine,

Bureau of Health Professions, Room 9A–

27, Parklawn Building, 5600 Fishers

Lane, Rockville, MD 20857.

Agenda items are subject to change as

priorities dictate.

Dated: December 12, 1996.

Jackie E. Baum,

Advisory Committee Management Officer.

[FR Doc. 95–30816 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–15–P

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following meeting