67390 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices

availability of a draft guidance for

industry entitled ‘‘Cancer Drug and

Biological Products—Clinical Data in

Marketing Applications.’’ The draft

guidance document provides

recommendations for sponsors

designing clinical trials to demonstrate

the safety and efficacy of cancer

treatments on the collection of data that

may be submitted to support marketing

claims in new drug applications

(NDA’s), biologics license applications

(BLA’s), or applications for

supplemental indications.

DATES: Submit written comments on the

draft guidance by January 8, 2001.

General comments on agency guidance

documents are welcome at any time.

ADDRESSES: Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

The document may also be obtained by

fax by calling the FAX Information

System at 1–888–CBER–FAX or 301–

827–3844. See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance.

Submit written comments on the

document to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Grant A. Williams, Center for Drug

Evaluation and Research (HFD–150),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5740, or Patricia Keegan,

Center for Biologics Evaluation and

Research (HFM–573), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–5093.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance for industry entitled

‘‘Guidance for Industry: Cancer Drug

and Biological Products—Clinical Data

in Marketing Applications.’’ This draft

guidance provides general principles for

data collection and submission for

sponsors of investigational new drug

applications, NDA’s, BLA’s, or

applications for supplemental

indications. It is intended to enable

sponsors to more effectively create plans

to record and report the data from

controlled trials that form the clinical

basis for approval of anticancer drug

and biological products.

This draft level 1 guidance is being

issued consistent with FDA’s good

guidance practices (65 FR 56468,

September 19, 2000). The draft guidance

represents the agency’s current thinking

on clinical data in marketing

applications for cancer drug or biologic

products. 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 statutes

and regulations.

II. Comments

Interested persons may submit written

comments on the draft guidance to the

Dockets Management Branch (address

above). 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

Persons with access to the Internet

may obtain the document at http://

www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/cber/

guidelines.htm.

Dated: October 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28776 Filed 11–8–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Statement of Mission, Organization,

Functions and Delegation of Authority

Part G, of the statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services, as amended at 60 FR 56606,

November 9, 1995, and most recently

amended at 61 FR 67048, December 19,

1996, is amended to reflect a

reorganization of the Office of Public

Health (GAB), Indian Health Service

(IHS).

The changes are as follows:

Delete the functional statements for

the Office of Public Health in their

entirety and replace with the following:

Section GAB–00, Office of Public

Health, IHS—Mission. The Office of

Public Health, IHS defines its mission as

a commitment to the well-being and

cultural integrity of Indian people

through a participatory and consultative

process. The goal of the Office of Public

Health is to elevate the health status of

American Indian and Alaska Native (AI/

AN) people to the highest possible level

by (1) providing and/or assuring

availability; (2) providing increasing

opportunities for Indians to manage and

operate their own health programs; and

(3) serving as an advocate for Indian

people.

Section GAB–10, Functions Office of

Public Health (OOH) (GAB). (1) Advises

and supports the Director, Indian Health

Service (IHS), on policy, budget

formulation, resource allocation

regarding the operation and

management of IHS direct, tribal, and

urban public health programs, risk

management, quality assurance,

facilities programs, and selfdetermination; (2) provides agency-wide

leadership and consultation to IHS

direct, tribal, and urban public health

programs on IHS goals, objectives,

policies, standards, and priorities; (3)

represents the IHS within the HHS and

external organizations for purposes of

liaison, professional collaboration,

cooperative ventures, and advocacy; (4)

manages and provides national

leadership and consultation for IHS and

Area offices on strategic and tactical

planning, program evaluation and

assessment, public health and medical

services, research agendas, and special

public health initiatives for the agency;

(5) manages the design, development,

and assessment for implementation of

resource requirements and resource

allocation methodology models for the

agency; (6) manages demographic and

program databases and performs

statistical and epidemiological analyses

and consultation; (7) carries out IHS

responsibilities as required by the

United States Federal Response Plan

under Emergency Support Function No.

8; (8) assures agency compliance with

the Code of Federal Regulations 45, Part

46, Protection of Human Subjects; and

(9) manages and administers the

functions related to business office

services, contract health care, clinical

and community services, preventive

services, managed care, hospitals and

ambulatory care centers, general public

health practices and advocacy,

environmental health, realty, facilities

construction, facilities operation and

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices 67391

management, and environmental

engineering.

Office of Executive Management

(GAB–1). (1) Provides leadership and

advice to the Director and public health

programs on policy, budget, personnel,

business office and the health care

financing administration issues, and

general administration; (2) represents

the Director, Office of Public Health

(OPH), in meetings with IHS employees

and high-level management officials

within the IHS, HHS, or other Federal

agencies, tribes, and other organizations

on administrative/management and

policy issues. (3) participates with the

National Council of Executive Officers,

and meets with HHS/IHS leadership to

provide agency advice on management

and administrative matters; (4)

administers, monitors, and assists in the

development of office and program

budgets and budget formulation; (5)

manages and oversees the IHS thirdparty revenue generation activity; (6)

participates in self-determination issues

and processes pertaining to budget and

tribal shares computation (7) functions

as operational manager for

administrative policies and activities

within the OPH; and (8) provides

guidance and carries out OPH

responsibilities regarding Equal

Employment Opportunities (EEO), labor

relations, and other employee relations

activities.

Administrative Management Team.

(1) Provides program budget execution,

analysis, and oversight; (2) provides

guidance and coordinates the

development and review of the OPH

sections of the Department and

Congressional budgets and presentation

materials; (3) coordinates and assists in

review of responses to budget inquiries

and budgets materials for Congressional

hearings and meetings; (4) coordinates,

develops, promulgates, and maintains

administrative policies, procedures, and

manual issuances for the OPH; (5)

monitors and administers existing

agency administrative policies for OPH;

(6) provides the OPH executive

secretariat function; (7) serves as the

review and coordinating point for OPH

managed intra and interagency

agreements; (8) serves as the principal

resource for OPH personnel

management and training issues

consultation; (9) serves as the principal

resource for OPH office space, property

and supply activities; (10) serves as a

general administrative resource for

special activities/initiatives; and (11)

provides direction and oversight on

daily operations for the OPH.

Business Office Services Team. (1)

Serves as the primary focal point for

Business Office Services (BOS) program

operations and policy issues and

represents BOS in national forums; (2)

ensures improvement of the

effectiveness and efficiency of the

revenue generation activity, and

provides support for local capacity

building. (3) develops, disseminates,

and maintains BOS policy and

procedures manual (4) develops and

promulgates standards and conducts

BOS program reviews on a recurring,

scheduled basis; (5) provides national

leadership for Medicare, Medicaid, and

private insurance reimbursement policy

and procedures; (6) serves as the

primary liaison with the Health Care

Financing Administration for rate

setting negotiations (7) serves as the

focal point regarding Medicare and

Medicaid managed care activities,

including the review, evaluation, and

monitoring of Sections 1115 and 1915(b)

Medicaid waiver proposals and other

State and Federal health care reform

activities; (8) provides programmatic

management of information systems for

patient registration and billing and

collections systems (9) assures training

on various regulatory issues and

negotiated managed care provider

agreements; and (10) develops thirdparty budget materials and responds to

congressional departmental inquiries

regulating to third-party issues.

Office of Program Support (GAB–2).

(1) Serves as a coordinating point for

public health advocacy and as a source

of technical support, development, and

dissemination of policy advice for IHS

Headquarters, OPH, Area offices, and

facilities programs on the full scope of

the public health and health data issues

and activities; (2) serves as a resource

and provides coordination and

consultation to the IHS direct, tribal,

and urban health programs (I/T/U) on

public health issues; (3) provides and

directs public health surveillance,

intervention, research and evaluation

programs, and the information systems

to support them; (4) develops and

coordinates agency strategic planning

and performance measurement efforts

with budgeting and requirements in

consultation with OPH program staff; (5)

provides consultation and coordination

on the IHS budget formulation activity

for planing and data purposes; (6)

maintains, analyzes, makes accessible,

and publishes results from national

demographic and program databases;

and (7) performs statistical and

epidemiological consultation and

coordination for the IHS in response to

special conditions and communicable

disease outbreaks of public health

significance.

Office of Clinical and Preventive

Service (GAB1). (1) Serves as the

primary source of technical and policy

advice, and supports local capacity

building for clinical and public health

infrastructure for the IHS, Area offices,

and I/T/U programs, on the full scope of

clinical health care programs, including

their quality assurance and preventive

aspects, and tort claims; (2) provides

leadership in articulating the clinical

needs of the American Indian/Alaska

Native (AI/AN) population and

competing health care needs; (3)

advocates the resource needs of

specialized health care delivery

providers of clinical services

disciplines; (4) provides leadership,

consultation and technical support to I/

T/U public health programs; (5)

develops, manages, and administers the

program functions that includes, but are

not limited to, behavioral health,

chronic disease such as diabetes and

cancer, dental services, emergency

medial services, health records,

maternal and child health, social

services, pharmacy services, nursing

services, nutrition and dietetics,

laboratory, disabilities, and contract

health care services; (6) investigates

evidence-based and best practice

models of service delivery for

dissemination to community service

locations; and (7) coordinates

development of staffing requirements

for new or replacement health care

facilities and approves Congressional

budget requests for staffing.

Division of Behavioral Health

(GAB11). (1) Identifies industry program

standards and monitors and evaluates

community and Area-wide services

provided through grants or contracts

with Indian tribes, Indian organizations,

and direct IHS operations in the area or

mental health, social services, alcohol/

substance abuse, and health education;

(2) coordinates the Indian community

behavioral health programs, such as

alcoholism/substance abuse, mental

health, social work, and health

education with tribal program directors,

division staff, Area line staff, and other

agencies and institutions; (3)

coordinates contracts and grants for

behavioral health services and monitors

services provides; (4) makes program

and policy changes using data analysis,

recommendations from operations

levels, and research results. Coordinates

resources allocation from program

policies; (5) plans, develops, and

coordinates a comprehensive mental

health, social service, substance abuse

and health education program and

programs for children with special

needs; (6) provides behavioral health

program consultation to tribal groups

and IHS staff; (7) provides leadership in

67392 Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices

the identification of behavioral change

interventions and supports

implementations at the community

level; (8) coordinates with State,

Federal, professional, private, and

community organizations on alternate

health care resource; (9) provides

leadership in measuring and evaluating

the quality of behavioral health care

services; and (10) prepares information

on behavioral health for budgetary

hearings, and program evaluation

results for the IHS Director, the

Congress, and the American people.

Division of Clinical and Community

Services (GAB12). (1) Manages,

develops, coordinates, and evaluates a

comprehensive clinical and community

program focusing on diabetes, maternal/

child health, Indian children services,

nutrition, AIDS, pharmacy, laboratory,

health records, and health promotion

and disease prevention; (2) develops

and establishes standards for clinical

and community services and special

initiatives; (3) develops objectives,

priorities, and methodologies for the

conduct and evaluation of clinical and

community health-based program; (4)

provides, develops, and implements IHS

guidelines, policies, and procedures on

clinical and community based programs

and initiatives; (5) monitors, evaluates,

and provides consultation to clinical

and community programs and new

initiatives; (6) plans jointly with other

agencies on research and coordinated

services; (7) coordinates training needs

and staff recruitment, assignment and

development to meet service unit, area,

and tribal needs; (8) provides increased

awareness for health promotion and

disease prevention and the maintenance

of health; (9) coordinates and monitors

contracts and grants with I/T/Us and

other entities; (10) coordinates model

diabetes program sites and provides

support and direction to I/T/Us on

diabetes related issues; (11) develops

and disseminates information and

materials to IHS facilities and (I/T/U);

and (12) develops program budget

materials and responds to congressional

and department inquiries.

Division of Nursing Services (GAB13).

(1) Manages the IHS Nursing Services,

Women’s Health, and Community

Health Representative programs and

advocates for program needs; (2) plans,

develops, coordinates, and evaluates

nursing and the community health

representative program; (3) identifies

and establishes standards for nursing

services and the community health

representative program; (4) provides

leadership, professional guidance, and

staff development; (5) plans, develops,

coordinates, manages, and evaluates

nursing education; (6) coordinates the

assignment and development of

professional staff, including nursing

recruitment staff, and scholarship

recipients, to meet Service Unit, Area,

and tribal needs in accordance with IHS

policies and procedures; (7) provides

guidance in planning, developing, and

maintaining management information

systems; and (8) prepares budgetary

data, analysis and program evaluations

and prepares information for program

and budget presentations and

congressional hearings.

Division of Oral Health (GAB14). (1)

Plans, develops, coordinates, and

evaluates dental health programs; (2)

establishes staffing, procedural, facility,

and dental contract standards; (3)

coordinates professional recruitment,

assignment, and staff development; (4)

improves effectiveness and efficiency of

dental programs; (5) develops resource

opportunities and monitors utilization

of resources for dental health programs;

(6) formulates and allocates dental

program budget; (7) advocates for oral

health needs of AI/AN population; (8)

coordinates health promotion and

disease prevention activities for the

dental program; and (9) monitors oral

health status and treatment needs of the

AI/AN population.

Division Contract Care and Risk

Management (GAB15). (1) Plans,

develops, and coordinates the Contract

Health Service (CHS) program; (2)

serves as the primary focal point for

Contract Health Support (CHS) program

operations and policy issues, and

represents CHS in national forums; (3)

develops, disseminates, and maintains

CHS policy and procedures manual; (4)

conducts CHS program reviews on a

recurring, scheduled basis; (5) monitors

the implementation of the IHS payment

policy and reports the status to the

Director, OPH; (6) administers the

Catastrophic Health Emergency Fund;

(7) administers the CHS Quality

Assurance Fund; (8) administers the

CHS claims adjudication activity for the

IHS Headquarters; (9) administers the

IHS fiscal intermediary contract and

conducts data analysis; (10) coordinates

the development of the CHS budget and

the allocation of resources; (11) provides

consultation to Headquarters and Area

offices, and responds to inquiries from

the Congress, tribes, and other Federal

agencies; (12) serves as the primary

source of technical and policy advice

and consultation for IHS Headquarters

and the OPH on risk management,

quality assurance, and workers

compensation; (13) manages the clinical

features of tort claims against the IHS;

(14) develops and disseminates clinical

and personal risk management

recommendations; (15) manages the IHS

workman’s compensation claims; and

(16) oversees IHS efforts in a variety of

quality assurance and improvement

activities.

Office of Environmental Health and

Engineering (GAB2). (1) Serves as the

primary source of technical and policy

advice for IHS Headquarters and Area

offices, tribal, and urban public health

programs on the full scope of health

care facilities, sanitation facilities

construction (SFC) and management,

environmental health, environmental

engineering, clinical engineering, and

realty services management; (2)

develops objectives, priorities,

standards, and methodologies for the

conduct and evaluation of

environmental health, environmental

engineering, and facilities engineering

and management activities; (3)

coordinates the formulation of the IHS

Facilities budget request and responds

to all inquiries about the budget request

and programs funded by the IHS

Facilities appropriation; (4) maintains

needs-based and workload-based

methodologies for equitable resource

distribution for all funds appropriated

under the IHS Facilities appropriation;

(5) provides leadership, consultation,

and staff development to assure

functional, safe, and well-maintained

health care facilities, a comprehensive

environmental health program, and the

availability of water, sewer, and solid

waste facilities for Indian homes and

communities; and (6) coordinates the

IHS responses to disasters and other

emergency situations.

Division of Sanitation Facilities

Construction (GAB21). (1) Develops,

implements, and manages the

environmental engineering programs

including the SFC program, and

compliance activities associated with

environmental protection and historic

preservation legislation; (2) provides

agency-wide management assistance

and special support/consultation to

address special environmental public

health problems, environmental

engineering/construction activities and

compliance with environmental

legislation; (3) works closely with other

Federal agencies to resolve

environmental issues and maximize

benefits to tribes by coordinating

program efforts; (4) develops,

implements, and evaluates agency

program activities, objectives, policies,

plans, guidelines, and standardized data

systems for SFC activities; (5) consults

with tribal groups/organizations in the

development and implementation of

SFC policies and initiatives, and in the

identification of sanitation needs; (6)

maintains a national inventory of

current tribal sanitation facilities needs,

Federal Register / Vol. 65, No. 218 / Thursday, November 9, 2000 / Notices 67393

and past and present projects to address

those needs; and (7) allocates financial

resources nationwide based on need and

workload using the national data

inventories.

Division of Environmental Health

Services (GAB22). (1) Develops,

implements, and manages IHS

Environmental Health Services

programs including the Injury

Prevention and Institutional

Environmental Health programs, and

serves as the primary source of technical

and policy advice for IHS Headquarters

and Area offices on the full scope of

environmental health issues and

activities; (2) maintains interagency

relationships with other Federal

agencies and tribes to maximize

interagency and intertribal responses to

environmental health issues and

maximize benefits to tribes by

coordinating program efforts; (3)

provides leadership in identifying and

articulating environmental health needs

of AI/AN populations and support

efforts to build tribal capacity; (4)

provides personnel support services and

advocates for environmental health

providers; (5) maintains, analyzes,

makes accessible, and publishes results

from national data bases; (6) manages

resource allocation activities in

accordance with established criteria

based on workload; (7) develops and

evaluates standards and guidelines for

environmental health programs and

activities; and (8) performs functions

related to environmental health

programs such as injury prevention,

emergency response, water quality, food

sanitation, occupational health and

safety, solid and hazardous waste

management, environmental health

issues in health care and non-health

care institutions, and vector control.

Division of Facilities Operations

(GAB23). (1) Develops, implements, and

manages the programs affecting health

care facilities operations, including

routine maintenance and improvement

(M&I), quarters, realty, and clinical

engineering programs; (2) develops,

implements, monitors, and evaluates

agency program activities, objectives,

policies, plans, guidelines, and

standardized data systems for health

care facilities operations; (3) serves as

principal resource for coordination of

facilities operations and provides

consultation to IHS and the tribes on

health care facilities operations; (4)

maintains realty and quarters

management systems; (5) maintains

clinical engineering management

systems; (6) formulates financial

resources allocation methodologies

nation-wide based on need and

workload data; (7) maintains nationwide data on Federal and tribal facilities

for program budget justification; and (8)

develops and evaluates technical

standards and guidelines for health care

facilities operations.

Division of Facilities Planning and

Construction (GAB24). (1) Develops,

implements, and manages IHS Health

Care Facilities Planning and

Construction program, including the

facilities planning process, facilities

design process, facilities acquisition,

and construction project management;

(2) develops, implements, monitors, and

evaluates agency program activities,

objectives, policies, plans, guidelines,

and standardized data systems for

health care facilities planning and

construction; (3) develops and

maintains construction priority systems

and develops project budget documents

for the health care facilities construction

program; (4) serves as the principal

resource in providing leadership,

guidance, and coordination of health

care facilities engineering activities for

the IHS Headquarters, Area offices, and

I/T/Us; (5) monitors construction

activities and the improvement,

alteration, and repair of health care

facilities; and (6) develops and evaluates

technical standards and guidelines for

health care facilities construction.

Division of Engineering Services

(Dallas, Seattle) (GAB25). (1)

Administers health care facilities

engineering and construction projects

for specified Area offices and

administers the engineering and

construction of certain projects for other

Federal agencies through interagency

agreements; (2) carries out management

activities relating to IHS-owned and

utilized health care facilities, including

construction, contracting, realty, and

leasing services; (3) serves as the source

of engineering and contracting expertise

for assigned programs/projects and

other technical programmatic areas

affecting the planning, design,

alteration, leasing, and construction of

IHS health care and sanitation facilities

for Indian homes and communities; (4)

assists in the development of Area office

annual work plans, and in studies,

investigations, surveys, audits, facilities

planning, and technical standards

development, related to IHS tribal

health care facilities.

Section GAB–20, Office of Public

Health—Delegations of Authority. All

delegations and redelegations made to

officials in the Office of Public Health

that were in effect immediately prior to

this reorganization, and that are

consistent with this reorganization,

shall continue in effect pending further

redelegation.

This reorganization shall be effective

on the date of signature.

Dated: October 13, 2000.

Michael H. Trujillo,

Director, Assistant Surgeon General.

[FR Doc. 00–28695 Filed 11–8–00; 8:45 am]

BILLING CODE 4160–16–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Substance Abuse and

Mental Health Services Administration

(SAMHSA) will publish a list of

information collection requests under

OMB review, in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

documents, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Administrative Reporting Form (ARF)

for the Women, Co-occurring Disorders

and Violence Cooperative Agreement

Program (Phase II)—New—The Women,

Co-occurring Disorders, and Violence

Study is funded by SAMHSA’s Center

for Substance Abuse Treatment (CSAT),

Center for Substance Abuse Prevention

(CSAP), and Center for Mental Health

Services (CMHS) to produce knowledge

on the development and effectiveness of

integrated services for women with cooccurring mental health and substance

abuse disorders who are victims of

violence. Fourteen sites were funded in

Phase I, and ten sites are expected to be

funded in Phase II. During Phase I of the

study (2 years), sites developed

integrated service models. In Phase II,

sites that successfully reapplied will test

their interventions in a multi-site

outcome study contrasting

comprehensive, integrated, traumaspecific and Consumer/Survivor/

Recovering Person (C/S/R) involved

services to services as usual.

The Administrative Reporting Form

(ARF) is a program monitoring

instrument which is to be completed

jointly by the project director, project

staff members, and directors of

participating organizations at each study

site annually. The ARF collects

information about the staffing and

governance of each project, project

accomplishments in the previous year,

and specific project components.

Information collected with the ARF

will be used in three ways. First,

evaluators will use information from the

ARF to describe the process of project