24312 Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices

Secretary is responsible for. The

Director IGA represents the Department

in special initiatives, such as the Human

Services Transportation Coordination

and the National Rural Development

Partnership initiatives.

III. Delete Chapter AD in its entirety

and replace with the following:

AD.00 Mission. The Regional

Director serves as the direct personal

representative of the Secretary with the

responsibility for carrying out the

Secretary’s policies in the Region. The

Regional Director provides leadership

for the Secretary’s special initiatives and

coordination of the complex activities of

the Region.

AD.10 Organization. The Office of

the Regional Director is under the

direction and control of the Regional

Director, who reports directly to the

Secretary and Deputy Secretary through

the Director for Intergovernmental

Affairs, and consists of the following:

Regional Director AD(1–X)

Regional Health Administrator ADA(1–

X)

AD.20 Function. A. The Regional

Director serves as the Secretary’s

representative in direct official dealings

with State, tribal and local government

organizations, non-government officials

and their respective representative

organizations. Establishes and maintains

effective relationships with Governors,

mayors, county officials, and other key

State and local officials; furnishes

advice and assistance and strives to

develop a mutually beneficial FederalState-local partnership; provides

guidance and coordination to the efforts

of all regional staff members on the

priorities, emphasis, and merits of

various programs based on the

expression of needs and analyses by

Governors, mayors, and other key

officials. In consultation with the Office

of the Assistant Secretary for

Legislation, provides a central focus in

the Region for department relations with

Congressional delegations and

individual members of Congress.

Promotes general public understanding

of programs, policies, and objectives of

the Department; participates in

developing and carrying out a regionwide public information program; and

provides regional clearance on official

public communiques.

Assesses the effectiveness of

Department activities and makes reports

and recommendations to the Secretary,

Deputy Secretary, Director of

Intergovernmental Affairs, and other

Departmental officials concerning the

application or improvement of policies

and service delivery systems. Serves as

coordinator, facilitator, and expediter in

solving cross-cutting issues to assure

effective, efficient, and responsible

actions in the interest of total service to

the public. Advises the Secretary on the

potential effect of proposed Department

action, whether legislative, regulatory,

or administrative decision. Provides

input into policy decisions and strategy

regarding the concerns and interests of

State and local governments and nongovernment organizations as derived

from their key officials. In conjunction

with the Regional Health

Administrators, develops plans for

emergency preparedness and directs all

Departmental activities necessary to

ensure continuity of essential functions

within the Region in case of an

emergency due to enemy action or

natural disaster.

B. The Regional Health Administrator

ADA(1–X)—Reports to the Secretary’s

Regional Director, receives professional

guidance from the Assistant Secretary

for Health, Director, Office of Public

Health and Science (OPHS) programs.

The Regional Health Administrator and

associated staff are a component of the

U.S. Public Health Service, along with

the OPHS and PHS Operating Divisions.

Participates in policy development

and implementation; directs and

coordinates regionally based programs

of OPHS, including the offices of

Emergency Preparedness, Minority

Health, Women’s Health, and

Population Affairs. Develops regional

goals and objectives consistent with the

needs of the population and in

conformity with national health

priorities and objectives and

Departmental plans and programs.

Serves as the principal official in the

assigned area of jurisdiction to provide

oversight and coordination for Public

Health Service programs. Solicits and

provides input from regional, State, and

local health, mental health and

substance abuse professional

organizations to assist the Regional

Director, the Assistant Secretary for

Health, Director, OPHS, Director IGA

and PHS Operating Divisions (OPDIVs)

in the formulation, development,

analysis, and evaluation of PHS OPDIV

field programs and cross cutting

Departmental initiatives in public

health.

IV. Under Part H, delete Chapter HD

in its entirety.

Dated: April 11, 1996.

John J. Callahan,

Assistant Secretary for Management and

Budget.

[FR Doc. 96–11946 Filed 5–13–96; 8:45 am]

BILLING CODE 4150–04–M

Agency for Health Care Policy and

Research

Meeting of the National Advisory

Council for Health Care Policy,

Research, and Evaluation

AGENCY: Agency for Health Care Policy

and Research.

ACTION: Notice of public meeting.

SUMMARY: In accordance with section

10(a) of the Federal Advisory Committee

Act, this notice announces a meeting of

the National Advisory Council for

Health Care Policy, Research, and

Evaluation.

DATES: The meeting will be open to the

public on Thursday, May 30, 1996, from

9:00 a.m. to 3:45 p.m. A closed portion

of the Council will meet from 4:00 p.m.

to 5:00 p.m.

ADDRESSES: The meeting will be held at

the Omni Shoreham Hotel, 2500 Calvert

Street, N.W., Washington, D.C. 20008.

FOR FURTHER INFORMATION CONTACT:

Deborah L. Queenan, Executive

Secretary of the Advisory Council at the

Agency for Health Care Policy and

Research, 2101 East Jefferson Street,

Suite 603, Rockville, Maryland 20852,

(301) 594–1459.

In addition, if sign language

interpretation or other reasonable

accommodation for a disability is

needed, please contact Linda Reeves,

the Assistant Administrator for Equal

Opportunity, AHCPR, on (301) 594–

6665 no later than May 23, 1996.

SUPPLEMENTARY INFORMATION:

I. Purpose

Section 921 of the Public Health

Service Act (42 U.S.C. 299c) establishes

the National Advisory Council for

Health Care Policy, Research, and

Evaluation. The Council provides

advice to the Secretary and the

Administrator, Agency for Health Care

Policy and Research (AHCPR), on

matters related to AHCPR activities to

enhance the quality, appropriateness,

and effectiveness of health care services

and access to such services through

scientific research and the promotion of

improvements in clinical practice and

in the organization, financing, and

delivery of health care services.

The Council is composed of public

members appointed by the Secretary.

These members are: Robert A. Berenson,

M.D.; F. Marian Bishop, Ph.D.; Linda

Burnes Bolton, Dr. P.H.; John W.

Danaher, M.D.; Helen Darling, M.A.;

Nancy J. Kaufman, M.S.; William S.

Kiser, M.D.; Robert M. Krughoff; Risa J.

Lavizzo-Mourey, M.D.; W. David Leak,

M.D.; Harold S. Luft, Ph.D.; Barbara J.
Federal Register / Vol. 61, No. 94 / Tuesday, May 14, 1996 / Notices 24313

McNeil, M.D.; Walter J. McNerney,

M.H.A.; Edward B. Perrin, Ph.D; Louis

F. Rossiter, Ph.D.; Albert L. Siu, M.D.;

and Ellen B. White, M.B.A.

There also are Federal ex-officio

members. These members are:

Administrator, Substance Abuse and

Mental Health Services Administration;

Director, National Institutes of Health;

Director, Centers for Disease Control

and Prevention; Administrator, Health

Care Financing Administration;

Commissioner, Food and Drug

Administration; Assistant Secretary of

Defense (Health Affairs); and Chief

Medical Director, Department of

Veterans Affairs.

II. Agenda

On Thursday, May 30, 1996, the

meeting will begin at 9:00 a.m. with the

call to order by the Council Chairman.

The Administrator, AHCPR, will update

the status of current Agency issues and

program initiatives. The Council will

then discuss issues concerning the

guideline program, public/private sector

collaboration, and improvements to the

large grant program. The Council will

recess at 3:45 p.m. The Council will

begin the closed portion of the meeting

to review grant applications from 4:00

p.m. to 5:00 p.m.

The meeting will adjourn at 5:00 p.m.

Agenda items are subject to change as

priorities dictate.

Dated: May 8, 1996.

Clifton R. Gaus,

Administrator.

[FR Doc. 96–12066 Filed 5–13–96; 8:45 am]

BILLING CODE 4160–90–M

Administration for Children and

Families

Agency Recordkeeping/Reporting

Requirements Under Emergency

Review by the Office of Management

and Budget (OMB)

Title: Request for Emergency OMB

Approval of Information Collection

Under the Paperwork Reduction Act.

OMB No.: New.

Description: The State and Tribal

JOBS plans are statutorily mandated and

serve as the agreement between the

State or the Tribal grantee and the

Federal government for how JOBS

programs will operate. The State/Tribal

plans provide assurances that the JOBS

program will be administered and

operated in conformity with titles IV–A

and IV–F of the Social Security Act,

pertinent Federal regulations, and other

applicable instructions or guidelines

issued by ACF. This new State and

Tribal JOBS plan section is being added

in response to the President’s recent

directive requiring States to address the

needs of teen parents so that they stay

in school and become self-sufficient.

Respondents: State, Local or Tribal

Govt.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of

responses

per respondent

Average

burden

hours per

response

Total burden hours

Tribal JOBS ...................................................................................................................... 76 1 5 380

State JOBS ....................................................................................................................... 54 1 5 270

Estimated Total Annual Burden

Hours: 650.

Additional Information

ACF is requesting that OMB grant a 90

day approval for this information

collection under procedures for

emergency processing by May 9, 1996.

A copy of this information collection,

with applicable supporting

documentation, may be obtained by

calling the Administration for Children

and Families, Reports Clearance Officer,

Roberta Katson at (202) 401–5756.

Comments and questions about the

information collection described above

should be directed to the Office of

Information and Regulatory Affairs,

Attn: OMB Desk Officer for ACF, Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street NW.,

Washington, DC 20503, (202) 395–7316.

Dated: May 8, 1996.

Roberta Katson,

Director, Office of Information Resource

Management Services.

[FR Doc. 96–11946 Filed 5–13–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

FDA Form 3439, Interim Form for

Application to Market a New Drug,

Biologic, or Antibiotic Drug for Human

Use; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of FDA Form 3439 entitled,

‘‘Application to Market a New Drug,

Biologic, or Antibiotic Drug for Human

Use.’’ This form is intended for use by

applicants for licenses for specified

biotechnology and specified synthetic

biological products. FDA Form 3439 has

received interim approval from the

Office of Management and Budget

(OMB) for use by applicants pending the

availability of a harmonized form for

use by applicants requesting approval of

drugs, biological products, and

antibiotics. The development of the

harmonized form and this action are

part of FDA’s continuing effort to

achieve the objectives of the President’s

‘‘Reinventing Government’’ initiatives.

EFFECTIVE DATE: The FDA Form 3439

may be used May 24, 1996.

ADDRESSES: Submit written requests for

single copies of FDA Form 3439 to

Division of Congressional and Public

Affairs (HFM–44), Center for Biologics

Evaluation and Research (CBER), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive

label to assist that office in processing

your requests. The form may also be

obtained by FAX by calling the CBER

Voice Information System at 1–800–

835–4709. FDA Form 3439 is available

for public examination in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Annette A. Ragosta, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA is

making available FDA Form 3439,

Application to Market a New Drug,