Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices 38565

relating to the use of the drug in the

pediatric population. The statute

permits the agency to issue a written

request for pediatric studies under

section 505A(a) or (c) of the act. A

written request is a specific document

in which the agency requests

submission of certain studies. The

studies are designed to provide

information on the health benefits of a

drug in the pediatric population.

Because the study of oncology drugs

in pediatric populations merits special

consideration, the agency is publishing

this guidance to assist sponsors who

wish to undertake pediatric oncology

studies.

This draft guidance is being issued

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). The draft guidance represents the

agency’s current thinking on pediatric

oncology studies. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statute,

regulations, or both.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

Copies of this draft guidance for

industry are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm, http://www.fda.gov/cder/

pediatrics, and at http://www.fda.gov/

cber/guidelines.htm.

Dated: June 14, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–15629 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions,

and Delegations of Authority

This notice amends Part R of the

Statement of Organization, Functions

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (60 FR 56605

as amended November 6, 1995, as last

amended at 65 FR 12021–4 dated March

7, 2000).

This notice reflects the organizational

and functional changes in the Northeast

Field Cluster (RF1).

Section RF–10 Organization

The Northeast Field Cluster is headed

up by the Field Director who reports

directly to the Associate Administrator,

Office of Field Operations. The

Northeast Field Cluster is organized as

follows:

A. Immediate Office of the Field

Director (RF14)

B. Office of Data and Analysis (RF15)

C. Philadelphia Field Office (RF11)

D. Boston Field Office (RF12)

E. New York Field Office (RF13)

Section RF;–20 Function

Immediate Office of the Field Director

(RF14)

Serves as HRSA’s senior public health

official in the Northeast cluster,

providing liaison with State and local

health officials as well as professional

organizations; (2) provides input from

local, regional and state perspectives to

assist the Administrator and the

Associate Administrators in the

formulation, development, analysis and

evaluation of HRSA programs and

initiatives; (3) at the direction of the

Administrator and/or in conjunction

with the HRSA Associate

Administrators and the Associate

Administrator, Office of Field

Operations, coordinates the field

implementation of special initiatives

which involve multiple HRSA programs

and/or field offices (e.g., Border Health);

(4) assists with the implementation of

HRSA programs in the field by

supporting the coordination of

activities, alerting program officials of

potential issues and assessing policies

and service delivery systems; (5)

represents the Administrator in working

with other Federal agencies, state and

local health departments, schools of

public health, primary care associations

and organizations, community health

centers, and others in coordinating

health programs and activities; and (6)

exercises line management authority as

delegated from the Administrator for

general administrative and management

functions within the field structure.

Office of Data and Analysis (RF15)

Provides technical assistance,

consultation, training to Field Cluster

staff, grantees related to data systems,

planning, and evaluation; (2) serves as

focal point for States and Agency

grantees on data and data systems issues

related to HRSA program requirements;

(3) develops statistical profiles of HRSA

grantees in the region, and analysis of

Geographic Information Systems

profiles and other profiles developed by

federal, state and local agencies in the

region; (4) develops State profiles; (5)

conducts and disseminates, as

appropriate, trend analysis of financial

data, health indicators, and service data

to identify emerging trends among

HRSA grantees and health service

catchment areas in the Northeast; (6)

provides consultation and support to

private nonprofit organizations involved

in health care delivery around special

studies, research, and evaluation related

to health disparities; (7) analyzes

program related reports; and (8)

maintains Field Cluster program related

database.

Philadelphia Field Office (RF11)

Directs and coordinates field

development and implementation of

HRSA programs and activities in 5

states within the Northeast Field Cluster

designed to increase access, capacity,

and capabilities of local and state health

systems and programs serving the

underserved populations in the states

served by the cluster, including primary

care programs, maternal and child

health, HIV/AIDS, health facilities

construction under the Hill-Burton

Program, rural health, and other health

related programs in the cluster; (2)

provides continuous program

monitoring of HRSA health service

grants and contracts for compliance

with applicable laws, regulations,

policies, and performance standards; (3)

assists in the implementation and

monitors policies related to National

Health Service Corps scholarship and

loan repayment programs; (4) provides

for development, implementation, and

monitoring of the annual field work

plan related to assigned program areas,

including setting objectives responsive

to national and field priorities based on

guidance provided by appropriate

HRSA bureau components and assigns

division resources required to attain

these objectives; (5) coordinates with

38566 Federal Register / Vol. 65, No. 120 / Wednesday, June 21, 2000 / Notices

other field office staff and headquarters

staff to develop and consolidate

objectives crossing program and

division lines; (6) serves as source of

expertise on health resources and

services development, primary health

care, maternal and child health, rural

health, HIV/AIDS, and health

professions programs; (7) establishes

effective communication and working

relationships with health-related

organizations of States and other

jurisdictions; and (8) serves as a focal

point for information on health resource

programs and related efforts, including

voluntary, professional, academic and

other private sector activities.

Boston Field Office (RF12)

Directs and coordinates field

development and implementation of

programs and activities in six states

within the Northeast Field Cluster

designed to increase access, capacity,

and capabilities of local and state health

systems and programs serving the

underserved populations in the states

served by the cluster, including primary

care programs, maternal and child

health, HIV/AIDS, health facilities

construction under the Hill-Burton

Program, rural health, and other health

related programs in the cluster; (2)

provides continuous program

monitoring of HRSA health service

grants and contracts for compliance

with applicable laws, regulations,

policies, and performance standards; (3)

assists in the implementation and

monitors policies related to National

Health Service Corps scholarship and

loan repayment programs; (4) provides

for development, implementation, and

monitoring of the annual field work

plan related to assigned program areas,

including setting objectives responsive

to national and field priorities based on

guidance provided by appropriate

HRSA bureau components and assigns

division resources required to attain

these objectives; (5) coordinates with

other field office staff and headquarters

staff to develop and consolidate

objectives crossing program and

division lines; (6) serves as source of

expertise on health resources and

services development, primary health

care, maternal and child health, rural

health, HIV/AIDS, and health

professions programs; (7) establishes

effective communication and working

relationships with health-related

organizations of States and other

jurisdictions; and (8) serves as a focal

point for information on health resource

programs and related efforts, including

voluntary, professional, academic and

other private sector activities.

New York Field Office (RF13)

Directs and coordinates field

development and implementation of

programs and activities in two states,

the Virgin Islands, and Puerto Rico

within the Northeast Field Cluster

designed to increase access, capacity,

and capabilities of local and state health

systems and programs serving the

underserved populations in the states

served by the cluster, including primary

care programs, maternal and child

health, HIV/AIDS, health facilities

construction under the Hill-Burton

Program, rural health, and other health

related programs in the cluster; (2)

provides continuous program

monitoring of HRSA health service

grants and contracts for compliance

with applicable laws, regulations,

policies, and performance standards; (3)

assists in the implementation and

monitors policies related to National

Health Service Corps scholarship and

loan repayment programs; (4) provides

for development, implementation, and

monitoring of the annual field work

plan related to assigned program areas,

including setting objectives responsive

to national and field priorities based on

guidance provided by appropriate

HRSA bureau components and assigns

division resources required to attain

these objectives; (5) coordinates with

other field office staff and headquarters

staff to develop and consolidate

objectives crossing program and

division lines; (6) serves as source of

expertise on health resources and

services development, primary health

care, maternal and child health, rural

health, HIV/AIDS, and health

professions programs; (7) establishes

effective communication and working

relationships with health-related

organizations of States and other

jurisdictions; and (8) serves as a focal

point for information on health resource

programs and related efforts, including

voluntary, professional, academic and

other private sector activities.

Section RF–30 Delegations of

Authority

All delegations and redelegations of

authority which were in effect

immediately prior to the effective date

hereof have been continued in effect in

them or their successors pending further

redelegation.

This reorganization is effective upon

the date of signature.

Dated: May 26, 2000.

Claude Earl Fox,

Administrator.

[FR Doc. 00–15552 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Statement of Organization, Functions,

and Delegations of Authority

This notice amends Part R of the

Statement of Organization, Functions,

and Delegations of Authority of the

Department of Health and Human

Services (DHHS), Health Resources and

Services Administration (60 FR 56605

as amended November 6, 1995, as last

amended at (65 FR 12021–4 dated

March 7, 2000).

This notice reflects the organizational

and functional changes in the Pacific

West Field Cluster (RF5).

Section RF—(10) Organization

The Pacific West Cluster is headed up

by the Field Director who reports

directly to the Associate Administrator,

Office of Field Operations. The Pacific

West Cluster is organized as follows:

A. Immediate Office of the Field

Director (RF53)

B. Office of Epidemiology and Data

Analysis (RF54)

C. Division I (RF55)

D. Division II (RF56)

E. Division III (RF57)

Section RF—(20) Function

Immediate Office of the Field Director

(RF53)

Serves as HRSA’s senior public health

official in the Pacific West cluster,

providing liaison with State and local

health officials as well as professional

organizations; (2) provides input from

local, regional and state perspectives to

assist the Administrator and the

Associate Administrators in the

formulation, development, analysis and

evaluation of HRSA programs and

initiatives; (3) at the direction of the

Administrator and/or in conjunction

with the HRSA Associate

Administrators and the Associate

Administrator, Office of Field

Operations, coordinates the field

implementation of special initiatives

which involve multiple HRSA programs

and/or field offices (e.g., Border Health);

(4) assists with the implementation of

HRSA programs in the field by

supporting the coordination of

activities, alerting program officials of

potential issues and assessing policies

and service delivery systems; (5)

represents the Administrator in working

with other Federal agencies, state and

local health departments, schools of

public health, primary care associations

and organizations, community health