Selected Topics in Federal Health Statistics

June 1979

NTIS order #PB-298449
Library of Congress Catalog Card Number 79-600093

For sale by the Superintendent of Documents, U.S. Government Printing Office

Washington, D.C. 20402
FOREWORD

The proliferation of Federal health programs since the advent of Medicare and Medicaid some 15 years ago has spawned a vast number of separate systems for the collection

of health data. The demand for information describing these programs is immense and

keeps growing. It now costs an estimated $100 million a year for Federal health statistical

activities.

This report reviews and assesses Federal data collection activities and finds them to

be overlapping, fragmented, and often duplicative. It was prepared at the request of the

Senate Committee on Labor and Human Resources and the House Committee on Interstate and Foreign Commerce.

The report is divided into two parts. Part I inventories the different health data collection systems administered by the Department of Health, Education, and Welfare and

other Federal agencies, outlines the problems of duplication and fragmentation that occur, and addresses the possibilities of improving the coordination of these systems.

Part II is a directory of statutory provisions that govern the collection of health data

by the Public Health Service and the Health Care Financing Administration. It is a convenient reference that Members of Congress can consult before enacting new data requirements. It may also be useful to executive agencies in the coordination of existing

ones.

This study was conducted by the OTA Health Group staff. We are grateful for the

advice and guidance provided in this assessment by OTA’s Health Advisory Committee,

chaired by Dr. Frederick C, Robbins. The report, however, does not necessarily reflect

the views of any individual member of the Committee.

DANIEL DE SIMONE

Acting Director

. . . 111
OTA HEALTH GROUP STAFF

Joyce C. Lashof, Assistant Director

Health and Life Sciences Division

H. David Banta, Health Group Manager

Pony M. Ehrenhaft, Study Director

Lynne Pepi Pietz, Congressional Fellow

Page S. Gardner, Editor

William S. Burnett Shirley A. Gayheart

OTA PUBLISHING STAFF

John C. Holmes, Publishing Officer

Kathie S. Boss Joanne Heming
OTA HEALTH GROUP ADVISORY COMMITTEE

Frederick C. Robbins, Chairman

Dean, School of Medicine, Case Western Reserve University

Stuart H. Altman Sidney S. Lee

Dean Associate Dean

Florence Heller School Community Medicine

Brandeis University McGill University

Robert M. Ball

Senior Scholar

Institute of Medicine

National Academy of Sciences

Bernard Barber

Professor

Department of Sociology

Barnard College

Columbia University

C. Frederick Mosteller

Professor and Chairman

Department of Biostatistics

School of Public Health

Harvard University

Helen Ewing Nelson

President

Consumer Research Foundation

Mill Valley, Calif.’

Rashi Fein Charles A. Sanders

Professor of the Economics of Medicine General Director

Center for Community Health and Massachusetts General Hospital

Medical Care

Harvard Medical School Kerr L. White

Deputy Director

Melvin A. Glasser Health Sciences

Director Rockefeller Foundation

Social Security Department

United Auto Workers
ACKNOWLEDGEMENTS

The Office of Technology Assessment (OTA) was assisted in the preparation of this

report by the following contractors and contributors: John Abbott, Frank Baker, Robert

Barnes, David R. Hutchinson, Robert F. Lewis, Robert F. Myers, Edward Perrin, and

William Weiss.

OTA would also like to thank the following people for their careful review of various draft documents: Sonia Bergman, Public Health Service; James Cooney, Jr., National Center for Health Statistics; Helen Darling, Institute of Medicine; Richard

Eisenger, Office of Management and Budget; Judith Galloway, Alcohol, Drug Abuse,

and Mental Health Administration; Clifton Gaus, Health Care Financing Administration; Harry Glass, Health Standards and Quality Bureau; Donald Goldstone, National

Center for Health Services Research; Evelyn Gordon, Food and Drug Administration;

George Hall, Office of Federal Statistical Policy and Standards; Ansis Helmanis, Food

and Drug Administration; Elvin Hilyer, Center for Disease Control; Charles Jackson,

Health Resources Administration; B. F. Keefe, Center for Disease Control; Samuel

Korper, National Center for Health Services Research; Lawrence Kucken, Health Care

Financing Administration; John Marshall, Bureau of Community Health Services; Mary

Miers, National Institutes of Health; Richard Millstein, Alcohol, Drug Abuse, and Mental Health Administration; James O’Rourke, Public Health Service; William Rhode, National Institutes of Health; Dorothy Rice, National Center for Health Statistics; Lawrence

Sauer, Health Services Administration; James Scanlon, Public Health Service; Robert

Sermier, Office of Assistant Secretary for Management and Budget; David R. Smith,

Health Care Financing Administration; Howard Stambler, Bureau of Health Manpower;

Richard Taeuber, Office of the Assistant Secretary for Planning and Evaluation; Carl

Taube, National Institute of Mental Health; Stephen Thacker, Center for Disease Control; Martin Wall, Health Services Administration; Howard West, Moshman Associates;

Robert Wetherell, Jr., Food and Drug Administration; Ronald W. Wilson, National

Center for Health Statistics; and Gooloo Wunderlich, Public Health Service.
CONTENTS

Page

Glossary of Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii

PART I–COORDINATION ISSUES . . . . . . . . . . . . . . . . . . . . .. ..1

Chapte r

1.

2.

3.

SUMMARY .,.... . . . . . . . . . . . . . . . . . . . . .

ScopeoftheReport . . . . . . . . . . . . . . . . . . . . .

Findings and Conclusions. . . . . . . . . . . . . . . . .

Organization oftheReport. . . . . . . . . . . . . . . .

OVERVIEW OF EXISTING HEALTH DATA

ACTIVITIES . . . . . . . . . . . . . . . . . . . . . . . .

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . .

Data Collection Activitiesof the Departmentof

and Welfare . . . . . . , . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

COLLECTION

. . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . .

Health, Education,

. . . . . . . . . . . . . . . . . . . .

Public Health Service: Office of Assistant Secretary for Health . . . . . . .

Public Health Service Agencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Health Care Financing Administration . . . . . . . . . . . . . . . . . . . . . . . . .

Social Security Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Data Collection Activities of Other Federal Agencies and Departments . .

CURRENT COORDINATION ACTIVITIES . . . . . . . . . . . . . . . . . . . . .

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Department ofCommerce and the Office ofManagement and Budget

The Department ofHealth, Education, andWelfare. . . . . . . . . . . . . . . . .

Health Care Financing Administration . . . . . . . . . . . . . . . . . . . . . . . . .

Public Health Service: Office of Health Research, Statistics,

and Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Public Health Service: Office of Planning and Evaluation . . . . . . . . . . .

Public Health Service Agencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Advisory Committees. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

STRUCTURING COORDINATION ACTIVITIES . . . . . . . . . . . . . . . .

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Conceptual Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Efficiency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Inadequate Technical Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Overlapping Data Collections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Lack of Comparability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Data Availability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Central Coordinating Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Location. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

4

4

6

11

11

15

16

18

22

24

24

29

29

30

34

34

35

37

38

39

45

45

45

47

48

48

51

52

54

55

57

61
LIST OF

Table

Number

1.

2.

3.

LIST OF

Figure

Number

1.

2.

3.

TABLES

Page

Public Health Service Expenditures for Health Statistics Projects,

as Reported by the HEW Health Statistics Plans . . . . . . . . . . . . . . . . . . . . 14

Public Health Service Expenditures for Health Statistics Projects,

as Reported by the Office of Management and Budget . . . . . . . . . . . . . . . 15

Coordination Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

FIGURES

Page

Department of Health, Education, and Welfare Organizational

Components Involved in Health Data Activities. . . . . . . . . . . . . . . . . . . . 12

Federal Executive Branch Components Involved in Health Data Activities 13

Reports Clearance Process for a Cancer Epidemiology Study Conducted

Under Contract and Requiring Household or Telephone Interviews . . . . . 33

Page

PART II–DIRECTORY OF STATUTORY AUTHORITIES

FOR THE COLLECTION OF HEALTH DATA, PUBLIC

HEALTH SERVICE AND HEALTH CARE FINANCING

ADMINISTRATION THROUGH JANUARY 15, 1979. . . . . . 65

I.

II.

III.

IV.

v .

VI.

VII.

VIII.

LIST OF

Table

Number

1.

2.

3.

4,

Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Office of the Assistant Secretary For Health . . . . . . . . . . . . . . . . . . . . . . . 81

Alcohol, Drug Abuse, and Mental Health Administration . . . . . . . . . . . . 109

Center for Disease Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

Food and Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

Health Resources Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

Health Services Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159

National Institutes of Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Health Care Financing Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . 193

TABLES

Page

List of Specific Authorities and Administering Agencies. . . . . . . . . . . . . . 69

List of General Authorities and Administering Agencies. . . . . . . . . . . . . . 70

List of Implied Authorities and Administering Agencies . . . . . . . . . . . . . . 71

Authorities for the Collection of Environmental Health Data . . . . . . . . . . 75
GLOSSARY OF ACRONYMS

ADAMHA:

AMIS:

ARF:

ASMB:

ASPE:

BCDSP:

BCHS:

BCRR:

BD:

BF:

BHE:

BHF:

BHM:

BHP:

BLS:

BMD:

BMS:

BoB:

BRH:

BVM:

CDC:

Alcohol, Drug Abuse, and Mental

Health Administration

Automated Management

Information System

Area Resource File

Assistant Secretary for Management

and Budget

Assistant Secretary for Planning and

Evaluation

Boston Collaborative Drug

Surveillance Program

Bureau of Community Health

Services

BCHS Common Reporting

Requirements

Bureau of Drugs

Bureau of Food

Bureau of Health Education

Bureau of Health Facilities

Financing, Compliance, and

Conversion

Bureau of Health Manpower

Bureau of Health Planning

Bureau of Labor Statistics

Bureau of Medical Devices

Bureau of Medical Services

Bureau of Biologics

Bureau of Radiological Health

Bureau of Veterinary Medicine

Center for Disease Control

CHAMPUS: Civilian Health and Medical

CHC:

CHSS:

CMIS:

CODAP:

CPSC:

DAWN:

DEA:

DEN:

DOD:

DOL:

DOT:

EMS:

EPA:

ESRD:

ESRD MIS:

Program of the Uniformed Services

Community Health Centers

Cooperative Health Statistics System

CHAMPUS Management

Information System

Client Oriented Data Acquisition

Process

Consumer Product Safety

Commission

Drug Abuse Warning Network

Drug Enforcement Administration

Devices Experience Network

Department of Defense

Department of Labor

Department of Transportation

Emergency Medical Services

Environmental Protection Agency

End-Stage Renal Disease

End-Stage Renal Disease Medical

Information System

FARS:

FDA:

FIC:

FP:

FY:

GAO:

HANES:

HCFA:

HDAC:

HDPC:

HDS:

HES:

HEW:

HIS:

HMO:

HRA:

HSA:

HSA:

HSCC:

HSQB:

HURA:

IHS:

MEDPAR:

MESA:

MCH:

MH:

MMDS:

MMIS:

NAMCS:

NARS:

NCHCT:

NCHS:

NCHSR:

NCI:

NCVHS:

NDATUS:

NEI:

Fatal Accident Reporting System

Food and Drug Administration

Fogarty International Center

Family Planning

Fiscal Year

General Accounting Office

Health and Nutrition Examination

Survey

Health Care Financing

Administration

Health Data Advisory Committee

Health Data Policy Committee

Hospital Discharge Survey

Health Examination Survey

Department of Health, Education,

and Welfare

Health Interview Survey

Health Maintenance Organization

Health Resources Administration

Health Services Administration

Health Systems Agency

Health Statistics Coordinating

Committee

Health Standards and Quality

Bureau

Health Underserved Rural Areas

Indian Health Service

Medicare Provider Analysis and

Review

Mining Enforcement and Safety

Administration

Maternal and Child Health

Migrant Health

Medicaid Minimum Data Set

Medicaid Management Information

System

National Ambulatory Medical Care

Survey

National Accident Reporting System

National Center for Health Care

Technology

National Center for Health Statistics

National Center for Health Services

Research

National Cancer Institute

National Committee on Vital and

Health Statistics

National Drug Abuse Treatment

Utilization Survey

National Eye Institute

xi
NEISS:

NEXT:

NHLBI:

NHSC:

NHTSA:

NIA:

NIAAA:

NIAID:

NIAMDD:

NICHD:

NIDA:

NIDR:

NIEHS:

NIGMS:

NIH:

NIMH:

NINCDS:

NIOSH:

NLM:

NPHPRS:

NRSFPS:

OAPP:

OASH:

ODPHP:

OFSPS:

National Electric Injury Surveillance

System

Nationwide Evaluation of X-ray

Trends

National Heart, Lung, and Blood

Institute

National Health Service Corps

National Highway Traffic Safety

Administration

National Institute on Aging

National Institute on Alcohol Abuse

and Alcoholism

National Institute of Allergy and

Infectious Diseases

National Institute of Arthritis,

Metabolism, and Digestive Diseases

National Institute of Child Health

and Human Development

National Institute on Drug Abuse

National Institute of Dental

Research

National Institute of Environmental

Health Sciences

National Institute of General

Medical Sciences

National Institutes of Health

National Institute of Mental Health

National Institute of Neurological

and Communicative Disorders and

Stroke

National Institute of Occupational

Safety and Health

National Library of Medicine

National Public Health Program

Reporting System

National Reporting System for

Family Planning Services

Office of Adolescent Pregnancy

Programs

Office of the Assistant Secretary for

Health

Office of Disease Prevention and

Health Promotion

Office of Federal Statistical Policy

and Standards

OHMO:

OHPRS:

OHRST:

OMB:

OPDP:

OPE:

.OPPR:

OSH:

OSHA:

OSP:

OSPC:

OTA:

PAID:

PDCC:

PHS:

PHSH:

PMIS:

PSRO:

PTF:

RWP:

SEER:

SIDS:

SPD:

SRS:

SSA:

TRIMIS:

UHDDS:

Use:

USDA:

VA:

Office of Health Maintenance

Organizations

Office of Health Policy, Research,

and Statistics

Office of Health Research, Statistics,

and Technology

Office of Management and Budget

Office of Policy Development and

Planning

Office of Planning and Evaluation

Office of Policy, Planning, and

Research

Office of Smoking and Health

Occupational Safety and Health

Administration

Office of Statistical Policy

Office of State Program

Coordination

Office of Technology Assessment

Personnel Accounting Integrated

Data System

Program Data Coordinating

Committee

Public Health Service

Public Health Service Hospitals

PSRO Management Information

System

Professional Standards Review

Organization

Patient Treatment File

Reimbursable Work Program

Surveillance, Epidemiology, and End

Results Data System

Sudden Infant Death Syndrome

Statistical Policy Division

Social and Rehabilitation Service

Social Security Administration

Tri-Service Medical Information

System

Uniform Hospital Discharge Data

Set

United States Code

United States Department of

Agriculture

Veterans Administration

xii
,

Part I

Coordination Issues
1 ●

SUMMARY

The Federal role in health care has grown rapidly since the passage of Medicare and

Medicaid legislation in 1965. During the past 15 years, Congress has enacted scores of

programs relating to health, including those that provide medical services, train health

professionals, assure access and quality of medical care, control medical care costs, and

regulate the adverse effects of the environment on health. Furthermore, Congress has

also broadened traditional public health programs, which were designed primarily to

control communicable and preventable diseases and to support biomedical research.

The health data collection systems of the Federal Government have grown dramatically in large part because of the expanding Federal role in health care. The increase in

both the numbers and types of Federal health programs has produced a concomitant

growth in the demands for information. Decisionmakers demand not only more health

data, but also increasingly sophisticated health data. Each new program creates unique

reporting needs for effective and efficient management, planning, evaluation, and congressional and public accountability. Hence, virtually every new Federal program has

spawned a data system that separately acquires data to fulfill its own program needs.

The purpose for which health data are needed largely dictates the design of a health

data collection system. The Federal Government acquires health data for program management and evaluation, regulation, research, and policymaking. Attributes of a statistical system that may vary as a function of purpose include: the timeliness and availability of data, the periodicity of collection, the number and types of respondents, the geopolitical detail, and the requirements for data quality (validity and reliability). For example, necessary quality requirements of data used for management decisions are usually

less rigorous than those used in research. The Department of Health, Education, and

Welfare (HEW) makes a distinction between general purpose and program-specific statistical systems based on function (26). General purpose systems are defined to include

baseline data that are available to multiple users; they are produced by data systems that

only collect statistical information. Program-specific statistical systems, in contrast, produce data as a result of activities primarily directed toward facilitating overall project

management. This distinction does not appear to be particularly useful, however; excluding the statistical projects of the National Center for HeaIth Statistics (NCHS), all

data collection systems in HEW have evolved from specific program needs.

The rapid proliferation of such program-specific health data projects has exacerbated the decentralization of the Federal health statistical system. A decentralized system

may increase the responsiveness of data projects to the needs of individual agencies, but

it inevitably creates difficulties in planning and coordination. Too much data are collected in some areas, duplicating expensive resources, and too little data are collected in

other areas. As new needs for information arise, the system leaves few alternatives to initiating more data collection activities. Other problems that currently characterize health

data collection systems include fragmentation, respondent burden, inefficient use, and an

inability to collect data that cut across agency jurisdictions.
Incentives for coordinating diverse data collection activities are minimal because the

growth in data-gathering activities has occurred to meet the program needs of administrative agencies and regulatory efforts. The limited ability of existing statistical

policy offices to orchestrate and plan data activities of administrative agencies is another

obstacle to coordination. The information collected for, and used by, individual agencies

also may be difficult to organize because Congress does not consider and coordinate data

requirements as it passes legislation. In fact, many Federal agencies cite legislative requirements as the reason for the proliferation of health data systems. Part II of this report

presents a directory of statutes that authorize the collection of health data by the Public

Health Service (PHS) and the Health Care Financing Administration (HCFA) in HEW. It

is designed to determine the extent to which legislation creates or furthers fragmentation

and duplication in Federal health data systems.

SCOPE OF THE REPORT

This report discusses the, need and opportunities for coordinating health statistical

activities of the Federal Government. It focuses, in particular, on the variety of HEW

data collection activities and coordination attempts.

The purpose of this report dictates the use of a broad definition of “health data. ” The

terms “data, “ “information, ” and “statistics” are used interchangeably. Health data are

defined as information describing the health status of people, their use of medical care

services and resources, and the costs and sources of funding for these services. Data

relating to health effects of the workplace and the environment, diseases, health problems, and health conditions are included in this definition. Finally, data on public knowledge and attitudes about health, perceived health needs, and behavior related to health,

health care, and health practices are also included.

The report does not address the quality and the value of individual data collection

systems. The discussion is also limited to Federal endeavors; health data systems operated by the private sector and those administered by other levels of government are not

examined. Consideration of how the Federal statistical system should relate to other data

collection activities is outside the scope of this report.

A number of other important issues that relate to health data policy are not specifically addressed in this study. For example, there are problems of consistency in policies

regarding confidentiality of health data. Provision of data on a small area basis is

another area of national concern that is not discussed. This report considers various possibilities for structuring efforts in HEW to achieve comprehensive and consistent policies

relative to health data collection systems.

FINDINGS AND CONCLUSIONS

The growth in Federal data activities is demonstrated by the increase in the number

of health data projects operated by PHS, the major collector of health statistics. In FY

1977’, PHS administered 153 data projects, more than a one-quarter increase over the

number operated the previous year. HCFA, the other principal component within HEW

concerned with health issues, operated at least an additional 13 large statistical projects

that year. Seven agencies and departments outside of HEW also conduct major health

statistical activities in pursuit of their missions.
Ch. l—Suttlttlary ● 5

Accurate figures on the costs of administering this great variety of health data systems are difficult to obtain. The Office of Management and Budget (OMB) estimates that

total expenditures for Federal health statistical activities in FY 1977 were $100 million.

PHS agencies, which all operate health data programs, spent more than $80 million of

this amount. OMB’S estimates are conservative, however, because available information

severely underreports the costs and numbers of data collection projects.

The Federal Government lacks a coherent policy to organize and manage the increasing numbers of assorted data collection projects. Activities relating to the acquisition, analysis, and use of statistical data that describe the health of people and the utilization of medical care services and resources are unstructured and decentralized. There is

no systematic and comprehensive appraisal of the adequacy or use of health data presently collected.

The U.S. statistical system, although sophisticated and generally responsive to the

needs of those who operate Federal health programs, is characterized by a number of

serious problems. The range of deficiencies in the health statistical systems highlighted in

this report are outlined below. As indicated above, the majority of these problems stem

from the fact that the growth in Federal health data efforts has occurred primarily outside

agencies with major statistical responsibilities.

s The categorical design of Federal endeavors results in duplicative and fragmented

data collection efforts.

● There is no central body, accountable to Congress and the public, that serves as a

reference for providing information regarding what and how health data can be

located.

● Data projects designed for the administration, evaluation, or regulation of specific

health programs are not responsive to the needs of the spectrum of potential users.

● The potential utility of available data is not being realized because of limited access to data.

Q Decisions regarding data collection, use, timeliness, and publication are made on

an ad hoc basis by the acquiring agency.

● The lack of common nomenclature, definitions, classifications, codes, and units

of measurement creates serious obstacles to fully linking data systems, and results

in an increasing incidence of data overlap, gaps, and underutility.

● The inability to integrate and link diverse data files for analyses that require more

than one data source makes it difficult to assess program achievements, to compare programs, to determine the relevance or meaning of data, and to form statistical profiles about a particular issue or problem.

. Staff of administrative agencies often do not have the necessary statistical and

analytical skills to utilize the latest statistical technologies. The effective and efficient supervision of data projects may also be hindered by the Federal Government personnel system, which restricts interagency movement of statisticians.

● The Federal health statistical system lacks an overarching set of principles and objectives that can be employed to rationally plan data activities, to allocate resources for data collection, and to comprehensively and systematically evaluate

current data projects.

4(! -11 14 () - i I - 2
● The absence of an administrative unit that supervises statistical activities and

gathers and provides accurate information regarding the type of data collected

and the method and cost of data collection is one of the system’s major deficiencies.

A number of offices currently have authority to establish policy concerning health

data systems. OMB and the Department of Commerce have responsibilities relating to

statistical oversight for the entire Federal Government. The coordination activities of

these offices are authorized under the Federal Reports Act of 1942 and the Budget and Accounting Procedures Act of 1950. At least five offices and three committees within HEW

also have been delegated some coordination duties. However, a number of these offices

are charged with similar health data policy, oversight, and coordination responsibilities,

and consequently, their activities tend to be duplicative.

There is a need to assign formal responsibility for the functions related to the coordination and planning of Federal health statistics to a central coordinating body within

HEW. Such a unit should have sufficient authority to impose decisions on agencies and

offices in the department, the necessary statistical and analytical capabilities to conduct

activities requiring technical expertise, and adequate resources to build a viable core effort. The coordinating unit should perform three essential functions: developing an analytical framework for planning the statistical system, improving the efficiency of data

collection activities, and ensuring data accessibility for potential users.

A number of offices within HEW could assume responsibility for comprehensively

supervising Federal health statistics. Different offices could be accountable for activities

requiring authority over substantive program agencies and for activities requiring technical capabilities. Additional staff and funding would be required regardless of which office or offices are selected. The fundamental requirement in assigning responsibility is an

unambiguous mandate to manage health statistics.

ORGANIZATION OF THE REPORT

The report is organized into two major parts. Part I consists of three remaining

chapters, Part 11 is a directory of statutory authorities that may be used to justify health

data collection by agencies within PHS and HCFA.

Chapter 2 of Part I presents and briefly describes a number of existing data collection systems administered by HEW and other major Federal departments and agencies,

such as the Department of Defense (DOD) and the Veterans Administration (VA).

Within HEW, the health data activities of PHS and HCFA are reviewed. The overview of

data collection systems is designed to be illustrative, not exhaustive.

Chapter 3 discusses activities presently conducted by Federal agencies that have responsibilities for health data policy, oversight, and coordination. The responsible Federal agencies are described hierarchically, beginning with OMB and the Department of

Commerce—the two executive branch components charged with Government-wide statistical oversight responsibilities. The remaining sections of the chapter describe offices

and committees within HEW.

Chapter 4 of Part I describes a structure designed to improve the coordination of

Federal health statistics. Requisite functions and activities are delineated. The need to

formally assign responsibilities is discussed and alternative locations within HEW for

such delegated authority are identified.
Ch. l—Summary ● 7

Part II of this report focuses on legislation that may be used to generate health data

collection projects. The directory is designed to determine the extent to which legislation

creates or amplifies fragmentation and duplication in HEW health data collection. Data

collection authorities are listed according to PHS and HCFA agencies that have been

delegated responsibilities for their implementation. This directory contains all the relevant statutory authorities enacted before January 15, 197’9.
.

Chapter 2.

OVERVIEW OF EXISTING HEALTH

DATA COLLECTION ACTIVITIES
2 ●

OVERVIEW OF EXISTING HEALTH DATA

COLLECTION ACTIVITIES

INTRODUCTION

The Department of Health, Education, and Welfare (HEW) is the major collector of

health statistics. Authority to administer data projects has, for the most part, been

delegated to the Public Health Service (PHS) and the Health Care Financing Administration (HCFA), the two principal operating components of HEW concerned with health. In

FY 1977, PHS operated 153 data projects, a 25- to 35-percent increase over the number of

projects operated in the previous fiscal year (41, 42). HCFA administered at least an additional 13 large statistical projects. Other Federal agencies and departments, such as the

Veterans Administration (VA), the Department of Defense (DOD), and the Consumer

Product Safety Commission (CPSC), also operate a number of health statistical systems,

independently of HEW, to meet their needs for information.

This chapter begins with a discussion of health data systems and health data collection. It provides background information on Federal expenditures for health statistics

and describes a number of health data collection activities. The inventory of Federal data

systems presented here is meant to be illustrative and descriptive, not inclusive and analytical. The focus of chapter 2 is on the statistical projects and systems administered by

HEW; they are described first. Within HEW, the health data collection activities of PHS

and HCFA are highlighted. Figure 1 illustrates the organizational position of HEW agencies discussed in this chapter. A discussion of data activities managed by other Federal

agencies, including those mentioned above, follows. These agencies are illustrated in

figure 2.

A health data system is defined as an organized, systematic acquisition and classification of health information. This definition encompasses a broad spectrum of data systems that are difficult to tally and compare because of the diversity in their purpose,

scope, and cost. Data for these systems may be collected on a continuing or a periodic

reporting basis; or, they may be gathered in a survey, conducted at a point in time or

over a specified time interval. Data can be collected on a sample, or on a universe of

respondents. They may be acquired either from a primary source, such as a questionnaire, an interview, or a physical examination, or from a secondary source, such as a

billing claim or a health professional license. When data are obtained for, or as a result

of, an activity not specifically related to data collection (i. e., a secondary source), these

data are frequently referred to as byproduct statistics.

A major expansion has occurred in the area of byproduct statistics because more

data are being obtained either for the administration of Federal programs or for regulatory purposes. The statistical output of the Medicare Bureau, for example, is derived

from four basic computer files that are centrally maintained for paying the medical bills

of eligible beneficiaries. Determining the number of health data systems in the Medicare

11
Fgiiii

Organ

i g .—Department of Health, Education, and Welfare

zational Components Involved in Health Data Activities*##

I

HDAC --------------- xxxxxxxxxxxxxxx~xx NCVHS

+

OPE

OSP

HSCC -–––––

I 1

OHRST

I

OHMO

I

I,

I I I

I

NCHSR H NCHS

I

NCHCT

,

I I 1

Med(care Medlcald HSOB

h

I

t

PSRO

ESRD

1 (PHS Agencies)

I I

1 .

ADAM HA CDC FDA HRA HSA NIH

I

- NIAA A

- B H E - BD —BHP — BMS -NC I

- NIDA —NIOSH - BMD - BHF - IH S -NHLBI

-NIM H - Other - BRH — BHM - BCHS - NICH D

Bureaus

NINCDS

~Othe r

Institutes

---_—— - — ———-

“ This diagram depicts only those parts of HEW that have major responsibilities for health data policy,

COI Iection, or coord inat ion.

# Full names of components are given in the Glossary of Acronyms, p. xi.

Code” ------ Internal Advisory Committee

XXXX External Advisory Committee
I

I

Figure 2.—Federal Executive Branch Components Involved

Executive Off Ice of the President

I

Off Ice of Management and Budget

I

— Regulatory PO IICY and

Reports Management Division

t

Bureau of (See Figure 1)

the Census

OFSPS99

in Health Data Activities*

P *

Department of Department of Department of

Defense Transportation Labor

— BL S

— MES A

‘OSH A

-- — —— - ———

● This diagram depicts only those parts of the executive branch that have major responsibilities for health data policy, collection, or coordination

# Full names of components are given in the Glossary of Acronyms, p. XI.
program is problematic. The program’s four basic files or its computer programs, which

are written to retrieve, integrate, and display data, could be counted individually as

discrete data systems.

As the numbers and types of health data systems increase, so do their costs. HEW is

the primary source of information about health data systems because it administers the

majority of Federal health programs. Under the auspices of a departmentwide committee, descriptive, cost, and other information on individual data projects are collected

through questionnaires distributed to agencies and are published in the HEW annual inventory of statistics (40, 41, 42). In an attempt to be inclusive, data projects, rather than

data systems, are used as the criteria for inclusion in the inventories. Single-time surveys

and evaluation and research studies that contain a large data collection component are

listed in HEW’s statistics plans. Biomedical research and studies funded by Federal grants

are explicitly excluded from these inventories.

The Office of Management and Budget (OMB) also supplies information on the

costs of Federal health statistical projects. OMB derives its figures from the budget

review process, which requires every agency to submit statistical budget requests for data

collection projects. Table 1 illustrates FY 1976 and FY 1977 PHS expenditures for

statistical projects as reported in the HEW statistics plans mentioned above. OMB’S data

on PHS expenditures for the same fiscal years are contrasted in table 2. OMB’S estimate is

approximately 20 percent greater than HEW’s; estimates for individual PHS agencies

vary even more.

Different administrative mechanisms used by OMB and HEW to collect agency cost

figures partially explain the variation in their estimates. Budgeting personnel prepare

statistical budget requests for OMB, and agencies that incur obligations of less than

$300,000 for statistical programs are exempted from filing budget requests. Program

planning staff complete the questionnaires for HEW’s statistical plans. HEW reports

direct costs associated with individual data projects. OMB’S cost estimates include the

substantial administrative expenses of maintaining data systems. OMB’S estimate for the

National Center for Health Statistics (NCHS), for example, includes that agency’s entire

budget; HEW reports costs only for NCHS surveys.

The accuracy of OMB and HEW estimates is questionable because of the difficulty of

obtaining complete cost figures for Federal data activities. Available information severely underestimates Federal expenditures on health statistical projects. Information pertaining to expenditures for a number of statistical activities are often omitted by agencies in

their reports to both OMB and HEW; and expenditures for statistical projects supported

by Federal grants and contracts are vastly underreported. Administrative costs for

statistical activities conducted by HEW-supported categorical programs, such as medical

treatment centers in underserved population groups and health planning agencies, are

usually not reported. For example, HCFA reported to OMB total obligations of $4.8

million in FY 1977 for health statistics (25). However, data processing expenditures by

local Professional Standards Review Organizations (PSROS), although covered under

Federal contract, are not included in HCFA’S statistical budget request to OMB. Rather,

HCFA reports expenditures only for processing and analyzing data sets forwarded to the

central PSRO office. In FY 1977, local PSROS spent $2.2 million for data processing;

HCFA central office costs were only $380,000 (7). If all these costs were included in
Ch. 2—O~~erzliew of Existing Health Data Collection Actizlities ● 15

Table 1 .—Public Health Service Expenditures for Health Statistics Projects,

as Reported by the HEW Health Statistics Plans* (in millions of dollars)

Agency I% 1976a w 1977b

Alcohol, Drug Abuse, and Mental Health Administration. . . . . 5.7

Center for Disease Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.7

Food and Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3

Health Resources Administration. . . . . . . . . . . . . . . . . . . . . . . . 21.5

Health Services Administration. . . . . . . . . . . . . . . . . . . . . . . . . . 3.7

National Institutes of Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19.9

Office of the Assistant Secretary for Health . . . . . . . . . . . . . . . 2.6

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57.4

6.5

2.8

1.9

1.5

3.2

33.2

20.0

69.1

‘ PHS warns that their cost estimates may not be comparable from year to year and that they represent “order of magnitude” figures

a SOURCE Public Health Service, U S Department of Health, Education, and Welfare health Statistics Plan, fiscaLFmca/ Years 1978.1982

Washington, D.C : U S. Government Printing Off Ice, 1977

b SOURCE publlc Health Service, u S, Department of Health, Education+ and Welfare Health STATISTICSfatlSfKs ~ePorf, Fiscal Year 1978 washlngton,G9GTONon,

D. C.: U.S. Government Prlntlng Office, 1978,

Table 2.—Public Health Service Expenditures for Health Statistics Projects,

as Reported by the Office of Management and Budget (in millions of dollars)

Agency FY 1976a FY 1977b

Alcohol, Drug Abuse, and Mental Health Administration . . . . . 6.8 8.5

Center for Disease Control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2.5 3.0

Food and Drug Administration . . . . . . . . . . . . . . . . . . . . . . . . . . 1.6 1.9

Health Resources Administration. . . . . . . . . . . . . . . . . . . . . . . . 32.0 4.5

Health Services Administration. . . . . . . . . . . . . . . . . . . . . . . . . . 2.4 4.1

National Institutes of Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23.4 29.3

Office of the Assistant Secretary for Health . . . . . . . . . . . . . . . — 32.4

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68.7 83.7

a SOURCE: Office of Management and Budget Speclal Analyses, Budget of the United States Government,Fiscal Year 1978 Washington, D C

U.S. Government Printing Office, 1977

b SOURCE. Of flee of Federal Statlstlcal Policy and Standards, U.S Department of Commerce “Federal Statistics 1977.” Stat/sf/ca/ Reporter

78-5 121-140, February 1978

estimates of Federal expenditures for statistical projects, OMB's total estimate of $100

million for health statistics could triple. *

Neither OMB nor HEW provides adequate followup on its requests to agencies for

information on statistical projects, and no uniform methods for calculating the costs of

data collection are imposed. Agencies have difficulty in isolating cost figures solely

related to data gathering activities that are a part or a byproduct of a program’s administrative expenses. Without appropriate guidelines, definitions, standards, and

followup, inconsistencies among costs reported by HEW agencies for their statistical programs are inevitable, and inaccurate and noncomparable estimates will continue.

DATA COLLECTION ACTIVITIES OF THE DEPARTMENT OF HEALTH,

EDUCATION, AND WELFARE

The Department of Health, Education, and Welfare (HEW) administers the majority

of Federal health programs and health data systems. The following material outlines data

collection projects and systems in the Department’s two principal health-related operating components, PHS and HCFA, and in the Social Security Administration (SSA).

*OMB includes under health statistical programs, in addition to the Public Health Service and the

Health Care Financing Administration, certain programs of the HEW Assistant Secretary for Planning and

Evaluation, the Consumer Product Safety Commission, the Drug Enforcement Administration, and the

Veterans Administration (12, 25).
Within PHS, data activities conducted by the Office of Health Research, Statistics, and

Technology (OHRST), the Office of Health Maintenance Organizations (OHMO), and

the six agencies are emphasized. Data collection activities supervised by HCFA’S

Medicare and Medicaid Programs, Health Standards and Quality Bureau (HSQB), and

Office of Policy, Planning, and Research (OPPR) are then discussed. Finally, SSA’S

health-related statistical activities are outlined.

Public Health Service: Office of Assistant Secretary for Health

The Office of Health Research, Statistics, and Technology (OHRST) was created as

part of an executive reorganization in January 1979. It has responsibility for NCHS, the

National Center for Health Services Research (NCHSR), and the National Center for

Health Care Technology (NCHCT). Formerly the Office of Health Policy, Research, and

Statistics (OHPRS), OHRST was established to strengthen the relationship between

health technology assessment, health statistics, and health services research.

The National Center for Health Statistics (NCHS) is the only Federal agency established specifically to collect and disseminate data on the health of the American people.

Congress first authorized a continuing survey and special studies of sickness and disability in the National Health Survey Act of 1956, Public Law 84-652. In 1960, the National

Health Survey merged with the National Office of Vital Statistics, which was established

in 1946, to form NCHS. Since that time, NCHS has played a major role in the development of national health statistics policy and programs. Organizationally, the Center has

moved several times within PHS; it is now located in OHRST.

The Health Services Research, Health Statistics, and Medical Libraries Act of 1974,

Public Law 93-353, established NCHS statutorily and expanded its responsibilities. The

law both listed the categories of general-purpose statistics to be collected by NCHS and

mandated that a detailed report analyzing the country’s health care costs and financing,

health resources, health resource utilization, and health status be submitted annually to

the President and Congress.

To fulfill its mission, NCHS conducts a number of data activities that provide vital

statistics and health facility, health manpower, and health status and health care utilization statistics. NCHS also has the primary administrative responsibility for the Cooperative Health Statistics System (CHSS), * a joint Federal, State, and local program for the

collection of health data.

The NCHS Division of Vital Statistics collects natality, mortality, marriage, and

divorce statistics. These statistics are derived either from microfilm copies of State certificates of marriage and divorce and State records of births and deaths, or from the computer tapes supplied through the vital statistics component of the CHSS program. NCHS

then publishes statistical summaries based on this State-supplied information. In addition, NCHS periodically conducts “followback” surveys that are based on samples of

birth or death records. They are designed both to provide national estimates for a range

of items that are not usually included in vital records, such as demographic characteristics, and to evaluate the quality of data contained in the vital records.

The NCHS Master Facility Inventory, initiated in 1962 and updated biennially, furnishes information on all inpatient health facilities that provide medical, nursing, personal, or custodial care, Data are collected on facility ownership, finances, patient

population, provision of services, number of beds, and pattern of staffing. Another facil-

*See chapter 3 for a detailed discussion of the CHSS program.
Ch. 2—Oz)erview of Existit~g Health Data Collertiorl Actiz?ities ● 17

ity inventory, also updated biennially, supplies information regarding family planning

clinics. A third example of a facility data system is the National Nursing Home Survey.

Conducted every 2 years, it gathers data from a sample of nursing homes, their residents,

and their staff.

NCHS manpower statistics consist of periodic inventories of various health professionals, including physicians, registered nurses, pharmacists, and optometrists. The

manpower inventories are conducted only in States that have not implemented the CHSS

program. In 1975 and 1976, for example, NCHS conducted a survey of hospital staff.

This survey covered 110 health occupations and was used both to identify manpower

shortages or oversupply and to assess trends in the recruitment and the employment of

allied health personnel.

NCHS also operates five major general-purpose surveys that provide statistics on

the health status of the U.S. population and on their use of health care services. The

Health Interview Survey (HIS), performed annually since 1957, provides data on the incidence of illness and accidental injuries, the prevalence of diseases and impairments, the

extent of disability, the utilization of hospitals and other health care services, and other

health-related topics. These data are obtained through interviews conducted in a probability sample of households.

The Health and Nutrition Examination Survey (HANES), * which was initiated in

1971, obtains standardized data from direct physical examinations of a sample of the

U.S. population. Data are collected periodically to estimate the prevalence of chronic

diseases, to establish physiological standards for various tests, to determine the nutritional status of the population, and to assess exposure Ievels to certain environmental

substances. Data are also collected, through interviews, on self-perceived health needs

and health practices. The National Survey of Family Growth acquires data on childbearing and family growth patterns. These data are needed to interpret current trends in

the birth rate, to aid in the planning, management, and evaluation of family planning

programs, and to provide guidance for efforts in the areas of infant and maternal health.

Data are collected through personal interviews with women of childbearing age. NCHS

began this survey in 1973.

The Hospital Discharge Survey (HDS), begun in 1965, collects data from the medical records of a sample of patients discharged from a number of the Nation’s short-stay

hospitals. Data abstracted from patients’ medical records include demographic characteristics, diagnoses, surgical procedures, and administrative information about the hospital

stay. Annual profiles on national and regional hospital use, organized according to

diagnoses, procedure, patient characteristics, and other variables, are then published by

NCHS. The National Ambulatory Medical Care Survey (NAMCS), first conducted in

1973, gathers data on a number of patient visits from a probability sample of office-based

physicians. Participating physicians complete a brief encounter form that requests information regarding patient characteristics, reason for visit, diagnoses, treatment and services, and disposition.

The National Center for Health Seruices Research (NCHSR) shares responsibility

with NCHS, the Assistant Secretary for Planning and Evaluation (ASPE), and HCFA for

the National Medical Care Expenditure Survey. This survey represents a cooperative effort between PHS and HCFA to supply data to users who require information on health

*The Health Examination Survey (HES) Was the precursor to HANES. HES collected data on the health

status of adults, between 1960 and 1962: of children, between 1963 and 1965: and of teenagers, between 1967

and 1968.
18 ● part l—coordination Issues

care costs. Begun in 1976, this large, one-time survey is collecting information from

households, physicians, hospitals, and health insurance companies. The survey is acquiring information on expenditures for health care by different population subgroups in

relation to utilization, health status, and health conditions. The survey is expected to be

completed this year.

The Office of Health Maintenance Organizations (OHMO) requires quarterly and

annual reports from qualified health maintenance organizations. Data are collected on

enrollment, financing, staffing patterns, and use of services. The reporting system is used

for program management, planning, and evaluation.

Public Health Service Agencies

The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) has the

major responsibility within the Federal Government for the prevention and treatment of

alcohol abuse and alcoholism, drug abuse, and mental and emotional illness. Its three Institutes, the National Institute on Alcoholism and Alcohol Abuse (NIAAA), the National

Institute on Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH),

award grants and contracts for research, prevention, training projects, and treatment

service delivery in community-based programs.

NIAAA has specific legislative authority to collect information on the cause, treatment, and consequences of alcohol abuse. Its primary data system, the Alcoholism Program Monitoring System, collects data that describe the clients, the services, and the

costs of alcoholism treatment programs funded by NIAAA. Data are used to plan, manage, and evaluate programs.

NIDA, which is required by statute to collect uniform statistics related to drug abuse

and the availability of treatment resources, operates three major health data collection

systems: the Client Oriented Data Acquisition Process (CODAP), the National Drug

Abuse Treatment Utilization Survey (NDATUS), and the Drug Abuse Warning Network

(DAWN). The CODAP system, also used by the VA and the Bureau of Prisons, gathers

client-related data at the time of admission to, and discharge from, federally supported

drug abuse treatment and rehabilitation programs. These programs are required to

report to NIDA. Data on nationwide resources devoted to drug abuse treatment, their

use, and their distribution are gathered through NDATUS. All drug abuse treatment

facilities are surveyed annually; however, participation in the NDATUS survey is voluntary. Finally, data on drug-related deaths, medical emergencies, and psychological crises

are collected from participating emergency rooms and medical coroners in DAWN,

which is jointly sponsored by NIDA and the Drug Enforcement Administration (DEA).

NIMH, through its Division of Biometry and Epidemiology, conducts annual inventories of public and private mental hospitals and community mental health centers.

Hospital psychiatric divisions, halfway houses, outpatient mental health clinics, and

other mental health facilities are inventoried biennially to collect data depicting caseload,

services, and expenditures. Sample surveys are also conducted periodically to gather

detailed data about patient characteristics and the use of services. Participation by institutions in NIMH surveys is voluntary.

Presently, NIMH is developing a statistics improvement program that would

enhance State and local capabilities for statistical collection and analysis. This FederalState-local system would be operated independently from the NCHS Cooperative Health

Statistics System. Consequently, NIMH and NCHS have established a joint coordinating
Ch. 2—Overview of Existing Health Data collection Activities ● 19

committee. At present, NIMH’s inventory data on mental health facilities are integrated

with the NCHS Master Facility Inventory to avoid duplication.

The Center for Disease Control (CDC) is responsible for monitoring and reducing

the incidence of preventable diseases. Its two major data reporting systems, the National

Disease Surveillance Program and the Morbidity and Mortality Weekly Report, are used

to examine disease patterns and trends, to identify regional problems, and to evaluate the

effectiveness of control measures. Through a variety of reporting systems, CDC receives

summary data from State, county, and city health authorities on 45 specific conditions.

These reporting systems are authorized primarily by State laws enacted to control communicable diseases.

CDC maintains special data programs to monitor congenital malformations, abortion-related complications, birth defects, diabetes, tuberculosis, and venereal diseases.

The manufacture rates of biologics is also monitored by CDC. Data regarding children’s

immunity levels against vaccine-preventable diseases are obtained from the U.S. Immunization Survey, which is conducted by the Bureau of the Census under contract to

CDC. CDC analyzes the Bureau of the Census data and prepares the reports.

For program evaluation purposes, CDC receives summary data from Federal grant

recipients who administer State and local health programs for disease prevention and

control. These programs are designed, for example, to prevent venereal disease and lead

poisoning, to control rats, and to immunize individuals against preventable diseases.

CDC’S Bureau of Health Education (BHE) and the Office of the Assistant Secretary for

Health (OASH) are responsible for informing the public about health practices and disease prevention. BHE therefore conducts surveys to determine public attitudes and

knowledge on topics such as smoking and immunizations.

Finally, CDC provides support for the regulatory functions of several other Federal

agencies. For example, CDC evaluates the qualifications and quality control practices of

clinical laboratories for the Medicare program. The National Institute of Occupational

Safety and Health (NIOSH), within CDC, assists the Department of Labor’s Occupational Safety and Health Administration (OSHA) in identifying occupational health hazards and in establishing workplace health standards. The National Occupational Hazard

Survey, conducted by NIOSH between 1972 and 1974, provides estimates of the proportion of employees exposed to potential health hazards in various industries. In addition,

NIOSH periodically conducts special industrywide studies to identify the health effects of

particular industrial processes and to determine the health experience of selected

employee populations. NIOSH also operates the National Surveillance Network which

receives data from State safety and health inspection programs that describe empIoyee

exposure to health hazards. Finally, an X-ray examination program for coal miners to

determine the prevalence of black lung disease (pneumoconiosis) and to provide epidemiological data for research is operated by NIOSH.

The Food and Drug Administration (FDA) is responsible for evaluating the safety of

food, drug, cosmetic, and medical device products before their introduction into the marketplace. It evaluates the efficacy as well as the safety of new drug and medical device

products. FDA also monitors manufacturer compliance with its regulations.

FDA conducts a number of special surveys and studies on topics ranging from consumer attitudes on, and knowledge of, nutrition to the use of selected drug products in

clinical practice and the health effects of exposure to specific types of radiation.

FDA supports four major ongoing health data collection projects. The FDA Bureau

of Drugs (BD), in collaboration with the National Institute of General Medical Sciences
in the National Institutes of Health (NIH), funds the Boston Collaborative Drug Surveillance Program (BCDSP). BCDSP monitors selected inpatient populations to determine

rates of adverse reactions to certain drugs and provides data on overall drug use in the

sampled population. BD also maintains a central system for reporting the incidence of

adverse drug reactions. However, statistical analyses of data are not possible because

reporting is voluntary and there is no sampling plan.

The Bureau of Radiological Health (BRH), operates the Nationwide Evaluation of

X-ray Trends (NEXT) system, the second major health data collection project operated

by FDA. NEXT is designed to detect and evaluate the extent of the population’s exposure

to X-rays used in medical and dental examinations. Data are collected from a sample of

hospitals, private offices, and clinics in States that participate in the survey.

The Medically Oriented Data System, the third data project, is operated by the

Bureau of Medical Devices (BMD). It is designed to analyze data collected from a small

sample of hospitals on drug abuse, medical device injuries, and other hospital-based

health hazards. BMD also operates the Medical Devices and Laboratory Product Problem Reporting Program; this system uses information collected by other agencies that

participate in the Devices Experience Network (DEN), a central network for all reports

concerning problems with medical devices.

The Health Resources Administration (HRA) is concerned with the identification,

development, and effective use of national health resources. A new administrative unit,

the Bureau of Health Facilities, Financing, Compliance and Conversion (BHF), was established in HRA by an executive reorganization in 1978. BHF operates a data system

that contains information on all health care facilities seeking grant or loan support under

the Hill-Burton program. The Hill-Burton reporting system has been modified a number

of times reflecting some conflict over the specific purposes it should serve.

The Bureau of Health Planning (BHP) oversees a nationwide network of local and

State health planning agencies. These planning agencies are expected to compile and

analyze data on the health status of residents in their area and on the effect of the area’s

health care resources. Federal guidelines establish minimum requirements specifying

categories of data to be collected, but these data are not required to be forwarded to

BHP. However, local and State agencies must submit annual health plans to BHP.

To the extent possible, local agencies are expected to rely on data assembled from

other sources. Although substantial progress has been made, health planning agencies

have had difficulty in obtaining data of appropriate geopolitical detail. They do not have

the funding resources necessary to undertake major data collection activities that would

fulfill their needs for small area data. Therefore, plans are underway to obtain selected

program data for the areawide agencies from the Medicare program and from NIMH. In

the future, CHSS is expected to provide much of the data needed by the planning agencies.

The Bureau of Health Manpower (BHM) is mandated by its enabling legislation to

meet extensive data requirements relating to health manpower supply, demand, specialty, productivity, and geographic distribution. Data that may be used to delimit the critical level of health manpower needed to adequately serve areas are also required from

BHM. Special studies and surveys of various categories of health manpower are conducted by BHM to fulfill some of its requirements. Examples of such surveys include a

national sample of registered nurses and studies on the delivery of dental care by various

types of dental personnel. BHM and NCHS have a formal agreement under which inventory data on various categories of health manpower are supplied by CHSS; this agree-
Ch. 2—Overview of Existing Health Data Collection Activities ● 21

ment is restricted, obviously, to the States in which the CHSS system now operates.

BHM also maintains the Area Resource File (ARF) system. ARF is a county-specific data

system that contains a wide range of health and socioeconomic information that are compiled from secondary sources. The ARF system is used to assist both Federal and nongovernmental planning efforts.

The Health Services Administration (HSA) is responsible for Federal programs that,

either directly or under grants or contracts, provide health care services to targeted population groups. Statutory language mandating collection of specific data apply, for the

most part, to grantees or contractors operating health services delivery projects sponsored by HSA.

The Bureau of Medical Services (BMS) is responsible for health care services provided in PHS hospitals. It operates several data systems to provide planning and management information both for PHS hospitals and outpatient clinics. BMS also operates a

data system that provides information about services delivered to eligible PHS beneficiaries in non-Federal contract programs. Finally, BMS is responsible for the emergency

medical services program for which a uniform reporting system is not yet operational.

The Indian Health Service (IHS) provides comprehensive health services to American Indians and Alaskan Natives. Nine data collection systems managed by IHS supply

information on services provided both by IHS hospitals, clinics, clinical laboratories,

and by community, social, and mental health workers for planning, management, and

evaluation purposes. IHS also administers sophisticated automated medical record systems in two of its service areas. These systems allow health team members to obtain detailed patient information immediately through computer terminals. Most data processing for the variety of data collection systems is done centrally at the IHS computer facility in Albuquerque, N. Mex.

The Bureau of Community Health Services (BCHS) oversees a number of categorical

programs that provide medical services for underserved populations. In 1977, BCHS instituted a management data system called the Bureau of Common Reporting Requirements (BCRR). This system collects uniform program data from all health services delivery projects, such as migrant or community health centers, that are funded by BCHS.

Aggregate data are collected on patient characteristics, service utilization, staffing, and

costs.

BCHS funds several other ongoing data collection projects, including one that collects data from a sample of clinics providing sickle cell anemia screening programs.

BCHS and NCHS jointly administer another system that collects detailed clinical information from a sample of patients who visit family planning clinics. BCHS contracts

with the Association of State and Territorial Health Officers for the operation of the National Public Health Program Reporting System (NPHPRS). This system is a summary

report of State expenditures for public health activities by program categories. The

qNPHPRS also provides data on State expenditures for activities under the Maternal and

Child Health and Crippled Children’s programs. Finally, BCHS also operates a data base

that uses existing data sources, including NCHS, the United States Census, and the

American Medical Association, to meet its legislative mandate to identify and designate

medically underserved areas.

The National Institutes of Health (NIH) is composed of 11 research institutes dedicated to biomedical research on the cause, prevention, diagnosis, and treatment of disease. These institutes both conduct research in their own facilities and support research

projects in universities, hospitals, and other non-Federal organizations.

46-fi43 () - 79 - 3
22 ● part ~—coordination Issues

Excluding laboratory research, NIH data collection projects are primarily epidemiological studies designed to trace the patterns of disease, to test specific hypotheses regarding the conditions and factors associated with significant disease rates, to identify

risk factors in the population, and to determine the effectiveness of various diagnostic

and treatment modalities. A small number of data collection projects focus on the incidence, prevalence, and related morbidity of specific diseases. NIH requires these data in

an effort to establish research priorities for the study of diseases, to apportion research

resources, and to determine population subgroups that may be at highest risk levels.

The National Cancer Institute (NCI), which is solely responsible for administering

more than one-fifth of all Federal health research funds, conducts the largest data collection activities within NIH. Several of NCI’S more extensive epidemiological studies relate

to screening for breast and cervical cancer. NCI also operates the Surveillance, Epidemiology, and End Results (SEER) data system to provide information for planning its

research, control, and evaluation programs. Data are obtained in the SEER program

from cancer registries that sample about 10 percent of the U.S. population. Data are

available by site of cancer on cancer incidence, trends in therapy, and associated changes

in patient survival.

Other NIH institutes that conduct numerous data activities are the National Heart,

Lung and Blood Institute (NHLBI), the National Institute of Child Health and Human Development (NICHD) and the National Institute of Neurological and Communicative

Disorders and Stroke (NINCDS). NINCDS has conducted major national surveys to obtain data regarding the incidence and prevalence of brain tumors, head and spinal cord

injury, multiple sclerosis, stroke, and epilepsy. NINCDS is now leading the efforts of

several institutes to explore the feasibility of using a revised NCHS Hospital Discharge

Survey to fulfill a substantial portion of their statistical needs.

Health Care Financing Administration

The Health Care Financing Administration (HCFA) was created as a part of an executive reorganization in March 1977 to unite public payment programs for health care

under a single administration (3). * HCFA has three divisions, the Medicare Bureau, the

Medicaid Bureau, and the Health Standards and Quality Bureau, each of which operates

large, ongoing health data collection projects. HCFA’S staff office, the Office of Policy,

Planning, and Research (OPPR), also operates a number of data projects.

The Medicare Bureau has primary responsibility for the Medicare program, which

consists of two separate national health insurance programs for the aged and for certain

other eligible categories of beneficiaries. The hospital insurance program, Part A of

Medicare, reimburses medical facilities for a large portion of the costs of inpatient

hospitalization and related services. The supplementary medical insuranc~ program, Part

B of Medicare, pays for a range of services furnished by physicians or other health care

professionals.

Program statistics for Medicare are collected as a byproduct of the claims review

and payment process. Four basic data files— the enrollment file on eligible beneficiaries,

the joint Medicare-Medicaid file on participating certified facilities, the Part A claims

record, and the Part B payment record—form an extensive data base for the Medicare

*Before IW7, the Medicare, Medicaid, and quality assurance programs were administered in three separate Federal agencies: the Social Security Administration (SSA), the Social and Rehabilitation Service (SRS),

and the Health Services Administration (HSA).
Ch. 2—Oueruiew of Existing Health Data Collection Activities c 23

program. Because beneficiaries and providers are identified in the data files, the Medicare

statistical system is the only nationwide data system that, for example, permits linkage of

hospital discharges with individual persons.

The diagnoses and surgical procedures contained in the Part A claims file are coded

for 20 percent of the beneficiaries. The data from these bills are then matched to the

enrollee and the provider data files so that use of medical services can be analyzed by

both the demographic and geographic characteristics of the aged population and by the

provider characteristics. The Medicare Provider Analysis and Review (MEDPAR), a

separate statistical system, restructures these data for use by PSROS and local health

planning agencies. For subsequent analytical use, MEDPAR generates statistical packages containing data on hospital utilization, inter-area facility comparisons, and utilization trends.

The Medicaid Bureau provides Federal financial support, through the Medicaid program, to State programs that pay for the medical care of low-income people. Each State

defines income eligibility criteria for its own program; Federal financial support ranges

from 50 to 83 percent of the State program’s cost.

In 1972, legislation was passed to encourage States to use an automated data system

in their Medicaid programs, the Medicaid Management Information System (MMIS).

MMIS, a generally designed system that can be adopted in whole, or in part, by States, is

a claims processing and information retrieval system composed of six subsystems: recipient file, provider file, claims processing, reference file, surveillance and utilization

review, and management and administrative reports. Federal guidelines specify the use of

114 standard data elements in the system, but only a small portion of these data are required to be forwarded to the Federal level. These Federal reporting requirements by

States are called the Medicaid Minimum Data Set (MMDS). Because State Medicaid programs vary in their eligibility requirements, services covered, and payment methods,

and, therefore, in program data requirements, reports produced from MMIS are not

necessarily comparable from State to State.

The Health Standards and Quality Bureau (HSQB) certifies health care facilities for

participation in the Medicare and Medicaid programs, and administers HCFA programs

that monitor the quality of care provided to beneficiaries. HSQB administers a variety of

data systems, including the Medicare/Medicaid Automated Certification System, the

End-Stage Renal Disease Medical Information System (ESRD MIS), and the PSRO Management Information System (PMIS), that are designed to assess health care institutions

and the health care services provided to Medicare and Medicaid recipients.

The Medicare/Medicaid Automated Certification System collects data on the number, type, characteristics, and geographic distribution of institutions that participate in

Medicare and Medicaid. Hospitals, home health agencies, independent laboratories,

skilled nursing facilities, and several other categories of providers are included in the data

base.

The ESRD MIS assesses the appropriateness of treatment and quality of care given

ESRD patients. Data are collected on medical support and treatment processes and on patient demographic characteristics, diagnoses, and outcomes. All ESRD patients whose

treatments and rehabilitation costs are reimbursed by Medicare are included in the

system.

Under the PSRO program, local physician-controlled organizations contract with

HCFA to review the quality and appropriateness of medical care services provided to

Medicare, Medicaid, and Maternal and Child Health program participants. The PMIS,
24 ● part I—Coord i

r

lation Issues

the national PSRO data system, collects a minimum set of hospital discharge data that

describe certain characteristics of every patient covered under a Federal payment program. With personal identifiers deleted, these data are forwarded to the Federal Government, along with summary information about the operation, the rev~ew process, and the

costs of each PSRO. The data are used at the Federal level for evaluating the management

and effectiveness of the PSRO program. Local PSROS use the data to generate profiles on

patients, practitioners, and institutions. These profiles serve as an analytical base for

developing standards for medical care. The PMIS data set requirements are established

by Federal guidelines; individual PSROS may collect information that is not federally

mandated to meet locally defined needs.

The Office of Policy, Planning, and Research (OPPR), a HCFA staff office, operates

an extensive research and demonstration program related to the administration and operation of Medicare and Medicaid, to experimental methods of reimbursement, and to

models for national health insurance. Data are gathered that describe costs, benefits, and

operations of hospitals and skilled nursing facilities, uniform hospital accounting systems, physicians’ practices and fees, and long-term care facilities. OPPR also analyzes

data collected in the Medicare program.

Social Security Administration

The Social Security Administration (SSA) manages the Disability Insurance Trust

Fund. The fund is used for paying monthly cash benefits to disabled workers who qualify

as beneficiaries and their dependents. It also provides rehabilitation services to the

disabled. Since 1937, SSA has maintained all employee records submitted by each company covered by the fund. These records, secured on microfilm, contain, at a minimum,

the name and social security number of each employee and specific information regarding benefit computation and actions related to employee entitlement. SSA publishes annual statistical supplements and periodically prepares detailed analyses in its special

report series. These reports are based on a sample of disability records and present data

depicting the basic characteristics of individuals who apply for disability benefits.

Several reports regarding specific disease entities have been published in this series.

Characteristics of workers disabled by diabetes, emphysema, heart disease, cancer, and

accidents, as well as mental illness, have been presented.

DATA COLLECTION ACTIVITIES OF OTHER FEDERAL AGENCIES

AND DEPARTMENTS

The U.S. Department of Agriculture (USDA) is responsible for measuring and appraising trends and variations in U.S. food consumption. Since 1936, large-scale surveys

have been conducted by USDA to study variations in household food consumption. In

1965, USDA expanded its efforts and initiated the Food Consumption Survey. This

survey, measuring not only household but also individual food consumption, has been

conducted twice. The information generated by the USDA surveys is used widely to evaluate the supply and use of food, per capita food consumption, and the nutritional status

of the U.S. population. USDA also collects data relating to the purchase of food stamps

and to participation in child nutrition programs.

The Consumer Product Safety Commission (cpsc’’SC) iS an independent agency emppowered to regulate certain products that may be hazardous. To identify the cause, frequency, and severity of injuries related to the use of particular products, CPSC operates
Ch. 2—Overview of Existing Health Data Collection Activities ● 25

the National Electronic Injury Surveillance System (NEISS). NEISS obtains data through

a network of telecommunications terminals located in emergency rooms across the country. Another ongoing statistical system administered by CPSC collects data from poison

control centers.

The Department of Defense (DOD) provides or funds health care services for over 9

million persons and operates more than 180 military hospitals for the benefit of activeduty personnel. The Assistant Secretary of Defense for Health Affairs is responsible for

overall planning and coordination, but each service branch, Army, Navy, and Air Force,

operates its own health services program. The General Accounting Office (GAO)

evaluated the DOD health care program in 1976 and reported that over 400 health information systems were in various stages of development or operation within the Department (11). The Tri-Service Medical Information System (TRIMIS) program was established by DOD in 197’4 to improve the effectiveness and economy of DOD’s health care

services through the use of computer technologies. At present, prototypic systems are

being evaluated by TRIMIS before systemwide implementation takes place.

In addition, DOD periodically conducts special studies, including those that examine the health education needs of the military services, the perceived value of health

care used by beneficiaries, and the feasibility of peer review for assuring quality of health

service delivery. DOD also operates the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). CHAMPUS, similar to private medical insurance programs, reimburses dependents of active duty personnel, retired members of the armed

services, and other eligible beneficiaries for private fee-for-service health care. DOD is

developing the CHAMPUS Management Information System (CMIS) to provide information for programmatic needs. A major element of CMIS is a computer file of all eligible beneficiaries; the system will also contain files on providers, claims processing, utilization review, and management and administrative reporting.

The Environmental Protection Agency (EPA) is charged with the regulation of environmental pollutants. EPA recently completed the Community Health Environmental

Surveillance Studies System. This system used large-scale epidemiological methods to

monitor the health of people in areas of high concentrations of air pollutants. EPA also

conducts a small ongoing project, the National Human Monitoring Program, that collects and analyzes human blood, urine, and adipose (fatty) tissues for residues of

regulated pesticides.

The Department of Labor (DOL) operates, through the Bureau of Labor Statistics

(BLS), the Occupational Safety and Health Survey, an annual Federal/State cooperative

survey that records the incidence and severity of occupation-related injuries and illnesses. The survey relies upon employers and employees to identify work-related

illnesses. Because of the long latency period of many diseases, however, illness rates are

inevitably underreported in this survey. BLS also conducts occupational employment

surveys that sample specific categories of health manpower. The Mining Enforcement

and Safety Administration (MESA), also in DOL, produces mine injury data and data on

black and brown lung diseases.

The Department of Transportation (DOT) operates the Fatal Accident Reporting

System (FARS) through its National Highway Traffic Safety Administration (NHTSA).

This system provides annual data on all fatal motor vehicle accidents in the United

States. FARS, fully automated and operational for more than a year, gathers information

from sources maintained by States. The National Accident Reporting System (NARS),

now being developed by NHTSA, will provide information on the rate of nonfatal motor
— —

26 ● p~~t ]—coordination l~~u e~

vehicle accidents. NARS will be supplemented by the National Accident Sampling System, which will provide detailed information on a sample of accidents.

The Veterans Administration (VA), an independent Federal agency, operates the

largest centrally directed hospital and clinic system in the United States. Its Department

of Medicine and Surgery conducts a number of medical research and other special

studies. The VA also operates several major automated information systems. The

Automated Management Information System (AMIS), for example, provides information on VA hospitals for central planning and management purposes. Aggregate data are

collected on admissions, the provision of services, and other categories of hospital operations. The Patient Treatment File (PTF) collects discharge data on all VA beneficiaries

treated in hospitals, nursing homes, or domiciliary care facilities. PTF provides information on the use of the health care system and on patient diagnoses, surgical procedures,

and other characteristics. A separate system gathers data on a sample of patients receiving outpatient care provided by VA facilities. The Personnel Accounting Integrated Data

(PAID) system contains data on all VA personnel, including health professionals.
Chapter 3.

CURRENT COORDINATION ACTIVITIES
CURRENT COORDINATION ACTIVITIES

INTRODUCTION

The U.S. Federal statistical system is decentralized and complex. Such decentralization often creates problems of fragmentation, redundancy, and user access. Furthermore,

priorities for current and future data collection projects are determined largely on an ad

hoc basis because major decisions regarding data collection activities usually are made or

implemented by Federal agencies that administer specific programs.

Some legislative authorities, particularly the Federal Reports Act of 1942 and the

Budget and Accounting Procedures Act of 1950, address the issues of health data policy

and coordination. However, no single congressional mandate exists for developing

health data systems in a coordinated and comprehensive fashion. In fact, a number of offices and agencies have been charged with similar health data policy, oversight, and

coordination responsibilities.

There is increasing congressional and executive branch concern, however, about

health data coordination and policy. In 1974, for example, Congress established a special

Commission on Federal Paperwork to investigate problems associated with Federal reporting requirements, including health information requests. In addition, the 95th Congress passed legislation, Public Law 95-623, to encourage coordination among various

health statistical systems.

Executive branch concern is evidenced in four executive reorganizations (March,

October, and December 1977, and January 1979) that realined many of the responsibilities of Federal agencies concerning health data policy. These organizational changes are

described in this chapter; however, it is difficult to predict their effect. As part of an overall reorganization effort, the President also established the Reorganization Project for the

Federal Statistical System. In December 1978, the reorganization project distributed a

draft report that identifies shortcomings in Federal data systems. Final recommendations

of the reorganization project are expected in 1979.

In this chapter, administrative units responsible for coordinating health statistical

systems are described according to their position within the Federal Government, beginning with major departments and agencies. * They are described in terms of their mission,

accomplishments, limitations, and problems. The analysis begins with the Office of

Management and Budget (OMB) and the Department of Commerce—the two executive

branch units charged with statistical oversight responsibilities for the entire Federal

Government. The Regulatory Policy and Reports Management Division in OMB is highlighted, as is the Office of Federal Statistical Policy and Standards (OFSPS) within the

Department of Commerce. The two administrative mechanisms used for supervising sta-

‘Figures 1 and 2 in chapter 2 show the organizational positions of the offices and committees described

here.

29
tistical projects, statistical budget requests and the reports clearance process, are discussed in detail.

The rest of the chapter describes offices and committees in the Department of

Health, Education, and Welfare (HEW) that have health data coordination responsibilities. The description begins at the level of the Secretary with the Offices of the Assistant

Secretary for Management and Budget (ASMB) and the Assistant Secretary for Planning

and Evaluation (ASPE). The functions and responsibilities of a number of offices within

the two principal health-related operating components of HEW, the Health Care Financing Administration (HCFA) and the Public Health Service (PHS), are then depicted.

Within HCFA, the Office of Policy, Planning, and Research (OPPR), a staff office to the

Administrator, is featured.

The review of PHS coordination and planning activities focuses on the activities of

the Office of Health Research, Statistics, and Technology (OHRST), the Office of

Statistical Policy (OSP) in the new Office of Planning and Evaluation, and the six PHS

agencies. Finally, the efforts of the three HEW Committees, the PHS Health Statistics

Coordinating Committee (HSCC), the Health Data Advisory Committee (HDAC), and

the National Committee on Vital and Health Statistics (NCVHS), to increase coordination of statistical activities within the Department are outlined.

THE DEPARTMENT OF COMMERCE AND

THE OFFICE OF MANAGEMENT AND BUDGET

Two major pieces of legislation, the Budget and Accounting Procedures Act of 1950

and the Federal Reports Act of 1942, authorize the President to coordinate and manage

Federal statistical activities. Section 103 of the Budget and Accounting Procedures Act

provides authority “to develop programs and to issue regulations and orders for the improved gathering, compiling, analyzing, publishing, and disseminating of statistical information for any purpose by the various [Federal] agencies . . .“(2). The Federal

Reports Act, as amended, mandates review and prior approval of Federal information requests that will sample 10 or more individuals (4).

Until October 1977, the Statistical Policy Division (SPD), located in OMB, had

primary responsibility for the coordination and review functions required by legislation.

As the central office responsible for the direction and coordination of Federal data activities, it had the opportunity to survey and oversee all data collection programs. Its

organizational position within the Executive Office of the President permitted it to foster

interagency collaboration and cooperation. However, its broadly defined responsibilities

and its limited staff resources hindered its ability to comprehensively and continuously

address problematic issues within any single statistical area. *

Under the President’s Reorganization Plan No. 1, some of SPD’S statistical policy

duties were transferred to the Commerce Department. Responsibility for section 103 of

the Budget and Accounting Procedures Act was delegated to the newly created Office of

Federal Statistical Policy and Standards (OFSPS) in Commerce. SPD’S successor in

OMB, the Regulatory Policy and Reports Management Division, retained authority for

the review and clearance of most Federal data collection forms and reporting requirements. * * It also maintained responsibility for coordinating administrative data collec-

*In 1976, 2 out of the 29 staff members assigned to SPD worked in the specific area of health statistics.

* *Responsibilities for clearing reporting requirements mandated by certain regulatory activities are held

by the General Accounting Office (GAO), not OMB.
Ch. 3—Current Coordination Activities ● 31

tion and managing paperwork burden (16). Despite the reorganization, overlapping responsibilities for some statistical policy functions still remained. Consequently, a memorandum of understanding was exchanged in July 1978 between OMB and Commerce to

clarify the respective functions of each office (27).

Under the authority of the Budget and Accounting Procedures Act, OFSPS is specifically responsible for the establishment of uniform statistical definitions, guidelines, and

standards for conducting surveys and for publishing and releasing Federal statistics. In

the past, SPD issued these standards through OMB Circular No. A-46. However, SPD

never set guidelines relating solely to health statistics. SPD had only one staff person,

who also was assigned other responsibilities, to develop statistical classifications and

standards (24). OFSPS had requested and received additional staff positions so that its

work in developing standards and guidelines can be expanded beyond that of SPD (9).

OFSPS conducts planning sessions with major statistical agencies, such as the National Center for Health Statistics (NCHS), to fulfill part of its mandate. It also manages

interagency committees involved in statistical issues. OFSPS has just published A Framework for Planning U.S. Federal Statistics for the 1980’s, the result of an interagency planning effort begun several years ago by OMB (26). The Framework examines the entire

range of Federal statistical activities, delineates statistical problems and areas of unmet

needs, and recommends general priorities and objectives for the Federal statistical system. The chapter on health statistics outlines areas in which more comparable and integrated data systems are necessary. It also recommends some methods for improving the

coordination, the development, the utility, and the overall quality of health data.

OFSPS and OMB rely on two administrative mechanisms to oversee Federal statistical projects: statistical budget requests and the reports clearance process. Both budget examiners in OMB and staff in OFSPS review statistical budget requests. These requests,

required under the authority of the Budget and Accounting Procedures Act for Federal

agencies incurring annual obligations of $300,000 or more for statistical activities, are

submitted to OMB (Exhibit 54 of Circular No. A-n). They consist of budget data and a

short narrative statement describing each data activity supervised by an agency. * Both

OFSPS and OMB may seek clarification of, or require additional information about, any

budget request.

Until 1978, OMB published a yearly analysis of the principal Federal statistical programs (Special Analysis G, Budget of the United States Government) based on these

budget requests. The special analysis displayed expenditures according to broad subject

areas and noted major changes in program funding levels. These analyses provided useful information to policymakers regarding Federal resource allocation to general statistical areas (e. g., health, energy, labor) but they lacked sufficient detail to determine the appropriateness of funding levels for specific program-related data activities within a subject area. The only figure in the area of health, for example, was the total Federal obligation. Expenditures by various agencies and bureaus in HEW for specific data systems

were not shown. Although OMB discontinued the special analysis of statistical programs, it plans to continue examining statistical budget requests. OFSPS plans to conduct its own analysis of statistical budgets which will be published in the Statistical

Reporter, a monthly journal primarily designed for the exchange of information among

Government employees engaged in statistical and research activities.

*As noted in chapter 2, the value of these budget requests for determining costs for Federal statistical activities is suspect because many data projects are omitted from them.
32 ● part I—Coord irla t ion Issue s

OMB’S Regulatory Policy and Reports Management Division retains responsibility

for the review of reports clearance requests, the second administrative mechanism for

supervising statistical projects. * Federal agencies and groups that contract with the

Federal Government may not collect information from the public without prior clearance

approval of the Director of OMB. Although OMB makes the final decision regarding

project clearance, OFSPS offers technical advice on statistical and methodological

aspects of requests and is responsible for the substantive review of all statistical surveys.

The objectives of the reports clearance procedure are to avoid duplicate or unnecessarily burdensome reports, to ensure the use of sound statistical procedures, and to improve the quality and general usefulness of the statistics obtained (11). The review and

clearance process also is being used now as the primary tool for implementing a special

Presidential initiative intended to reduce the Federal reporting burden on the public (13).

Forms or reporting plan requests are submitted to the OMB clearance office (Standard Form 83), and contain fairly comprehensive information about projected statistical

activities. OMB maintains and periodically circulates a list of approved projects that are

currently in use. The OMB files containing the clearance requests and sample forms or

reports are open to the public; however, no attempt has been made to computerize them,

nor are they available for use outside OMB offices. Currently, OMB is testing the feasibility of a computerized keyword system to retrieve information on projects approved by

the clearance office.

The clearance process has been partially effective in preventing data collection activities of obviously inadequate quality and design. However, this process has a number

of limitations. First, certain reports are exempted from the process, including clinical

trials, data projects conducted under grants, and data collection projects mandated under

the Health Professions Educational Assistance Act of 1976. In fact, the Commission on

Federal Paperwork estimated that fewer than 50 percent of the reports requested by the

Federal Government are reviewed by OMB (23). Second, the clearance process is extremely slow. Each level of the bureaucracy, from originating office to OMB, reviews

every proposed project (see figure 3). Third, the clearance procedure does not set priorities for choosing reports to review, and the result is a backlog of requests which vary in

significance. Finally, although agencies’ clearance procedures vary, review by OMB

begins at the final stage of an agency’s planning process. Delaying an active review of a

project until its final planning stages is untimely and inappropriate, given the large investment of resources already made in the project. Until the clearance and planning processes are linked, little improvement in coordination can be expected.

OMB also has authority, under the Federal Reports Act, to determine the necessity

for collecting information, to designate a central collection agency if doing so would

more efficiently serve the needs of two or more agencies, and to require the cooperation

of Federal agencies in exchanging and sharing information. In practice, OMB has rarely

exercised this broad authority for coordinating statistical activities in the health area.

One of the few OMB attempts to provide coordinating leadership in this area met with

mixed success. In 1975, OMB ruled that, in order to reduce the burden on respondents, a

Bureau of Labor Statistics (BLS) survey, which focused on employees in hospitals working in nonhealth occupations, should be incorporated into a joint survey of hospital staff

conducted by NCHS and supported by the Bureau of Health Manpower (BHM) (35). A

survey of nursing personnel, normally conducted by a professional society, was also in-

● Requests to conduct statistical activities may also go through other clearance mechanisms, including

those for grants and contracts and internal evaluation reviews.
Ch. 3—Current Coordination Activities ● 33

Figure 3.— Reports Clearance Process for a Cancer Epidemiology Study

Conducted Under Contract and Requiring Household or Telephone Interviews

Level of Review

Executive Branch

L

Type of Review

Signature

Policy Review

Technical Review

A

1

Depart ment t 1

I

Reporting Burden

Reduction

I

4

component +

Principal Operating

I

Policy Review

Technical Review

I

Agency

Program

Technical Review

(at discretion of OSP)

t

1

Signature

Policy Review

4

Policy Review

Preparation of

Documents

Contract Peer Review

Office

Deputy Associate Director for Regulatory

Policy and Reports Management, Office of

Management and Budget

Regulatory Policy and Reports Management

Division, Office of Management and Budget

Office of Federal Statistical Policy and

Standards, Department of Commerce

Office of the Assistant Secretary for

Management and Budget, Department of

Health, Education, and Welfare

Assistant Secretary for Health

Office of Statistical Policy, Public

Health Service

National Center for Health Statistics, Public

Health Service

Director, National Institutes of Health

Office of Collaborative Research, National

Institutes of Health

Management Policy Branch, Office of

Director, National Cancer Institute

Environmental Epidemiology Branch,

National Cancer Institute

Collaborative Program Director

corporate. The response rate to this survey, conducted by NCHS in 1976, was only sO

percent. The volume of data the survey instrument attempted to capture caused the unacceptably low response rate. Other factors, such as lack of support from professional

groups, may also have contributed to the low response rate. This example illustrates that

coordinating data collection activities solely to achieve maximum efficiency and minimal

respondent burden may not always provide necessary data of adequate quality for the

community of users.

The implications of the 1977 reorganization that transferred certain responsibilities

for statistical policy from OMB to Commerce are unclear. Under the reorganization,
34 ● part l—coordination Issues

OMB’S Regulatory Policy and Reports Management Division was assigned 24 positions

and Commerce’s OFSPS, 15 (17). * Core staff of the new Commerce office, including the

Director, are former members of the OMB Statistical Policy Division. Both this transfer

of staff and the active commitment of the Commerce Department to fulfill a Government-wide statistical policy function could result in the improved planning and coordination of Federal statistical activities. The fact that OMB retains sufficient authority to

resolve any interagency differences that cannot be handled by Commerce increases the

likelihood of success (14). However, the division of oversight responsibilities, all of

which were formerly administered by OMB, between OMB and a Federal agency that

itself collects data, could reduce the intended effectiveness of the reorganization. The

President’s Reorganization Project for the Federal Statistical System indicated in its preliminary report that it would recommend reunifying statistical policy functions in a

strengthened central office (16).

THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

The Department of Health, Education, and Welfare (HEW) has a number of offices

with responsibilities relating to health data policy and coordination. Authority to coordinate data projects has, for the most part, been delegated to the Health Care Financing

Administration (HCFA) and the Public Health Service (PHS). However, two staff offices

at the level of the Secretary, ASMB and ASPE, maintain some oversight responsibilities

for health data activities throughout the Department.

The Assistant Secretary for Management and Budget (ASMB) is responsible for the

implementation of reports clearance procedures throughout HEW. ASMB has delegated

this authority to the Assistant Secretary for Health and to the Administrator of HCFA.

This office also has overall responsibility for the development of policies and standards

concerning public use of reports and reviews departmental statistical budget requests as

part of its budgeting function. In 1976, ASMB instituted a special review of large new

data projects (those requiring 20,000 or more reporting hours) to comply with the Presidential directive to reduce reporting burden on the public.

The Assistant Secretary for Planning and Evaluation (ASPE) provides guidance for

the planning activities of the Department. The ASPE staff also conducts several large

surveys in conjunction with their planning and evaluation responsibilities, and are involved in basic research on statistical methodologies. Presently, ASPE is one of several

participants preparing a departmentwide health statistics plan for FY 1978.

Health Care Financing Administration

Each of the three major HCFA divisions, the Medicare Bureau, the Medicaid

Bureau, and the Health Standards and Quality Bureau (HSQB), maintains large ongoing

health data collection activities. The Office of Policy, Planning, and Research (OPPR), a

staff oftice to the HCFA Administrator, has primary responsibility for data policy and

coordination of statistical activities throughout the agency. However, the final reports

clearance unit before transmittal to OMB is in the HCFA Office of Management and Budget, another staff office to the Administrator. OPPR has recently established the HCFA

Health Data Policy Committee to serve as a forum for discussing internal data policy

*As mentioned previously, OFSPS has subsequently received additional staff members.
Ch. 3—Current Coordination Activities ● 3S

issues, including coordination. Representatives from each of the HCFA bureaus will

serve on the Committee, which has not yet met to discuss its plans and functions.

OPPR is already leading efforts to develop common statistical reporting requirements for Medicare and Medicaid. Uniform billing and discharge data requirements were

mandated by section 19 of the Medicare-Medicaid Anti-Fraud and Abuse Amendments

of 1977. Duplicative collection of discharge data by several agencies in HCFA and by

other programs in PHS has been a source of problems for a number of years. In 1978, the

Secretary of HEW delegated responsibility for development and collection of uniform

billing and discharge data to HCFA. Two internal task forces, one on uniform billing and

another on discharge data, have been formed by OPPR. The agency is now in the process

of drafting proposed regulations concerning the implementation of the task forces’ recommendations.

OPPR and NCHS, a PHS agency, are collaborating on another important statistical

activity. They have proposed a joint, expanded survey to replace both the former Current Medicare Survey of the Medicare program and the Medical Care Expenditures

Survey, a single-time survey conducted by NCHS and the National Center for Health

Services Research (NCHSR). The expanded survey, the Medical Utilization and Expenditures Survey, will be initiated in FY 1980. HCFA and NCHS will both provide funding

for the new survey; NCHS will administer its data collection activities.

Public Health Service: Office of Health Research, Statistics, and Technology

The Office of Health Research, Statistics, and Technology (OHRST) was created by

a January 1979 reorganization of the Office of the Assistant Secretary for Health (OASH)

to replace the Office of Health Policy, Research, and Statistics (OHPRS). This new Office

will supervise the activities of NCHS, NCHSR, and the National Center for Health Care

Technology (NCHCT). The Office was established to augment PHS’S ability to foster and

assess technological developments in health and to strengthen the relationship between

health statistics, health services research, and health technology assessment.

The 1979 reorganization transferred the Office of Statistical Policy (OSP), which

was located in OHPRS before the reorganization, to another new office, the Office of

Planning and Evaluation (OPE). The responsibilities of OPE and the ongoing activities of

OSP will be discussed in a later section.

The National Center for Health Statistics is the only Federal agency expressly established to collect and distribute information describing the health of Americans. NCHS

was created statutorily* by the Health Services Research, Health Statistics, and Medical

Libraries Act of 1974, Public Law 93-353. This Act directed the Secretary of HEW to use

NCHS to coordinate, to the maximum extent possible, all health statistical activities

begun and supported by HEW. The law also authorized NCHS to design and implement

a cooperative health statistics system to produce comparable and uniform health data

and statistics at the Federal, State, and local levels.

NCHS’S latest enabling legislation, the Health Services Research, Health Statistics,

and Health Care Technology Act of 1978, Public Law 95-623, mandated the establishment of standardized means for collecting all health information and statistics that are

authorized by laws administered by HEW. It also directed the review of all health data

collections that are subject to the reports clearance process to insure their conformance

*As noted in chapter 2, NCHS was first created in 1960 by the merger of the National Health Survey

with the National Office of Vital Statistics.
36 . Part ]_ Coordination Issues

not only to promulgated standards, but also to the minimum data sets that have been established for several substantive areas. NCHS began conducting technical reviews for

some proposed health data collections as part of the reports clearance process in 1978.

It is too early to predict NCHS’S effectiveness in fulfilling its new responsibilities.

The Secretary has not yet formally delegated authority for Public Law 95-623, but it

could be interpreted as considerably strengthening NCHS’S role within the Department

for coordinating health statistics. In addition, this legislation may create the statutory

base for NCHS participation in the reports clearance process and provide authority for

taking corrective action should data projects fail to conform to the standards.

Public Law 95-623 also authorized NCHS to expand its epidemiological activities

and to coordinate the development of a Government-wide statistical program on the

health effects of the environment. However, no additional funds were appropriated to

NCHS in FY 1979 for these tasks.

NCHS administers two programs that are designed expressly to improve the efficiency and coordination of health statistics. These programs, the Cooperative Health Statistics System (CHSS) and the Reimbursable Work Program (RWP), were created to fulfill

the Agency’s legislative mandate to produce comparable and uniform health information

and statistics. Despite NCHS’S latest enabling legislation, both CHSS and RWP are likely

to continue to be the primary NCHS programs for coordination.

CHSS is an organizational mechanism for the development of health data systems

that can be shared by data producers and users at the local, State, and Federal levels. The

conceptual basis of the program is that data should be collected and processed by the

level of government or by the agency best equipped to collect them, and that the data

should be shared with all other levels and users in machine-readable form. The longrange strategy of this hierarchical and linked data collection approach is to reduce cost

and respondent burden while meeting informational needs of users at all levels of government.

When fully developed, CHSS will include seven components, each of which will

provide a different type of health-related data: vital statistics, health manpower, health

facilities, hospital care, ambulatory care, long-term care, and health survey data. Within

each component, standard definitions, comparable methods, and a core data set will be

established to ensure the quality and comparability of data across States. Operationally,

the system will work through either a State center for health statistics or a consortia of

data users and producers within a State. NCHS provides contracts to these State agencies

or data consortia for the development of statistical components, conducts technical assistance and training programs, and pays the appropriate Federal share of the costs.

NCHS also is coordinating efforts among Federal agencies so they will link their data

needs to CHSS. This program may be unable to fulfill its intended purpose, however,

because participation by these various data users and producers is voluntary.

Although receiving a statutory base in Public Law 95-623 and high priority from

NCHS, CHSS is developing slowly. By the end of FY 1978, 44 States had contracts for the

vital statistics component, and 36 States had contracts for both the health manpower and

the health facilities components. Hospital discharge data systems, the fourth active

CHSS component, were being implemented in 9 States (19). Even if CHSS were completely implemented in all the States, national data would not be available for at least 4

to 5 years, and time series data would take even longer to develop. In addition, within

the data components that are operational in some States, many problems of comparabil-
Ch. 3—Current Coordination Activities ● 37

ity, completeness, data element uniformity, and periodicity of data collection are evident

(21, 35).

NCHS is seeking additional Federal funds to accelerate the implementation of

CHSS. In FY 1978, Federal expenditures for CHSS totaled $14.3 million (25). If additional funds are allocated to the program, NCHS plans to implement the vital statistics,

health manpower, and health facilities components in all States by 1979 and all seven

CHSS components by 1983 (34). OSP has awarded a contract to fully evaluate CHSS, including its concept, organization, and costs. A preliminary report is anticipated in 1979

and a full report in 1980.

RWP allows NCHS, with its superior technical capabilities and expertise, to be reimbursed for performing statistical activities that supply data to other Federal agencies. For

example, RWP derived estimates of “problem drinkers” by States for the National Institute on Alcoholism and Alcohol Abuse (NIAAA). These estimates were used by NIAAA

in decisions concerning the allocation of Federal funds to alcoholism treatment centers.

Through the Health Interview Survey (HIS), NCHS also collected data for the Office of

Smoking and Health (OSH). NCHS views the RWP as an important mechanism for increasing the reliability and validity of data, eliminating overlap, and reducing overall

Federal costs (34). Its statistical services include not only methodology design, technical

assistance, and data analysis but also the actual data collection for other Federal programs.

NCHS established the RWP in FY 1976 under the authority provided by section 601

of the Economy Act of 1932. Staff restrictions on NCHS, however, have limited its

growth and hindered the performance of its duties. In RWP’S first year, NCHS allotted 25

positions for the program. This allocation increased the total number of staff positions to

34. Previously, NCHS had informally delegated nine positions to the program in order to

begin responding to Federal agencies’ requests for technical assistance. Since 1976, no

new staff positions have been created.

Public Health Service: Office of Planning and Evaluation

The Office of Planning and Evaluation (OPE), as mentioned previously, was created

as part of the January 1979 reorganization of OASH. The health policy, evaluative, and

legislative development responsibilities of the Office of Health Policy, Research and

Statistics (OHPRS), now OHRST, were transferred to the Office of Planning and Evaluation. The Office of Statistical Policy (OSP), the focal point within PHS of efforts to

develop and coordinate health data and statistical policy, was also transferred from

OHPRS to the new office. Statutory authority for the activities of OSP derives from section 301 of the Public Health Service Act which requires the Surgeon General to promote

the conduct and coordination of data collection activities.

The Office of Statistical Policy (OSP) has responsibilities for coordinating and

standardizing all health data policy for PHS and acts as a liaison for statistical policy

with other Federal agencies concerned with health issues. OSP reviews and makes recommendations on PHS statistical budgets, plans, evaluation studies, and legislative proposals, and is responsible for the final reports clearance within PHS. It reviews and comments upon reports, papers, and studies relative to statistical policy issues for the

Surgeon General and provides a statistical perspective to the PHS policy development

process. OSP was instrumental in the development of, and now provides staff support

for, both the PHS Health Statistics Coordinating Committee (HSCC) and the Health
38 ● Part l—coordination Issues

Data Advisory Committee (HDAC). The direction, coordination, and much of the work

of the HEW annual inventory of health data projects are being conducted by OSP.

OSP was established by a December 1977 reorganization of OASH that gave special

attention to data policy. Before 1977, OSP was part of the Office of Policy Development

and Planning (OPDP), a predecessor of OHPRS. Despite subsequent reorganizations,

OSP has retained many of the same broad responsibilities, delegated by the Secretary for

statistical coordination and planning, as OPDP (43). Thus, the accomplishments and

problems of OSP can best be viewed in an historical context.

OPDP concentrated its staff resources on final clearance activities, and its efforts

were successful in reducing Federal reporting burden. Approximately 340 data projects

were initially reviewed by the Office in FY 1974, the number of projects submitted for

review in FY 1977 had decreased to approximately 170. In FY 1978, OSP reported the

submittal of 156 projects (48).

The reports clearance process, which reviews projects for technical, substantive, and

policy concerns, has improved the technical quality of surveys and other data collection

activities conducted by PHS. To further enhance technical quality, OSP initiated a procedure by which any project submitted for clearance that contains complex methodological or sampling designs is routed to statisticians in NCHS for technical review. OSP also

routes data projects involving surveys of hospitals or health manpower to NCHS, which

then checks samples to assure they do not duplicate selection of the same health professionals or hospitals responding to current data projects.

OSP’S successes in planning and coordinating data projects are less clear than its

achievements in reducing reporting burden. Limited authority and insufficient staff in

both OPDP and OSP have prevented aggressive planning for the majority of health data

systems and projects. Presently, there is little indication that OSP will provide greater

leadership in health data policy matters than its predecessor.

Public Health Service Agencies

The six agencies of the Public Health Service independently and jointly conduct

some activities related to the coordination of health data. A representative of each agency is a member of PHS’S HSCC. Each agency has its own clearance officer who reviews

agency forms, reports, and data systems before their transmittal to OSP. In addition,

several agencies have made substantial efforts toward improving the coordination and

compatibility of their own data systems.

The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) is planning to establish a new data-related committee to replace the recently abolished Program

Data Coordinating Committee (PDCC). During its existence, PDCC examined the conceptual and definitional compatibility of data elements used in the client-oriented data

systems of ADAMHA’s three institutes. Goals of the PDCC included determining minimum data sets and, while not combining Federal-level data systems, encouraging individual States to develop an integrated data system for all programs administered by

ADAMHA. As part of a mental health statistics improvement program in the National

Institute of Mental Health (NIMH), one of the three ADAMHA institutes, uniform data

sets for mental health facilities, manpower, and client data are being developed. To ensure consistency with CHSS, a memorandum of understanding was exchanged between

NIMH and NCHS and an interbureau committee was established to maintain coordination.
Ch. .3-current Coordination Activities ● 3 9

The Center for Disease Control (CDC) has a staff activity that evaluates current national surveillance systems in an effort to coordinate them. Currently, a number of

surveillance systems obtain data from various sources, including city and county health

departments, State health departments and vital registrars, hospitals, physicians, and

clinical laboratories. The CDC staff activity, organized in early 1978, has initiated

several studies to determine the best methods for obtaining unduplicated counts of different health conditions. Results of the studies, which are expected within 3 years, are

meant to indicate which surveillance systems should be combined or eliminated.

The Health Services Administration (HSA) maintains no formal data coordinating

committee for its three major divisions, the Indian Health Service (IHS), the Bureau of

Medical Services (BMS), and the Bureau of Community Health Services (BCHS). However, BCHS has successfully consolidated the requirements for its health services programs into a common program management reporting system. The new data system, the

BCHS Common Reporting Requirements (BCRR), became operational in early 1977, replacing six diverse program data systems.

The Health Resources Administration (HRA) and two of its bureaus, the Bureau of

Health Planning (BHP) and the Bureau of Health Manpower (BHM), work closely with

NCHS to determine and meet the data needs of their programs. Enabling legislation for

BHP, Public Law 93-641, and for BHM, Public Law 94-484, mandated this cooperation

with NCHS. Currently, NCHS is assisting BHP in the preparation of manuals about data

resources for local and State planning agencies; and BHM and NCHS are jointly developing methods to gather data for extensive manpower-related requirements. Successful

coordination may have been facilitated by NCHS’S former location within HRA.

The National Institutes of Health (NIH) has customarily allowed each of the 11 individual institutes to assume responsibilities for their own data needs. In 1977, NIH formed

an inter-Institute coordinating committee of epidemiologists to encourage the efficient

use of funds in meeting the data needs of the 11 institutes and to respond to the increase in

epidemiological research. The committee, which also has representatives from other PHS

agencies, serves as a forum for discussing major epidemiological research projects during

the early stages of planning. A second committee, the Cost of Illness Coordinating

Group, was formed at NIH to investigate methods for developing data on the incidence,

prevalence, and cost of diseases.

Advisory Committees

The PHS Health Statistics Coordinating Committee (HSCC) was established in

mid-1978 to ensure greater technical and operational coordination of statistical activities

within PHS. It acts as an internal forum for information exchange and operational and

technical coordination. Representatives from each of the six PHS agencies serve on the

Committee. The Director of NCHS chairs the Committee, and OSP serves as executive

secretariat.

HSCC meets on a monthly basis and has formed several task forces. One task force,

concerned with comparability and standards, has just completed guidelines for standard

definitions and minimum categories for data collection for eight data items. HSCC will

serve as the conduit for agency comments on the guidelines as well as for their promulgation through PHS reports clearance channels. Another task force is reviewing the NIMH

Mental Health Demographic Profile System in terms of its ability to fulfill various PHS

agency needs.
40 ● part I—coordination Issues

The Health Data Advisory Committee (HDAC) was formed to ensure that the health

statistical systems of HEW are coordinated, produce complementary statistics, and minimize the impact of Federal reporting requirements on health care institutions. HDAC is

responsible for evaluating data policies and systems, encouraging the coordination of

statistical activities between HEW and other Federal agencies, recommending requirements and reviewing proposals for uniform data sets and for standard definitions of data

elements, and advising the Secretary on cross-cutting issues relative to health statistical

systems (28).

HDAC is a newly established committee; its charter was signed by the Secretary on

February 3, 1979. HDAC was created to replace and augment the work of its

predecessor, the Health Data Policy Committee (HDPC). In light of the recent signing of

the charter, it is premature to assess the new Committee’s impact. The accomplishments

and limitations of HDPC are instructive in understanding HDAC’S anticipated role.

The Assistant Secretary for Health established HDPC in March 1974 to provide

policy guidance and coordination for HEW health data activities. Identified as the focal

organization within HEW for health data policy, the HDPC charter assigned the Committee major responsibilities that were very similar to those now delegated to the new

HDAC (29). Until mid-1977, HDPC met on a monthly basis. HDPC ceased functioning

at that time, pending the reorganization of OASH.

HDPC essentially served a reactive function because its activities centered around

general and specific statistical issues brought to its attention. Its major accomplishment

was the sponsorship of an annual health statistics plan for HEW. The initial health statistics plan, issued in 1976, represents the first inventory of HEW health data projects. The

second and final HDPC plan was issued in 1977 and included a descriptive framework for

health statistics. It also inventoried HEW health data collection projects and described

health data systems operated by VA and DOD.

A fundamental problem of HDPC was its lack of authority to force decisionmaking

or implement policies, especially those decisions involving agencies outside PHS.

Although composed of agency representatives from throughout the Department, the

Committee was dominated, in terms of the composition of its membership and its

organizational placement, by PHS. Consequently, each member functioned as a peer

within HDPC, usually without relinquishing agency viewpoints. In addition, the anticipated role of HDPC in setting priorities for remedial actions in data projects was not

realized; it did not function as a policymaking body (5). This shortcoming was recognized by members of HDPC. In interviews with the Office of Technology Assessment

(OTA), one member expressed the view that, although the Committee was a useful

forum for expressing agency interests, the group was not successful in reaching consensus. Other members expressed frustrations with the lack of Committee progress.

HDAC was formed to correct some of the more fundamental shortcomings of

HDPC. Therefore, HDAC’S members are more broadly representative of the entire

Department and less representative of PHS. The Committee will be chaired, on an annual rotating basis, by the Deputy Assistant Secretary for OHRST in PHS and the

Associate Administrator for OPPR in HCFA. The Director of OSP will serve as the executive director of the Committee and provide the necessary staff. The new Committee

will have members from ASPE, ASMB, the Office of the Assistant Secretary for Human

Development, the Office of Inspector General, HCFA, PHS, and NCHS. In addition,

representatives of OFSPS in Commerce, VA, and DOD will be invited as nonvoting

members to participate in the Committee’s meetings. The Assistant Secretary for
Ch. 3—Clirrent Coordination Activities . 41

Management and Budget will arbitrate issues that cut across agency jurisdictions when

they cannot be resolved within the Committee (28).

The need for a departmentwide committee is partially demonstrated by the absence

of an inventory of health data systems during the year no committee existed. PHS did

publish a statistics report for FY 1977, but it included only PHS data systems. A statistical plan for FY 1978 is now being prepared under the auspices of HDAC. The plan includes an inventory of the health data activities of PHS, HCFA, ASPE, and the Office of

Human Development Services.

The National Committee on Vital and Health Statistics (NCVHS) was mandated by

the Health Services Research, Health Statistics, and Medical Libraries Act of 1974, Public

Law 93-353, to serve as an external public advisory committee on health statistical matters to the Secretary of HEW. NCVHS was originally chartered, at the request of the

World Health Organization, in the late 1940’s to represent the United States at international meetings. Although NCVHS still continues to serve in an advisory role for international statistical and classification activities, its statutory authority considerably expanded the role of the 15-member advisory committee (30). Its membership, selected by

the Assistant Secretary for Health, is composed of nongovernmental experts representing

several health-related disciplines.

To assist and advise the Secretary, NCVHS is charged by legislation with three

primary functions: to delineate statistical problems bearing on health and health status

and to stimulate studies of such problems whenever possible; to determine, approve, and

revise the terms, definitions, classifications, and guidelines for assessing heaIth status,

health services, and health service distribution and cost; and to counsel on the design and

approval of health information systems concerned with the collection, processing, and

tabulation of health statistics within HEW. Legislation passed in 1978, Public Law

95-623, added advisory responsibilities relating to both CHSS and the formulation of

standardized means for the collection of health information and statistics. This Committee’s ability to fulfill such a large mandate is limited, however, because it meets only three

times a year and has few staff resources.

NCVHS reviews and comments upon the various documents concerning health data

prepared by HEW and OMB. It is briefed on the health data activities of various agencies

within HEW and makes suggestions for their improved coordination with NCHS. Finally, it examines specific problem areas brought to its attention, including the need for promulgating and implementing the uniform hospital discharge data set throughout HEW

and the lack of a single departmentwide policy on confidentiality. NCVHS has made

strong recommendations for the solution of these data problems. It has also suggested

several HEW reorganization plans that would facilitate coordinating and monitoring

health data systems.

Substantive contributions are made primarily through its subcommittees. A number

of subcommittees are currently designing uniform data sets for basic categories of health

data that can be used by various Federal agencies. The subcommittee on hospital

discharge data has completed its work and serves as a model for other NCVHS subcommittees concerned with uniform data sets for ambulatory care, long-term care, manpower, and facilities. Four other subcommittees are also active: One is evaluating the I

NCHS Health Interview Survey (HIS); another is considering needs for health information under national health insurance; a third is advising on issues related to CHSS; and

the fourth is examining the needs for mental health statistics and the best methods to

meet these needs.
42 ● part l— coord j

n a

t j

on Z s su es

A problem confronted by NCVHS is its traditional association with PHS, despite the

fact that its enabling legislation established it in the Office of the Secretary. The Assistant

Secretary for Health appoints its members and staff support is provided by NCHS. Furthermore, the Committee spends a majority of its time inspecting programs of NCHS

(26). NCVHS has not been assigned clear responsibility for monitoring statistical activities outside PHS. In particular, it has not exercised oversight responsibilities for the

data collection activities of HCFA, although HCFA maintains large data collection programs in the area of health cost and expenditure data. In early 1978, the NCVHS charter

was rewritten to explicitly state that the Committee must report to the Secretary and

must act as an advisor to the Department on all health statistical matters. The Secretary

has not yet acted upon this new charter.
Chapter 4.

STRUCTURING COORDINATION

ACTIVITIES
4 ●

STRUCTURING COORDINATION ACTIVITIES

INTRODUCTION

The Federal health statistical program is a patchwork of numerous data collection

projects, each of which addresses different needs or purposes, Individually designed projects prevent easy linkage of data and, therefore, the formation of statistical profiles. Excluding the data systems of the National Center for Health Statistics (NCHS), which provide baseline, general-purpose health data, Federal data activities are geared to the programmatic needs of agencies that operate them. There is no systematic appraisal of the

content, adequacy, needs for, or uses of health data currently collected. Rather, decisions

regarding data collection, use, and release are made primarily by the acquiring agency.

Uses and needs for statistical information cut across agency jurisdictions; yet, there

is no central control over health data activities, even those supervised by the Department

of Health, Education, and Welfare (HEW). The two primary administrative mechanisms

for monitoring data projects—statistical budgeting and the reports clearance process—

exert some pressure against increased proliferation of different types of health data collection projects. However, insufficient attention has been given to coordinating the

numerous data collection activities of various Federal health programs.

The lack of a systemwide approach in Federal endeavors is not unique to the area of

statistics. The generic problem of fragmentation is a result of each agency’s pursuit of its

own specific mission; consequently, no constituencies and few incentives for coordinating agency activities exist. HEW, however, has recognized the problem of fragmentation

in the area of health technologies and has begun to address it. To systematically link the

activities of various agencies, HEW has proposed a major initiative for managing the lifecycle of technology development, evaluation, transfer, diffusion, utilization, and phaseout (38). A similar strategy for managing and coordinating health data projects throughout the Federal Government is also needed.

This chapter describes a structure that would coordinate health statistics according

to three constituent functions: developing an analytical framework for planning the

statistical system, improving the efficiency of data collection activities, and ensuring data

accessibility for potential users. Activities that might be undertaken to fulfill each of

these three functions are suggested. The need to formally delegate and institutionalize

responsibility for coordinating activities is highlighted. The characteristics and resources

that such a coordinating body would require are delineated and possible alternative

organizational locations within the Federal bureaucracy are identified.

CONCEPTUAL FRAMEWORK

Designing a conceptual framework is a critical prerequisite to the development of a

unified, comprehensive health statistical system. Planning the design of such a frame45
46 . Part I_ Coordination issues~~ue~

work should initially entail defining the objectives of a comprehensive

system, determining the kinds and amounts of data needed to meet the

health statistical

various goals of

the system, and applying a set of organizing principles to the data. Long-term comprehensiveness, flexibility, and balance in statistical coverage of substantive areas should be

built into the framework in order to identify ongoing statistical systems that have little

further utility and to respond to changing needs for information.

A conceptual framework would establish an analytical foundation for rational planning. With a definitive list of specific items of information being collected, the framework could further serve a clearinghouse function by providing information about what

and how data can be located. Careful analysis of the framework would permit identification of overlapping jurisdictions in data collection and areas in which there are gaps in

our knowledge. Decisionmakers who examine the framework could both determine how

Federal statistical dollars are spent and what uses are made of data collected, and, as necessary, shift priorities for data collection. They could also use the framework as the basic

tool for administering and allocating resources to the Federal health information system.

Devising the conceptual framework requires much initial theoretical work by technically skilled staff, who are familiar with the diversity of health statistics, in order to

develop the matrix and methods for systematic analyses of data in each cell. Thereafter,

staff would be needed both to collect and maintain information about existing data collection activities and to respond to requests directed to the clearinghouse. Personnel with

statistical expertise and analytical abilities also would be required to determine the needs

of data producers and users, to identify data gaps, and to aid in setting data collection

priorities. These latter activities are integral to the planning process, and staff would

have to be able to exercise sufficient authority to effect results based on their analyses.

Once the design of the conceptual framework is completed, a detailed inventory or

audit of existing data systems must be conducted with the objective of integrating them

into the framework. The survey could take the form of periodic requests to Federal agencies or it could be institutionalized as part of an existing administrative mechanism, such

as the statistical budget request or the reports clearance procedure. If one of the current

mechanisms for auditing data activities was used to build the analytical framework, it

would need to be modified to ensure coverage of all health data systems and to permit the

exhaustive collection of information about each data system. The framework should include all data systems that could potentially meet broad purposes; therefore, projects

operated by State and local governments and by private national organizations should

also be inventoried.

Information derived from such inventories would form the data base for the creation

of a matrix that illustrates the relationships among existing health data systems. To be a

worthwhile planning tool, the matrix must be comprehensive and permit the interaction

of many health data system variables, including:

●

●

●

●

●

●

●

class of data collected (such as demographic characteristics, facilities, manpower,

service usage, costs, health status, lifestyle, and environmental measures);

standard variables and/or identifiers collected;

type of respondent and coverage;

method of collection (mandatory or voluntary);

collector of data (Federal, State, local, or private), level of aggregation at each

stage, and data flow;

statistical methodology;

costs of the project for data collection, processing, analysis, and publication;
Ch. 4—Structuring Coordination Activities Q 47

● provisions for confidentiality;

● periodicity of data collection;

● users of data and their requirements for timeliness and geopolitical detail; and

● determinants of access to data (such as official publications and availability of

computer tapes).

The establishment of a clearinghouse of information on statistical systems has been

advocated periodically. In 1971, the President’s Commission on Federal Statistics recommended that the Bureau of the Census be funded to maintain a catalog of Federal statistics that would list the activities of all agencies (15). In 1977, the Commission on Federal Paperwork, echoing the earlier recommendation, suggested the development of a Federal Information Locator System that would provide a reference point for Federal agencies and others wishing to know what data are collected (23). Citing deficiencies in available data for estimating reporting burden, the Federal Paperwork Commission also recommended that a detailed register of all Federal reports, to be derived from improved

clearance request forms, be designed, automated, and used for planning by the Office of

Management and Budget (OMB) (24). Specifically noting duplicative requests for information about the health industry, this Commission urged OMB to develop a comprehensive inventory of data already collected in the health field (22). Finally, the President’s

Reorganization Project recommends, in its 1978 draft report, locating a Federal Data

Locator Service and data user inquiry service in a central statistical organization (16).

Recognizing the need for a systematic data base, the HEW Health Data Policy Committee published a list of all health data projects conducted by the Department in FY 1975

and FY 1976 (40, 41). The Public Health Service (PHS) prepared a similar inventory for

FY 1977 but limited the list to PHS data activities (42). The newly created Health Data

Advisory Committee (HDAC) is preparing another departmentwide inventory that includes data projects administered in FY 1978. These inventories provide a brief description of each data project and reference staff to contact for further information.

Some attempt has been made to use these inventories as the basis for a conceptual

framework. PHS, for example, presented its 1975 health statistics plan as a descriptive

framework for arraying all health program management data systems (4o). Also, the

1976 health statistics plan incorporated elements of a preliminary conceptual framework

for health statistics by organizing data projects into four primary subject-matter categories: health status, health care resources, health services utilization, and health care expenditures. It was proposed that the framework be used to promote cross-program

analysis, to identify opportunities for standardizing data collection, and to facilitate future

decisions on the development and modification of statistical systems (41). It is not clear,

however, whether the health statistics plans have been used for such analytical purposes.

EFFICIENCY

Once the conceptual framework has been developed, efforts can begin to improve

the efficiency of data collection activities, the second coordinative function. Efficiency

means conducting health data collection activities in the most cost-effective manner

possible. To achieve cost-effectiveness in health data collection, existing health data projects may need to be modified, combined, or terminated. New data collection systems also

may be needed. Three specific problems are addressed with regard to efficiency: inadequate technical design, overlapping data collection, and lack of comparability.
Inadequate Technical Design

The appropriate use of the latest technical capabilities is one method of ensuring

optimal efficiency. Sophisticated statistical methods may obviate the need for costly repetitive data collection efforts. For example, synthetic estimates derived from data

gathered on a regional or national basis, despite certain recognized limitations, may be

sufficient for the statistical needs of local jurisdictions. Sampling procedures often serve

statistical purposes as well as, or better than, responses from an entire universe of respondents. Recent advances in survey research, such as computer-assisted telephone interviewing techniques, offer cost-cutting alternatives in the field of statistical surveys.

Efficiency can also be improved by redesigning independently conducted surveys or

studies to meet the needs of several users. In FY 1976, the National Center for Health

Services Research (NCHSR) and the National Center for Health Statistics (NCHS) spent

more than $5 million on a large national survey that examined the sources and amounts

of health care expenditures by various population groups for episodes of illness. The National Cancer Institute (NCI) spent $500,000 in the same year on a survey designed to

provide similar types of information, but the NCI survey focused on costs solely associated with the care of cancer patients. Several institutes in the National Institutes of

Health (NIH) now are working on a collaborative effort with NCHS to “piggyback” some

of their data needs on the Hospital Discharge Survey of NCHS. The impetus for this cooperative endeavor came from several researchers at NIH in an effort to obtain data that

they could not have gathered themselves given the budgetary constraints of their respective institutes.

NCHS has the greatest number of statistical experts within HEW. NCHS provides

technical statistical services to Federal agencies through its Reimbursable Work Program

(RWP). However, the effectiveness of the RWP in assuring the use of appropriate

methods is limited because it has a small staff and its services must be requested by other

agencies. NCHS also does technical reviews of some new data projects at the request of

the PHS forms clearance office. Technical reviews appear to be an effective mechanism

for identifying major statistical deficiencies in data activities, but they further delay an

already lengthy clearance process (43).

Overlapping Data Collections

Agencies tend to collect data that meet their specific program needs for planning,

monitoring, and evaluation without regard for the needs of other agencies. Because most

Federal health programs are categorical in approach, that is, designed to serve carefully

defined groups, the activities of various programs often overlap.

The magnitude of the problem should not discourage efforts to reach the goal of onetime collection of the same or similar data from the same respondents. Grouping data in

a conceptual framework by the class of information collected and by type of respondent

would aid in identifying overlapping data collection activities. Careful analysis of total

costs for each project should indicate the most cost-effective methods for collecting necessary data.

Addressing the issue of overlapping data collection, the Commission on Federal

Paperwork advanced the concept of the “cognizant” agency (22). A “cognizant” agency is

the one assigned to lead data collection activities and provide appropriate data to other

Federal agencies collecting similar data. The Commission also advised that a separate

agency collect data that have applications for multiple users. Regarding the latter recom-
mendation, the Commission

Ch. 4—Structuring Coordination Activities ● 49

specifically mentioned the Bureau of the Census. However,

in the area of health statistics, -NCHS a-rid its program, the Cooperative Health Statistics

System q(CHSS), must also be considered as suitable candidates.

At present, OMB has the authority, provided by the Federal Reports Act, to designate a central collection agency; the Secretary of HEW also has the authority to coordinate statistical activities within the Department. OMB has recognized inefficiencies in

the statistical systems of HEW and has suggested organizational changes. In 1971, OMB

recommended that collection and processing of statistical information be combined in a

service-oriented data collection and processing center in HEW (20). Informational requests would be channeled to this center, which would then review these requests and

decide how they could best be fulfilled. The service center was intended to provide necessary statistical services, including staff and equipment, for the substantive program agencies throughout the Department. HEW did not reorganize, however, in response to the

OMB request. OMB maintains the principle that major and continuing multipurpose

data collections should be undertaken through statistical collection centers. However, it

traditionally has deferred responsibility to HEW for deciding agency roles in statistical

matters (26).

One attempt to coordinate HEW data activities through the Federal Reports Act

mechanism was successful. In 1968, OMB’S predecessor, the Bureau of the Budget,

assigned responsibility for a uniform and coordinated system of reports on family planning programs to the Office of the Assistant Secretary for Health. At that time, Federal

funds for programs in family planning were provided by at least four different Federal

agencies. Potential users of the data included a wide range of both public and private

groups. The Assistant Secretary delegated operating responsibility to q4NCHS, and a

uniform reporting system, which collected encounter data from both private and publicly

funded family planning clinics, was operational by 1972.

Data collected on hospital use is the most dramatic example of overlap in health data

collection systems. The Medicare administrative program, the Medicaid Management Information System (MMIS), the Professional Standards Review Organization (PSRO)

Management Information System (PMIS), the CHSS hospital care component, and the

NCHS Hospital Discharge Survey all collect discharge data concerning patients whose

hospital costs are reimbursed under Federal programs. Private organizations, such as insurance companies and abstracting services, also collect similar data.

Federal officials have long been aware of duplication in the collection of hospital use

data. However, as the requirements of each agency differed with respect to timeliness of

data reporting, completeness of coverage of hospitals and patients, and specificity of

data elements, consensus on a single data collector could not be obtained. Despite the

fact that the claims payment process in the Medicare program has been operational since

1966, planning and implementation of the other major data systems—MMIS, PMIS, and

the hospital care component of CHSS—occurred concurrently during the mid-seventies.

During this period, efforts were made to incorporate a core of common data elements,

the Uniform Hospital Discharge Data Set (UHDDS), into each system. In April 1975, the

Secretary of HEW approved the policy of implementing the UHDDS in all appropriate

Department data systems.

As of October 1978, none of the three newer data collection systems was operational

countrywide. * Total Federal expenditures through FY 1978 exceed $7 million for the

*Of a total 171 PSROS, 10.s had operating data systems (7); 17 States had an HEW-approved MMIS

(44); and the hospital care component of the CHSS was funded in 9 States (19).
PSRO data system and $3 million for the hospital care component of the CHSS (7, 19).

Information on costs for the hospital discharge data component of MMIS are unavailable. Under the MMIS program, the Federal Government provides matching grants to

States for the development and operation of the automated information system. Similarly, the Medicare program is unable to separate its statistical system costs from its

administrative costs for claims processing.

Because the agencies collecting discharge data are located in both the Health Care

Financing Administration (HCFA) and PHS, the Secretary of HEW is responsible for resolving conflicting interests. Under the Carter administration, the Secretary has actively

pursued a solution to this 6-year problem. HCFA and PHS submitted a joint memorandum of understanding on the subject to the Secretary in the spring of 1978. Lacking other

resources with unbiased interests, the Office of the Secretary sought technical advice and

options from two staff offices, the Assistant Secretary for Management and Budget

(ASMB) and the Assistant Secretary for Planning and Evaluation (ASPE). A tentative

decision regarding the method of collecting discharge data for Federal purposes was

reached in late summer, 1978; an implementation plan hopefully will be forthcoming.

Fortunately, such evident duplication does not characterize other components of the

Federal health statistical system, although there does appear to be redundancy in the activities of the Medicare and Medicaid programs, NCHS, the Bureau of Health Planning,

and the Bureau of Health Facilities regarding health facility data. The hospital discharge

data systems example, along with the one on family planning data, illustrate that if the

problem is of sufficient magnitude, action will be taken eventually. However, the

weaknesses of present policy mechanisms for combating such duplication are underscored in three respects.

First, there was a complete failure to address the duplication problem during the

planning period for the data collection systems. Planning for statistical projects proceeds

as an internal agency activity, and involvement by other levels of government usually

comes only at the later stages of the process when clearance is sought. In the case of the

hospital discharge data systems, officials were aware of the duplication problem during

the planning stages but unable to resolve the conflicts in perceived data needs among the

different agencies. Consequently, millions of taxpayer dollars were spent for data systems that, even today, do not meet total programmatic needs. If planned data collection

activities are not obviously overlapping, duplication may not even be recognized, much

less appropriately reduced.

Second, the attention, interest, and intervention of the Secretary of HEW was required before resolution of the problem began. Duplicative Federal hospital discharge

data systems have spanned three administrations. Knowledge and interest in the subject

have changed and hindered reaching what is basically a management decision. Secretarial involvement comes only when a binding decision is sought by agencies. If data systems are operating and meeting programmatic needs, the interests of the agencies are not

served by elevating the debate to the level of the Secretary.

Third, no impartial staff with statistical expertise and indepth knowledge about the

varying needs of programs were available to the Secretary when a decision was made to

act. Sporadic involvement of planning and management staff may be adequate in the

hospital discharge data systems case, but such erratic activity constitutes neither a timely

nor ongoing policy mechanism.
Ch. 4—Structuring Coordination Activities “ 51

Lack of Comparability

Numerous data collection systems, serving both general and programmatic needs,

are likely to continue given the decentralized nature of the health statistical system.

Much of the data now collected are of good quality, but their utility is seriously limited

by the inability to link data systems. Most analyses require more complete information

than any single data system is able to provide. For example, examining the use of U.S.

hospitals requires the integration of data from the American Hospital Association’s annual survey, the Medicare summary utilization file, and the NCHS Hospital Discharge

Survey.

There are at least two barriers to linking, or “networking,” data systems. First, the

majority of Federal health data systems are referenced to differing base populations (the

denominator figure in ratios). Again, the referencing difference results from the categorical approach of the Federal Government in targeting programs to particular groups,

facilities, or disease categories. Even with the general-purpose statistical program of

NCHS, researchers have difficulties linking data collected in surveys that use sampling

methods with mortality data, which are collected on the total U.S. population.

The linkage of data systems can be partially improved by referencing existing data

systems to national, regional, or local-area populations. However, the long-term solution to this problem is probably the creation of a totally integrated information system.

A technical panel of the National Committee on Vital and Health Statistics (NCVHS) is

developing criteria and guidelines for such an integrated system to be used under national

health insurance. The panel recommended in an interim statement that the information

system be population-based and have the ability to count “persons” (36). An information

system based on “persons” would not only allow calculation of rates for specific populations but also provide identifiers (such as Social Security numbers) that permit linkage to

measures of resources, use, costs, and health status.

A second barrier to linking heaIth data systems is the lack of common nomenclature,

definitions, codes, and units of measurement. It is difficult to assess program achievements, compare programs, or even relate data from a particular program to the situation

in the country generally without comparable terminology and measures. Standardization

is the critical prerequisite to this type of linkage.

The need for standard definitions in HEW data collection systems is highlighted by a

study conducted under the auspices of the Health Data Policy Committee (37). Forty-two

common data elements in 73 of HEW’s major repetitive statistical systems were analyzed

in the study. Over 800 variations were found in the way the data elements were collected

or displayed.

The Office of Federal Statistical Policy and Standards (OFSPS) in the Department of

Commerce is responsible for the development and implementation of statistical standards and guidelines. Excluding the designations for geographic areas and ethnicity, no

uniform definitions that are applicable in the health area have been issued as guidelines.

The Office of Statistical Policy (OSP), in the Office of Planning and Evaluation, serves as

a focal point for coordinating statistical standards within PHS. OSP has the authority to

mandate use of standards by agencies within PHS through the forms clearance procedure, but has no authority over Federal agencies outside PHS, such as those in HCFA.

OSP has only recently developed guidelines for eight data elements: sex, race, date of

birth, marital status, residence, date of admission, date of discharge, and type of ownership. These guidelines are expected to be promulgated through PHS reports clearance

channels in the near future.
52 ● part I_ Coord i

rla t ion ]Ssue s

A related effort in standardizing data is the development and implementation of uniform minimum data sets for well-defined substantive areas. These minimum data sets

represent the basic items of information considered useful by major providers and users

in a particular area of statistics. Each data element has a uniform, standard definition,

and as a group, these elements form a core of information that facilitates linkage among

data systems. The use of minimum data sets is a basic concept underlying CHSS, which

establishes an organizational mechanism for sharing data among multiple users.

Responsibilities for the minimum data sets are shared by a number of offices and

committees within HEW (31). NCVHS, through its technical subpanels, develops and

designs the minimum data sets. NCHS provides staffing and technical advice for these

groups. OSP has responsibility for promulgating the data sets within PHS once they have

been established as a policy of HEW. Finally, the departmentwide Health Data Advisory

Committee (HDAC) is supposed to provide leadership in advising the Secretary of HEW

on policy and procedures for the establishment, implementation, and review of the

minimum data sets. Only the Secretary has authority to approve the policy of implementing the minimum data sets throughout the Department. Both NCVHS and the Commission on Federal Paperwork have recommended that a single, central office have

responsibility for promulgating and monitoring implementation of all minimum data sets

(22, 33).

DATA AVAILABILITY

The third coordinative function is ensuring that the data collected in ongoing statistical projects are both accessible and responsive to the needs of potential users. Data dissemination and interpretive analyses normally are discrete from data collection. Efforts

to ensure that data are, in fact, analyzed and used should parallel activities designed to

improve the efficiency of data collection.

Most Federal agencies with large ongoing data projects conduct inhouse analyses

and publish statistical summaries for the public. Improvements have been made in the

dissemination of routinely collected data. An important example of improved dissemination efforts is the annual publication of Health, United States, a report mandated under

the Health Services Research, Health Statistics, and Medical Libraries Act of 1974. The

report, compiled jointly by NCHS and NCHSR, comprehensively addresses selected

health issues and relies on data sources throughout HEW.

Published statistical documents, however, often do not contain sufficient detail for

research and policy analyses. Computer tapes designed for public use provide the

greatest flexibility to users because they contain fully disaggregated microdata with individual identifiers removed. Obtaining computer tapes of disaggregated data, which are

not routinely made available by the sponsoring agency, presents many difficulties for

analysts. If special computer programing is required to merge data from several files, insurmountable problems may be encountered.

The statistical system of the Medicare program in HCFA illustrates problems of data

availability. Four basic data files, the enrollment file on eligibile beneficiaries, the file on

certified facilities, the hospital and skilled nursing facility use record, and the physician

payment record, form an extensive data base. These files can be linked through provider

and beneficiary identifiers and could potentially produce a wealth of information for

health care researchers and decisionmakers. Operating statistics, such as aggregate reimbursements by number of beneficiaries, are published monthly in the Social Security Bulletin-
Ch. 4—Structuring Coordination Activities ● 53

Ietin, and, periodically, summary volumes are produced for public use. Special statistical

tabulations are difficult, however, to obtain from these data. Thus a single user—the

Medicare program—defines what information is extracted from this large data base.

The Medicare program does attempt to accommodate the needs of other Federal programs and users. A special staff is maintained in the Office of Policy, Planning, and Research (OPPR) in HCFA to respond to individual requests. In 1978, over 2,000 requests

for data were promptly answered (6). In addition, the first set of statistical tables specifically designed for use by local-area PSROS and planning agencies was generated in

mid-1978 from the Medicare statistical system. Years of planning preceded the publication of this initial set of statistical tables that contained data for 1975. This lack of timeliness results partially from the technical problems of linking and merging large data files.

Administrative priorities within the Medicare program also function to constrain the

ready availability of data. Because statistical projects do not directly aid the primary

mission of the Medicare program, administrators who are involved with daily program

operations are sometimes unaware or unconvinced of the contribution that statistical efforts can make. As a result of increasing budgetary controls, administrative policy often

dictates that statistical operations have a low priority. Consequently, the research office

within the Medicare program, itself, has had periodic difficulties in obtaining computer

services for inhouse statistical analyses, and computer time for users outside the Medicare program has been extremely limited. Outside work is permitted only when it does

not interfere with program-related activities, and restrictions protecting the confidentiality of information preclude the release of unedited computer tapes (1). Under the reorganization that established HCFA in 1977, computer services for the Medicare statistical

program remained in the Social Security Administration (SSA). SSA does not have a formal statistical service function. The necessity of crossing bureaucratic lines to obtain data

will probably increase problems of availability in future statistical projects.

Like the Medicare statistical system, most other Federal statistical activities are components of larger programs. Programmatic statistical and data processing units increase

the utility of data tabulations and analyses for programmatic needs. Data usually are

gathered in response to expressed management interests; consequently, definitions and

data categories are tailored to specific problems. However, the availability and responsiveness of data decreases for users outside the organization. In light of the fact that each

program must pay for statistical services within the constraints of its overall budget,

statistical output and analyses not directly related to the program cannot be justified.

Even if a health data system is operated by a statistical agency, the program that

funds it determines its scope and viability. The National Reporting System for Family

Planning Services (NRSFPS) illustrates this point. As previously described, NCHS began

operating this system in 1972 because no single agency had responsibility for the diverse

Federal programs related to family planning services. Since 1972, most family planning

projects have been administratively reorganized under the Bureau of Community Health

Services (BCHS) in the Health Services Administration (HSA). Although the Planned

Parenthood Federation of America, a private organization, was a primary user of

NRSFPS, BCHS became its main source of funding. In 1976, BCHS paid three-quarters of

the total $1 million cost, NCHS funded the remainder and provided staffing.

A report by the General Accounting Office (GAO) in 1975 questioned the utility of

data produced in NRSFPS (46). It found that reports often were incomplete, inaccurate,

and tardy, and that many family planning projects did not participate in the system.

Moreover, KHS had no programmatic need for the detailed clinical data provided by

4(, -1,43 0 - 7 I - j
54 ● Part I--Coordination Issues

the system because the management needs of BCHS are met through another reporting

system. As a result, BCHS recommended adoption of a more economical sample system

that would permit better quality control. In 1977, the NRSFPS was converted to a sample

system; some observers question its continued survival (47).

Under the Budget and Accounting Procedures Act of 1950, OFSPS has the authority

to issue regulations for the improved analysis, publication, and dissemination of statistical information. OMB is mandated under the Federal Reports Act to ensure that information collected by Federal agencies is tabulated to maximize the usefulness of information

for other Federal agencies and for the public. OMB also has authority to require sharing

of information among agencies.

Although both OFSPS and OMB have responsibilities for statistical activities across

the Federal Government, neither organization has sufficient staff resources to adequately

address the problems of access in the area of health data. Furthermore, OMB’S involvement comes only when an agency seeks clearance for a data project. In the example of the

family planning reporting system, OMB did hold several special hearings before approving conversion to a sample system. However, OMB’S powers primarily reside in its ability to disapprove projects. OMB cannot force an agency to collect data for which it has

little or no use.

Improvements in data responsiveness and availability for the spectrum of users are

necessary to obtain maximum utility from data that are collected in the Federal statistical

system. Examination of a conceptual framework would allow identification of potential

users for various types of data. In addition, user requirements for reporting levels and

periods, timeliness, and other data specifications could be analyzed. If a central organization with adequate resources and sufficient authority over agency statistical activities

was established, it could implement the results of such analyses. In addition, data collection activities could be modified to meet the needs of multiple users. Arrangements also

could be made for sharing data among programs, and computer tapes with appropriate

specifications for authorized users could be provided automatically.

Excessive time lags in availability of data could be reduced if necessary resources,

such as personnel and computer services, were partially controlled by a central organization. If demands for statistical information were justified, additional facilities and manpower could be provided to the agencies processing data. Alternatively, processing of

multipurpose data could be done centrally in facilities designed for such purposes. Confidentiality provisions restricting use of agency data should be considered carefully under

the latter alternative.

CENTRAL COORDINATING UNIT

There is a clear need to assign formal responsibility for the functions relating to the

coordination of Federal health statistics. Agencies that independently operate programmatic statistical projects can neither resolve interagency jurisdictional disputes nor comprehensively address systemwide needs. Institutionalizing the coordinative functions

within the Federal bureaucracy will not solve all the problems associated with the fragmentation of the health statistical system. The complexity and breadth of Federal health

programs make solutions that are easy and widely accepted extremely difficult to attain.

Delineating clear lines of authority regarding statistical matters, however, would provide

the basis for more rational, knowledgeable, and impartial decisionmaking.
Ch. 4—Structuring Coordination Activities ● 55

The Regulatory Policy and Reports Management Division in OMB and the Office of

Federal Statistical Policy and Standards (OFSPS) in the Department of Commerce

together have sufficient statutory authority to conduct coordination activities. Their responsibilities extend over the entire Federal statistical establishment; yet, they have not

had the necessary resources for extensive involvement in subject areas or the data activities of individual departments. Reconstituting these offices only to improve statistical

operations in the health area is not a realistic option. The Commission on Federal Paperwork recommended that these offices should be strengthened and continue to monitor

departmental actions. However, the Commission also recommended assigning planning

and coordinating responsibilities to focal organizations within each department (23, 24).

There are a number of advantages to vesting authority over statistical matters in a

central coordinating body within HEW. An organization clearly responsible for coordinating statistical activities could at least ensure that appropriate activities are undertaken. A necessary degree of continuity and public accountability also would be provided by institutionalizing coordination responsibilities. The coordinating unit could

serve to encourage data users to participate in the Federal health statistical system. Users

could depend on this central coordinating body both to learn about the availability of

data and to mediate conflicting needs. The central unit could advocate and help ensure

balance and comprehensiveness in the Federal health statistical system.

A potential disadvantage to centralizing coordinative functions is decreased responsiveness to the substantive needs of program managers. Giving planning powers for

statistical operations to staff in an office that does not use data could reduce the relevance

and utility of the data collected. Professional statisticians are experts in the methods of

data collection, not in the use of statistics for decisionmaking purposes. Consequently,

trade-offs may be necessary between coordination and efficiency and programmatic

responsiveness.

Characteristics

A strengthened coordinating and planning unit within HEW should embody three

basic characteristics: sufficient authority to impose decisions on agencies, the necessary

statistical and analytical capabilities to conduct activities requiring technical expertise

and judgement, and adequate resources to build a viable core effort.

The coordination activities that require authority over Federal agencies are shown in

table 3. Statutory authority for such activities already is provided by the Federal Reports

Act and the Budget and Accounting Procedures Act (2, 4). These authorities could be

delegated either legislatively or administratively to an HEW coordinating unit. To exercise its authority effectively, the coordinating body should also have final responsibility

for, and control over, the statistical budgeting and the forms clearance procedures. The

ability to approve, veto, or reallocate resources among data collection projects is crucial

for setting priorities and planning rationally for a Federal health statistical system.

Moreover, giving control over the existing administrative tools to the coordinating body

would expedite the implementation of its decisions.

Table 3 also shows those coordination activities requiring technical skills. Planning,

managing, and coordinating the health statistical system is a staff function, and therefore, the quality and competence of personnel is essential. A critical level of manpower is

necessary to accomplish the various tasks associated with coordination activities. HEW

is bureaucratically complex, technically diverse, and politically dynamic. Staff of the

coordinating office need to be isolated from both operational and organizational pres-
—

56 ● Part I--Coordination Issues

Table 3.—Coordination Activities

Activities Requiring Authority Over Federai Agencies

●

●

●

●

●

●

●

●

●

●

Collect complete information on health data projects from Federal agencies.

Establish priorities for data collection projects.

Designate appropriate agencies to collect health data.

Modify, combine, or terminate data collection projects, or parts thereof, as necessary.

Initiate new data collect ion projects.

Determine and implement standards for terms, definitions, codes, and units of measurement for use in

health data projects.

Determine and implement uniform minimum data sets where appropriate.

Release health data and statistical information to appropriate users.

Detail technical support to agencies.

Allocate supplemental funds and manpower among agencies for data collection, processing, analysis, dissemination, and publication.

Activities Requiring Technical Capabilities

●

●

●

●

●

●

●

●

●

Develop conceptual framework for health statistics.

Collect and maintain information about health data projects.

Respond to requests for information about health data collection activities and data availability.

Examine existing data collection projects for duplication and inefficiencies.

Analyze alternatives for data collection to determine most cost-effective methods.

Conduct technical reviews of data projects for statistical methodology and quality; propose alternative

methodologies if suitable.

Develop standards for terms, definitions, codes, and units of measurement used in health data projects.

Identify user problems in areas of data responsiveness and access.

istical and other technical services for agencies.

sures. Addressing the lack of coordination in Federal statistical activities, past commissions have stressed the necessity of leadership by strong, independent professional staff

(15, 23, 24).

Adequate funding and staff resources are the third prerequisite for building an effective coordinating unit. To utilize existing statistical programs to the fullest possible extent, supplemental funds should be appropriated for discretionary use by the coordinating unit in an effort to realize systemwide goals. Such funds would support core

staff, provide extra resources to meet emerging statistical needs and fill gaps, and permit

flexibility in arrangements for integrating data sources and sharing data among programs.

In addition to a special appropriation, the central organization could manage funds

now allocated for the performance of multi-purpose data collection. At present, each

agency determines its own statistical needs and funds activities from its programs’

budgets. If an agency conducting a data project is also the sole Federal user of the

statistical product, that agency should fund and operate the data project. However, if

statistical information can be used by a number of agencies, the data project’s operating

costs should be shared. Channeling funds for such data systems through a central organization would facilitate the equitable distribution of costs for data collection, processing,

and dissemination among various Federal users. Federal agencies can now, and sometimes do, reimburse one another; but the necessity of negotiating and signing formal

agreements prolongs and complicates the process. If the central coordinating unit had the

authority to allocate funds, it could create an ongoing, simple administrative mechanism

for exchange among agencies and non-Federal public and private users.

The central organization should not only receive and disburse funds but also provide

statisticians on an as-needed basis to agencies requiring technical assistance in survey

design, computer programing, or special analyses of data. Restrictions on agency staffing
Ch. 4—Structuring Coordination Actiz?ities . 57

levels by the personnel system of the Federal Government currently limit opportunities

for transferring staff to different agencies as their programmatic needs change.

Designating specific staff positions in the central coordinating unit for such roving

assignments would alleviate this problem.

Location

A number of offices within HEW could possibly assume responsibilities for coordinating health statistics. The offices described below as possible alternatives should not

be considered mutually exclusive. Placing authority with several offices may be appropriate. Some activities for coordinating health statistics are already performed by offices in HEW. Different offices could be delegated responsibilities for activities requiring

authority over substantive program agencies and for activities requiring technical capabilities. No office now performs all the necessary tasks, and therefore, additional staff

and funding would be required regardless of which office or offices are selected. The fundamental requirement in assigning responsibility is an unambiguous mandate to manage

health statistics.

A New Office Within the Office of the Secretary. Establishing a new staff office that

reports directly to the Secretary of HEW would highlight the importance of coordinating

health statistics. Location in the Office of the Secretary would both facilitate necessary

negotiations with agencies outside HEW that collect health data and provide the necessary jurisdiction over the HEW bureaucratic hierarchy. An office whose sole function is

to coordinate health statistical activities would have no competing tasks and programs to

interfere with the fulfillment of its mission. Its decisions would not be biased by programmatic interests. However, the risk of politicizing coordinative activities is increased if

they are located in the Office of the Secretary. In addition, attracting skilled and knowledgeable personnel to an office without an established statistical and analytical reputation may be difficult, and building adequate resources is a lengthy process.

The Office of the Assistant Secretary for Management and Budget (ASMB). This Office has established ongoing relationships with the principal operating components in

HEW as well as with other departmental staff agencies. ASMB is responsible for making

recommendations to the Secretary concerning the allocation of budgeted funds to all programs in the Department. It also advises the Secretary on matters relating to the delegation of legislative authorities to HEW agencies. ASMB now functions as the final reports

clearance office for HEW. It also has major responsibilities in the area of automated data

processing. The Commission on Federal Paperwork has recommended that units coordinating the several functions relating to information resources management be placed in

offices, such as ASMB, that are responsible for general management (23). A possible

disadvantage of placing such units in ASMB is that this Office is budget-oriented and

might give statistical matters only secondary attention.

The Office of the Assistant Secretary for Planning and Evaluation (ASPE). Like

ASMB, ASPE is a staff office to the Secretary that has established communication lines

with agencies throughout HEW. It has experience in conducting objective policy analysis,

planning, and evaluation. However, in the area of health statistics, its responsibilities

have been limited. Before their transmittal to the Secretary, it reviews and comments on

major new data projects originating from the health bureaucracy. ASPE also conducts

some basic methodological research in the statistical area. ASPE’S major responsibility is

planning departmental initiatives for health programs and, therefore, it has some

substantive interests. As a result, it might not be impartial if it had responsibility for

determining statistical priorities among all programs.
The Office of Statistical Policy (OSP). The Public Health Service (PHS) is the principal operating component of HEW that is concerned with health matters; it operate: the

great majority of health statistical projects. OSP, as a staff office to the Surgeon General,

relates closely with the six PHS agencies. It is the final PHS reports clearance office. Furthermore, the Office now serves, at least nominally, as the departmental focal point for

the coordination of health data and statistical policy. The ability of OSP to effectivelyarbitrate disputes among agencies over statistical matters may be hindered, however, by its

position in the same administrative level as other operating components of HEW.

The National Center for Health Statistics (NCHS). NCHS is also in a staff office to

the Surgeon General. The advantages and disadvantages of its placement within the bureaucracy are similar to those of OSP. NCHS is described separately because it has the

largest number of health statisticians in HEW. For coordination activities requiring technical capabilities, it is the logical agency within which to place such responsibility. Furthermore, PHS has stated that NCHS should function as the key agency for coordinating

the collection of health statistics (3 I). NCHS now administers two programs designed to

improve the efficiency and coordination of health statistics: the Cooperative Health Statistics System (CCHS) and the Reimbursable Work Program (RWP). Also, legislation

passed in the 95th Congress, Public Law 95-623, apparently authorizes new responsibilities for NCHS in relation to setting standards and coordinating health statistical activities. In the past, however, NCHS has been unable to fulfill the coordinating role adequately (26). Agencies collecting data have sought advice from NCHS at their own discretion and on an irregular basis. Because NCHS itself operates large data collection projects, its ability to be impartial may also be questioned.
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The President’s Commission on Federal Statistics. Federal Statistics (vol. 1). U.S. Government Printing Office, 1971.

The President’s Reorganization Project for the Federal Statistical System. Federal Statistical

System Project: Issues and Options. Mimeographed. Nov. 30, 1978.

Reese, B. Regulatory Policy and Reports Management Division, Office of Management and

Budget. Interview, Oct. 25, 1977.

Rhode, W. National Institutes of Health, Public Health Service. Interview, Mar. 17, 1977.

Rice, D. National Center for Health Statistics, Public Health Service. Memorandum to the

Office of Technology Assessment. Washington, D. C., Nov. 16, 1978.

Shultz, G. P. Office of Management and Budget. “Reorganization of Federal Statistical Activities.” Memorandum to the Secretary of Health, Education, and Welfare, July 15, 1971.

Stambler, H. V. Bureau of Health Manpower, Public Health Service. Letter to the Office of

Technology Assessment. Washington, D. C., Jan. 12, 1979.

61
62 ● part ]—coordination Issues

22.

23.

24.

25.

26.

27.

28.

29.

30,

31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

U.S. Commission on Federal

ing Office, 1977.

Paperwork. Federal Health Programs. U.S. Government Print-

———. The Reports Clearance Process. U.S. Government Printing Office, 1977.

—––. Statistics. U.S. Government Printing Office, 1977.

U.S. Department of Commerce, Office of Federal Statistical Policy and Standards. “Federal

Statistics 1977. ” Statistical Reporter 78-5:121-140. U.S. Government Printing Office, February 1978.

———. Office of Federal Statistical Policy and Standards. A Framework for U.S. Federal Statistics for the 1980’s. U.S. Government Printing Office, 1978.

U.S. Department of Commerce and the Office of Management and Budget. “Memorandum of

Understanding Between the Department of Commerce and the Office of Management and

Budget Concerning Federal Statistical Policy Matters.” July 1978.

U.S. Department of Health, Education, and Welfare. “Charter, Health Data Advisory Committee. ” Washington, D. C., Feb. 3, 1979.

———. “Charter, Health Data Policy Committee.” Washington, D. C., Mar. 19, 1974.

———. “Charter, United States National Committee on Vital and Health Statistics. ” Washington, D. C., Dec. 19, 1974.

———0 “Department of Health, Education, and Welfare Report to Congress as Requested by

House Report No. 95-381.” February 1978.

———. Alcohol, Drug Abuse, and Mental Health Administration. ADAMHA: The Forward

Plan for FY 1979-83. Mimeographed. September 1977.

— — — National Center for Health Statistics. Annual Report of the United States National

Comrn;ttee on Vital and Health Statistics Fiscal Year 2977. Publication No. (PHS) 78-1205.

Hyattsville, Md., 1978.

———. National Center for Health Statistics. FY 1979-83 Forward PZan-NCZ-ZS. Manuscript.

1977.

———. National Center for Health Statistics. “Report of the Technical Consultant Panel on

Meeting Multiple Health Data Needs Through Modification of National and State Statistical

Programs.” Cooperative Health Statistics System Advisory Committee. Washington, D. C.,

May 1977.

———. National Committee on Vital and Health Statistics. “Information Needs on National

Health Insurance: A Statement of Principles and Issues. ” Technical Consultant Panel on Statistical Systems for National Health Insurance. Washington, D. C., January 1978.

–––. Office of Assistant Secretary for Health. “Evaluation of the Comparability of Health

Data Collected in Major Health Statistical Systems of the Department of Health, Education,

and Welfare. ” Moshman Associates. Washington, D. C., 1977.

———. Office of Assistant Secretary for Health and Office of Assistant Secretary for Planning and Evaluation. “Health Technology Management at the Department of Health, Education, and Welfare.” Final Phase I Report for the Secretary. Washington, D. C., 1977.

——— . Public Health Service. Forward Plan for Health, FY 1978-82. U.S. Government Printing Office, 1976.

———. Public Health Service. Health Statistics Plan, Fiscal Years 1976-1977. U.S. Government Printing Office, 1975.

———. Public Health Service. Health Statistics Plan, Fiscal Years 2978-82. U.S. Government

Printing Office, 1977.

——— Public Health Service, Health Statistics Report Fiscal Year 1978. U.S. Government

Printing Office, 1978.
References ● 6 3

43, ––– . Public Health Service. Public Health Service Organization Handbook. Mimeographed, February 1976.

44. U.S. General Accounting Office, Attainable Benefits of the Medicaid Management Information System Are Not Being Realized. Publication No. HRD 78-151. U.S. General Accounting

Office, Washington, D. C., Sept. 26, 1978.

45. –——. Better Communication, Cooperation, and Coordination Needed in Department of

Defense Development of Its Tri-Sewice Medical Information System Program. Publication

No. LCD-76-117. U.S. General Accounting Office, Washington, D. C., 1976.

46. ———. Zmproving Federally Assisted Family Planning Programs, Department of Health,

Education, and Welfare. Publication No. MWD 75-25. U.S. GeneraI Accounting Office,

Washington, D. C., Apr. 15, 1975.

47. Wunderlich, G. Office of Health Policy, Research, and Statistics, Public Health Service. Letter to the Office of Technology Assessment. Washington, D. C., Aug. 18, 1978.

48. ———. Office of Health Policy, Research, and Statistics, Public Health Service. Letter to the

Office of Technology Assessment. Washington, D. C., Nov. 15, 1978.
Part II

Directory of

Statutory Authorities for the

Collection of Health Data

Public Health Service and

Health Care Financing Administration

Through January 15,1979
CONTENTS

SUMMARY

Introduction. . . . . . . . . . . . . . . . . . . . . ., . . .

Scope and Definitions . . . . . . . . . . . . . . . . . . .

Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . .

MandatotyorDiscretionaryDataCollection . . .

DelegatedAuthorities . . . . . . . . . . . . . . . . .

Overlapping LegislativeRequirements . . . . . .

Congressional Intent. .. . $ . . . . . . . . . . . . .

Coordination Requirements . . . . . . . . . . . . .

Reporting Burden.., . . . . . . . . . . . . . . . . .

User’s Guide and Methodology, . . . . . . . . . . . .

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . .

GLOSSARY OF TERMS. . . . . . . . . . . . . . . . . . . .

DIRECTORY LISTING . . . . . . . . . . . . . . . . . . . . .

L

A.

B.

c.

D.

E.

F.

Il.

A.

B.

c.

IIL

A.

B.

Iv.

A.

B.

c.

D.

E.

Office of Assistant Secretaryfor

Health . . . . . . . . . . . . . . . . . . . . . . . . .

General Authority Applicable to all Public

Health Service Agencies. . . . . . . . . . . . .

Health Maintenance Organizations . . . . . .

Office ofAdolescentPregnancyPrograms .

Office of Disease Prevention and Health

Promotion, ....... ... . . . . . . . . . . . . . . . .

l. Office of Health Information, Health

Promotion, and Physical Fitness and

Sports Medicine . . . . . . . . . . . . . . . .

Office of Smoking and Health. . . . . . . . . .

Office of Health Research, Statistics and

Technology, . . . . . . . . . . . . . . . . . . . . .

1. National Center forHealth Care

Technology . . . . . . . . . . . . . . . . . . . .

2. National Center forHealth Services

Research, . . . . . . . . . . . . . . . . . . . .

3. National Center for Health Statistics . . .

Alchol DrugAbuse,and Mental Health

Administration . . . . . . . . . . . . . . . . . . . .

National lnstitute on Alchol Abuse and

Alcoholism ......,. . . . . . . . . . . . . . .

National lnstitute on Drug Abuse .,...,.

National lnstituteof Mental Health . . . . . .

CENTER FOR DISEASE CONTROL . . ...:.....

Center for Disease Control-GeneralJy. . . .

National lnstitute for Occupational Safety

andHealth . . . . . . . . . . . . . . . . . . . . . .

Food and Drug Administration. . . . . . . . .

General Authority Applicable toall FDA

Bureaus ......,.. . . . . . . . . . . . . . . .

Bureau of Biologics . . . . . . . . . . . . . . . .

Bureau of Drugs . . . . . . . . . . . . . . . . . .

Bureau of Foods . . . . . . . . . . . . . . . . . .

Page

67

67

72

72

73

73

74

76

77

79

80

80

81

81

81

82

82

83

83

88

88

88

91

94

10!I

109

110

115

119

119

126

135

135

135

135

138

Bureau of Medical Devices . . . . . . . . . . . 140

F.

G.

v.

A.

B.

c.

VL

A.

B.

c.

WI.

A.

B.

c.

D.

E.

F.

G.

H.

1.

J.

K.

L.

M.

N.

VIII.

A.

B,

c.

D.

-.

Page

Bureau of Radiological Health . . . . . . . . . 142

Bureau of Veterinary Medicine. . . . . . . . . 146

Heatth Resources Administration. . . . . . . 147

Bureau of Health Facilities Financing,

Compliance,and Conversion. . . . . . . . . . 147

Bureau of Health Manpower . . . . . . . . . . 148

Bureau of Health Planning. . . . . . . . . . . . 154

Health Services Administration . . . . . . . . 159

Bureau of Community Health Services . . . 159

1,

2.

3<

4.

5!

6.

7,

8.

Community Health Centers . . . . . . . . . 159

Family Planning . . . . . . . . . . . . . . . . 160

Genetic Diseases, Hemophilia ,and

Sudden lnfant Death Syndrome. . . . . . 161

Health Underserved Rura lAreas . . . . . 163

Maternal and Child Health . . . . . . . . . 165

Migrant Health . . . . . . . . . . . . . . . . . 166

National Health Service Corps. . . . . . . 167

Office of State Program Coordination:

Grants to States . . . . . . . . . . . . . . . .

Bureau of Medical Services. . . . . . . . . . .

1. Emergency Medical Services . . . . . . .

2. Public Health Service Hospitals . . . . . .

Indian Health Service. . . . . . . . . . . . . . .

National Institutes of Health . . . . . . . . . .

General Authority Applicable toall NIH

Institutes . . . . . . . . . . . . . . . . . . . . . . .

Fogarty International Center . . . . . . . . . .

National Cancer Institute. . . . . . . . . . . . .

National Eye Institute . . . . . . . . . . . . . . .

National Heart, Lung, and Blood Institute.

National Institution Aging . . . ., . . . . . ,

National Institute of Allergy and Infectious

Diseases, . . . . . . . . . . . . . . . . . . . . . . .

National Institute of Arthritis, Metabolism,

and Digestive Diseases. . . . . . . . . . . . . .

National Institute of Child Health and

Human Development . . . ... , . . . . . . . .

National Institute of Dental Research ... ,

National Institute of Environmental Health

Sciences . . . . . . . . . . . . . . . . . . . . . . .

National Institute of General Medical

Sciences . . . . . . . . . . . . . . . . . . . . ., .

National Institute of Neurological and

Communicative Disorders and Stroke. . . .

National Library of Medicine ., . . . . . . . .

Health Care Financing Administration . . . .

Office of the Administrator. . . . . . . . . . . .

1. Office of Policy, Planning, and Research

Health Standards and Quality Bureau . . . .

Medicaid . . . . . . . . . . . . . . . . . . . . . . .

Medicare . . . . . . . . . . . . . , . . . ., ., . .

169

172

172

174

174

176

176

177

178

180

I

181 ,

183 1

i

184

187

188 ‘

191 1

191

193

193

193

199

202

204

index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209
Summary

INTRODUCTION

This section of the report is a directory of statutory authorities that may be used to

authorize the collection of health data within the two principal health-related operating

components of the Department of Health, Education, and Welfare (HEW), the primary

collector of Federal health data. Legislation establishing new health programs or supplementing existing programs frequently contains data requirements. Some statutes even

specify the office or entity responsible for collecting new data. These statutes may cause

responsible agencies to collect data that are the same, or similar to, data currently being

gathered. Federal agencies, such as HEW, frequently cite such legislative requirements as

the reason for the proliferation of health data systems (1, 2, 3). Executive officials also

argue that the legislation, not its implementation, causes the coordination and planning

problems discussed in Part I of this report.

The primary goal of Part II is to determine the extent to which legislation creates or

exacerbates fragmentation and duplication in Federal health data collection. The directory is designed to 1) present the relevant statutory authorities that support HEW data

collection activities, 2) provide a reference of existing authorities that Members of Congress may consult before passing new data requirements, 3) allow executive agencies to

match current data systems with legislative authorities for coordination and planning

purposes, and 4) analyze what influence these authorities have had in intensifying the

problems that currently characterize HEW data collection.

Addressing the issue of legislative influence in creating problems within the Federal

health statistical system initially requires the compilation of all relevant statutory

authorities for Federal data collection. This document is designed to make a major contribution to such a compilation. Specifically, the directory lists data collection authorities

for agencies within the Public Health Service (PHS) and the Health Care Financing Administration (HCFA). Legislative authorities for the collection of health-related data in

other Federal departments and agencies, particularly the Departments of Defense

(D O D), Labor (DOL), Agriculture (USDA), Interior, Justice, and the Veterans Administration (VA), the Environmental Protection Agency (EPA), and the Consumer Product Safety Commission (CPSC) are not listed.

SCOPE AND DEFINITIONS

The purpose and design of this directory dictate the use of a broad definition of

“health data.” The terms “data,” “information,” and “statistics” are considered

synonymous. Health data are information describing the health status of people, their

use of medical care services and resources, and the costs and sources of funding for these

services. Data relating to health effects of the workplace and the environment, diseases,

health problems, and health conditions are included in this definition. Finally, data on

public knowledge and attitudes about health, perceived health needs, and behavior

related to health, health care, and health practices are also included.

The directory focuses on legislation that may generate health data collection. The

terms “legislation,” “sections,” and “statutory authorities” are used interchangeably.

Statutes chosen by OTA for inclusion in this document reflect a loose interpretation of

the way in which legislation can “authorize” data collection. Legislation that either

67
68 . part I] —Directory of Statutory Authorities

directly or indirectly specifies any action resulting in health data collection is listed. Some

statutory sections are explicit in mandating the collection of information (for example,

sec. 438 of the Public Health Service Act, 42 U.S. C. $289c-5, which establishes an Arthritis Data System); other authorities are more indirect. General program mandates to conduct research, for example, are frequently cited by agencies as authorizing the collection

of certain statistics and are, therefore, listed in this directory.

Agency use of general program mandates to authorize data collection is justified by

the legal principle of delegation of authority. This principle holds that explicit authority

to perform an act is generally accompanied by implied authority to fulfill any subsidiary

tasks necessary to complete the act. Data collection is often viewed as such a subsidiary

function.

Three criteria were used to determine the type of statutory requirements included in

this directory. First, statutory requirements that result in data that will be used exclusively for administrative or managerial purposes, such as program budgeting, grants management, and personnel payroll data, are excluded. However, data used primarily for administrative purposes may serve several other functions; for example, they also may provide useful information about topics such as health status. Legislation that authorizes the

collection of data that may be used for a variety of health-related purposes are contained

here.

Second, OTA focused on requirements for data used primarily by the Federal Government. Consequently, statutory requirements for data collection at the non-Federal

level are included only if all, or part, of the data are ultimately channeled to HEW, or, at

least, are available for Federal Government use.

Third, statutes authorizing one-time data collection with a specific deadline, at

which point the legislative authority expires, are excluded except in cases where the data

can be accessed subsequently. An example of this type of authority is section sos of the

Federal Food, Drug and Cosmetic Act (21 U.S.C. §355). This section explicitly requires

investigators to include certain information in new drug applications to the Food and

Drug Administration (FDA). The application itself is a single-time endeavor. FDA, however, retains the information, thereby creating a data base on the safety and efficacy of

new drugs. The directory concentrates on ongoing and repetitive data activities because

these have the greatest potential for being coordinated. -

OTA classified the statutory authorities that meet these three criteria

types to determine the extent of congressionally mandated data collection.

types are specific, general, and implied authorities.

into three

The three

Specific authority explicitly mandates (1) the initiation of a data collection system

and/or (2) the collection of explicitly identified data.

General authority mandates the performance of a function, such as research or the

preparation of a report, that requires the collection of original data. The required data,

however, are not identified; only the subject area for which the data are to be gathered is

indicated.

Implied authority mandates a particular function that may require collecting

original data if the data necessary to fulfill the function are unavailable. Examples are

mandates to establish information clearinghouses, disseminate information about particular topics, or prepare reports summarizing available data.
Summary ● 6 9

Tables 1, 2, and 3 below, catalog the specific, general, and implied authorities listed

in this directory according to United States Code citation and administering agency.

Table l.— List of Specific Authorities and Administering Agencies

U.S. Code citation Administering agency U.S. Code citation Administering agency

15 USC $793 . . . . . . NIH (NIEHS)

21 USC $346a . . . . . FDA (BF) & EPA

21 USC ~348 . . . . . . FDA (BF)

21 USC $355 . . . . . . FDA (BD)

21 Usc 51173 . . . .. ADAMHA (NIDA)

21 USC $1176 , . . . . ADAMHA (NIDA)

25 USC $1653 . . . . . HSA (IHS)

29 USC $657 . . . . . .CDC (NIOSH) & DOL

29 USC $669 . . . . . .CDC (NIOSH) & DOL

29 USC $673 . . . . . .CDC (NIOSH) & DOL

30 USC S813 . . . . . .CDC (NIOSH) & DOL

30 USC $843 . . . . . . CDC (NIOSH) & DOL

30 Usc $951 . . . . . .CDS (NIOSH) & DOI

42 USC $241(b)(4) . . NIH (NCI)

42 USC $242 b(a-c) . . OASH (NCHS) &

(NCHSR) & (NCHCT)

42 USC $242b(e) . . . OASH (NCHS)

42 USC $242k . . . . . OASH (NCHS)

42 USC $242m(a). . . OASH (NCHS) &

(NCHSR)

42 USC $242p . . . . . OASH (NCHS)

42 USC $ 246(ci) . . . .CDC & HSA (BCHS)

42 USC $246(g) . . . . ADAMHA (NIMH)

42 USC S247a note. . NIH (NIEHS)

42 USC S247C. . . . . . CDC

42 USC $247d . . . . . HSA (BCHS)

42 USC $254c. . . . . . HSA (BCHS)

42 USC $254f . . . . . . HRA (BHM) & HSA

(BCHS)

42 USC s254i . . . . . . HRA (BHM) & HSA

(BCHS)

42 USC ~263e. . . . . . FDA (BRH)

42 USC ~263/ . . . . . . FDA (BRH)

42 USC 45285 . . . . . . NIH (NCI)

42 USC $289c-5 . . . . NIH (NIAMDD)

42 USC $289k-4 . . . . NIH (NIA)

42 USC $291d . . . . . HRA (BHF)

42 USC $292h . . . . . OASH (NCHS) & HRA

(BHM)

42 USC $295h-2 . . . . OASH (NCHS) & HRA

(BHM)

42 USC ~295h-4 . . . . OASH (NCHS) & HRA

(BHM)

42 USC $296 note, . . HRA (BHM)

42 USC $300a-6a . . . HSA (BCHS)

42 USC $300a-26 . . . OASH (OAPP)

42 USC $300 b-6 . . . .CDC & HSA (BCHS)

42 USC S300d-5 . . . . HSA (BMS)

42 USC $300d-7 . . . . HSA (BMS)

42 USC $300e. . . . . . OASH (HMO)

42 USC ~300/-2 . . . . OASH (NCHS) & HRA

(BHP)

42 USC ~300n-2 . . . . HRA (BMP)

42 USC $300n-2(d). . HCFA (OPPR)

42 USC ~300n-4 . . . . HRA (BHP)

42 USC $j3000-2 . . . . HRA (BHF)

42 USC $300u-l(b) . . OASH (ODPHP) & CDC

42 USC $300u-4 . . . . OASH (ODPHP) & CDC

42 USC $1320a. . . . . OASH (NCHS) & HCFA

42 USC $1320c-5 . . . HCFA (HSQB)

42 USC $1320c-21 . . HCFA (HSQB)

42 USC $1395x. . . . . HCFA (OPPR) ‘

42 USC ~1395rr . . . . HCFA (Medicare)

42 USC $1396a. . . . . HCFA (Medicaid)

42 USC ~2689 . . . . . ADAMHA (NIMH)

42 USC $2689e. . . . . ADAMHA (NIMH)

42 USC $2689q . . . . ADAMHA (NIMH)

42 USC $4585 . . . . . ADAMHA (NIAAA)

./I) -f! ‘/J () - 7’+ - 1)
TO . Part Z1—Director y of Statutory Authorities

Table 2.—List of General Authorities and Administering Agencies

U.S. Code citation Administering agency U.S. Code citation Administering agency

21 USC $355 . . . . . . FDA (BD)

21 USC $357 . . . . . . FDA (BD)

21 USC $360b . . . . . FDA (BVD)

21 USC ~360i . . . . . . FDA (BMD)

21 USC $360j . . . . . . FDA (BMD)

21 USC $1164 . . . . . ADAMHA (NIDA)

21 USC $1172 . . . . . ADAMHA (NIDA)

21 USC $1176 . . . . . ADAMHA (NIDA)

21 USC ~1191 . . . . . ADAMHA (NIDA)

22 USC $2103 . . . . . NIH (Fogarty

International Center)

25 USC $1655 . . . . . HSA (IHS)

29 USC $669 . . . . . . CDC (NIOSH) & DOL

29 USC ~71 . . . . . . CDC (NIOSH)

29 USC $813 . . . . . . CDC (NIOSH) & DOL

42 USC s218(e) . . . . ADAMHA (NIDA)

42 USC $241(a) . . . . OASH

42 USC $241(b)(l) . . NIH (NCI)

42 Usc

~241(b)(2),(3) . . . . NIH (Director’s Office)

42 USC $242 . . . . . . ADAMHA (NIDA) &

FDA & DEA

42 USC $242a . . . . . ADAMHA (NIDA) &

(NIMH) & FDA

42 USC ~242c. . . . . . OASH (NCHSR)

42 USC 52421 . . . . . . CDC

42 USC $242n . . . . . OASH (NCHCT)

42 USC $247b . . . . . CDC & HSA (BCHS)

42 USC $247b-2 . . . . OASH (OSH) &

ADAMHA (NIAAA)

42 USC $247d . . . . . HSA (BCHS)

42 USC ~256 . . . . . . HSA (BCHS)

42 USC ~263a . . . . . HCFA (HSQB) & CDC

42 USC ~263d . . . . . FDA (BRH)

42 USC ~263i . . . . . . FDA (BRH)

42 USC $268 . . . . . . CDC

42 USC ~282 . . . . . . NIH (NCI)

42 USC $287a . . . . . NIH (NHLBI)

42 USC $287b . . . . . NIH (NHLBI)

42 USC ~287h . . . . . NIH (NHLBI)

42 USC $288a ., . . . NIH (NIDR)

42 USC $288b . . . . . NIH (NIDR)

42 USC ~289c-1 . . . . NIH (NIAMDD)

42 USC $289c-2 . . . . NIH (NIAMDD)

42 USC s289c-3a . . . NIH (NIAMDD)

42 USC ~289c-6 . . . . NIH (NIAMDD)

42 USC ~289c-7 . . . . NIH (NIAMDD)

42 USC $289d . . . . . NIH (NICHD)

42 USC $289k . . . . . NIH (NEI)

42 USC ~289k4 . . . . NIH (NIA)

42 USC ~291d . . . . . HRA (BHF)

42 USC $295g-1 . . . . HRA (BHM)

42 USC ~300a-2 . . . . HSA (BCHS) & NIH

(NICHD)

42 USC ~300b . . . . . HSA (BCHS)

42 USC ~300b-1 . . . . HSA (BCHS) & NIH

(NIGMS)

42 USC ~300c-11 . . . HSA (BCHS)

42 USC ~300d-4 . . . . HSA (BMS)

42 USC $300d-21 . . . HSA (BMS) & NIH

(NIGMS)

42 USC $300e-14 . . . OASH (HMO)

42 USC ~300f-2 . . . . OASH (NCHS) & HRA

(BHP)

42 USC $300m-1 . . . OASH (NCHS) & HRA

(BHP)

42 USC ~300u . . . . . OASH (ODPHP) & CDC

42 USC $300u-l(a). . OASH (ODPHP) & CDC

42 USC $300u-3 . . . . OASH (ODPHP) & CDC

42 Usc 5300U-5 . . . . OASH (ODPHP)

42 USC $300u-8 ., . . OASH (ODPHP)

42 USC $705 . . . . . . HSA (BCHS)

42 USC $713 . . . . . . HSA (BCHS)

42 USC $1312 . . . . . HSA (BCHS)

42 USC $1320c-4 . . . HCFA (HSQB)

42 USC $1320c-12 . . HCFA (HSQB)

42 USC $1320c-20 . . HCFA (HSQB)

42 USC $139sh . . . . HCFA (Medicare)

42 USC $1395u . . . . HCFA (Medicare)

42 USC s1395kk . . . HCFA (Medicare)

42 USC ~1395// . . . . HCFA (Medicare)

42 USC ~1395rr . . . . HCFA (Medicare)

42 USC $1396a. . . . . HCFA (Medicaid)

42 USC 94551 . . . . . ADAMHA (NIAAA)

42 USC $4821 . . . . . CDC & HUD

Agencies listed within parentheses are components of the larger HEW agencies listed on their left
Summary “ 71

Table 3.—List of Implied Authorities and Administering Agencies

U.S. Code citation Administering agency U.S. Code citation Administering agency

15 USC $1337 . . . . . OASH (OSH)

21 USC $360c. . . . . . FDA (BMD)

21 USC $360j . . . . . . FDA (BMD)

21 USC $375 . . . . . . FDA (General)

21 USC S376 . . . . . . FDA (BF)

21 USC $1177 . . . . . ADAMHA (NIDA)

21 Usc $1191 . . . . . ADAMHA (NIDA )

21 USC $1192 . . . . . ADAMHA (NIDA)

25 USC $1653 . . . . . HSA (IHS)

29 USC %75 . . . . . . CDC (NIOSH) & DOL

30 USC $811 . . . . . . CDC (NIOSH) & DOL

30 USC ~936 . . . . . . CDC (NIOSH)

30 USC $958 . . . . . . CDS (NIOSH)

42 USC $218(c)(2) . . ADAMHA (NIMH)

42 USC $j218(d) . . . . ADAMHA (NIAAA )

42 USC $242 note. . . ADAMHA (NIDA)

42 USC $242m (a) . . OASH (NCHS) &

(NCHSR)

42 USC $242m(g). . . OASH (NCHSR)

42 USC $2420 . . . . . OASH (General)

42 USC $248 . . . . . . HSA (BMS)

42 USC $254c. . . . . . HSA (BCHS)

42 USC $254e. . . . . . HRA (BHM) & HSA

(BCHS)

42 USC s254i . . . . . . HRA (BHM) & HSA

(BCHS)

42 USC $262 . . . . . . FDA (BoB)

42 USC $263 . . . . . . FDA (BRH)

42 USC $280b . . . . . NIH (NLM)

42 USC $280b-5 . . . . NIH (NLM)

42 USC $280b-9 . . . . NIH (NLM)

42 USC $284 . . . . . . NIH (NCI)

42 USC ~287b . . . . . NIH (NHLBI

42 USC $287g . . . . . NIH (NHLBI

42 USC S288C. . . . . . NIH (NIDR)

42 USC ~289a(a) . . . NIH (NIAMDD) &

(NINCDS)

42 USC ~289a(b) . . . NIH (General)

42 USC ~289c. . . . . . NIH (General)

42 USC ~289c-3a . . . NIH (NIAMDD)

42 USC ~289c-6 . . . . NIH (NIAMDD)

42 USC s289d . . . . . NIH (NICHD)

42 USC $289e. . . . . . NIH (NIEHS)

42 USC $289i . . . . . . NIH (NEI)

42 USC $289k-1 . . . . ADAMHA (NIMH)

42 USC $289k-4 . . . . NIH (NIA)

42 USC ~300a-3 . . . . HSA (BCHS)

42 USC ~300d-9 . . . . HSA (BMS)

42 USC $3001-2 . . . . OASH (NCHS’

(BHP)

42 USC ~300m-1 . . . OASH (NCHS

(BHP)

42 USC $300m-2 . . . HRA (BHP)

42 USC $300m-3 . . . HRA (BHP)

42 USC $300n-2. . . . HRA (BHP)

& HRA

& HRA

42 USC ~300u . . . . . OASH (ODPHP) & CDC

42 USC ~300u-l(a). . OASH (ODPHP) & CDC

42 USC $300u-3 . . . . OASH (ODPHP) & CDC

42 Usc $300U-4 . . . . OASH (ODPHP)

42 USC $300u-5 . . . . OASH (ODPHP)

42 USC $300u-8 . . . . OASH (ODPHP)

42 USC ~712 , . . . . . HSA (BCHS)

42 USC ~1306 . . . . . HCFA (Medicare),

(Medicaid), (HSQB)

42 USC $1320c-5 . . . HCFA (HSQB)

42 USC $1395b-1 . . . HCFA (OPPR)

42 Usc 51395X

note 1. . . . . . . . . . HCFA (OPPR)

42 USC ~1320x

note 2. . . . . . . . . . HSA (BCHS)

42 USC $1396b . . . . HCFA (Medicaid)

42 USC ~1396g. . . . . HCFA (Medicaid)

42 USC s2689q . . . . ADAMHA (NIMI-)

42 USC &4551 ‘. ... , ADAMHA (NIAAA)

42 USC $4552 . . . . . ADAMHA (NIAAA)

42 USC $7454 . . . . . NIH (NCI) & (NIEHS) &

EPA

Agencies Iisted within parentheses are components of the larger HEW agencies Iisted on their left
72 ● part ]~—~irectory iiof Statutory Authorities

FINDINGS

The degree to which legislative authorities create problems in Federal health data

collection activities is examined broadly in terms of six issue areas. Findings in each of

the six areas are discussed briefly below. Stated as questions, the six issues are:

1. Does legislation mandate or simply allow data collection?

2. How are legislative authorities delegated to agencies within HEW?

3. Are there overlapping legislative requirements for the collection of health data?

4. What is the intent of Congress in requiring specific data collections?

5. Does legislation contain requirements for coordinating data collection?

6. Does legislation consider the extent of reporting burden on respondents?

Mandatory or Discretionary Data Collection

OTA analyzed the legislative language to determine the degree to which data collection is allowed or required. Based on the specificity of the language supporting agencies’

data collection, the 169 statutes listed in this directory are classified as specific, general,

or implied authorities to collect certain data (see definitions above). The language also

was examined to determine whether a statute states that data “shall, ” rather than “may,”

be collected. Language in a specific authority stating that data “shall” be collected was

regarded as mandating data acquisition.

The largest number of authorities are either general or implied and allow, rather

than require, data collection. There are 75 general and 67 implied authorities cited in this

directory. Every Federal agency administers at least one general or one implied authority

and, therefore, has some statutory basis for justifying its data collection activities.

Many of these statutes begin with the word “shall,” but do not identify a data collection system or mandate the collection of a particular type of health data. Most general

and implied authorities are mandatory only with respect to functions other than data collection, such as research. Consequently, causal relationships between these legislative authorities and the data systems described in Part I are, at best, weak. The existence of a

general or implied authority to collect data does not necessarily lead to the creation, or

signify the existence, of a data collection system. Conversely, agencies may use these authorities to generate large and complex data systems. For example, the Medicare Program in the Health Care Financing Administration (HCFA) operates an extensive statistical program that uses a single general authority, 42 U.S. C. $139511, as its legislative

mandate. An agency’s resources and internal priorities, rather than legislative directive,

often determine the existence and scope of its data collection activities.

OTA determined that 60 sections, or 36 percent, of the 169 authorities listed in this

directory are specific. The majority of authorities classified as specific state that data

“shall” or “must” be collected and are, therefore, considered mandatory. The legislative

mandate to establish an end stage renal disease medical information system (ESRD MIS)

is an example of such a specific authority (42 U. S.C. $1395rr). It states that the Secretary
shall

Summary ● 7 3

submit an annual report to Congress on the end stage renal disease program that includes, for example, data on the number of patients on dialysis, the number and use of facilities providing dialysis, the number of patients awaiting kidney transplants, patient

mortality and morbidity rates, the costs of kidney acquisition, and the number of facilities providing transplants.

Legislation specifying the kinds and types of data to be collected is a relatively new

phenomenon in Congress. Only nine of the specific authorities listed in this directory

originated in legislation passed before 1970. Conversely, almost every law with data requirements passed in this decade enumerates the class of data required.

Twenty-eight agencies within HEW have responsibilities for fulfilling the requirements of the 60 specific sections. Thirteen of these sections are jointly administered by at

least two agencies within HEW; responsibility for seven more sections is shared with several other departments and agencies, such as the Departments of Labor and Interior and

the EPA.

Delegated Authorities

Congress occasionally indicates which agency within HEW is responsible for collecting data required by legislation. However, broad mandates usually are given to the

Secretary or, in some instances, to the Surgeon General, either of whom delegates responsibility to the administrative unit deemed appropriate. Forty-two of the 169 statutes

authorize particular agencies to collect health data. The Occupational Safety and Health

Act of 1970, for example, specifically directs the National Institute for Occupational

Safety and Health (NIOSH) to conduct industrywide studies on the effects of chronic exposures to certain industrial materials (29 U.S. C. $669 and 671). In contrast, 51 statutory

sections direct recipients of Federal funds, such as grantees, contractors, State agencies,

and advisory councils, rather than particular agencies, to collect data. For example,

migrant health centers (42 U.S. C. 247d), community health centers (42 U.S. C. $254c),

and health maintenance organizations (42 U.S. C. $300e) are all required by statute to develop effective recordkeeping procedures for reporting program-related information to

the Secretary of HEW.

The majority of legislative authorities are delegated by the Secretary of HEW, who

is guided by the recommendations of the Assistant Secretary for Management and

Budget (ASMB), an HEW staff office. The Secretary enjoys a great deal of latitude in

delegating data collection authorities, and no policy precludes separating data collection

responsibilities from other program responsibilities. However, the Secretary usually

delegates data authorities to agencies responsible for program administration, and only

29 of the 169 statutory authorities relating to health data collection are jointly delegated

by the Secretary to two agencies within HEW. Hence, the role legislation plays in determining the agency responsible for and the method of administering data collection

authorities is relatively minor.

Overlapping Legislative Requirements

Using statutory authorities to determine the extent of overlap in the data collection

projects of various agencies is difficult because the required data elements are not usually

itemized in the legislation, even in specific authority sections. This directory illustrates

the diversity of legislative language authorizing data collections; legislation requiring

research to be conducted, questions to be answered, or, more infrequently, recordkeeping systems to be established may justify creating new health data systems. The texts of
74 ● part ]Z—Directory of Statutory Authorities

authorizing legislation are often too imprecise to determine whether such authorities

result in duplicative data collection activities.

OTA reviewed this directory for statutory authorities that are obviously duplicative. Although several such instances were found, multiple sections authorizing precisely

the same data requirements are rare. An example of such exact duplication are the two

legislative sections authorizing the collection of information relating to the causes of sudden infant death syndrome (SIDS). One section is delegated to the National Institute of

Child Health and Human Development (NICHD) (42 U.S.C. ~289d) and the other, to the

Bureau of Community Health Services (BCHS) (42 U.S.C. $300c-11). However, considerable leeway exists in the interpretation and implementation of statutory requirements.

Even in cases where statutes mimic one another, the information obtained by agencies

may be quite different. This diversity reflects different agency needs and responsibilities.

Comparing legislative authorities can serve as the starting point for grouping potentially overlapping data activities. Each agency’s statutory requirements for data collection can then be evaluated systematically in terms of existing data projects. OTA used a

category of data, health effects of the environment, to illustrate this approach to identifying potential overlap in data collection activities. Because broad terminology is used in

legislative language, a class of information like environmental data is a good basis for

analysis. Environmental data include a range of subjects and are parallel to data

categories such as health manpower or health status.

Environmental data were chosen, moreover, because they are collected primarily by

agencies outside HEW. However, OTA did identify 20 HEW statutory authorities that

reference either the term “environmental data” or data primarily considered part of the

environment category. A summary of the legislative authorities for HEW agencies is

shown in table 4.

By focusing on classes of data, rather than specific data elements, it appears that a

number of these authorities contain overlapping data mandates. The Center for Disease

Control (CDC) and the National Institute for Environmental Health Sciences (NIEHS)

both have responsibilities with respect to lead-based paint poisoning (42 U.S.C. ~4821

and 42 U.S. C. $247a note, respectively). FDA and the National Institutes of Health

(NIH) are both directed to study the effects of ionizing radiation. The broader language

employed in the majority of statutes also could lead to overlapping agency authorities.

Comparison of the data systems of these agencies is outside the scope of this report. Such

analysis would reveal duplication, if it exists, as well as identify opportunities for coordinating statistical activities.

Congressional Intent

Understanding why Congress mandates the collection of health data helps to explain

the proliferation of data authorities. Part of this proliferation can be attributed to the increasing number of Federal programs in the health area; data collection is a necessary

corollary to most program activities. Another reason for the growth in data authorities is

the increased reliance on data by Congress to identify and define issues or problems and

to develop legislation designed to address them.

To examine the issue of congressional intent in greater detail, OTA categorized

specific authorities listed in the directory according to their purpose: program management, evaluation, regulation, needs assessment, research, monitoring and surveillance,

or policymaking. Congressional intent for collecting data usually is not explicitly stated

in statute; consequently, the following analysis is largely subjective. Many specific
Summary ● 7 5

Table 4.—Authorities for the Collection of Environmental Health Data

U.S. Code Administering

citation agency (ies) Data mandate

42 USC $242b(a)

42 USC $242b(e)

42 USC ~242k

42 USC $300u-3

42 USC ~4821

29 USC $$657,

669,675

30 USC f$811, 813

42 USC ~$263e, 263/

42 USC ~300L2

42 USC $247d

42 USC ~254c

42 USC 241(b)

15 Usc $793

42 USC §247a note

42 USC ~7454

42 USC $287b

OASH (NCHCT,

NCHS, NCHSR)

OASH (NCHS)

OASH (NCHS)

OASH (ODPHP) &

C DC

CDC & HUD

CDC (NIOSH)

CDC (NIOSH)

FDA (BRH) & EPA

HRA (BHP) &

OASH (NCHS)

HSA (BCHS)

HSA (BCHS)

N I H

NIH (NIEHS) &

EPA

NIH (NIEHS)

EPA (in

coordination

with NIEHS &

NCI )

NIH (NHLBI)

Study the impact of the environment on individual

health and health care.

Study the present and projected future health

care costs of pollution and other environmental

conditions.

Collect statistics on environmental health

hazards and on the effects of the environment on

health.

Disseminate information about environmental

health.

Research the nature and extent of lead-based

paint poisoning.

Collect data concerning exposure of employees

to toxic substances.

Collect data concerning exposure of miners to

toxic substances.

Collect data on the health hazards from

electronic product radiation and other types

of ionizing radiation and the incidence of

resultant health problems.

Collect data concerning environmental and

occupational exposure factors affecting

immediate and long-term health conditions.

Assess problems related to sanitation,

pesticide hazards, and other environmental

health hazards to which migratory agriculture

workers are exposed.

Assess the needs of the community health

centers’ population for environmental health

services.

Research the biological effects of low-level

ionizing radiation.

Study the health effects of emissions of

sulfur oxides to the air.

Study long-term effects on child development

of various levels of lead in blood.

Research the effects of changes in the ozone

in the stratosphere upon human health.

Research the environmental determinants and

influences on all aspects of heart, blood vessel, lung,

and blood diseases.

Agenc,e. Ilsted wlthm parentheses are components of the larger HEW agenc]es hsted on them left.
76 ● part ]] —~jrecfory of Statutory Authorities

authorities appear to have multiple purposes and are, therefore, difficult to classify.

However, some general comparisons can be made.

The largest number of specific legislative data requirements apply to recipients of

Federal funds, not to Federal agencies. The implied purposes of these requirements are efficient management and uniform recordkeeping by grantees or contractors. Health maintenance organizations, drug abuse treatment centers, community mental health centers,

community health centers, migrant health centers, and emergency medical service

systems all must meet extensive data requirements. Congress does not stipulate that these

data be forwarded to the Federal level, but such data are available for Federal review.

Other similar sections provide for uniform reporting by States about public health services and medical facilities. Uniform accounting and reporting systems designed to be used

by health care providers are mandated, as are employer-maintained records concerning

the health of employees. Finally, health planning agencies and Professional Standards

Review Organizations (PSROS) also are expected to meet minimum data requirements.

Some data collection projects are authorized to evaluate Federal programs, including, for example, quality assurance in medical care, health planning, family planning

services, emergency medical services, end stage renal disease, and health manpower in

medically underserved areas. Other sections enumerate data, necessary for regulatory

purposes, that must be included in applications to Federal agencies, including those for

new food additives, new drugs, and use of chemical pesticides.

Assessment of need is another purpose implied by a number of sections. The Bureau

of Health Manpower (BHM) is authorized to gather extensive data regarding the supply

of and demand for health manpower resources. Community health centers and urban Indian organizations must demonstrate need in their respective populations in order to receive Federal funds for health services. State plans for medical facilities are mandated in

order to determine the need for new facilities or capital improvements.

Data collections also may be authorized to investigate general problem areas,

monitor diseases, or study research questions. CDC, in particular, is mandated to monitor the occurrence of specific diseases, NIOSH, a part of CDC, is responsible both for

measuring miners’ exposure to toxic materials and conducting research on black lung

disease (pneumoconiosis). Other agencies are authorized for research purposes to collect

specific data concerning arthritis, alcohol abuse, and cancer.

Congress sometimes requests information about the extent and nature of particular

problems. For example, data collections are required for policymaking purposes on the

following topics: the adverse health effects of sulfur oxide emissions, the incidence and

type of health problems caused by electronic product radiation, the actual incidence of

forcible rape, and the extent to which preventive health services are covered under

various insurance plans.

Finally, there are some specific authorities, relating to health research and statistics,

that are considered general-purpose in nature because they do not relate to particular

program needs. These authorities are administered by the National Center for Health

Statistics (NCHS), the National Center for Health Services Research (NCHSR), and the

National Center for Health Care Technology (NCHCT).

Coordination Requirements

OTA examined the legislative authorities to determine congressional awareness of

the need for agency coordination in meeting data requirements. The great majority of au-
Summary ● 7 7

thorities in this directory make no reference to coordinating data collection. Approximately 20 statutory sections do mandate some type of coordination, but usually in programs rather than in agencies. The national end stage renal disease medical information

system (ESRD MIS), for example, is required to be coordinated with the data activities of

Professional Standard Review Organizations (PSROS) and health systems agencies

(HSAS) (42 U.S.C. $1395rr). The legislation governing HSAS specifies that they coordinate their data collection with PSROS (42 U.S.C. $300/-2). PSROS are directed, in turn,

to coordinate with one another and with other public and private agencies having related

data activities (42 U.S.C. $1320c-14).

A major attempt by Congress to orchestrate, by statute, the coordination of data

collection is evidenced in legislation originally passed in 1974, Public Law 93-353, and

amended in 1978, by Public Law 95-623.

The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical and epidemiological activities, and all research, evaluations,

and demonstrations respecting the assessment of health care technology undertaken and

supported through units of the Department of Health, Education, and Welfare. To the

maximum extent feasible such coordination shall be carried out through the National

Center for Health Services Research, the National Center for Health Statistics, and the

National Center for Health Care Technology.

The Secretary shall coordinate the health services research, evaluations, and demonstrations, and health statistical and (where appropriate) epidemiological activities, and the

research, evaluations, and demonstrations respecting the assessment of health care

technology authorized by this Act through the National Center for Health Services

Research, the National Center for Health Statistics, and the National Center for Health

Care Technology. (42 U.S.C. $242b)

The establishment of the Cooperative Health Statistics System (CHSS) in 1974 also

reflects congressional interest in improving health data collection (42 U.S. C. ~242k).

CHSS, as described in Part I of this report, is a cooperative Federal, State, and local

system for the collection of comparable and uniform health statistics. Subsequent to its

initiation, Congress directed several agencies to either coordinate with CHSS, or, if

possible, use CHSS as the primary collector of required data.

The Health Professions Educational Assistance Act, Public Law 94-484, directed the

Secretary to coordinate required data collection with NCHS, which administers CHSS

(42 U.S. C. $295h-2 and ~295h-4 note); and the Health Planning and Resource Development Act, Public Law 93-641, stipulated that mandated data collection also be coordinated, to the extent possible, with CHSS (42 U.S.C. $300/-2, $300m-1). In the 1977

Medicare-Medicaid Anti-Fraud and Abuse Amendments to the Social Security Act,

Public Law 95-142, Congress referenced CHSS, but did not explicitly require that data be

collected through the cooperative system (42 U.S. C. $1320a).

The statutes cited above represent recent attempts by Congress to address the issue

of coordination in health data activities, The intent of Congress is clear in these examples; coordination of health data activities must be undertaken and that the Secretary of

HEW has the greatest responsibility for determining the manner in which that goal is accomplished.

Reporting Burden

One problem directly related to the increased number of data collection activities is

the burden placed upon the individuals and public and private organizations that must
7g ● Part ]z—Directory of Statutory Authorities

supply the requested data. Complaints have grown as the number of reports required by

the Federal Government has increased.

Reporting burdens imposed on the public as a result of Federal data requirements are

not directly correlated with the number of statutory sections authorizing health data collection, and the impact of data requirements varies widely. The majority of specific legislative data requirements listed in the directory, for example, only apply to defined

groups of Federal grantees or contractors. The general public is unaffected, and such

recordkeeping requirements are in keeping with efficient management practices and prudent purchase of services.

However, a single statutory requirement may necessitate a number of costly data

collection activities involving many respondents and may, therefore, significantly increase reporting burden. If Congress requires information about the extent or incidence

of particular problems or hazards, costly special data projects that sample groups nationwide may have to be initiated. For example, PHS’S initial estimate for meeting data requirements relating to health manpower (contained in only a few statutory sections mandated under the Health Professions Educational Assistance Act of 1976, Public Law

94-484) totaled $26.6 million over 3 years and involved 38 discrete data projects (4).

Moreover, Congress specifically exempted data projects conducted under these

authorities from the reports clearance procedure, the primary administrative review for

supervising Federal statistical activities.

Congress usually does not assess the impact of data requirements mandated in

legislation. In reviewing HEW legislative authorities, OTA identified only two statutes

that require the agencies responsible for implementing the legislation to avoid

unreasonable paperwork burden on respondents. These requirements are contained in

the Occupational Safety and Health Act of 1970 and the Federal Coal Mine Health and

Safety Act of 1969, as amended.

Congressional concern is growing, however, regarding the impact of legislation on

statistical and data-gathering activities of Federal agencies and on reporting burden. In

February 1977, the Senate amended its own Standing Rules to require that a regulatory

impact evaluation accompany each bill reported by a Committee. The rule was enacted

primarily to ensure against needless or excessive Government regulation on the public,

and requires, among other provisions, a paperwork assessment statement. Such an

assessment must include estimates of the cost both to Government and respondents for

the gathering and processing of information. The purpose of this rule is to alert Congress

to the potential impact of legislation on paperwork and to provide guidance for executive

agencies interpreting congressional intent.

A bill introduced in the 95th Congress, H.R. 11253, would have broadened the information requirements of the Senate Standing Rule for statistical impact statements and

would have applied to all proposed legislation that provides Federal authority for the collection of information. An amended version of H.R. 11253, the Federal Statistical Activity Control Act of 1978, which was considered by the House of Representatives, retained

a requirement for a computerized catalog of all Federal statistical activities and added requirements for a continuing review and analysis of these activities. However, Congress

took no action on this legislation; whether it will be considered in the 96th Congress is

unknown.
Summary ● 7 9

User’s Guide and Methodology

This directory is designed to be used as a planning tool. It lists data collection

authorities according to HEW agencies that have been delegated responsibilities for their

implementation. Linking the legislation that generates data collection with the HEW offices responsible for implementing their statutory requirements is essential for planning

purposes; without this information, coordination is impossible. iPHS agencies appear

first, in alphabetical order; offices within HCFA follow, also alphabetically. Each

legislative section within the directory is also listed by parallel citation; both Public Law

section numbers and United States Code citations are used. These sections are cataloged

in ascending numerical order and include the date of original enactment. An index to all

statutory sections cited is also provided at the end of the directory and cross-referenced

to the appropriate administering agencies and page numbers. Entries in the directory are

made according to legislative sections; and subsections are grouped under corresponding

sections. The initial number of a provision denotes the section; this is followed by alternating letters and numbers in parentheses to designate subsections. For example: -

United States

Code Title

42 U.S.C. 301a (a)(l) (A)(II)(a)(iii)

section subsection

This citation refers to Title 42 of the United States Code, section 301a, subsection

(a)(l) (A)(II)(a)(iii). The subsequent section would be: 42 U.S.C. 301b, and the subsequent subsection would be: 42 U.S.C. 301a(a) (l)(A) (II)(a) (iv).

Legislative sections cited here were identified by a two-step process. First, the HEW

administrative units assumed to be collecting health data were requested to supply a list

of all their statutory authorities. The lists returned by each office were not limited to the

data collection function. OTA then examined these lists to determine which sections appeared to directly or indirectly authorize data collection. Each legislative section was

then classified by the type of authority—specific, general, or implied. In some cases, sections were classified by more than one type of authority. Each office was contacted again

to comment and verify OTA’s classifications. Through this process, OTA was able both

to link legislative authorities with individual agencies and determine “jointly administered” authorities.

Relying on HEW-supplied statutory authorities was essential in order to determine

how these authorities were delegated because most legislation does not designate the administrative office responsible for implementation. Delegation is an internal administrative decision that may or may not be accompanied by formal documents of

delegation. Informal delegation grants the Secretary the greatest freedom in determining

how best to administer a law; however, it also makes efforts to organize laws by agencies

dependent on information supplied by HEW.

One further point should be noted, all offices within PHS could cite section 301(a) of

the Public Health Service Act (42 U.S. C. ~241(a)), as authority for data collection activities. This section is a general authorization for the Surgeon General to perform research

and collect information relating to the “causes, diagnosis, treatment, control, and

prevention of physical and mental diseases and impairments of man.” Section 301(a) is

listed only once in the directory under the general authority of the Assistant Secretary for

Health. In certain cases, however, the authority of section 301(a), 42 U.S. C. ~241(a), is

explicitly incorporated into other statutory sections. In such cases, the section is footnoted with an explanatory note.
go ● part ]] —Directory of Statutory Authorities

REFERENCES

1. Rice, D., Director, National Center for Health Statistics. Speech given before the

National Leadership Conference, sponsored by the National Journal.

Washington, D.C. May 23, 1978.

2. U.S. Department of Commerce, Office of Federal Statistical Policy and Standards. A Framework for U.S. Federal Statistics for the 1980’s. U.S. Government

Printing Office. 1978.

3. U.S. Department of Health, Education, and Welfare, Public Health Service,

Health Statistics Plan, Fiscal Years 2976-2977. U.S. Government Printing Office.

November 1975.

4. Wunderlich, G.. Director, Office of Policy Development and Planning, Office of

Assistant Secretary of Health. Memorandum to George Hall, Statistical Policy

Division, Office of Management and Budget. June 20, 1977.

GLOSSARY OF TERMS

Specific authority —explicitly mandates (1) the initiation of a data collection system

and/or (2) the collection of explicitly identified data.

General authority—mandates the performance of a function, such as research or the

preparation of a report, that requires the collection of original data. The required data,

however, are not identified; only the subject area for which the data are to be gathered is

indicated.

Implied authority—mandates a particular function that may require collecting original

data if the data necessary to fulfill the function are unavailable. Examples are mandates

to establish information clearinghouses, disseminate information about particular topics,

or prepare reports summarizing available data.
1. Office of the Assistant Secretary for Health ● 81

1. OFFICE OF THE ASSISTANT SECRETARY FOR HEALT H

Type of

Legal citation authority Legislative text

A. General Authority Applicable to all Public Health Service Agencies

a) Public Health General (a) “The Secretary shall conduct in the Service, and

●

●

Service Act encourage, cooperate with, and render assistance to other appropriate public authorities, scientific institutions, and scienP.L. 78-410$301 tists in the conduct of, and promote the coordination of,

(1944), and research, investigations, experiments, demonstrations, and

amended studies relating to the causes, diagnosis, treatment, control

and prevention of physical and mental diseases and impair42 USC ~ 241 ments of man . . . In carrying out the foregoing the Secretary

is authorized to—

(1) collect and make available through publications and

b) Public Health

Service Act

● P.L. 78-410$310,

as added by P.L.

93-353 $107(a)

(1974)

other appropriate means, information as to, the practical application of, such research and other activities . . .

(6) make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assistance on the application of

statistical methods to experiments, studies and surveys in

health and medical fields;”

Transfer of functions

[All functions of the Public Health Service, of the Surgeon

General of the Public Health Service, and of all other officers

and employees of the Public Health Service, and all functions

of all agencies of or in the Public Health Service were transferred to the Secretary of Health, Education, and Welfare by

1966 Reorg. Plan No. 3, 31 F.R. 8855, as a note under section

202 of title 42 of the United States Code. ]

Implied “From time to time the Secretary shall issue information

related to public health, in the form of publications or otherwise, for the use of the public, and shall publish weekly reports of health conditions in the United States and other countries and other pertinent health information for the use of persons and institutions concerned with health services. ”

● 42 USC ~2420
i82 ● part 11—Directory Of Statutory Authorities

Type of

Legal citation authority Legislative text

B. Health Maintenance Organizations (HMOs)

a) Public Health Specific (c) “Each health maintenance organization shall– . . .

●

●

Service Act (11) provide, in accordance with regulations of the

Secretary (including safeguards concerning the confidentiality

P.L. 78-410 ~1301 of the doctor-patient relationship), an effective procedure for

as added by P.L. developing, compiling, evaluating, and reporting to the

93-222$2 Secretary, statistics and other information (which the

(1973) and Secretary shall publish and disseminate on an annual basis

amended and which the health maintenance organization shall disclose,

in a manner acceptable to the Secretary, to its members and

42 USC $300e the general public) relating to (A) the cost of its operations, (B)

the patterns of utilization of its services, (C) the availability,

b) Public Health

Service Act

● P.L. 78-410 ~1315

as added by P.L.

93-222$2

(1973) and

amended

accessibility, and acceptability of its services, (D) to the extent

practical, developments in the health status of its members,

and (E) such other matters as the Secretary may require. ”

General (a) “The Secretary shall periodically review the programs of

assistance authorized by this title and make an annual report

to the Congress of a summary of the activities under each program. The Secretary shall include in such summary— . . .

(2) The statistics and other information reported in such

period to the Secretary in accordance with section Shoe

of . . . title [42];”

● 42 USC ~300e-14

C. Office of Adolescent Pregnancy Programs

a) Health Services Specific (a) “An application for a grant under this Act shall be in

and Centers such form and contain such information as the Secretary may

Amendments of require, and shall include—

1978 (1) an identification of the incidence of adolescent

pregnancy and related problems;

● P.L. 95-626$606 (2) a description of the economic conditions and income

(1978) levels in the geographic area to be served;

(3) a description of existing pregnancy prevention and

● 42 USC ~300a-26 pregnancy-related services (including family life and sex

education), and including where, how, by whom and to

whom they are provided, and the extent to which they are

coordinated in the geographic area to be served;

(4) a description of the major unmet needs for services for

adolescents at risk of initial or repeat pregnancies, the number
Z. Office of the Assistant Secretary for Health ● 83

C. Office of Adolescent Pregnancy Programs—continued

Type of

Legal citation authority Legislative text

of adolescents currently served in the area, and the number of

adolescents not being served in the area;

(5) a description of how all of the core services will be

provided in the project using funds under this Act or otherwise provided by the grantee, to whom they will be provided,

how they will be coordinated, integrated, and linked with

other related programs and services and the source or sources

of funding of such core services;

(6) a description of how adolescents needing services

other than those provided directly by the grantee will be identified and how access and appropriate referral to those services (such as medicaid, public assistance, employment services; child care services for adolescent parents; and other city,

county, and State programs related to adolescent pregnancy)

will be provided including a description of the plan to coordinate such services with activities funded under this Act;

(12) assurances that the’applicant shall have a system for

maintaining the confidentiality of patient records in accordance with regulations promulgated by the Secretary;

(b) Each grantee which participates in the program established by this title shall make such reports concerning its use of

Federal funds as the Secretary may require. Reports shall include the impact the project has had on reducing the rate of

first and repeat pregnancies among adolescents, and the effect

on factors usually associated with welfare dependency. ”

D. Office of Disease Prevention and Health Promotion

1. Office of Health Information, Health Promotion, and Physical Fitness, and Sports

Medicine

a) Public Health

Service Act

● P.L. 78-410$1701

as added by P.L.

94-317$102

(1976), a nd

amended

● 42 USC ~300u

General (a) “The Secretary shall– . . .

(4) undertake and support research and demonstrations

respecting health information and health promotion, preventive health services, and education in the appropriate use of

health care; . . .

(7) foster the exchange of information respecting, and

foster cooperation in the conduct of, research, demonstration, I

and training programs respecting health information and

health promotion, preventive health services, and education

in the appropriate use of health care; . . .
84 . Part 11—Directory of Statutory Authorities

1). Office of Disease Prevention and Health Promotion

1. Office of Health Information, Health Promotion, and Physical Fitness, and Sports Medicine—continued

Type of

Legal citation authority Legislative text

Implied

b) Public Health General

●

●

Service Act

P.L. 78-410 ~1702,

as added by P.L.

94-317 ~lo2

(1976)

42 USC ~300u-1 Implied

General

(c) It shall be the duty of the State Council on Physical

Fitness to— . . .

(2) assess the physical fitness and nutrition status of residents of the State;

(3) plan and administer a program of grants-in-aid to support physical fitness projects, research projects, and public information efforts to promote the development of physical

fitness for the residents of the State;

(4) evaluate and improve the availability and quality of

sports medicine and athletic trainer programs in the State. ”

[Jointly administered with the Center for Disease Control. ]

(a) “The Secretary is authorized to conduct and support by

grant or contract . . . research in health information and

health promotion, preventive health services, and education

in the appropriate use of health care. . . . The Secretary shall

also—

* * *

(2) determine the best methods of disseminating information concerning personal health behavior, preventive

health services and the appropriate use of health care and of

affecting behavior so that such information is applied to maintain and improve health, and prevent disease, reduce its risk,

or modify its course or severity; , . .

(4) develop

(A) methods by which the cost and effectiveness of activities respecting health information and health’th promotion,

preventive health services, and education in the appropriate

use of health care, can be measured, including methods for

evaluating the effectiveness of various settings for such activities and the various types of persons engaged in such activities,

(B) methods for reimbursement or payment for such

activities, and

(C) models and standards for the conduct of such ac

-

tivities . . .

(5) develop a method for assessing the cost and effectiveness of specific medical services and procedures under

various conditions of use, including the assessment of the sensitivity and specificity of screening and diagnostic procedures;

and

(6) enumerate and assess, using methods developed under

paragraph (5), preventive health measures and services with
I. Office of the Assistant Secretary for Health 85

f). Office of Disease Prevention and Health Promotion

1. Office of Health Information, Health Promotion, and Physical fitness, and Sports Medicine—contiflued

Type of

Legal citation authority Legislative text

c) Public Health

Service Act

● P.L. 78-410 ~1704,

as added by P.L.

94-317 ~l02

(1976)

● 42 USC $300u-3

respect to their cost and effectiveness under various conditions

of use.

Specific (b) The Secretary shall make a periodic survey of the needs,

interest, attitudes, knowledge, and behavior of the American

public regarding health and health care. The Secretary shall

take into consideration the findings of such surveys and the

findings of similiar surveys conducted by national and community health education organizations, and other organizations and agencies for formulating policy respecting health information and health promotion, preventive health services,

and education in the appropriate use of health care. ”

[Jointly administered with the Center for Disease Control. ]

Implied “The Secretary is authorized to conduct and support . . . such activities as may be required to make

information respecting health information and health promotion, preventive health services, and education in the appropriate use of health care available to the consumers of

medical care, providers of such care, schools, and others who

are or should be informed respecting such matters. Such activities may include at least the following:

(1) The publication of information, pamphlets, and other

reports which are specially suited to interest and instruct the

health consumer, which information, pamphlets and other

reports shall . . . pertain to the individual’s ability to improve

and safeguard his own health shall include material, accompanied by suitable illustrations, on child care, family life

and human development, disease prevention . . . physical

fitness, dental health, environmental health, nutrition, safety

and accident prevention, drug abuse and alcoholism, mental

health, management of chronic diseases . . . and venereal

diseases;

* * *

General (6) Assess, with respect to the effectiveness, safety, cost,

and required training for and conditions of use, of new aspects

of health care, and new activities, programs, and services

designed to improve human health and publish in readily

understandable language . . . such assessments . . . “

[Jointly administered with the Center for Disease Control. ]

.4h -f, 43 () - 7 I - 7
86 ● part Z]—Dir ectory of Statutory Authorities

D. Office of Disease Prevention and Health Promotion

1. Office of Health Information, Health Promotion, and Physical Fitness, and Sports Medicine—continued

Type of

Legal citation authority Legislative text

d) Public Health

Service Act

● P.L. 94-317 ~102

(1976)

● 42 USC ~300u-4

e) Public Health

Service Act

● P.L. 78-410 ~1706

as added by P.L.

94-317$102

(1976), and

amended

● 42 USC ~300u-5

Implied

Specific

Implied

(a) “The Secretary shall, not later than two years after June

23, 1976, and annually thereafter, submit to the President for

transmittal to Congress a report on the status of health information and health promotion, preventive health services,

and education in the appropriate use of health care. Each such

report shall include—

(1) a statement of the activities carried out under this subchapter since the last report and the extent to which such activity achieves the purposes of this subchapter;

(2) an assessment of the manpower resources needed to

carry out programs relating to health information and health

promotion, preventive health services, and education in the

appropriate use of health care, and a statement describing the

activities currently being carried out under this subchapter

designed to prepare teachers and other manpower for such

programs;

(3) the goals and strategy formulated pursuant to section

300u(a)(l) of title 42. . .

(4) such recommendations as the Secretary considers appropriate for legislation respecting health information and

health promotion, preventive health services, and education

in the appropriate use of health care . . .

(b) “The Secretary shall conduct a study of health education

services and preventive health services to determine the

coverage of such services under public and private health insurance programs, including the extent and nature of such

coverage and the cost sharing requirements required by such

programs for coverage of such services. ”

[Jointly administered with the Center for Disease Control]

(a) “The Secretary shall establish within the Office of the

Assistant Secretary for Health an Office of Health Information and Health Promotion and Physical Fitness and Sports

Medicine which shall—

(3) establish a national information clearinghouse to

facilitate the exchange of information concerning matters

relating to health information and health promotion, preventive health services, and education in the appropriate use of

health care, to facilitate access to such information, and to

assist in the analysis of issues and problems relating to such

matters; and

(4) support projects, conduct research, and disseminate

information in the areas of physical fitness and sports

medicine.
1. Office of the Assistant Secretary for Health . 87

D. Office of Disease Prevention and Health Promotion

1. Office of Health Information, Health Promotion, and Physical Fitness, and Sports Medicine—continued

Type of

Legal citation authority Legislative text

f) Public Health

Service Act

● P.L. 78-410 ~1709

as added by P.L.

95-626$502 (1978)

 42 USC $300u-8

General (b) The Office shall also–

(1) assist, and foster research, investigations, and model

projects on the nature of physical fitness, the development of

physical fitness, and the relation of physical fitness to health;

(2) assist, and foster research and investigations into the

utilization of sports medicine, the development of sports

medicine techniques, and the application of sports medicine

throughout organized systems of athletic competition and in

personal physical fitness development activities at every age

and competition level;

(3) foster and assist research into the proper role of nutrition in physical fitness programs;

(4) promote the coordination of research and model programs conducted by the Office with similar programs conducted by other agencies of the Federal Government and other

public and private organizations;

(5) communicate the results of the studies in the widest

possible manner to the American people and to special groups

with particular interests and special needs in the development

of physical fitness, such as young children, the handicapped,

senior citizens, and workers in occupations which present

special risks of physical disability; . . . “

General (a) “The Office shall establish a program of project grants to

conduct research into the problem of athletic injuries with

specific concentration on frequency of injuries, seriousness of

injuries, the development of training and conditioning techniques and the development of athletic protective equipment

to enable participants to avoid injuries to the maximum extent

feasible, recovery rates, and problems associated with full

recovery from athletic injuries.

Implied (b) The Office shall, in cooperation with the President’s

Council on Physical Fitness, establish a Clearinghouse on

Sports Medicine Research to disseminate the results of that

research to practioners in relevant fields of health care and

physical fitness. . . . “
$8 ● part I] —Directory of Statutory Authorities

Type of

Legal citation authority Legislative text

E. Office of Smoking and Health

a) Federal Cigarette

Labeling and

Advertising Act

● P.L. 89-92, $8

(1965), and

amended

● 15 USC $1337

b) Health Services

and Centers

Amendments of

1978

● P.L. 95-626 ~402

(1978)

● 42 USC $247b-2

Implied (a) “The Secretary of Health, Education, and Welfare shall

transmit a report to the Congress not later than January 1,

1971, and annually thereafter, concerning

(A) current information on the health consequences of

smoking, and

(B) such recommendations for legislation as he may

deem appropriate.”

General (a) “The Secretary of Health, Education, and Welfare, after

consultation with appropriate public and private entities, shall

establish a comprehensive program designed to deter smoking

and the use of alcoholic beverages among children and

adolescents. Such a program shall include—

(1) the undertaking or support (through grants or contracts or both) of biomedical and behavioral research designed

to increase understanding of the biological and behavioral

determinants of smoking and the use of alcoholic beverages

among children and adolescents, with special emphasis on

children aged twelve or below, . . . “

[Jointly administered with National Institute on Alcohol

Abuse and Alcoholism (ADAMHA). ]

F. Office of Health Research, Statistics, and Technology

1. National Center for Health Care Technology

a) Public Health Specific

Service Act

● P.L. 78-410 ~304,

as added by P.L.

93-353$103,

(1974), and

amended

● 42 USC $242b

(a)(l) “The Secretary, acting through the National Center

for Health Services Research, the National Center for Health

Statistics, and the National Center for Health Care

Technology, shall conduct and support research, demonstrations, evaluations, and statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States.

(2) In carrying out paragraph (l), the Secretary shall give

appropriate emphasis to research, demonstrations, evaluations, and statistical and epidemiological activities respecting —

(A) the accessibility, acceptability, planning, organization, distribution, utilization, and financing of systems for the

delivery of health care,

(B) alternative methods for measuring and evaluating

the quality of systems for the delivery of health care,
—

Z. Office of the Assistant Secretary for Health ● 89

F. Office of Health Research, Statistics, and Technology

1. National Center for Health Care Technology—continued

Type of

Legal citation authority Legislative text

(C) the collection, analysis, and dissemination of

health related statistics,

(D) alternative methods to improve and promote

health statistical and epidemiological activities,

(E) the safety, efficacy, effectiveness, cost effectiveness,

and social, economic, and ethical impacts of health care

technologies,

(F) alternative methods for disseminating knowledge

concerning health and health related activities,

(G) the special health problems of low income and

minority groups and the elderly to insure that these problems

are assessed on a periodic regular basis,

(H) the prevention of illness, disability, and premature

deaths in the United States,

(I) health care costs, increases in such costs, and the

reasons for such increases, and

(J) the impact of the environment on individual health

and on health care. . . .

(b) To implement subsection (a), the Secretary may, in addition to any other authority which under other provisions of

this Act or any other law may be used by him to implement

such subsection, do the following:

(1) Utilize personnel and equipment, facilities, and other

physical resources of the Department of Health, Education,

and Welfare . . . provide technical assistance and advice,

make grants, and when appropriate enter into contracts.

(c)(1) The Secretary shall coordinate all health services

research, evaluations, and demonstrations, all health

statistical and epidemiological activities, and all research,

evaluations, and demonstrations respecting the assessment of

health care technology undertaken and supported through

units of the Department of Health, Education, and Welfare.

To the maximum extent feasible such coordination shall be

carried out through the National Center for Health Services

Research, the National Center for Health Statistics, and the

National Center for Health Care Technology.

(2) The Secretary shall coordinate the health services

research, evaluations, and demonstrations, the health

statistical and (where appropriate) epidemiological activities,

and the research, evaluations, and demonstrations respecting

the assessment of health care technology authorized by this

Act through the National Center for HeaIth Services Research,

the National Center of Health Statistics, and the National

Center for Health Care Technology. ”

[Jointly administered with the National Center for Health
—.——. -.

90 ● Part 11—Directory of Statutory Authorities

F. Office of Health Research, Statistics, and Technology

1. National Center for Health Care Technology—continued

Type of

Legal citation authority Legislative text

Statistics and the National Center for Health Services

Research. ]

b) Public Health

Service Act

● P.L. 78-410$309,

as added by P.L.

95-623, $6 (1978)

● 42 USC ~242n

General (a) “There is established in the Department of Health,

Education, and Welfare the National Center for Health Care

Technology (hereinafter in this section referred to as the

‘Center’) which shall be under the direction of a Director who

shall be appointed by the Secretary and supervised by the

Assistant Secretary for Health (or such other officer of the

Department as maybe designated by the Secretary as the principal adviser to him for health programs).

(b)(l) The Secretary, acting through the Center, shall

undertake and support (by grant or contract) assessments of

health care technology. Such assessments shall take into account the safety, effectiveness, and cost effectiveness of, and

the social, ethical, and economic impact of health care technologies.

(2) The Secretary, acting through the Center, shall encourage, undertake, and support (by grant or contract) research, demonstrations, and evaluations respecting—

(A) the factors that affect the use of health care technologies in the United States;

(B) methods for disseminating information on health

care technologies, and

(C) the effectiveness, cost effectiveness, and social,

ethical, and economic impacts of particular medical technologies.

(3) The Secretary, acting through the Center, shall en-

.ourage and support (by grant or contract) research, evaluations, and demonstrations respecting the safety and efficacy of

particular health care technologies.

(4) The Secretary, acting through the Center and in consultation with the National Council on Health Care Technology, shall establish priorities for the activities prescribed by

paragraphs (1), (2), and (3). In determining if an activity respecting a particular health care technology should be given

priority, emphasis shall be placed on—

(A) the actual or potential risks and the actual or potential benefits to patients associated with the use of the technology,

(B) the actual or potential cost of the technology,

(C) the actual or potential rate of its use, and

(D) the stage of development of the technology . . . “
Z. Office of the Assistant Secretary for Health ● 91

F. Office of Health Research, Statistics, and Technology

2. National Center for Health Service Research

Type of

Legal citation authority Legislative text

2. National Center for Health Services Research

a) Public Health Specific (a)(l) “The Secretary, acting through the National Center

●

●

Service Act for Health Services Research, the National Center for Health

Statistics, and the National Center for Health Care TechP.L. 78-410$304 nology, shall conduct and support research, demonstrations,

and added by evaluations, and statistical and epidemiological activities for

P. L.93-353 $103 the purpose of improving the effectiveness, efficiency, and

1974) and quality of health services in the United States.

amended (2) In carrying out paragraph (1), the Secretary shall give

appropriate emphasis to research, demonstrations, evalua42 USC ~242b tions, and statistical and epidemiological activities

respecting—

(A) the accessibility, acceptability, planning, organization, distribution, utilization, and financing of systems for the

delivery of health care,

(B) alternative methods for measuring and evaluating

the quality of systems for the delivery of health care,

(C) the collection, analysis, and dissemination of

health related statistics,

(D) alternative methods to improve and promote

health statistical and epidemiological activities,

(E) the safety, efficacy, effectiveness, cost effectiveness,

and social, economic, and ethical impacts of health care technologies,

(F) alternative methods for disseminating knowledge

concerning health and health related activities,

(G) the special health problems of low income and

minority groups and the elderly to insure that these problems

are assessed on a periodic regular basis,

(H) the prevention of illness, disability, and premature

deaths in the United States,

(1) health care costs, increases in such costs, and the

reasons for such increases, and

(J) the impact of the environment on individual health

and on health care . . .

(b) To implement subsection (a), the Secretary may, in addition to any other authority which under other provisions of

this Act or any other law may be used by him to implement

such subsection, do the following:

(1) Utilize personnel and equipment, facilities, and other

physical resources of the Department of Health, Education,

and Welfare . . . provide technical assistance and advice,

make grants, and when appropriate enter into contracts.

(c)(1) The Secretary shall coordinate all health services
92 . part 11 Directory of Statutory Authorities

F. Office of Health Research, Statistics, and Technology

2. National Center for Health earch—continued

Type of

Legal citation authority Legislative text

research, evaluations, and demonstrations, all health

statistical and epidemiological activities, and all research,

evaluations, and demonstrations respecting the assessment of

health care technology undertaken and supported through

units of the Department of Health, Education, and Welfare.

To the maximum extent feasible such coordination shall be

carried out through the National Center for Health Services

Research, the National Center for Health Statistics, and the

National Center for Health Care Technology.

(2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health statistical

and (where appropriate) epidemiological activities, and the

research, evaluations, and demonstrations respecting the

assessment of health care technology authorized by this Act

through the National Center for Health Services Research, the

National Center for Health Statistics, and the National Center

for Health Care Technology.”

[Jointly administered with the National Center for Health Statistics and the National Center for Health Care Technology. ]

b) Public Health

Service Act

● P.L. 78-4105305,

as added by P.L.

93-353 ~lo4

(1974), and

amended

● 42 USC $242c

General (b) “In carrying out section 242b(a) of this title, the

Secretary, acting through the Center, shall undertake and support research, evaluation, and demonstration projects (which

may include and shall be appropriately coordinated with experiments and demonstration activities authorized by the

Social Security Act and the Social Security Amendments of

1967) respecting—

(1) the accessibility, acceptability, planning, organization, distribution, technology, utilization, quality, and financing of health services and systems;

(2) the supply and distribution, education and training,

quality, utilization, organization, and costs of health manpower;

(3) the design, utilization, organization, cost of facilities

and equipment; and

(4) the uses of computer science in health services delivery

and medical information systems. ”
—

1. Office of the Assistant Secretary for Health “ 93

F. Office of health~ea/th Research, Statistics, and Technology

2. Nationa/ Center for Health Service Research—continued

Type of

Legal citation authority Legislative text

c) Public Health

Service Act

P.L. 78-410$308,

as added by P.L.

93-353 $107(a)

(1974), and

amended

42 USC ~242m

Implied (a)(l) “Not later than December 1, of each year, the

Secretary shall make a report to Congress respecting—

(A) the administration of sections 242b, 242c, 242k,

and 2421 and 242n of this title during the preceding fiscal year,

and

(B) the current state and progress of health services

research, health statistics, and health care technology. ”

Specific (a)(2) The Secretary, acting through the National Center for

Health Services Research and the National Center for Health

Statistics, shall assemble and submit to the President and the

Congress not later than December 1, of each year the following reports:

(A) A report on health care costs and financing. Such

report shall include a description and analysis of the statistics

collected under section 242k(b)(l)(G) of this title.

(B) A report on health resources. Such report shall include a description and analysis, by geographic area, of the

statistics collected under section 242k(b)(l)(E) of this title.

(C) A report on the utilization of health resources.

Such report shall include a description and analysis, by age,

sex, income, and geographic area, of the statistics collected

under section 24 Zk(b)(l )(F) of this title.

(D) A report on the health of the Nation’s people. Such

report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under

section 242k(b)(l)(A) of this title. ”

[Jointly administered with the National Center for Health

Statistics. ]

Implied (g)(l) The Secretary shall–

(A) publish, make available and disseminate promptly

in understandable form and on as broad a basis as practicable,

the results of health services research, demonstration, and

evaluations undertaken and supported under sections 242b

and 242c of this title;

(B) Make available to the public data developed in such

research, demonstrations, and evaluations; and

(C) provide indexing, abstracting, translating, publishing, and other services leading to a more effective and

timely dissemination of information on health services research, demonstrations, and evaluations in health care delivery to public and private entities and individuals engaged in

the improvement of health care delivery and the general public; and undertake programs to develop new or improved

methods for making such information available. . . . “
94 ● part 1l—Directory of Statutor y Authorities

F. Office of Health Research, Statistics, and Technology

3. National Center for Health Statistics

Type of

Legal citation authority Legislative text

3. National Center for Health Statistics

a) Public Health Specific

Service Act

● P.L. 78-410 ~304,

as added by P.L.

93-353 ~l03

(1974), and

amended

● 42 USC ~242b

(a)(l) “The Secretary, acting through the National Center

for Health Services Research, the National Center for Health

Statistics, and the National Center for Health Care Technology, shall conduct and support research, demonstrations,

evaluations, and statistical and epidemiological activities for

the purpose of improving the effectiveness, efficiency, and

quality of health services in the United States.

(2) In carrying out paragraph (1), the Secretary shall give

appropriate emphasis to research, demonstrations, evaluations, and statistical and epidemiological activities respecting—

(A) the accessibility, acceptability, planning, organization, distribution, utilization, and financing of systems for the

delivery of health care,

(B) alternative methods for measuring and evaluating

the quality of systems for the delivery of health care,

(C) the collection, analysis, and dissemination of

health related statistics,

(D) alternative methods to improve and promote

health statistical and epidemiological activities,

(E) the safety, efficacy, effectiveness, cost effectiveness,

and social, economic, and ethical impacts of health care technologies,

(F) alternative methods for disseminating knowledge

concerning health and health related activities,

(G) the special health problems of low income and minority groups and the elderly to insure that these problems are

assessed on a periodic regular basis,

(H) the prevention of illness, disability, and premature

deaths in the United States,

(I) health care costs, increases in such costs, and the

reasons for such increases, and

(J) the impact of the environment on individual health

and on health care . . .

(b) To implement subsection (a), the Secretary may, in addition to any other authority which under other provisions of

this Act or any other law may be used by him to implement

such subsection, do the following:

(1) Utilize personnel and equipment, facilities, and other

physical resources of the Department of Health, Education,

and Welfare . . . provide technical assistance and advice,

make grants . . . and when appropriate enter into contracts. . . .
I. Office of the Assistant Secretary for Health . i9S

F. Office of Health Research, Statistics, and Technology

3. National Center for Health Statistics—continued

Type of

Legal citation authority Legislative text

(c)(l) The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical

and epidemiological activities, and all research, evaluations,

and demonstrations respecting the assessment of health care

technology undertaken and supported through units of the

Department of Health, Education, and Welfare. To the maximum extent feasible such coordination shall be carried out

through the National Center for Health Services Research, the

National Center for Health Statistics, and the National Center

for Health Care Technology.

(2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health statistical

and (where appropriate) epidemiological activities, and the

research, evaluations, and demonstrations respecting the

assessment of health care technology authorized by this Act

through the National Center for Health Services Research, the

National Center for Health Statistics, and the National Center

for Health Care Technology.”

[Jointly administered with the National Center for Health

Services Research and the National Center for Health Care

Technology. ]

Specific (e)(l) The Secretary and the National Academy of Sciences

(acting through the Institute of Medicine and other appropriate units) shall, jointly and in cooperation with the Administrator of the Environmental Protection Agency, the Secretary

of Labor, the Consumer Product Safety Commission, the

Council of Economic Advisers, the Council on Wage and

Price Stability, the Council on Environmental Quality, and

other entities of the Federal Government which the Secretary

determines have the expertise in the subject of the study

prescribed by this paragraph, conduct, with funds appropriated under section 308(i)(2) [42 USC S242m], an ongoing

study of the present and projected future health costs of pollution and other environmental conditions resulting from

human activity (including human activity in any place in the

indoor or outdoor environment, including places of employment and residence). In conducting the study, the Secretary

and the National Academy of Sciences (hereinafter in this subsection referred to as the ‘Academy’) shall, to the extent

feasible—

(A) identify the pollution (and the pollutants responsible for the pollution) and other environmental conditions

which are, or may reasonably be anticipated to be, resportsible for causing, contributing to, increasing susceptibility to, or

aggravating human diseases and adverse effects on humans;
96 ● part 11—Directory of Statutory Authorities 

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(B) identify each such disease and adverse effect on

humans and specifically determine whether cancer, birth defects, genetic damage, emphysema, asthma, bronchitis, and

other respiratory diseases, heart disease, stroke, and mental

illness and impairment are such a disease or effect;

(C) identify (on a national, regional, or other geographical basis) the source or sources of such pollutants and

conditions and estimate the portion of each pollutant and the

extent of each condition which can be traced to a specific type

of source;

(D) ascertain

(i) the extent to which the pollutants and conditions

identified under subparagraph (A) are, or may reasonably be

anticipated to be, responsible, individually or collectively, for

causing, contributing to, increasing susceptibility to, or aggravating the diseases and effects identified under subparagraph

(B), and

(ii) the effect upon the incidence or severity of

specific diseases and effects of individual or collective, as appropriate, incremental reductions in the pollutants and

changes in such conditions, and

(E) quantify

(i) the present and projected future health costs of the

diseases and effects identified under subparagraph (B), and

(ii) the reduction in health costs which would result

from each incremental reduction and change referred to in

subparagraph (D)(ii).

* * *

(3) The first report on the study prescribed by paragraph

(1) shall be made to the Committee on Human Resources of

the Senate and the Committee on Interstate and Foreign Commerce of the House of Representatives by the Secretary and

the Academy not later than eighteen months after the date of

the enactment of this subsection. Subsequent reports on the

study shall be made by the Secretary and the Academy every

two years after the date the first report is submitted. Each

report shall

(A) identify deficiencies and limitations in the data on

the matters considered in the study and recommend actions

which may be taken to eliminate such deficiencies and limitationstions,

(B) include such recommendations for legislation as the

Secretary determines appropriate,

(C) include recommendations for facilitating studies of

the effects of hazardous substances on humans, and
1. Office of the Assistant Secretary for Health . i97

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(D) include a description of any administrative action

proposed to be taken by the Secretary, the Administrator of

the Environmental Protection Agency, the Secretary of Labor,

and the Consumer Product Safety Commission to reduce the

costs which have been quantified under paragraph (l)(E)(i). In

conducting the study, the Secretary and the Academy shall

seek assistance from public and private health financing entities in securing the data needed for the study.

(4) For purposes of paragraph (1), the term ‘health costs

of pollution and other environmental conditions’ means the

costs of human diseases and other adverse effects on humans

which pollution and other environmental conditions are, or

may reasonably be anticipated to be, responsible for causing,

contributing to, increasing susceptibility to, or aggravating,

including the costs of preventing such diseases and effects, the

costs of the treatment, cure, convalescence, and rehabilitation

of persons afflicted by such diseases, costs reasonably attributable to pain and suffering from such diseases and effects,

loss of income and future earnings resulting from such

diseases and effects, adverse effects on productivity (and thus

increases in production costs and consumer prices) resulting

from such diseases and effects, loss of tax revenues resulting

from such decreases in earnings and productivity, costs to the

welfare and unemployment compensation systems and the

programs of health benefits under titles XVIII and XIX of the

Social Security Act resulting from such diseases and effects,

the overall increases in costs throughout the economy resulting from such diseases and effects, and other related direct and

indirect costs. ”

[National Center for Health Statistics has the lead responsibility, though there is coordination with other Federal agencies. ]

b) Public Health

Service Act

● P.L. 78-410$306,

as added by P.L.

93-353$105

(1974 ), and

amended

● 42 USC $242k

Specific (b) “In carrying out section 242b(a) of this title, the

Secretary, acting through the Center, shall

(1) collect statistics on—

(A) the extent and nature of illness and disability of the

population of the United States (or of any groupings of the

people included in the population), including life expectancy,

the incidence of various acute and chronic illnesses, and infant

and maternal morbidity and mortality,

(B) the impact of illness and disability of the population on the economy of the United States and on other aspects

of the well-being of its population (or of such groupings).

(C) environmental, social, and other health hazards,
i98 ● part 11—Directory of Statutory Authorities

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(D) determinants of health,

(E) health resources, including physicians, dentists,

nurses, and other health professionals by specialty and type of

practice and the supply of services by hospitals, extended care

facilities, home health agencies, and other health institutions,

(F) utilization of health care, including utilization of

(i) ambulatory health services by

types of practice of the health professionals

services, and

(ii) services of hospitals, extended

home health agencies, and other institutions

(G) health care costs and financing,

specialties and

providing such

care facilities,

including the

trends in health care prices and cost, the sources of pay-merit

for health care services, and Federal, State and local government expenditures for health care services, and

(H) family formation, growth and dissolution;

and . . .

(3) may undertake and support . . . epidemiological research, demonstrations, and evaluations on the matters referred to in paragraph (1); and .

(4) may collect, furnish, tabulate, and analyze statistics,

and prepare studies, on matters referred to in paragraph (1)

upon request of public and nonprofit private entities under arrangements under which the entities will pay the cost of the

service provided. . . .

(e) for the purpose of producing comparable and uniform

health information and statistics, there is established the

Cooperative Health Statistics System. The Secretary, acting

through the Center, shall—

(1) coordinate the activities of Federal agencies involved

in the design and implementation of the System;

(2) undertake and support (by grant or contract) research, development, demonstrations, and evaluations respecting the System;

(3) make grants to and enter into contracts with State and

local health agencies to assist them in meeting the costs of data

collection carried out under the System; and

(4) review the statistical activities of the Department of

Health, Education, and Welfare to assure that they are

consistent with the System.

States participating in the System shall designate a State

agency to administer or be responsible for the administration

of the statistical activities within the State under the System.

The Secretary, acting through the Center, shall prescribe

guidelines to assure that statistical activities within States par-
Z. Office of the Assistant Secretary for Health ● 99

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ticipating in the system produce uniform and timely data and

assure appropriate access to such data. . . .

(g) TO secure uniformity in the registration and collection of

mortality, morbidity, and other health data, the Secretary

shall prepare and distribute suitable and necessary forms for

the collection and compilation of such data which shall be

published as a part of the health reports published by the

Secretary.

(h) There shall be an annual collection of data from the

records of births, deaths, marriages, and divorces in registration areas. The data shall be obtained only from and restricted

to such records of the States and municipalities which the

Secretary, in his discretion, determines possess records affording satisfactory data in necessary detail and form. . . .

(j) In carrying out the requirements of this title [42 USC]

and paragraph (1) of subsection (e) of this section, the

Secretary shall coordinate health statistical and epidemiological activities of the Department of Health, Education,

and Welfare by—

(1) establishing standardized means for the collection of

health information and statistics under laws administered by

the Secretary;

(2) developing, in consultation with the National Committee on Vital and Health Statistics, and maintaining the

minimum sets of data needed on a continuing basis to Fulfill

the collection requirements of subsection (b)(l) of this section;

(3) after consultation with the National committee onn

Vital and Health Statistics, establishing standards to assure

the quality of health statistical and epidemiological data collection, processing, and analysis;

(4) in the case of proposed health data collections of the

Department which are required to be reviewed by the Director

of the Office of Management and Budget under section 3509 of

title 44, United States Code, reviewing such proposed collections to determine whether they conform with the minimum

sets of data and the standards promulgated pursuant to paragraphs (2) and (3), and if any such proposed collection is

found not to be in conformance, by taking such action as may

be necessary to assure that it will conform to such sets of data

and standards; and

(5) periodically reviewing ongoing health data collections

of the Department, subject to review under such section 3509,

to determine if the collections are being conducted in accordance with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3) and, if any such
100 c Part 11—Directory of Statutory Authorities

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collection is found not to be in conformance, by taking such

action as may be necessary to assure that the collection will

conform to such sets of data and standards not later than the

ninetieth day after the date of the completion of the review of

the collection. . . .

(1)(1) The Secretary, acting through the Center, shall

develop a plan for the collection and coordination of statistical and epidemiological data on the effects of the environment on health. Such plan shall include a review of the data

now available on health effects, deficiencies in such data, and

methods by which existing data deficiencies can be corrected.

The Secretary shall submit such plan to the Congress not later

than January 1, 1980.

(2)(A) The Secretary, acting through the Center, shall

establish, not later than two years after November 9, 1978,

guidelines for the collection, compilation, analysis, publication, and distribution of statistics and information necessary

for determining the effects of conditions of employment and

indoor and outdoor environmental conditions on the public

health. , . . The guidelines shall be reviewed and, if appropriate, revised at least every three years after the date they

are initially established. Guidelines shall take effect on the

date of the promulgation of the regulation establishing or

revising the guidelines or such later date as may be specified in

the guidelines.

(B) The guidelines shall be designed–

(i) to improve coordination of environmental and

health studies, statistics, and information, and to prevent

overlap and unnecessary duplication with respect to such

studies, statistics, and information;

(ii) to assure that such studies, statistics, and information will be available to executive departments responsible

for the administration of laws relating to the protection of the

public health and safety or the environment;

(iii) to encourage the more effective use by executive

departments of such studies, statistics, and information;

(iv) to improve the statistical validity and reliability

of such studies, statistics, and information; and

(v) to assure greater responsiveness by the Department of Health, Education, and Welfare and other executive

departments in meeting informational and analytical needs for

determining the effects of employment and indoor and outdoor environmental conditions on public health.
1. Office of the Assistant Secretary for Flealth ● 101

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(C) In establishing and revising guidelines under subparagraph (A), the Secretary shall take into consideration the

plan developed pursuant to paragraph (1).

(D) The Center shall serve as a clearinghouse for statistics and information with respect to which guidelines have

been established under subparagraph (A) and shall assist executive departments in obtaining such statistics and information for purposes of administering laws under their jurisdiction relating to environmental health protection or the safety and health of employees. . . .

(F) In carrying out his duties under this paragraph, the

Secretary, acting through the Center, shall, insofar as practicable, provide for coordination of his activities with those of

other Federal agencies and interagency task forces relating to

the collection, analysis, publication, or distribution of statistics and information necessary for determining the effects of

conditions of employment and indoor and outdoor environmental conditions on the public health. ”

c) Public Health

Service Act

● P.L. 78-410$308,

as added by P.L.

93-353 ~107a

(1974), and

amended

● 42 USC $242m

Implied (a)(l) “Not later than December 1, of each year the

Secretary shall make a report to Congress respecting—

(A) the administration of sections 242b,242c, 242k,

2421 and 242n of this title during the preceding fiscal year, and

(B) the current state and progress of health services

research, health statistics, and health care technology.

Specific (a)(2) The Secretary, acting through the National Center for

Health Services Research and the National Center for Health

Statistics, shall assemble and submit to the President and the

Congress not later than December 1, of each year the following reports:

(A) A report on health care costs and financing. Such

report shall include a description and analysis of the statistics

collected under section 242k(b)(l )(G) of this title.

(B) A report on health resources. Such report shall include a description and analysis, by geographic area, of the

statistics collected under section 242k(b)(l)(E) of this title.

(C) A report on the utilization of health resources.

Such report shall include a description and analysis, by age,

sex, income, and geographic area, of the statistics collected

under section 242k(b)(l)(F) of this title.

(D) A report on the health of the Nation’s people. Such

report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under
102 ● Part 11—Directory Of Statutory Authorities

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d) Health Services

●

●

and Centers

Amendments of

1978

P.L. 95-626 ~404

42 USC $242p

e) Public Health

Service Act

● P.L. 78-410$708,

as added by P.L.

94-484 ~206

(1976) and

amended

● 42 USC ~292h

section 242k(b)(l)(A) of this title. ”

[Jointly administered with the National Center for Health

Services Research. ]

Specific (a) “The Secretary, acting through the National Center for

Health Statistics, shall submit to Congress on December 1,

1980, and on December 1 of every third year thereafter, a national disease prevention data profile in order to provide a

data base for the effective implementation of this Act and to

increase public awareness of the prevalence, incidence, and

any trends in the preventable causes of death and disability in

the United States. Such profile shall include at a minimum—

(1) mortality rates for preventable diseases;

(2) morbidity rates associated with preventable diseases;

(3) the physical determinants of health of the population

of the United States and the relationship between these determinants of health and the incidence and prevalence of

preventable causes of death and disability; and

(4) the behavioral determinants of health of the population of the United States including, but not limited to, smoking, nutritional and dietary habits, exercise, and alcohol consumption, and the relationship between these determinants of

health and the incidence and prevalence of preventable causes

of death and disability.

(b) In preparing the profile required by subsection (a) of this

section, the Secretary, acting through the National Center for

Health Statistics, shall comply with all relevant provisions of

sections 306 and 308 of the Public Health Service Act [42 USC

242k, 242m].

Specific (a) “The Secretary shall establish a program, including a

uniform health professions data reporting system, to collect,

compile, and analyze data on health professions personnel

which shall initially include data respecting all physicians and

dentists in the States. The Secretary is authorized to expand

the program to include, whenever he determines it necessary,

the collection, compilation, and analysis of data respecting

pharmacists, optometrists, podiatrists, veterinarians, public

health personnel, audiologists, speech pathologists, health

care administration personnel, nurses, allied health personnel,

medical technologists, and any other health personnel in

States designated by the Secretary to be included in the programs. Such data shall include data respecting the training,

licensure status (including permanent, temporary, partial,

limited, or institutional), place or places of practice, professional speciality, practice characteristics, place and date of
1. Office of the Assistant Secretary for Health ● 103

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birth, sex, and socio-economic background of health professions personnel and such other demographic information

regarding health professions personnel as the Secretary may

require.

(b)(l) In carrying out subsection (a) of this section, the Secretary shall collect available information from appropriate

local, State, and Federal agencies and other appropriate

sources.

(2) The Secretary shall conduct or enter into contracts for

the conduct of analytic and descriptive studies of the health

professions, including evaluations and projections of the supply of, and requirements for, the health professions by specialty and geographic locations.

(3) The secretary is authorized to make grants and to

enter into contracts with States (or an appropriate nonprofit

private entity in any State) for the purpose of participating in

the program established under subsection (a) of this section. . . . To be eligible for a grant or contract under this paragraph a State or entity shall submit an application in such

form and manner and containing such information as the

Secretary may require. Such application shall include

reasonable assurances, satisfactory to the Secretary, that—

(A) such State (or nonprofit entity within a State) will

establish a program of mandatory annual registration of the

health professions personnel described in subsection (a) of this

section who reside in or practice in such State and of health institutions licensed by such State, which registration shall include such information as the Secretary shall determine to be

appropriate;

(B) such State or entity shall collect such information

and report it to the Secretary in such form and manner as the

Secretary shaIl prescribe; and

(C) such State or entity shall comply with the requirements of subsection (e) of this section.

(c) For purposes of providing the Secretary with information under this section, each school which receives financial

support under section 295f of . . . title [42] shall annually report to the Secretary information, determined to be appropriate by the Secretary, respecting the students who attend such

school. The Secretary may collect such additional data respecting students of the health professions as he determines to

be appropriate.

(d) The Secretary shall assemble and submit to the President

and Congress a report on the status of health professions personnel in the United States, which report shall include a

description and analysis of the data collected pursuant to this
104 ● Part 11—Directory of Statutory Authorities

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section. Such report may be included as part of the report

made under section 242m (a)(2)(C) of this title. Such report

shall be submitted biennially, and the first such report shall be

due not later than October 1, 1979. . . .

(f) In carrying out his responsibilities under this section, the

Secretary shall not be subject to the provisions of Chapter 35

of Title 44 [providing for exemption from the Federal Reports

Clearance Act. ]

[Jointly administered with the Bureau of Health Manpower

(HRA). ]

f) Public Health

Service Act

● P.L. 78-410$793,

as added by P.L.

94-484, $701(a)

(1976)

● 42 USC $295h-2

g) Public Health

Service Act

● P.L. 78-410 ~795

note, as added by

P. L.94-484 $702

(1976)

● 42 USC 295h-4

note

Specific (a) “The Secretary shall, in coordination with the National

Center for Health Statistics . . . continuously develop, publish, and disseminate on a nationwide basis statistics and other

information respecting public and community health personnel, including—

(1) detailed descriptions of the various types of activities

in which public and community health personnel are engaged,

(2) the current and anticipated needs for the various types

of public and community health personnel, and

(3) the number, employment, geographic locations,

salaries, and surpluses and shortages of public and community health personnel, the educational and licensure requirements for the various types of such personnel, and the cost of

training such personnel. . . .

(c) The Secretary shall submit biennially to the Committee

on Interstate and Foreign Commerce of the House of

Representatives and the Committee on Labor and Public

Welfare of the Senate a report on—

(1) the statistics and other information developed pursuant to subsection (a) of this section, and

(2) the activities conducted under this subpart, including

an evaluation of such activities. ”

[Jointly administered with the Bureau of Health Manpower

(HRA). ]

Specific (b) “ . . . The Secretary shall, in coordination with the

National Center for Health Statistics (established under section 306 of the Public Health Service Act) (section 242k of

Title 42), develop, publish, and disseminate on a nationwide

basis a report containing statistics and other information respecting allied health personnel, including—

(1) detailed descriptions of the various types of such personnel and the activities in which such personnel are engaged,

(2) the current and anticipated needs for the various types

of such health personnel,
1. Office of the Assistant Secretary for Health ● 105

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h) Public Health

Service Act

● P.L. 78-410 ~1513

as added by P.L.

93-641$3 (1975)

and amended

● 42 USC ~300/-2

(3) the number, employment, geographic locations, salaries, and surpluses and shortages of such personnel .“

[Jointly administered with the Bureau of Health Manpower

(HRA). ]

Specific (b) “In providing health planning and resources

development for its health service area, a health system agency shall perform the following functions:

(1) The agency shall assemble and analyze data concerning—

(A) the status (and its determinants) of the health of the

residents of its health service area,

(B) the status of the health care delivery system in the

area and the use of that system by residents of the area,

(C) the effect the area’s health care delivery system has

on the health of the residents of the area,

(D) the number, type, and location of the area’s health

resources, including health services, manpower, and facilities,

(E) the patterns of utilization of the area’s health resources, and

(F) the environmental and occupational exposure factors affecting immediate and Iongterm health conditions. . . .

In carrying out this paragraph, the agency shall to the maximum extent practicable use existing data (including data

developed under Federal health programs) and coordinate its

activities with the cooperative system provided for under section 242k(e) of . . . tide [42].

(2) The agency shall, after appropriate consideration of

the recommended national guidelines for health planning

policy issued by the Secretary under section 300k-1 of . . .

title [42], the priorities set forth in section 300k-2 of . . . title

[42], and the data developed pursuant to paragraph (l),

establish, annually review, and amend as necessary a health

systems plan (hereinafter in this subchapter referred to as the

“HSP”) . . .

Implied (c) A health systems agency shall implement its HSP and

AIP, and in implementing the plans it shall perform at least

the following functions:

(2) The agency may provide, in accordance with the

priorities established in the AIP, technical assistance . . . for

the development of projects and programs which the agency

determines are necessary to achieve the health systems

described in the HSP, . . .
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(d) Each health systems agency shall coordinate its activities

with—

(1) each Professional Standards Review Organization

(designated under section 1320c-1 of . . . title [42],

(2) entities referred to in paragraphs (1) and (2) of section

3334(a) of this title and regional and local entities the views of

which are required to be considered under regulations

prescribed . . . to carry out section 4231(b) of this title.

(3) other appropriate general or special purpose regional

planning or administrative agencies, and

General (4) any other appropriate entity, in the health systems

agency’s health service area. The agency shall, as appropriate,

secure data from them for use in the agency’s planning and

development activities, . . .

Implied (g)(l) Except as provided in paragraph (2), each health

systems agency shall review on a periodic basis (but at least

every five years) all institutional health services offered in the

health service area of the agency and shall make recommendations to the State health planning and development agency . . . respecting the appropriateness in the area of such services,

(2) A health systems agency shall complete its initial

review of existing institutional health services within three

years after the date of the agency’s designation under section

300 Z-4(C) of this title.”

[Jointly administered with the Bureau of Health Planning

(HRA).]

i) Public Health

Service Act

● P.L. 78-410$1522,

as added by P.L.

93-641~3 (1975)

● 42 USC ~300m-1

General (a) “A State administrative program (hereinafter in this

section referred to as the “State Program”) is a program for the

performance within the State by its State Agency of the functions prescribed by section 300m-2 of this title [42]. . . .

(b) The State Program of a State must—

* * *

(7)(A) provide for the coordination . . . with the cooperative system provided for under section 242k(e) of . . . title

[42] of the activities of the State Agency for the collection,

retrieval, analysis, reporting and publication of statistical and

other information related to health and health care, and

(B) require providers of health care doing business in

the State to make statistical and other reports of such information to the State Agency; . . .

Implied (8) provide, in accordance with methods and procedures

prescribed or approved by the Secretary, for the evaluation,
1. Office of the Assistant Secretary for Health . 107

F. Office of Health Research, Statistics, and Technology

3. Nationa/ Center for Health Statistics—continued

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j) Social Security

●

●

Act

P.L. 74-241$1121

as added by P.L.

95-142 ~19(a)

(1977)

42 USC $1320a

General

Specific

at least annually, of the performance by the State Agency of

its functions and of their economic effectiveness,

(9) provide that the State Agency wilI from time to time,

and in any event not less often than annually, review the State

Program and submit to the Secretary required modifications;

(10) require the State Agency to make such reports, in

such form and containing such information, concerning its

structure, operations, performance of functions, and other

matters as the Secretary may from time to time require, and

keep such records and afford such access thereto as the

Secretary may find necessary to verify such records; . . .“

[Jointly administered with the Bureau of Health Planning

(HRA). ]

(a) “For the purposes of reporting the cost of services

provided by, of planning, and of measuring and comparing

the efficiency of an effective use of services in hospitals, skiI1ed

nursing facilities, intermediate care facilities, home health

agencies, health maintenance organizations, and other types

of health services facilities and organizations to which payment may be made under this Act, the Secretary shall

establish by regulation, for each such type of health services

facility or organization a uniform system for the reporting by

a facility or organization of that type of the following information:

(1) The aggregate cost of operation and the aggregate

volume of services.

(2) The costs and volume of services for various functional accounts and sub-accounts.

(3) Rate, by category of patient and class of purchaser.

(4) Capital assets, as defined by the Secretary, including

(as appropriate) capital funds, debt services, lease agreements

used in lieu of capital funds, and the value of land, facilities,

and equipment.

(5) Discharge and bill data.

The uniform reporting system for a type of health services

facility or organization shall provide for appropriate variation

in the application of the system to different classes of facilities

or organizations within that type and shall be established, to

the extent practicable, consistent with the cooperative system

for producing comparable and uniform health information

and statistics described in section 306(e)(l) of the Public

Health Service Act. In reporting under such a system hospitals

shall employ such chart of accounts, definitions, principles,

and statistics as the Secretary may prescribe in order to reach
208 c Part I] —Directory of Statutory Authorities

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a uniform reconciliation of financial and

specified uniform reports to be provided to

statistical data for

the Secretary,

(b) The Secretary shall– -

(1) monitor the operation of the systems established

under subsection (a);

(2) assist with and support demonstrations and evaluations of the effectiveness and cost of the operation of such

systems and encourage State adoption of such systems; and

(3) periodically revise such systems to improve their effectiveness and diminish their cost.

(c) The Secretary shall provide information obtained

through use of the uniform reporting systems described in

subsection (a) in a useful manner and format to appropriate

agencies and organizations, including health systems agencies

(designated under section 1515 of the Public Health Service

Act) and State health planning and development agencies

(designated under section 1521 of such Act), as may be

necessary to carry out such agencies’ and organizations’ functions. ”

[Delegation is to the Health Care Financing Administration,

and HCFA is directed to coordinate with the National Center

for Health Statistics in carrying out portions of its duties

under the above-cited authority. ]
—.

11. Alcohol, Drug Abuse, and Mental Health Administration ● 109

Il. ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION

Type of

Legal citation authority Legislative text

A. National Institute on Alcohol Abuse and Alcoholism

a) Public Health

Service Act

● P.L. 78-410 ~217,

as added by P.L.

91-616 $401(a)

(1970) and

amended

● 42 USC $218

b) Health Services

and Centers

Amendments of

1978

● P.L. 95-626 ~402

(1978)

● 42 USC ~247b-2

c) Comprehensive

●

●

AlcoholAbuse

and Alcoholism

Prevention,

Treatment, and

Rehabilitation

Act of 1970

P.L. 91-616$101

(1970), and

amended

42 USC $4551

Implied (d) “The National Advisory Council on Alcohol Abuse and

Alcoholism shall advise, consult with, and make recommendations to, the Secretary . . . in the field of alcohoI abuse and

alcoholism . . . The Council is authorized . . . (2) to collect

information as to studies being carried on in the field of

alcohol abuse and alcoholism, and with the approval of the

Secretary, make available such information through appropriate publications for the benefit of health and welfare

agencies or organizations . . . or physicians or any other

scientists, and for the information of the general public . . . “

General (a) “The Secretary of Health, Education, and Welfare, after

consultation with appropriate public and private entities, shall

establish a comprehensive program designed to deter smoking

and the use of alcoholic beverages among children and

adolescents. Such a program shall include—

(1) the undertaking or support (through grants or contracts or both) of biomedical and behavioral research designed

to increase understanding of the biological and behavioral

determinants of smoking and the use of alcoholic beverages

among children and adolescents, with special emphasis on

children aged twelve or below; . . . “

[Jointly administered with the Office of Smoking and Health

(OASH). ]

Implied (a) “There is established the National Institute on Alcohol

Abuse and Alcoholism . . . to administer the programs and

authorities assigned to the Secretary of Health, Education,

and Welfare . . . by this chapter and part C of the Community Mental Health Centers Act (42 USC 2688e et seq.). The

General Secretary, acting through the Institute, shall, in carrying out

the purposes of section 241 and 242a of . . . title [42] with

respect to alcohol abuse and alcoholism, develop and conduct

comprehensive health, . . . research, and planning programs

for the prevention and treatment of alcohol abuse and

alcoholism and for the rehabilitation of alcohol abusers and

alcoholics. The Secretary shall carry out through the Institute the . . . policy development and planning, evaluation,

and public information functions which are required for the

implementation of such programs and authorities.”*

● Section 301 of the Public Health Service Act, 42 USC ~241, is the general data collection authority for the Secretary of HEW.
110 ● Part 11—Directory of Statutory Authorities

A. National Institute on Alcohol Abuse and Alcoholism—continued

Type of

Legal citation authority Legislative text

d) Comprehensive

Alcohol Abuse

and Alcoholism

Prevention,

Treatment, and

Rehabilitation

Act of 1970

P.L. 91-616 ~102

(1970), and

amended

42 USC $4552

e) Comprehensive

●

●

Alcohol Abuse

and Alcoholism

Prevention,

Treatment, and

Rehabilitation

Act of 1970

P.L. 91-616 ~501,

as added by P.L.

94-371 ~7 (1976),

and amended

42 USC &1585

Implied “The Secretary shall— . . .

(2) submit to Congress on or before the expiration of the

one-year period beginning December 31, 1970 and every three

years thereafter, a report (A) containing current information

on the health consequences of using alcoholic beverages . . . “

Specific (a) “The Secretary, acting through the Institute, shall carry

out a program of research, investigations, experiments,

demonstrations, and studies, directly and by grant or contract, into—

(1) the behavioral and biomedical etiology of,

(2) treatment of,

(3) mental and physical health consequences of,

(4) social and economic consequences of, and

(5) the impact on families of,

alcohol abuse and alcoholism.

(b) In carrying out the program described in subsection (a)

of this section, the Secretary, acting through the Institute, is

authorized to—

(1) collect and make available through publications and

other appropriate means, information as to, and the practical

application of, the research and other activities under the program, . . . “

B. National Institute on Drug Abuse

a) Drug Abuse General “To facilitate the preparation of the strategy, the [Strategy]

●

●

Officeand Council shall - -

—. —.

Treatment Act

of 1972 (2) at the request of any member, require departments

and agencies engaged in Federal drug abuse prevention funcP.L. 92-255 ~304, tions and drug traffic prevention functions to submit such

(1972) and studies and surveys as are necessary to carry out the purposes

amended of this subchapter, and the departments and agencies shall

submit to the Council and to the requesting member the in21 USC $1164 formation, reports, studies, and surveys so required, . . . “
11. Alcohol, Drug Abuse, and Mental Health Administration . 111

B. National Institute on Drug Abuse—continued

Type of

Legal citation authority Legislative text

b) Drug Abuse

Office and

Treatment Act

of 1972

● P.L. 92-255$405,

(1972) and

amended

● 21 USC $1172

c) Drug Abuse

Office and

Treatment Act

of 1972

● P.L. 92-255$406

(1972)

● 21 USC $1173

General (b) “The Secretary shall submit to the President and the

Congress with respect to each fiscal year on—

(1) the health consequences and extent of drug abuse in

the United States,

(2) a description and evaluation of the effectiveness of the

drug abuse prevention functions carried out through any entity of the Department of Health, Education, and Welfare in the

fiscal year for which the report is made,

(3) a description of the manner in which such functions

were carried out, a description of the amount of funds expended in carrying out such functions, and a description and

evaluation of the coordination within the Department of

Health, Education, and Welfare in carrying out such functions,

(4) a description and evaluation of the effectiveness of

experimental methods and programs implemented in carrying

out such functions, recommendations for implementation of

such methods and programs by others in carrying out their

drug abuse prevention functions, and a description and

evaluation of the effectiveness of the means used to disseminate information respecting such methods and programs, and

(5) proposals for changes in the drug abuse prevention

functions carried out through the Department of Health,

Education, and Welfare (including recommendations for legislation). The report required by this subsection shall be

transmitted not later than January 15 of each year . . . “

Specific (a) “The Secretary shall–

(1) operate an information center for the collection, preparation, and dissemination of all information relating to drug

abuse prevention functions, including information concerning

State and local drug abuse treatment plans, and the availability of treatment resources, training and educational programs,

statistics, research, and other pertinent data and information;

(2) investigate and publish information concerning uniform methodology and technology for determining the extent and kind of drug use by individuals and effects which individuals are likely to experience from such use;

(3) gather and publish statistics pertaining to drug abuse

and promulgate regulations specifying uniform statistics to be

furnished, records to be maintained, and reports to be submitted, on a voluntary basis by public and private entities and

individuals respecting drug abuse; . . .
212 ● Part I]—Directory of Statutory Authorities

B. National Institute on Drug Abuse—continued

Type of

Legal citation authority Legislative text

d) Drug Abuse

●

●

Office and

Treatment Act

of 1972

P.L. 92-255 ~409

(1972), and

amended

21 USC ~1176

e) Drug Abuse

●

●

Office and

Treatment Act

of 1972

P.L, 92-255

$410 (1972)

and amended

21 USC $1177

(b) After December 31, 1974, the Secretary shall carry out

his functions under subsection (a) of this section through the

National Institute on Drug Abuse. ”

Specific (e) “Any State desiring to receive a grant under subsection

(b)(2) or (b)(3) of this section shall submit t. the

Secretary . . . a State plan for . . . the development of more

effective drug abuse prevention functions in the State and for

evaluating the conduct of such functions . . . Each State plan

shall . . .

(5)(A) set forth, in accordance with criteria established by

the Secretary, a detailed survey of the local and State needs

for prevention and treatment of drug abuse and drug dependence, including a survey of the health facilities needed to

provide services for drug abuse and drug dependence, and a

plan for the development and distribution of such facilities

and programs throughout the State in accordance with such

needs;

(B) include in the the survey conducted pursuant to

subparagraph (A) an identification of the need for prevention

and treatment of drug abuse and drug dependence by women

and by individuals under the age of eighteen and provide

assurance that prevention and treatment programs within the

State will be designed to meet such need;

General (9) provide that the State ~g~ncy will make such reports,

in such form and containing such information as the Secretary

may from time to time reasonably require, and will keep such

records and afford such access thereto as the Secretary may

find necessary to assure the correctness and verification of

such reports; . . . “

Implied (a) “The Secretary, acting through the National Institute on

Drug Abuse, shall

* * *

(3) make grants . . . and enter into contracts with public

and private agencies, organizations, institutions, and individuals to establish, conduct, and evaluate drug abuse prevention, treatment, and rehabilitation programs within State

and local criminal justice systems;

(4) make grants to or contracts with groups composed of

individuals representing a broad cross-section of medical, scientific or social disciplines for the purpose of determining the

causes of drug abuses in a particular area, prescribing

methods for dealing with drug abuse in such an area, or con-
11. Alcohol, Drug Abuse, and Mental Health Administration . 113

B. National Institute on Drug Abuse—continued

Type of

Legal citation authority Legislative text

ducting programs for dealing with drug abuse in such an

area; . . .

(5) make research grants . . . and enter into contracts

with public and private agencies, organizations, and institutions, and individuals for improved drug maintenance techniques or programs, and

(6) make grants . . . and enter into contracts with public

and private agencies, organizations, institutions, and individuals to establish, conduct, and evaluate drug abuse

prevention and treatment programs. . . . “

f) Drug Abuse

Office and

Treatment Act

of 1972

● P.L. 92-255$501

(1972), and

amended

● 21 USC $1191

Implied “There is established the National Institute on Drug

Abuse . . . to administer the programs and authorities of the

Secretary of Health, Education, and Welfare . . . with respect

to drug abuse prevention functions. The Secretary, acting

through the Institute, shall in carrying out the purposes of sections 301, 302, and 303 [42 USC ~$241, 242, 242a] of the

Public Health Service Act with respect to drug abuse, develop

and conduct comprehensive health, education, training,

research, and planning programs for the prevention and treatment of drug abuse and for the rehabilitation of drug abusers.

The Secretary shall carry out through the Institute the administrative and financial management, policy development and

planning, evaluation, and public information functions which

are required for the implementation of such programs and

authorities. *

g) Drug Abuse Implied

Office and

Treatment Act

of 1972

● P.L. 92-255 ~502,

as added by P.L.

94-237 $12(b)(l)

(1976)

● 21 USC $1192

(a) “The Director shall–

* * *

(2) provide for a central clearinghouse for Federal,

State, and local governments, public and private agencies,

and individuals seeking drug abuse information and

assistance from the Federal Government.

(b) In carryin g out his functions under thi s

section, the Director may—

(1) provide technical assistance . . . to analyze and

identify State and local drug abuse problems and assist

in the development of plans and programs to meet the

problems so identified; . . . “

‘Section 301 of the Public Health Service Act, 42, USC ~241, is the genera] data collection authority for the Secretary of HEW.
I ——

114 ● Part 11—Directory of Statutory Authorities

B. National Institute on Drug Abuse—continued

Type of

Legal citation authority Legislative text

h) Public Health General (e)(2) “The [National Advisory Council on Drug

●

Service Act Abuse] . . . shall advise , consult with and make

recommendations to the Secretary

P.L. 78-410 S217(e) (A) concerning matters

- relating to the activities

as added by P.L.

92-255 ~502(a)

(1972)

● 42 USC ~218

i) Public Health

Service Act

● P.L. 78-410$302

(1944), and

amended

● 42 USC ~242

j) Marihuana and

Health Reporting

Act

● P.L. 91-296, ~502

(1970), and

amended

● 42 USC ~242 note

General

and functions of the Secretary in the field of drug abuse,

including, but not limited to, the development of new

programs and priorities, the efficient administration

of programs, and the supplying of needed scientific and

statistical data and program information to professionals,

paraprofessionals, and the general public; . . . “

(a) “In carrying out the purposes of section 241 of . . . title

[42] with respect to drugs the use or misuse of which might

result in drug abuse or dependency, the studies and investigations authorized therein shall include the use and

misuse of narcotic drugs and other drugs. Such studies and

investigations shall further include the quantities of

crude opium, coca leaves, and their salts, derivatives and

preparations, and other drugs subject to control under the

Controlled Substances Act and Controlled Substances Import

and Export Act, together with reserves thereof, necessary to

supply the normal and emergency medicinal and scientific requirements of the United States. The results of studies and investigations of the quantities of narcotic drugs or other drugs

subject to control under such Acts, together with reserves of

such drugs, that are necessary to supply the normal and

emergency medicinal and scientific requirements of the United

States, shall be reported not later than the first day of April of

each year to the Attorney General, to be used at his discretion

in determining manufacturing quotas or importation requirements under such Act .“*

[Jointly administered with the Bureau of Drugs (FDA), and the

Drug Enforcement Administration. ]

Implied “The Secretary of Health, Education, and Welfare, after

consultation with the Surgeon General and other appropriate

individuals, shall transmit a report to the Congress on or

before January 31, 1971 and biennially thereafter (1) containing current information on the health consequences

of using marihuana, and (2) containing such recommendations for legislative and administrative action , as he

may deem appropriate. A preliminary report shall be

transmitted to the Congress by the Secretary concerning

current information on the health consequences of using

● Section 301 of the Public Health Service Act, 42 USC $241, is the general data collection authority for the Secretary of HEW.
II. Alcohol, Drug Abuse, and Mental Health Administration . 115

B. Nationai institute on Drug Abuse—continued

Type of

Legal citation authority Legislative text

marihuana not later than ninety (90) days after the date of

enactment of this title. ”

k) Public Health

Service Act

● P.L. 78-410 ~303,

as added by P.L.

79-787 ~7(c)

(1946) and

amended

● 42 USC ~242a

General (a) “In carrying out the purposes of section 241 of . . . title

[42] with respect to mental health, the Surgeon General is

authorized—

* * *

(2) to make grants . . . for investigations, experiments,

demonstration, studies, and research projects with respect to

the development of improved methods of diagnosing mental

illness [such as research on the use and effect of alcohol and

other psychoactive drugs], and of care, treatment, and

rehabilitation of the mentally ill . . . “*

[Jointly administered with the National Institute of

Mental Health, and the Food and Drug Administration,

FDA authority extends to regulation of protection of research

subjects and confidentiality. ]

C. National Institute of Mental Health

a) Public Health

Service Act

● P.L. 78-410$217,

(1944) and

amended

● 42 USC ~218

b) Public Health

Service Act

 P.L. 78-410 ~303,

as added by P.L.

79-487 $7(c)

(1946) and

amended

● 42 USC ~242a

Implied (c)(2) “The Nationa l Advisory Mental Health

Council . . . is authorized . . . (2) to collect information as to

studies being carried on in the field of mental health and, with

the approval of the Surgeon General, make available such information through the appropriate publications for the benefit

of health and welfare agencies or organizations (public and

private), physicians, or any other scientists, and for the information of the general public . . . “

General (a) “In carrying out the purposes of section 241 of . . . title

[42] with respect to mental health, the Surgeon General is

authorized—

* *

(2) to make grants . . for investigations, experiments,

demonstrations, studies, and research projects with respect to

the development of improved methods of diagnosing mental

illness, (such as research on the use and effect of alcohol and

other psychoactive drugs), and of care, treatment, and

rehabilitation of the mentally ill . . . “*

[Jointly administered with the National Institute on Drug

Abuse, and the Food and Drug Administration; FDA authority extends to regulation of protection of research subjects and

confidentiality. ]

● Section 301 of the Public Health Service Act, 42 USC S241, is the general data collection authority for the Secretary of HEW.
116 ● Part n-Directory of Statutory Authorities

C. National Institute of Mental Health—continued

Type of

Legal citation authority Legislative text

c) Public Health Specific

Service Act

● P.L. 78-410$314

(1944), as added

by P.L. 95-622

~109 (1978)

● 42 USC §246

d) Public Health

Service Act

Implied

● P.L. 78-410 ~455,

as added by P.L.

93-282 §202

(1974)

● 42 USC §289k-1

e) Mental Specific

●

●

Retardation

Facilities and

Community Mental

Health Centers

Construction Act

P.L. 88-164 §201,

as added by P.L.

94-635303 (1975),

and amended

42 USC §2689

(g)(2) “NO grant may be made [to State mental health

authorities to assist them in meeting the costs of providing

mental health services] . . . unless an application . . . has

been submitted . . . in such form and manner and shall contain such information as the Secretary may require, and shall

contain or be supported by assurances satisfactory to the

Secretary that— . . .

(C) the State mental health authority will–

(ii) from time to time, but not less often than annually, report to the Secretary (through a uniform national reporting system and by such categories as the Secretary may

prescribe) a description of the mental health services provided

in the State in the fiscal year for which the grant applied for is

made . . . ; and

(iii) make such reports (in such form and containing

such information as the Secretary may prescribe) as the

Secretary may reasonably require, and keep such records and

afford such access thereto as the Secretary may find necessary

to assure the correctness of, and to verify, such reports, . . . “

(a) “There is established the National Institute of Mental

Health . . . to administer the programs and authorities of the

Secretary with respect to mental health. The Secretary, acting

through the Institute, shall . . . with respect to mental illness,

develop and conduct comprehensive health, education, training, research, and planning programs for the prevention and

treatment of mental illness and for the rehabilitation of the

mentally ill. The Secretary shall carry out through the Institute the administrative and financial management, policy

development and planning, evaluation, and public information functions which are required for the implementation of

such programs and authorities. . . . “

(d) “A [community mental health] center shall have

established, in accordance with regulations prescribed by the

Secretary, . . . (2) an integrated medical records system

(including a drug use profile) which, in accordance with applicable Federal and State laws respecting confidentiality, is designed to provide access to all past and current information regarding the health status of each patient and to maintain

safeguards to

of the patient

preserve confidentiality and to protect the rights
11, Alcohol, Drug Abuse, and Mental Health Administration ● IIY

C. National Institute of Mental Health—continued

Type of

Legal citation authority Legislative text

f) Mental Specific

●

●

Retardation

Facilities and

Community Mental

Health Centers

Construction Act

P.L. 88-164 §206

as added by P.L.

94-63 §303 (1975),

and amended

42 USC §2689e

g) Mental

Retardation

Facilities and

Community Mental

Health Centers

Construction Act

● P.L. 88-164$231

as added by P.L.

94-63$303 (1975),

and amended

● 42 USC §2689q

Specific

(c)(l) “An application for a [community mental health

center] grant under this part shall be submitted in such form

and manner as the Secretary shall prescribe and shall contain

such information as the Secretary may require . . . An application for a grant under . . . this title shall contain . . .

assurances . . . that

(A) the community mental health center for which the

application is submitted will provide . . . (ii) an effective procedure for developing, compiling, evaluating, and reporting

to the Secretary statistics and other information (which the

Secretary shall publish and disseminate on a periodic basis

and which the center shall disclose at least annually to the

general public) relating to

(I) the cost of the center’s operation,

(II) the patterns of use of its services,

(III) the availability, accessibility and acceptability of its services,

(IV) the impact of its services upon the mental

health of the residents of its catchment area, and,

(V) such other matters as the Secretary may require; . . . “

(a) “The Secretary shall establish within the National

Institute of Mental Health . . . the National Center for the

Prevention and Control of Rape (hereinafter in this section

referred to as the “Center”).

(b)(l) The Secretary, acting through the Center, may,

directly or by grant, carry out the following:

(A) A continuing study of rape, including a study and

investigation of—

(i) the effectiveness of existing Federal, State, and

local laws dealing with rape;

(ii) the relationship, if any, between traditional legal

and social attitudes toward sexual roles, the act of rape, and

the formulation of laws dealing with rape;

(iii) the treatment of the victims of rape by law enforcement agencies, hospitals or other medical institutions,

prosecutors, and the courts;

(iv) the causes of rape, identifying to the degree

possible—

(1) social conditions which encourage sexual attacks, and

(II) the motives of offenders; and

(v) the impact of rape on the victim and the family of

the victim;

46-643 0 - 79 - 9
i118 ● Part 11-Directory of Statutory Authorities

C. National Institute of Mental Health—continued

Tvpe of . s

Legal citation authority Legislative text

(vi) sexual assaults in correctional institutions;

(vii) the actual incidence of forcible rape as compared to the reported incidence of forcible rape and the

reasons for any difference in such incidence; and

(viii) the effectiveness of existing private and local

and State government educational, counseling, and other programs designed to prevent and control rape.

(B) The compilation, analysis, and publication of summaries of the continuing study conducted under subparagraph

(A) and the research and demonstration projects conducted

under subparagraph (E). The Secretary shall annually submit

to the Congress a summary of such study and

together with recommendations where appropriate.

Implied (C) The development and maintenance

information clearinghouse with regard to—

rape and

(i) the prevention and control of rape;

projects

of an

(ii) the treatment and counseling of the victims of

their families; and

(iii) the rehabilitation of offenders. . . . “
111. Center for Disease Control c 119

Ill. CENTER FOR DISEASE CONTROL

Type of

Legal citation authority Legislative text

A. Center for Disease Control—Generally

a) Public Health

Service Act

● P.L. 78-410$307

formerly 308, as

added by P.L.

86-610 §3 (1960)

renumbered

and amended

● 42 USC §242/

b) Public Health

Service Act

● P.L. 78-410$314

as added by P.L.

94-63$102

(1975) and

amended

● 42 USC §246

General (a) “For the purpose of advancing the status of the health

sciences in the United States (and thereby the health of the

American people), the Secretary may participate with other

countries in cooperative endeavors in biomedical research and

the health services research and statistical activities authorized

by sections 242b, 242c, and 242k of this title. ”

Specific (d)(l) . . . “The Secretary shall make grants to State health

authorities . . . to assist in meeting the costs of providing

comprehensive public health services.

(2) No grant may be made under paragraph (1) to the

State health authority of any State unless an application therefor has been submitted to and approved by the Secretary.

Such an application shall be submitted in such form and manner and shall contain such information as the Secretary may

require, and shall contain or be supported by assurances

satisfactory to the Secretary that—

(A) the comprehensive public health services which

will be provided within the State with funds under a grant

under paragraph (1) will be provided in accordance with the

State health plan in effect under section 1524(c); . . .

(ii) from time to time as prescribed by the Secretary,

report to the Secretary (through a uniform national reporting

system and by such categories as the Secretary may prescribe)

a description of the comprehensive public health services provided in the State in the fiscal year for which the grant applied

for is made and the amount and source of funds expended in

that fiscal year and in the preceding fiscal year for the provision of each such category of services; and

(iii) make such other reports (in such form and containing such information as the Secretary may prescribe) as

the Secretary may reasonably require, and keep such records

and afford such access thereto as the Secretary may find

necessary to assure the correctness of, and to verify, such

reports; . . .

Implied (4)(A) . . . In determining the amount of a grant to a

State health authority under subclause (I), the Secretary shall
120 . Part 11—Directory of Statutory Authorities

A. Center for Disease Control-WinUe d

Type of

Legal citation authority Legislative text

c) Public Health

Service Act

● P.L. 78-410 §317,

as added by P.L.

87-868 ~2 (1962),

and amended

c 42 USC §247b

take into account the financial need of such State and the level

of State and local expenditures for comprehensive public

health services [as defined in subparagraph (C)]. In determining the financial need of a State, the Secretary shall consider,

as major factors, the proportion of the State’s population

whose income level is below the poverty income level

established by the Secretary and the proportion of its population which is living in medical underserved areas. ”

[Jointly administered with the Bureau of Community Health

Services (HSA). ]

General (a) “The Secretary may make grants—

(1) to State health authorities to assist them in meeting the

costs of establishing and maintaining preventive health service

programs for screening for, the detection, diagnosis, prevention, and referral for treatment of, and follow-up on compliance with treatment prescribed for hypertension; and

(2) to States and, . . . to political subdivisions of States

and to other public entities to assist them in meeting the costs

of establishing and maintaining preventive health service programs (other than programs described in paragraph (1)).

(b) No grant may be made under section (a) unless an application therefore has been submitted to, and approved by,

the Secretary. Such an application shall be in such form and

be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—

(1) a complete description of the type and extent of the

program for which the applicant is seeking a grant under

subsection (a);

(2) with respect to each such program, . . .

(B) a description of the services provided by the applicant in such program in such period . . . and,

(D) if the applicant proposes changes in the provision

of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of

Federal funds needed by the applicant to make such

changes; . , .

(s) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or

programs; .

(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such

information as the Secretary may by regulation prescribe) as

the Secretary may reasonably require and keep such records

and afford such access thereto as the Secretary may find
111. Center for Disease Control ● 121

A. Center for Disease Control—Generally—continued

Type of

Legal citation authority Legislative text

d) Public Health

Service Act

s P.L. 78-410$318,

as added by P.L.

92-499 ~203

(1972), and

amended

● 42 USC §247c

e) Public Health

Service Act

● P.L. 78-410$353,

as added by P.L.

90-174 $5(a)

(1967)

● 42 USC §263a

necessary to assure the correctness of, and to verify, such

reports; . . .

(h) The Secretary shall include, as part of the report required by section 1705 [42 USC $300u-4] a report on the extent of the problems presented by the diseases and conditions

referred to in subsection (j) [concerning preventive health

service programs to immunize children against immunizable

diseases, and influenza], . . . and on the effectiveness of the

activities assisted under grants under subsection (a) in controlling such diseases and conditions.

[Center for Disease Control administers all but the authority

concerning hypertension; the Bureau of Community Health

Services (HSA), administers the hypertension program. ]

Specific (b) “The Secretary is authorized to make grants . . . for the

conduct of research . . . [and] public information . . . for the

prevention and control of venereal disease.

(c) The Secretary is also authorized to make project

grants . . . for—

(1) venereal disease surveillance activities, including the

reporting, screening, and followup of diagnostic tests for, and

diagnosed cases of, venereal disease;

(2) casefinding and case followup activities respecting venereal disease, including contact tracing of infectious cases of

venereal disease and routine testing, including laboratory tests

and followup systems;

(3) interstate epidemiologic referral and followup activities respecting venereal disease;

(4) professional (incIuding appropriate allied health personnel) venereal disease education training and clinical skills

improvement activities; and

(5) such special studies or demonstrations to evaluate or

test venereal disease prevention and control strategies and activities as may be prescribed by the Secretary. ”

General (d)(l) “A license shall not be issued in the case of any

clinical laboratory unless

(A) the application therefor contains or is accompanied

by such information as the Secretary finds necessary, and

(B) the applicant agrees and the Secretary determines

that such laboratory will be operated in accordance with

standards found necessary by the Secretary to carry out the

purposes of this section. Such standards shall be designed to

assure consistent performance by the laboratories of accurate

laboratory procedures and services, and shall include among

others, standards to assure—
222 . Part 11—Directory of Statutory Authorities

A. Center for Disease Control—Generally—conthwed

Type of

Legal citation authority Legislative text

(i) maintenance of a quality control program adequate and appropriate for accuracy of the laboratory procedures and services;

(ii) maintenance of records, equipment, and facilities

necessary to proper and effective operation of the laboratory;

(iii) qualifications of the director of the laboratory

and other supervisory professional personnel necessary for

adequate and effective professional supervision of the operation of the laboratory (which shall include criteria relating to

the extent to which training and experience shall be

substituted for education); and

(iv) participation in a proficiency testing program established by the Secretary. ”

[Jointly administered with the Health Standards and Quality

Bureau (HCFA). ]

f) Public Health

Service Act

● P.L. 78-410$365

(1944), and

amended

● 42 USC §268

General (a) “Any consular or medical officer of the United States,

designated for such purpose by the Secretary, shall make reports to the Surgeon General, on such forms and at such intervals as the Surgeon General may prescribe, of the health conditions at the port or place at which such officer is stationed. ”

g) Public Health Specific

Service Act

● P.L. 78-410$1107,

as added by P.L.

95-626, §205

(1978)

● 42 USC $300 b-6

“The Secretary, acting through an identifiabl e

administrative unit, shall—

(1) conduct epidemiological assessments and surveillance

of genetic diseases to define the scope and extent of such

diseases and the need for programs for the diagnosis, treatment, and control of such diseases, screening for such

diseases, and the counseling of persons with such diseases;

(2) on the basis of the assessments and surveillance

described in paragraph (1), develop for use by the States programs which combine in an effective manner diagnosis, treatment, and control of such diseases, screening for such

diseases, and counseling of persons with such diseases; . . . “

[Jointly administered with the Bureau of Community Health

Services (HSA). ]
Ill. Center for Disease Control ● 123

A. Center for Disease Control—General/y— continued

Type of

Legal citation authority Legislative text

h) Public Health General

●

●

Service Act

P.L. 78-410 §1701,

as added by P.L.

94-317 §lo2

(1976), and

amended

42 USC §300u

i) Public Health

Service Act

● P.L. 78-410 §1702,

as added by P.L.

94-317$102

(1976)

● 42 USC $300u-1

Implied

General

Implied

General

(a) “The Secretary shall–

(4) undertake and support research and demonstrations

respecting health information and health promotion, preventive health services, and education in the appropriate use of

health care.

(7) foster the exchange of information respecting, and

foster cooperation in the conduct of, research, demonstration,

and training programs respecting health information and

health promotion, preventive health services, and education

in the appropriate use of health care.

* * *

(c) It shall be the duty of the State Council on Physical

Fitness to—

(2) assess the physical fitness and nutrition status of

residents of the State;

(3) plan and administer a program of grants-in-aid to support physical fitness projects, research projects, and pubIic information efforts to promote the development of physical

fitness for the residents of the State;

(4) evaluate and improve the availability and quality of

sport medicine and athletic trainer programs in the State. ”

[Jointly administered with the Office of the Disease Prevention and Health Promotion (OASH). ]

(a) “The Secretary is authorized to conduct and support by

grant or contract . . . research in health information and

health promotion, preventive health services, and education

in the appropriate use of health care. . . . The Secretary shall

also—

* * *

(2) determine the best methods of disseminating

information concerning personal health behavior, preventive

health services and the appropriate use of health care and of

affecting behavior so that such information is applied to maintain and improve health, and prevent disease, reduce its risk,

or modify its course or severity,

(4) develop

(A) methods by which the cost and effectiveness of activities respecting health information and health promotion,

preventive health services, and education in the appropriate

use of health care, can be measured, including methods for
———

124 Part 11—Directory of Statutory Authorities

A. Center for Disease Control—Generally—continued

Type of

Legal citation authority Legislative text

j) Public Health

Service Act

P.L. 78-410$1704

as added by P.L.

94-317$102

(1976)

42 USC §300u-3

Specific

Implied

evaluating the effectiveness of various settings for such activities, and the various types of persons engaged in such activities,

(B) methods for reimbursement or payment for such

activities, and

(C) models and standards for the conduct of such ac

-

tivities . . .

(5) develop a method for assessing the cost and effectiveness of specific medical services and procedures under

various conditions of use, including the assessment of the sensitivity and specificity of screening and diagnostic procedures;

and

(6) enumerate and assess, using methods developed under

paragraph (5), preventive health measures and services with

respect to their cost and effectiveness under various conditions

of use.

b) The Secretary shall make a periodic survey of the needs,

interest, attitudes, knowledge, and behavior of the American

public regarding health and health care. The Secretary shall

take into consideration the findings of such surveys and the

findings of similar surveys conducted by national and community health education organizations, and other organizations and agencies for formulating policy respecting health information and health promotion, preventive health services,

and education in the appropriate use of health care. ”

[Jointly administered with the Office of Disease Prevention

and Health Promotion (OASH). ]

“The Secretary is authorized to conduct and support . . .

such activities as may be required to make information respecting health information and health promotion, preventive

health services, and education in the appropriate use of health

care available to the consumers of medical care, providers of

such care, schools, and others who are or should be informed

respecting such matters. Such activities may include at least

the following:

(1) The publication of information, pamphlets, and other

reports which are specially suited to interest and instruct the

health consumer, which information, pamphlets and other

reports shall . . . pertain to the individual’s ability to improve

and safeguard his own health; shall include material, accompanied by suitable illustrations, on child care, family life and

human development, disease prevention . . . physical fitness,

dental health, environmental health, nutrition, safety and accident prevention, drug abuse and alcoholism, mental health,
— —

III, Center for Disease Control ● 125

A. Center for Disease Control- Generally —continued

Type of

Legal citation authority Legislative text

management of chronic diseases . . . and venereal

diseases; . . .

General (6) Assess, with respect to the effectiveness, safety, cost,

and required training for and conditions of use, of new aspects

of health care, and new activities, programs, and services

designed to improve human health and publish in readily

understandable language . . . such assessments . . . “

[Jointly administered with the Office of Disease Prevention

and Health Promotion (OASH). ]

k) Public Health

Service Act

● P.L. 78-410$1705,

as added by P.L.

94-317 §102

(1976)

● 42 USC §300u-4

Implied (a) “The Secretary shall, not later than two years after June

23, 1976, and annually thereafter, submit to the President for

transmittal to Congress a report on the status of health information and health promotion, preventive health services,

and education in the appropriate use of health care. Each such

report shall include—

(1) a statement of the activities carried out under this subchapter since the last report and the extent to which such activity achieves the purposes of this subchapter;

(2) an assessment of the manpower resources needed to

carry out programs relating to health information and health

promotion, preventive health services, and education in the

appropriate use of health care, and a statement describing the

activities currently being carried out under this subchapter

designed to prepare teachers and other manpower for such

programs;

(3) the goals and strategy formulated pursuant to section

300u(a)(l) of title 42. . . the models and standards developed

under this subchapter, and the results of the study required by

subsection (b) of this section; and

(4) such recommendations as the Secretary considers appropriate for legislation respecting health information and

health promotion, preventive health services, and education

in the appropriate use of health care . . .

Specific (b) “The Secretary shall conduct a study of health education

services and preventive health services to determine the

coverage of such services under public and private health insurance programs, including the extent and nature of such

coverage and the cost sharing requirements required by such

programs for coverage of such services. ”

[Jointly administered with the Office of Disease Prevention

and Health Promotion (OASH). ]
126 ● Part IZ—Directory of Statutory Authorities

A. Center for Disease Control—GenerallY—continued

Type of

Legal citation authority Legislative text

1) Lead-Based General (a) “The Secretary of Housing and Urban Development, in

Paint Poisoning consultation with the Secretary of Health, Education, and

Prevention Act Welfare, shall develop and carry out a demonstration and

research program to determine the nature and extent of the

● P.L. 91-695 problem of lead based paint poisoning in the United States,

§301 (1971), and particularly in urban areas, including the methods by which

amended the lead based paint hazard can most effectively be removed

from interior surfaces, porches, and exterior surfaces of resi-

. 42 USC $4821 dential housing to which children maybe exposed.”

[Jointly administered with the Department of Housing and Urban Development. ]

B. National Institute for Occupational Safety and Health

a) Occupational Specific (c)(l) “Each employer shall make, keep and preserve, and

Safety and make available to the Secretary of Health, Education,

Health Act and Welfare, such records regarding his activities relating to

this chapter as the Secretary [of Labor], in cooperation with

● P.L. 91-596$8 the Secretary of Health, Education, and Welfare, may

(1970) prescribe by regulation as necessary or appropriate for the enforcement of this chapter or for developing information

● 29 USC ~657 regarding the causes and prevention of occupational accidents

and illnesses. . . .

(2) The Secretary [of Labor], in cooperation with the

Secretary of Health, Education, and Welfare, shall prescribe

regulations requiring employers to maintain accurate records

of, and to make periodic reports on, work-related deaths, injuries and illnesses other than minor injuries requiring only

first aid treatment and which do not involve medical treatment, loss of consciousness, restriction of work or motion, or

transfer to another job.

(3) The Secretary [of Labor], in cooperation with the

Secretary of Health, Education, and Welfare, shall issue

regulations requiring employers to maintain accurate records

of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or

measured under section 655 of . . . title [29]. Such regulations

shall provide employees or their representatives with an opportunity to observe such monitoring or measuring, and to

have access to the records thereof. Such regulations shall also

make appropriate provision for each employee or former

employee to have access to such records as will indicate his
111, Center for Disease Control ● 127

B. National Institute for Occupational Safety and Health—continued

Type of

Legal citation authority Legislative text

own exposure to toxic materials or harmful physical

agents. . . .

(d) Any information obtained by . . . the Secretary of

Health, Education, and Welfare, or a State agency under this

chapter shaIl be obtained with a minimum burden upon

employers, especially those operating small businesses. Unnecessary duplication of efforts in obtaining information shall

be reduced to the maximum extent feasible. . . .

(g)(l) The Secretary [of Labor] and Secretary of Health,

Education, and Welfare are authorized to compile, analyze,

and publish, either in summary or detailed form, all reports or

information obtained under this section. ”

[Jointly administered with the Secretary of Labor. ]

b) Occupational

Safety and

Health Act

● P.L. 91-596$20

(1970)

● 29 USC $669

General (a)(l) “The Secretary of Health, Education, and Welfare,

after consultation with the Secretary [of Labor] and with other

appropriate Federal departments or agencies, shall conduct . . . research, experiments, and demonstrations relating

to occupational safety and health, including studies of psychological factors involved, and relating to innovative methods, techniques, and approaches for dealing with occupa~

tional safety and health problems.

(2) The Secretary of Health, Education, and Welfare shall

from time to time consult with the Secretary [of Labor] in

order to develop specific plans for such research, demonstrations, and experiments as are necessary to produce criteria, including criteria identifying toxic substances, enabling the

Secretary [of Labor] to meet his responsibility for the formulation of safety and health standards under this chapter; and the

Secretary of Health, Education, and Welfare, on the basis of

such research, demonstrations, and experiments and any

other information available to him, shall develop and publish

at least annually such criteria as will effectuate the purposes of

this chapter.

(3) The Secretary of Health, Education, and Welfare, on

the basis of such research, demonstrations, and experiments,

and any other information available to him, shall develop

criteria dealing with toxic materials and harmful physical

agents and substances which will describe exposure levels that

are safe for various periods of employment, including but not

limited to the exposure levels at which no employee will suffer

impaired health or functional capacities or diminished life expectancy as a result of his work experience.

(4) The Secretary of Health, Education, and Welfare shall

also conduct special research, experiments, and demonstra-
128 ● Part I] —Directory of Statutory Authorities

B. National Institute for Occupational Safety and health—continued

Type of

Legal citation authority Legislative text

tions relating to occupational safety and health as are

necessary to explore new problems, including those created by

new technology in occupational safety and health, which may

require ameliorative action beyond that which is otherwise

provided for in the operating provisions of this chapter. The

Secretary of Health, Education, and Welfare shall also conduct research into the motivational and behavioral factors

relating to the field of occupational safety and health.

Specific (5) The Secretary of Health, Education, and Welfare, in

order to comply with his responsibilities under paragraph (2),

and in order to develop needed information regarding potentially toxic substances or harmful physical agents, may

prescribe regulations requiring employers to measure, record,

and make reports on the exposure of employees to substances

or physical agents which the Secretary of Health, Education,

and Welfare reasonably believes may endanger the health or

safety of employees. The Secretary of Health, Education, and

Welfare also is authorized to establish such programs of

medical examinations and tests as may be necessary for determining the incidence of occupational illnesses and the susceptibility of employees to such illnesses. . . .

(7) Within two years of December 29, 1970, and annually

thereafter the Secretary of Health, Education, and Welfare

shall conduct and publish industrywide studies of the effect of

chronic or low-level exposure to industrial materials, processes, and stresses on the potential for illness, disease, or loss

of functional capacity in aging adults. . . .

(d) Information obtained by the Secretary [of Labor] and

the Secretary of Health, Education, and Welfare under this

section shall be disseminated by the Secretary to employers

and employees and organizations thereof.

(e) The functions of the Secretary of Health, Education, and

Welfare under this chapter shall, to the extent feasible, be

delegated to the Director of the National Institute for Occupational Safety and Health established by section 671 of this

title.”

[Jointly administered with the Secretary of Labor. ]
111. Center for Disease Control ● 129

B. Nationa/ Institute for Occupational Safety and Health—continued

Legal citation

c) Occupational

Safety and

Health Act

● P.L. 91-596 §21

(1970)

● 29 USC $671

d) Occupational

Safety and

Health Act

● P.L. 91-596$24

(1970)

● 29 USC ~673

e) Occupational

Safety and

Health Act

● P.L. 91-596$26

(1970)

● 29 USC $675

Type of

authority Legislative text

General (b) “There is hereby established in the Department of

Health, Education, and Welfare a National Institute for Occupational Safety and Health. The Institute shall be headed by a

Director who shall be appointed by the Secretary of Health,

Education, and Welfare, . . .

(c) The Institute is authorized to–

(1) develop and establish recommended occupational

safety and health standards; and

(2) perform all functions of the Secretary of Health, Education, and Welfare under sections 669 and 670 of . . .

title [29].

(d) Upon his own initiative, or upon the request of the

Secretary [of Labor] or the Secretary of Health, Education,

and Welfare, the Director is authorized (1) to conduct such

research and experimental programs as he determines are

necessary for the development of criteria for new and improved occupational safety and health standards . . . “

Specific (a) “In order to further the purposes of this chapter, the

Secretary [of Labor], in consultation with the Secretary of

Health, Education, and Welfare, shall develop and maintain

an effective program of collection, compilation, and analysis

of occupational safety and health statistics. Such program

may cover all employments whether or not subject to any

other provisions of this chapter but shall not cover employments excluded by section 653 of this title. The Secretary [of

Labor] shall compile accurate statistics on work injuries and

illnesses which shall include all disabling, serious, or significant injuries and illnesses, whether or not involving loss of

time from work, other than minor injuries requiring only first

aid treatment and which do not involve medical treatment,

loss of consciousness, restriction of work or motion, or

transfer to another job . . . “

[NOTE: The Secretary of Labor, not the Secretary of Health,

Education, and Welfare, has primary authority for administration of this section. ]

Implied “Within one hundred and twenty days following the

convening of each regular session of each Congress, the Secretary [of Labor] and the Secretary of Health, Education, and

Welfare shall each prepare and submit to the President for

transmittal to the Congress a report upon the subject matter of

this chapter, the progress toward achievement of the purpose

of this chapter, the needs and requirements in the field of occupational safety and health, and any other relevant information. Such reports shall include information regarding occupa-
—

230 . Part 11—Directory of Statutory Authorities

B. National Institute for Occupational Safety and Health—continued

Type of

Legal citation authority Legislative text

f) Federal Coal Mine

Health and Safety

Act

● P.L. 91-173$101

(1969), and

amended

● 30 USC §811

Implied

tional safety and health standards, and criteria for such standards, developed during the preceding year; evaluation of

standards and criteria previously developed under this

chapter, defining areas of emphasis for new criteria and standards; an evaluation of the degree of observance of applicable

occupational safety and health standards, and a summary of

inspection and enforcement activity undertaken; analysis and

evaluation of research activities for which results have been

obtained under governmental and nongovernmental sponsorship; an analysis of major occupational diseases, evaluation of

available control and measurement technology for hazards for

which standards or criteria have been developed during the

preceding year; description of cooperative efforts undertaken

between Government agencies and other interested parties in

the implementation of this chapter during the preceding year;

a progress report on the development of an adequate supply of

trained manpower in the field of occupational safety and

health, including estimates of future needs and the efforts being made by Government and others to meet those needs;

listing of all toxic substances in industrial usage for which

labeling requirements, criteria, or standards have not yet been

established; and such recommendations for additional legislation as are deemed necessary to protect the safety and health

of the worker and improve the administration of this

chapter. ”

[Jointly administered with the Secretary of Labor. ]

(a) “The Secretary [of Labor] shall by rule . . . develop,

promulgate, and revise as may be appropriate, improved

mandatory health or safety standards for the protection of life

and prevention of injuries in coal or other mines.

(1) Whenever the Secretary, [of Labor], upon the basis of

information submitted to him in writing by . . . the Secretary

of Health, Education, and Welfare, the National Institute for

Occupational Safety and Health . . . determines that a rule

should be promulgated in order to serve the objectives of this

Act, the Secretary [of Labor] may request the recommendation of an advisory committee. . . . The Secretary [of Labor]

shall provide such an advisory committee with . . . all pertinent factual information developed by the Secretary [of

Labor] or the Secretary of Health, Education, and Welfare, or

otherwise available, including the results of research, demonstrations, and experiments. . . .

(6)(A) The Secretary [of Labor], in promulgating mandatory standards dealing with toxic materials or harmful
111, Center for Disease Control ● 131

B. National Institute for Occupational Safety and Health—continued

Type of

Legal citation authority Legislative text

physical agents under this subsection, shall set standards

which most adequately assure on the basis of the best

available evidence that no miner will suffer material impairment of health or functional capacity even if such miner has

regular exposure to the hazards dealt with by such standard

for the period of his working life. Development of mandatory

standards under this subsection shall be based upon research,

demonstrations, experiments, and such other information as

may be appropriate. In addition to the attainment of the highest degree of health and safety protection for the miner, other

considerations shall be the latest available scientific data in the

field, the feasibility of the standards, and experience gained

under this and other health and safety laws . . .

(B) The Secretary of Health, Education, and Welfare,

as soon as possible after the date of enactment of the Federal

Mine Safety and Health Amendments Act of 1977 but in no

event later than 18 months after such date and on a continuing

basis thereafter, shall, for each toxic material or harmful

physical agent which is used or found in a mine, determine

whether such material or agent is potentially toxic at the concentrations in which it is used or found in a mine. The Secretary of Health, Education, and Welfare shall submit such

determinations with respect to such toxic substances or harmful physical agents to the Secretary [of Labor]. Thereafter, the

Secretary of Health, Education, and Welfare shall submit to

the Secretary [of Labor] all pertinent criteria regarding and

such substances determined to be toxic or any such harmful

agents as such criteria are developed. . . .

(7) . . . Where appropriate, such mandatory standard

[promulgated under this subsection]. . . . shall provide for

monitoring or measuring miner exposure at such locations

and intervals, and in such manner so as to assure the maximum protection of miners. In addition, where appropriate,

any such mandatory standard shall prescribe the type and frequency of medical examinations or other tests which shall be

made available, by the operator at his cost, to miners exposed

to such hazards in order to most effectively determine whether

the health of such miners is adversely affected by such exposure. . . . In the event such medical examinations are in the

nature of research, as determined by the Secretary of Health,

Education, and Welfare, such examinations may be furnished

at the expense of the Secretary of Health, Education, and

Welfare. The results of examinations or tests made pursuant

to the preceding sentence shall be furnished only to the

Secretary [of Labor] or the Secretary of Health, Education,
132 Part 11 —Directory of Statutory Authorities

6. National Institute for Occupational Safety and Health—continued

Type of

Legal citation authority Legislative text

g) Federal Coal Mine

Health and Safety

Act

● P.L. 91-173 §~103

(1969), and

amended

● 30 USC $813

and Welfare, and, at the request of the miner, to his

designated physican.”

[Jointly administered with the Secretary of Labor. ]

Specific (a) “Authorized representatives of the Secretary [of Labor]

or the Secretary of Health, Education, and Welfare shall make

frequent inspections and investigations in coal or other mines

each year for the purpose of (1) obtaining, utilizing, and disseminating information relating to health and safety conditions, the causes of accidents, and the causes of diseases and

physical impairments originating in such mines, (2) gathering

information with respect to mandatory health or safety standards, (3) determining whether an imminent danger exists, and

(4) determining whether there is compliance with the mandatory health or safety standards . . .

(c) The Secretary [of Labor], in cooperation with the Secretary of Health, Education, and Welfare, shall issue regulations requiring operators to maintain accurate records of

employee exposures to potentially toxic materials or harmful

physical agents which are required to be monitored or measured under any applicable mandatory health or safety standard promulgated under this Act. . . .

(e) Any information obtained by the Secretary [of Labor] or

by the Secretary of Health, Education, and Welfare under this

Act shall be obtained in such a manner as not to impose an unreasonable burden upon operators, especially those operating

small businesses, consistent with the underlying purposes of

this Act. Unnecessary duplication of effort in obtaining information shall be reduced to the maximum extent feasible. . . .

General (h) In addition to such records as are specifically required

by this Act, every operator of a coal or other mine shall establish and maintain such records, make such reports, and provide such information, as the Secretary [of Labor] or the

Secretary of Health, Education, and Welfare may reasonably

require from time to time to enable him to perform his functions under this Act. The Secretary [of Labor] or the Secretary

of Health, Education, and Welfare is authorized to compile,

analyze, and publish, either in summary or detailed form,

such reports or information so obtained. Except to the extent

otherwise specifically provided by this Act, all records, information, reports, findings, citations, notices, orders, or decisions required or issued pursuant to or under this Act may be

published from time to time, maybe released to any interested

person, and shall be made available for public inspection. ”

[Jointly administered with the Secretary of Labor. ]
111. Center for Disease Control ● 133

B. National Institute for Occupation/ Safety and Health—continued

Type of

Legal citation authority Legislative text

h) Federal Coal Mine

Health and Safety

Act

● P.L. 91-173$203

(1969)

● 30 USC §843

i) Federal Coal Mine

Health and Safety

Act

● P.L. 91-173$426

(1969) and

amended

● 30 USC $936

j) Federal Coal Mine

●

●

Health and Safety

Act

P.L. 91-173$501

(1969) and

amended

30 Usc ~951

Specific (a) “The operator of a coal mine shall cooperate with the

Secretary of Health, Education, and Welfare in making available to each miner working in a coal mine the opportunity to

have a chest roentgenogram. . . . Each worker who begins

work in a coal mine for the first time shall be given, as soon as

possible after commencement of his employment, and again

three years later if he is still engaged in coal mining, a chest

roentgenogram; . . . All chest roentgenograms shall be given

in accordance with specifications prescribed by the Secretary

of Health, Education, and Welfare and shall be supplemented

by such other tests as the Secretary of Health, Education, and

Welfare deems necessary. The films shall be read and

classified in a manner to be prescribed by the Secretary of

Health, Education, and Welfare, and the results of each

reading on each such person and of such test shall be submitted to the Secretary [of Labor] and to the Secretary of Health,

Education, and Welfare, and, at the request of the miner, to

his physician. The Secretary [of Labor] shall also submit such

results to such miner and advise him of his rights under this

chapter related thereto. Such specifications, readings,

classifications, and tests shall, to the greatest degree possible,

be uniform for all coal mines and miners in such mines.”

[Jointly administered with the Secretary of Labor. I

Implied (b) “Within 120 days following the convening of each

session of Congress the Secretary of Health, Education, and

Welfare shall submit to the Congress an annual report upon

the subject matter of part B of this subchapter . . . “

Specific (a) “The Secretary [of the Interior] and the Secretary of

Health, Education, and Welfare, as appropriate, shalI conduct

such studies, research, experiments, and demonstrations as

may be appropriate— . . .

(5) to develop epidemiological information to (A) identify

and define positive factors involved in occupational diseases

of miners, (B) provide information on the incidence and

prevalence of pneumoconiosis and other respiratory ailments

of miners, and (C) improve mandatory health standards; . . .

(7) to evaluate the effect on bodily impairment and occupational disability of miners afflicted with an occupational

disease;

46-643 0 - ’79 - 10
134 ● Part I]—Directory of Statutory Authorities

B. National Institute for Occupational Safety and Health—continued

Type of

Legal citation authority Legislative text

k) Federal Coal Mine

Health and Safety

Act

● P.L. 91-173$511

(1969), and

amended

● 30 USC $958

(8) to prepare and publish from time to time, reports on

all significant aspects of occupational diseases of miners as

well as on the medical aspects of injuries, other than diseases

which are revealed by the research carried on pursuant to this

subsection;

(9) to study the relationship between coal or other mine

environments and occupational diseases of miners, and . . .

(11) for such other purposes as they deem necessary to

carry out the purposes of this chapter.

(b) Activities under this section in the field of coal or other

mine health shall be carried out by the Secretary of Health,

Education, and Welfare, through the National Institute for

Occupational Safety and Health. . . .

(d) The Secretary of Health, Education, and Welfare shall

also conduct studies and research into matters involving the

protection of life and the prevention of diseases in connection

with persons, who although not miners, work with, or around

the products of, coal or other mines in areas outside of such

mines and under conditions which may adversely affect the

health and well-being of such persons.”

[Jointly administered with the Secretary of Interior. ]

Implied (b) “Within one hundred and twenty days following the

convening of each session of Congress, the Secretary of

Health, Education, and Welfare shall submit through the

President to the Congress and to the Office of Science and

Technology an annual report upon the health matters covered

by this chapter, . . . the needs and requirements in the field of

coal or other mine health, a description and the anticipated

cost of each project and program he has undertaken under sections 861(b) and 951 of . . . title [30], and any other relevant

information, including any recommendations he deems appropriate. The first such report shall include the recommendations of the Secretary of Health, Education, and Welfare as to

necessary mandatory health standards, including his recommendations as to the maximum permissible individual exposure to miners from respirable dust during a shift .“
IV. Food and Drug Administration . 135

IV. FOOD AND DRUG ADMINISTRATION

Type of

Legal citation authority Legislative text

A. General Authority Applicable to all FDA Bureaus

a) Federal Food, Drug Implied (b) “The Secretary may also cause to be disseminated

and Cosmetic Act information regarding food, drugs, devices, or cosmetics in

situations involving, in the opinion of the Secretary, immi-

● P.L. 75-517$705 nent danger to health or gross deception of the consumer.

(1938) as amended Nothing in this section shall be construed to prohibit the

Secretary from collecting, reporting, and illustrating the

● 21 Usc $37 5 results of the investigations of the Department. ”

B. Bureau of Biologics

a) Public Health

Service Act

● P.L. 78-410$351

(1944)

● 42 USC $262

C. Bureau of Drugs

a) Federal Food, Drug

and Cosmetic Act

● P.L. 75-717$505

(1938) and

amended

● 21 Usc $355

Implied (d) “Licenses for the maintenance of establishments for

the propagation or manufacture and preparation of products

described in subsection (a) of this section may b e

issued only upon a showing that the establishment and the

products for which a license is desired meet standards,

designed to insure the continued safety, purity, and potency of

such products, prescribed in regulations, and licenses for new

products may be issued only upon a showing that they meet

such standards . . .“

Specific (b) “Any person may file with the Secretary an

application with respect to any drug subject to the provisions

of subsection (a) of this section. Such person shall submit to

the Secretary as a part of the application (1) full reports of investigations which have been made to show whether or not

such drug is safe for use and whether such drug is effective in

use; (2) a full list of the articles used as components of

such drug; (3) a full statement of the composition of such

drug; (4) a full description of the methods used in and the

General

facilities and controls used for, the manufacture, processing,

and packing of such drug; (5) such samples of such drug and

of the articles used as components thereof as the Secretary

may require; and (6) specimens of the labeling proposed to be

used for such drug.

(i) The Secretary shall ‘promulgate regulations for

exempting from the operation of the foregoing subsections of

this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs. Such regula-
236 ● Part I] —Directory of Statutory Authorities

C. Bureau of Drugs—continued

Type of

Legal citation authority Legislative text

b) Federal Food, Drug

and Cosmetic Act

● P.L. 75-717$507,

as added by Act of

July 6,1945,$3,

and amended

● 21 Usc ~35 7

tions may, within the discretion of the Secretary . . . provide

for conditioning such exemption upon—

(1) the submission to the Secretary, before any clinical

testing of a new drug is undertaken, of reports, by the

manufacturer or the sponsor of the investigation of such drug,

of preclinical tests (including tests on animals) of such drug

adequate to justify the proposed clinical testing;

(2) the manufacturer or the sponsor of the investigation

of a new drug proposed to be distributed to investigators for

clinical testing obtaining a signed agreement from each of such

investigators that patients to whom the drug is administered

will be under his personal supervision, or under the supervision of investigators responsible to him, and that he will not

supply such drug to any other investigators or to clinics, for

administration to human beings; and

(3) the establishment and maintenance of such records,

and the making of such reports to the Secretary, by the

manufacturer or the sponsor of the investigation of such drug,

of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use

of such drug, as the Secretary finds will enable him to evaluate

the safety and effectiveness of such drug in the event of the filing of an application pursuant to subsection (b) of this section.

(j)(l) In the case of my Lr~g*fm which an approval of an

application filed pursuant to this section is in effect, the applicant shall establish and maintain such records, and make such

reports to the Secretary, of data relating to clinical experience

and other data or information, received or otherwise obtained

by such applicant with respect to such drug, as the Secretary

may . . . prescribe on the basis of a finding that such records

and reports are necessary in order to enable the Secretary to

determine . . . whether there is or may be grounds for invoking subsection (e) of this section . . .“

General (d) “The Secretary shall promulgate regulations

exempting from any requirement of this section and of section

352(]) of this title, (1) drugs which are to be stored,

processed, labeled, or repacked at establishments other than

those where manufactured . . .; (2) drugs which conform to

applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in

manufacturing other drugs; and (3) drugs which are intended solely for investigational use by experts qualified by
— —

IV. Food and Drug Administration . 137

C. Bureau of Drugs—continued

Type of

Legal citation authority Legislative text

scientific training and experience to investigate the safety and

efficacy of drugs. Such regulations may, within the discretion

of the Secretary . . . provide for conditioning the exemption

under clause (3) of this subsection upon—

(1) the submission to the Secretary, before any clinical

testing of a new drug is undertaken, of reports, by the

manufacturer or the sponsor of the investigation of such drug,

or preclinical tests (including tests on animals) of such drug

adequate to justify the proposed clinical testing;

* * *

(3) the establishment and maintenance of such records,

and the making of such reports to the Secretary, by the

manufacturer or the sponsor of the investigation of such drug,

of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use

of such drug, as the Secretary finds will enable him to evaluate

the safety and effectiveness of such drug in the event of the filing of an application for certification or release pursuant to

subsection (a) of this section.

* * *

(g)(l) Every person engaged in manufacturing, compounding, or processing any drug within the purview of this section

with respect to which a certificate or release has been issued

pursuant to this section shall establish and maintain such

records, and make such reports to the Secretary, of data

relating to clinical experience and other data or information,

received or otherwise obtained by such person with respect to

such drug, as the Secretary may by general regulation, or by

order with respect to such certification or release, prescribe on

the basis of a finding that such records and reports are

necessary in order to enable the Secretary to make, or to

facilitate, a determination as to whether such certification or

release should be rescinded or whether any regulation issued

under this section should be, amended or repealed . . .“

c) Public Health

Service Act

● P.L. 78-410$302,

(1944)

• 42 USC $242

General (a) “In carrying out the purposes of section 241 of . . . title

[42] with respect to drugs, the use or misuse of which might

result in drug abuse or dependency, the studies and investigations authorized therein shall include the use and

misuse of narcotic drugs and other drugs. Such studies and

investigations shall further include the quantities of crude

opium, coca leaves, and their salts, derivatives and

preparation, and other drugs subject to control under the

Controlled Substances Act and Controlled Substances Import

and Export Act, together with reserves thereof, necessary to
138 ● Part 11—Directory of Statutory Authorities

C. Bureau of Drugs—continued

Type of

Legal citation authority Legislative text

supply the normal and emergency medicinal and scientific requirements of the United States. The results of studies and investigations of the quantities of narcotic drugs or other drugs

subject to control under such Acts, together with reserves of

such drugs, that are necessary to supply the normal and

emergency medicinal and scientific requirements of the United

States shall be reported not later than the first day of April of

each year to the Attorney General, to be used at his discretion

in determining manufacturing quotas or importation requirements under such Acts”. *

[Jointly administered with the National Institute on Drug

Abuse (ADAMHA), and the Drug Enforcement Administration. ]

d) Public Health

Service Act

● P.L. 78-910$303,

as added by P.L.

79-487 §7(c)

(1946) and amended

● 42 USC §242a

General (a) “In carrying out the purposes of section 241 of . . . title

[42] with respect to mental health, the Surgeon General is

authorized—. . .

(2) to make grants . . . for investigations, experiments,

demonstrations, studies, and research projects with respect

to the development of improved methods of diagnosing

mental illness (such as research on the use and effect of alcohol

and other psychoactive drugs), and of care , treatment, and rehabilitation of the mentally ill. . . .“*

[Jointly administered with the National Institute on Drug

Abuse, and the National Institute of Mental Health,

(ADAMHA); FDA authority extends to regulations of protection of research subjects and confidentiality. ]

D. Bureau of Foods

a) Federal Food, Drug Specific

and Cosmetic Act

● P.L. 75-717 §408

as added by Act of

July 22,1954,$3

(1954) and amended

● 21 USC §346a

(d)(l) “Any person who has registered, or who has

submitted an application for the registration of a pesticide

under the Federal Insecticide, Fungicide, and Rodenticide

Act may file with the Administrator, a petition proposing

the issuance of a regulation establishing a tolerance for a

pesticide chemical which constitutes, or is an ingredient of,

such pesticide, or exempting the pesticide chemical from the

requirement of a tolerance. The petition shall contain data

showing— .

‘Section 301 of the Public Health Service Act, 42 USC $241, is the general data collection authority for the Secretary of HEW.
IV, Food and Drug Administration ● 139

D. Bureau of Foods—continued

Type of

Legal citation authority Legislative text

b) Federal Food, Drug

and Cosmetic Act

w P.L. 75-717$409,

as added by P.L.

85-929 §4 (1958),

and amended

● 21 USC §348

(A) the name, chemical identity, and composition of the

pesticide chemical;

(B) the amount, frequency, and time of application of the

pesticide chemical;

(C) full reports of investigation made with respect to the

safety of the pesticide chemical;

(D) the results of tests on the amount of residue remaining, including a description of the analytical methods used;

(E) practicable methods for removing residue which exceeds any proposed tolerance;

(F) proposed tolerances for the pesticide chemical if tolerances are proposed; and

(G) reasonable grounds in support of the petition.

Samples of the pesticide chemical shall be furnished to the Administrator upon request. . . . Such notice shall include the

analytical methods available for the determination of the

residue of the pesticide chemical for which a tolerance or exemption is proposed, ”

[This authority was transferred to the Environmental Protection Agency (EPA) under Reorganization Plan No. 3, 1970.

FDA enforces tolerances established by EPA through FDA’s

food inspection program. ]

Specific (b)(l) “Any person may, with respect to any intended

use of a food additive, file with the Secretary a petition proposing the issuance of a regulation prescribing the conditions under which such additive may be safely used.

(2) Such petition shall, in addition to any explanatory

or supporting data, contain—

(A) the name and all pertinent information concerning such food additive, including, where available, its

chemical identity and composition;

(B) a statement of the conditions of the proposed use of

such additive, including all directions, recommendations, and

suggestions proposed for the use of such additive, and including specimens of its proposed labeling;

(C) all relevant data bearing on the physical or other

technical effect such additive is intended to produce, and the

quantity of such additive required to produce such effect;

(D) a description of practicable methods for determining the quantity of such additive in or on food, and any

substance formed in or on food, because of its use; and

(E) full reports of investigations made with respect to

the safety for use of such additive, including full information
140 ● Part 1l—Directory of Statutory Authorities

0. Bureau of Foods—continued

Type of

Legal citation authority Legislative text

c) Federal Food, Drug

and Cosmetic Act

● P.L. 75-717 ~706,

(1938), and

amended

● 21 USC §376

as to the methods and controls used in conducting such investigations. ”

Implied (b)(S)(A) “In determining, for the purposes of this section,

whether a proposed use of a color additive is safe, the

Secretary shall consider, among other relevant factors—

(i) the probable consumption of, or other relevant exposure from, the additive and of any substance formed in

or on food, drugs or devices, or cosmetics because of the use

of the additive;

(ii) the cumulative effect, if any, of such additive in the

diet of man or animals, taking into account the same or any

chemically or pharmacologically related substance or

substances in such diet;

(iii) safety factors which, in the opinion of experts

qualified by scientific training and experience to evaluate the

safety of color additives for the use or uses for which the additive is proposed to be listed, are generally recognized as appropriate for the use of animal experimentation data; and

(iv) the availability of any needed practicable methods of

analysis for determining the identity and quantity of (I) the

pure dye and all intermediates and other impurities contained

in such color additive, (11) such additive in or on any article of

food, drug or device, or cosmetic, and (III) any substance

formed in or on such article because of the use of such additive . . .“

E. Bureau of Medical Devices

a) Federal Food, Drug Implied (a)(3)(A) “Except as authorized by subparagraph (B), the

and Cosmetic Act effectiveness of a device is, for purposes of this section and

sections 360d and 360e of this title, to be determined, in ac-

● P.L. 75-717$513 cordance with regulations promulgated by the Secretary, on

as added by P.L. the basis of well-controlled investigations, including clinical

94-295 §2 (1976) investigations where appropriate, by experts qualified by

training and experience to evaluate the effectiveness of the

● 21 USC §360c device, from which investigations it can fairly and responsibly

be concluded by qualified experts that the device will have the

effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the

labeling of the device.”
IV. Food and Drug Administration ● 1+11

E. Bureau of Medical Devices—continued

Type of

Legal citation authority Legislative text

b) Federal Food, Drug

and Cosmetic Act

● P.L. 75-717 §519,

as added by P.L.

94-295 §2 (1976)

 21 USC §360 i

c) Federal Food, Drug

and Cosmetic Act

● P.L. 75-717$520,

as added by P.L.

94-295$2 (1976)

● 21 USC §360j

General (a) “Every person who is a manufacturer, importer,

or distributor of a device intended for human use shall

establish and maintain such records, make such reports, and

provide such information, as the Secretary may by regulation reasonably require to assure that such device is not

adulterated or misbranded and to otherwise assure its safety

and effectiveness. Regulations prescribed— . . .

(3) which require submission of a report or information

to the Secretary shall state the reason or purpose for the submission of such report or information and identify to the

fullest extent practicable such report or information;”

General (g)(2)(A) “The Secretary shall, within the one hundred

and twenty-day period beginning on May 28, 1976, by

regulation prescribe procedures and conditions under which

devices intended for human use may upon application be

granted an exemption from the requirements of section 352,

360, 360d, 360e, 360f, 360i or 376 of this title or subsection (e)

or (f) of this section or from any combination of such requirements to permit the investigational use of such devices by

experts qualified by scientific training and experience to inImplied

vestigate the safety ‘and effectiveness of such devices.

(B) The conditions prescribed pursuant to subparagraph

(A) shall include the following:

(i) A requirement that an application be submitted to

the Secretary before an exemption may be granted and that

the application be submitted in such form and manner as the

Secretary shall specify.

(ii) A requirement that the person applying for an exemption for a device assure the establishment and maintenance of such records, and the making of such reports to the

Secretary of data obtained as a result of the investigational use

of the device during the exemption, as the Secretary determines will enable him to assure compliance with such conditions, review the progress of the investigation, and evaluate

the safety and effectiveness of the device.

(iii) Such other requirements as the Secretary may

determine to be necessary for the protection of the public

health and safety. . . .“

(h)(z) “The Secretary shall promulgate regulations under

which each advisory committee established under section 360e

(g)(2)(B) of this title shall make available to the public a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the

advisory committee and which was the basis for its recom-
142 ● Part 11—Directory of Statutory Authorities

E. Bureau of Medical Devices—continued

Type of

Legal citation authority Legislative text

mendation to the Secretary made pursuant to Section

360e(g)(2)(A) of this title. A summary of information upon

which such a recommendation is based shall be made available pursuant to this paragraph only after the issuance of the

order with respect to which the recommendation was made

and each summary shall include information respecting any

adverse effect on health of the device subject to such order.

(3) Any information respecting a device which is made

available pursuant to paragraph (1) or (2) of this subsection

(A) may not be used to establish the safety or effectiveness of another device for purposes of this chapter by any

person other than the person who submitted the information

so made available, and

(B) shall be made available subject to subsection (c) of

this section. . . .“

F. Bureau of Radiological Health

a) Public Health

Service Act

● P.L. 78-410 ¦354,

as added by P.L.

90-602 §2(3)

(1968)

● 42 USC §263b

b) Public Health

Service Act

● P.L. 78-410 §356,

as added by P.L.

90-602 §2(3)

(1968)

● 42 USC §263d

Implied “The Congress hereby declares that the public health and

safety must be protected from the dangers of electronic product radiation. Thus, it is the purpose of this subpart to provide

for the establishment by the Secretary of an electronic product

radiation control program which shall include the development and administration of performance standards to control

the emission of electronic product radiation from electronic

products and the undertaking by public and private organizations of research and investigation into the effects and control

of such radiation emissions. ”

General (a) “The Secretary shall establish and carry out an

electronic product radiation control program designed to

protect the public health and safety from electronic product

radiation. As a part of such program, he shall—. . .

(2) plan, conduct, coordinate, and support research . . .

to minimize the emissions of and the exposure of people to,

unnecessary electronic product radiation; . . .

(4) study and evaluate emissions of, and conditions of

exposure to, electronic product radiation and intense magnetic

fields; . . .

(b) In carrying out the purposes of subsection (a) of this section, the Secretary is authorized to—

(1)(A) collect and make available, through publications

and other appropriate means, the results of, and other in-
W. Food and Drug Administration ● 143

F. Bureau of Radiological Health—continued

Type of

Legal citation authority Legislative text

formation concerning, research and studies relating to the

nature and extent of the hazards and control of electronic

product radiation . . .

(c)(l) each recipient of assistance under this subpart . . . shall keep such records as the Secretary shall

prescribe . . .“

c) Public Health

Service Act

● P.L. 78-410$357

as added by P.L.

90-602 §2(3),

(1968)

● 42 USC §263e

Specific (a) “The Secretary shall conduct the foIlowing studies,

and shall make a report or reports of the results of such studies

to Congress on or before January 1, 1970, and from

time to time thereafter as he may find necessary, together

with such recommendations for legislation as he may deem

appropriate:

(1) A study of present State and Federal control of health

hazards from electronic product radiation and other

types of ionizing radiation, which study shall include, but not

be limited to—

(A) control of health hazards from radioactive materials other than material regulated under the Atomic Energy

Act of 1954;

(B) any gaps and inconsistencies in present controls;

(C) the need for controlling the sale of certain used electronic products, particularly antiquated X-ray equipment,

without upgrading such products to meet the standards for

new products or separate standards for used products;

(D) measures to assure consistent and effective control

of the aforementioned health hazards;

(E) measures to strengthen radiological health programs of State governments; and

(F) the feasibility of authorizing the Secretary to enter

into arrangements with individual States or groups of States

to define their respective functions and responsibilities for the

control of electronic product radiation and other ionizing

radiation;

(2) A study to determine the necessity for the development of standards for the use of nonmedical electronic products for commercial and industrial purposes; and

(3) A study of the development of practicable procedures

for the detection and measurement of electronic product

radiation which may be emitted from the electronic products

manufactured or imported prior to the effective date of any

applicable standards established pursuant to this subpart. . . .

(c) The Secretary or his designee shall organize the studies

and the participation of the invited participants as he deems

best. Any dissent from the findings and recommendations of
144 ● Part 11—Directory of Statutory Authorities

F. Bureau of Radiological Health—continued

Type of

Legal citation authority Legislative text

d) Public Health

●

●

Service Act

P.L. 78-410 §360A,

as added by P.L.

90-602 §2(3)

(1968)

42 USC §263i

e) Public Health

Service Act

P.L. 78-410 §60D,

as added by P.L.

90-602 62(3)

(1968)

42 USC §2631

the Secretary shall be included in the report if so requested by

the dissenter. ”

General (b) “Every manufacturer of electronic products shall

establish and maintain such records (including testing

records), make such reports, and provide such information,

as the Secretary may reasonably require to enable him to

determine whether such manufacturer has acted or is acting

in compliance with this subpart and standards prescribed

pursuant to this subpart and shall, upon request of an officer

or employee duly designated by the Secretary, permit such officer or employee to inspect appropriate books,

papers, records and documents relevant to determining

whether such manufacturer has acted or is acting in compliance with standards prescribed pursuant to this subpart.

(c) Every manufacturer of electronic products shall provide

to the Secretary such performance data and other technical

data related to safety as may be required to carry out the purposes of this subpart. The Secretary is authorized to require

the manufacturer to give such notification of such performance and technical data at the time of original purchase to

the ultimate purchaser of the electronic product, as he determines necessary to carry out the purposes of this subpart after

consulting with the affected industry. . . .

(f) The Secretary may by regulation

(1) require dealers and distributors of electronic products,

to which there are applicable standards prescribed under this

subpart and the retail prices of which is not less than $50, to

furnish manufacturers of such products such information as

may be necessary to identify and locate, for purposes of section 263g of this title, the first purchasers of such products for

purposes other than resale, and

(2) require manufacturers to preserve such information. . . . If a dealer or distributor discontinues the dealing in

or distribution of electronic products, he shall turn the information over to the manufacturer. . . . “

Specific (a) “The Secretary shall prepare and submit to the

President for transmittal to the Congress on or before April 1

of each year a comprehensive report on the administration

of this subpart for the preceding calendar year. Such report

shall include— .

(1) a thorough appraisal (including statistical analyses,

estimates, and long-term projections) of the incidence of

biological injury, and effects, including genetic effects, to the

population resulting from exposure to electronic product
IV. Food and Drug Administration ● 145

F. Bureau of Radiological Health—continued

Type of

Legal citation authority Legislative text

radiation, with a breakdown, insofar as practicable, among

the various sources of such radiation;

(2) a list of Federal electronic product radiation control

standards prescribed or in effect in such year, with identification of standards newly prescribed during such year;

(3) an evaluation of the degree of observance of applicable standards, including a list of enforcement actions, court

decisions, and compromises of alleged violations by location

and company name;

(4) a summary of outstanding problems confronting the

administration of this subpart in order of priority;

(5) an analysis and evaluation of research activities completed as a result of Government and private sponsorship, and

technological progress for safety achieved during such year;

(6) a list, with a brief statement of the issues, of completed or pending judicial actions under this subpart;

(7) the extent to which technical information was

disseminated to the scientific, commercial, and labor community and consumer oriented information was made

available to the public; and

(8) the extent of cooperation between Government officials and representatives of industry and other interested

parties in the implementation of this subpart including a log or

summary of meetings held between Government officials and

representatives of industry and other interested parties.

(b) The report required by subsection (a) of this section shall

contain such recommendations for additional legislation as

the Secretary deems necessary to promote cooperation among

the several States in the improvement of electronic product

radiation control and to strengthen the national electronic

product radiation control program. ”

NOTE: Under 42 USC 263, FDA authority extends to electronic product radiation control. Environmental aspects were

transferred to EPA under Reorganization Plan No. 3, 1970.
—

146 ● Part 11—Directory of Statutory Authorities

G. Bureau of Veterinary Medicine

Type of

Legal citation authority Legislative text

G. Bureau of Veterinary Medicine

a) Federal Food, Drug General (1)(1) “In the case of any new animal drug for which an

●

●

and Cosmetic Act approval of an application filed pursuant to subsection (b) of

this section is in effect, the applicant shall establish and

P.L. 75-717 §512, maintain such records, and make such reports to the Secreas added by P.L. tary, of data relating to experience and other data or in90-399 §Iol(b) formation, received or otherwise obtained by such applicant

(1968) and amended with respect to such drug, or with respect to animal feeds

bearing or containing such drug, as the Secretary may by

21 USC ~360b general regulation, or by order with respect to such

application, prescribe on the basis of a finding that such

records and reports are necessary in order to enable the

Secretary to deiermine, or facilitate a determination, whether

there is or may be ground for invoking subsection (e) or

subsection (m) (4) of this section. Such regulation or order

shall provide, where the Secretary deems it to be appropriate,

for the examination, upon request, by the persons to whom

such regulation or order is applicable, of similar information

received or otherwise obtained by the Secretary.

(m)(5) In case of an animal feed for which an approval of an

application filed pursuant to this subsection is in effect—

(A) the applicant shall establish and maintain such

records, and make such reports to the Secretary, or (at the option of the Secretary) to the appropriate person or persons

holding an approved application filed under subsection (b) of

this section, as the Secretary may by general regulation, or by

order with respect to such application, prescribe on the basis

of a finding that such records and reports are necessary . . . to

determine, or facilitate a determination, whether there is or

may be ground for invoking subsection (e) of this section or

paragraph (4) of this subsection. . . .“
V. Health Resources Administration “ 147

V. HEALTH RESOURCES ADMINISTRATION

Type of

Legal citation authority Legislative text

A. Bureau of Health Facilities Financing, Compliance, and Conversion

a) Public Health Specific

Service Act

● P.L. 78-410$604,

as added by P.L.

88-443 $3(a)

(1964) and amended

● 42 USC §291d

General

b) Public Health

Service Act

● P.L. 78-410

Specific

~1603,

as added by P.L.

93-641 §4 (1975)

● 42 USC 3000-2

(a) “Any State desiring to participate in this part [e.g., to

obtain grants and loans for construction and modernization of

hospitals and other medical facilities] may submit a State

plan. Such plan must— . . .

(4) set forth, . . . on the basis of a statewide inventory

of existing facilities, a survey of need, and . . . community,

area or regional plans—

(A) the number of general hospital beds and long-term

care beds, and the number and types of hospital

facilities and facilities for long-term care, needed to provide

adequate facilities for inpatient care of people residing in the

State, and a plan for the distribution of such beds and facilities

in service areas throughout the State;

(B) the pubIic health centers needed to provide adequate public health services for people residing in the State,

and a plan for the distribution of such centers throughout the

State;

(C) the outpatient facilities needed to provide adequate

diagnostic or treatment services to ambulatory patients

residing in the State, and a plan for distribution of such

facilities throughout the State;

(D) the rehabilitation facilities needed to assure adequate rehabilitation services for disabled persons residing in

the State, and a plan for distribution of such facilities

throughout the State; and

(E) . . . the extent to which existing facilities referred to

in section 291a(a) or (b) of this title in the State are in need of

modernization; . . .

(10) provide that the State agency will make such reports,

in such form and containing such information, as the Surgeon

General may from time to time reasonably require, and will

keep such records and afford such access thereto as the

Surgeon General may find necessary to assure the correctness

and verification of such reports; . . .“

(a) “Before an application for assistance . . . for a medical

facility project described in section 3000 of . . . title [42] may

be approved, the State Agency of the State in which

such project is located must have submitted to the Secretary

and had approved by him a State medical facilities plan. To

be approved by the Secretary a State medical facilities plan for

a State must— * * *

(4) set forth, in accordance with criteria established in

regulations prescribed under section 3000-l(a) of . . . title
148 ● Part 11—Directory of Statutory Authorities

A. Bureau of Health Facilities Financing, Compliance, and Conversion—continued

Type of

Legal citation authority Legislative text

[42] and on the basis of a statewide inventory of existing medical facilities, a survey of need, and the plans of health systems

agencies within the State—

(A) the number and type of medical facility beds and

medical facilities needed to provide adequate inpatient care to

people residing in the State, and a plan for the distribution of

such beds and facilities in health services areas throughout the

State,

(B) the number and type of outpatient and other medical facilities needed to provide adequate public health services

and outpatient care to people residing in the State, and a plan

for the distribution of such facilities in health services areas

throughout the State, and

(C) the extent to which existing medical facilities in the

State are in need of modernization or conversion to new

uses;. . . “

B. Bureau of Health Manpower

a) Public Health Implied

Service Act

● P.L. 78-410 §~332,

as added by P.L.

94-484 $407(b)(3),

(1976)

● 42 USC ~254e

(b) “The Secretary shall establish by regulation,

promulgated not later than May 1, 1977, criteria for the

designation of areas, population groups, medical facilities,

and other public facilities, in the States, as health manpower shortage areas. In establishing such criteria, the Secretary shall take into consideration the following:

(1) The ratio of available health manpower to the number

of individuals in an area or population group, or

served by a medical facility or other public facility under

consideration for designation.

(2) Indicators of a need, notwithstanding the supply of

health manpower, for health services for the individuals in an

area or population group or served by a medical facility or

other public facility under consideration for designation, with

special consideration to indicators of—

(A) infant mortality,

(B) access to health services, and

(C) health status.

(3) The percentage of physicians serving an area, population group, medical facility, or other public facility under consideration for designation who are employed by hospitals and

who are graduates of foreign medical schools. . . .

(d) In accordance with the criteria established under subsection (b) of this section and the considerations listed in subsec-
V. Health Resources Administration . 149

B. Bureau of Health Manpower—continued

Type of

Legal citation authority Legislative text

b) Public Health Specific

Service Act

● P.L. 78-410 §333,

as added by P.L.

94-484 $407(b)(3),

(1976)

● 42 USC §254f

c) Public Health

Service Act

Implied

● P.L. 78-410$336,

as added by P.L.

94-484 §407(b)(3)

(1976)

● 42 USC §254i

Specific

tion (c) of this section, the Secretary shall designate, not later

than November 1, 1977, health manpower shortage areas in

the States, publish a descriptive list of the areas, population

groups, medical facilities, and other public facilities so designated, and at least annually review and, as necessary, revise

such designations. . . .“

[Jointly administered with the National Health Service Corps

(HSA). ]

(g) ‘The Secretary shall conduct, or enter into contracts

for the conduct of, studies of the methods of assignments of

Corps members to health manpower shortage areas. Such

studies shall include studies of—

(1) the characteristics of physicians, dentists, and other

health professionals who are more likely to remain in practice in health manpower shortage areas;

(2) the characteristics, including utilization and reimbursement patterns, of areas which have been able to retain

health manpower personnel; and

(3) the appropriate conditions for the assignment and use

of nurse practitioners, physician assistants, and expanded

function dental auxiliaries in health manpower shortage

areas. ”

[Jointly administered with the National Health Service Corps

(HSA). ]

“The Secretary shall submit an annual report to Congress

on May 1 of each year, and shall include in such report with

respect to the previous calendar year—

(1) the number, identity, and priority of all health manpower shortage areas designated in such year and the

number of health manpower shortage areas which the Secretary estimates will be designated in the subsequent year;

(2) the number of applications filed under section 254f

of . . . title [42] in such year for assignment of Corps

members and the action taken on each such application;

(3) the number and types of Corps members assigned in

such year to health manpower shortage areas, the number and

types of additional Corps members which the Secretary estimates will be assigned to such areas in the subsequent year,

and the need for additional members for the Corps;

(4) the recruitment efforts engaged in for the Corps in

such year and the number of qualified individuals who applied

for service in the Corps in such year;

(5) the number of patients seen and the number of patient

visits recorded during such year with respect to each health

46-643 0 - ?9 - 11
150 ● Part 11—Directory of Statutory Authorities

B. Bureau of Health Manpower—continued

Type of

Legal citation authority Legislative text

manpower shortage area to which a Corps member was assigned during such year;

(6) the number of Corps members who elected, and the

number of Corps members who did not elect, to continue to

provide health services in health manpower shortage areas

after termination of their service in the Corps and the reasons

(as reported to the Secretary) of members who did not elect

for not making such election;

(7) the results of evaluations and determinations made

under section 254 f(a)(l)(D) of this title during such Year; and

(8) the amount charged during such year for health services provided by Corps members, the amount which was collected in such year by entities in accordance with agreements

under section 254g of this title, and the amount which was

paid to the Secretary in such year under such agreements. ”

[Jointly administered with the National Health Service Corps

(HSA 

d) Public Health

Service Act

● P.L. 78-410 §708,

as added by P.L.

94-484$206 (1976)

and amended

● 42 USC §292h

Specific (a) “The Secretary shall establish a program, including a

uniform health professions data reporting system, to collect,

compile, and analyze data on health professions personnel

which shall initially include data respecting all physicians and

dentists in the United States. . . . The Secretary is authorized

to expand the program to include, whenever he determines it

necessary the collection, compilation, and analysis of data

respecting pharmacists, optometrists, podiatrists, veterinarians, public health personnel, audiologists, speech

pathologists, health care administration personnel, nurses,

allied health personnel, medical technologists, and any other

health personnel in States designated by the Secretary to be included in the program. Such data shall include data respecting

the training, Iicensure status (including permanent, temporary, partial, limited, or institutional), place or places of

practice, professional specialty, practice characteristics, place

and date of birth, sex, and socio-economic background of

health professions personnel and such other demographic information regarding health professions personnel as the

Secretary may require.

(b)(l) In carrying out subsection (a) of this section, the

Secretary shall collect available information from appropriate

local, State and Federal agencies and other appropriate

sources.

(2) The Secretary shall conduct or enter into contracts for

the conduct of analytic and descriptive studies of the health

professions, including evaluations and projections of the sup-
V. Health Resources Administration ● iii151

B. Bureau of Health Manpower—continued

Type of

Legal citation authority Legislative text

ply of, and requirements for, the health professions by specialty and geographic location.

(3) The Secretary is authorized to make grants and to

enter into contracts with States (or an appropriate nonprofit

private entity in any State) for the purpose of participating in

the program established under subsection (a) of this section. . . . To be eIigible for a grant or contract under this

paragraph a State or entity shall submit an application in such

form and manner and containing such information as the

Secretary shall require. Such application shall include

reasonable assurances, satisfactory to the Secretary, that—

(A) such State (or nonprofit entity within a State) will

establish a program of mandatory annual registration of the

health professions personnel described in subsection (a) of this

section who reside or practice in such State and of health institutions licensed by such State, which registration shall include such information as the Secretary shall determine to be

appropriate;

(B) such State or entity shall collect such information

and report it to the Secretary in such form and manner as the

Secretary shall prescribe; and

(C) such State or entity shall comply with the requirements of subsection (e) of this section.

(c) for purposes of providing the Secretary with information

under this section, each school which receives financial support under section 295f of . . . title [42] shall annually report

to the Secretary information, determined to be appropriate

by the Secretary, respecting the students who attend such

school. The Secretary may collect such additional data respecting students of the health professions as he determines to

be appropriate.

(d) The Secretary shall assemble and submit to the President

and Congress . . . a report on the status of health professions

personnel in the United States, which report shall include a description and analysis of the data collected pursuant to this

section. Such report may be included as part of the report

made under section 242m(a)(2)(C) of this title. Such report

shaII be submitted biennially, and the first such report shall be

due not later than October 1, 1979. . . .

(f) In carrying out his responsibilities under this section, the

Secretary shall not be subject to the provisions of chapter 35

of title 44. ” [providing for exemption from the Federal Reports

Clearance Act. ]

[Jointly administered with the National Center for Health

Statistics (OASH). ]
152 ● Part n-Directory of Statutory Authorities

B. Bureau of Health Manpower—continued

Type of

Legal citation authority Legislative text

e) Public Health

Service Act

● P.L. 78-410 §781,

as added by P.L.

94-484 §801(a)

(1976)

● 42 USC §295g-1

f) Public Health

Service Act

● P.L. 48-410$793,

as added by P.L.

94-484, $701(a)

(1976)

● 42 USC y~295h-2

g) Public Health

Service Act

● P.L. 78-410 §795

note, as added by

P.L. 94-484$702

(1976)

● 42 USC §295h-4

note

General (d)(2) “Each area health education center shall–

(B) assess the health manpower needs of the area served

by the center and assist in the planning and development of

training programs to meet such needs; . . .“

Specific (a) “The Secretary

Center for Health

shall, in coordination with the National

Statistics . . . continuously develop,

publish, and disseminate on a nationwide basis statistics and

other information respecting public and community health

personnel, including—

1) detailed descriptions of the various types of activities

in which public and community health personnel are engaged,

(2) the current and anticipated needs for the various types

of public and community health personnel, and

(3) the number, employment, geographic locations, salaries, and surpluses and shortages of public and community

health personnel, the educational and licensure requirements

for the various types of such personnel, and the cost of training such personnel. . . .

(c) The Secretary shall submit annually to the Committee

on Interstate and Foreign Commerce of the House of Representatives and to the Committee on Labor and Public Welfare

of the Senate a report on—

(1) the statistics and other information developed pursuant to subsection (a) of this section, and

(2) the activities conducted under this subpart, including

an evaluation of such activities. . . .“

[Jointly administered with the National Center for Health

Statistics (OASH). ]

Specific (b) . . . “The Secretary shall, in coordination with the

National Center for Health Statistics [established under

section 306 of the Public Health Service Act (section 242k of

. . . title 42)], develop, publish, and disseminate on a nationwide basis a report containing statistics and other information

respecting allied health personnel, including—

(1) detailed descriptions of the various types of such

personnel and the activities in which such personnel

are engaged,

(2) the current and anticipated needs for the various types

of such health personnel, and
V. Health Resources Administration ● 153

B. Bureau of Health Manpower—continued

Tvpe of J .

Legal citation authority Legislative text

h) Special Health

●

●

Revenue Sharing

Act of 1975

P.L. 94-63, Title

Ix, $951 (1975)

42 USC §296 note

(3) the number, employment, geographic locations, salaries, and surpluses and shortages of such personnel. ”

[Jointly administered with the National Center for Health

Statistics (OASH). ]

Specific (a)(l) Using procedures developed in accordance with

paragraph (3), the Secretary of Health, Education, and

Welfare (hereinafter in this section referred to as the

‘Secretary’) shall determine on a continuing basis—

(A) the supply (both current and projected and within

the United States and within each State) of registered nurses,

licensed practical and vocational nurses, nurse’s aides,

registered nurses with advanced training or graduate degrees,

and nurse practitioners;

(B) the distribution, within the United States and

within each State, of such nurses so as to determine

(i) those areas of the United States which are oversupplied, or which are undersupplied, or which have an adequate supply of such nurses in relation to the population of the

area, and

(ii) the demand for the services which such nurses

provide; and

(C) the current and future requirements for such

nurses, nationally and within each State.

(2) The Secretary shall survey and gather data, on a continuing basis, on—

(A) the number and distribution of nurses, by type of

employment and location of practice;

(B) the number of nurses who are practicing full time

and those who are employed part time, within the United

States and within each State;

(C) the average rates of compensation for nurses, by

type of practice and location of practice;

(D) the activity status of the total number of registered

nurses within each State;

(E) the number of nurses with advanced training or

graduate degrees in nursing by specialty, including nurse practitioners, nurse clinicians, nurse researchers, nurse educators,

and nurse supervisors and administrators; and

(F) the number of registered nurses entering the United

States annually from other nations, by country of nurse training and by immigrant status.

(3) within six months of the date of the enactment of this

Act [July 29, 1975], the Secretary shall develop procedures for

determining (on both a current and projected basis) the supply
.— —

154 Part Z] —Directory of Statutory Authorities

B. Bureau of Health Manpower—continued

Type of

Legal citation authority Legislative text

and distribution of and requirements for nurses within the

United States and within each State.

(b) Not later than October 1, 1979, and October 1 of each

odd-numbered year thereafter, the Secretary shall report to

the Congress—

(1) his determinations under subsection (a)(l) and the

data gathered under subsection (a)(2);

(2) an analysis of such determination and data; and

(3) recommendations for such legislation as the Secretary

determines, based on such determinations and data, will

achieve

(A) an equitable distribution of nurses within the

United States and within each State, and

(B) adequate supplies of nurses within the United States

and within each State . . .“

C. Bureau of Health Planning

a) Public Health Specific

Service Act

● P.L. 78-410$1513,

as added by P.L.

93-641$3 (1975),

and amended

● 42 USC $300/-2

(b) “In providing health planning and resources development for its health service area, a health systems agency shall

perform the following functions:

(1) The agency shall assemble and analyze data concerning —

(A) the status (and its determinants) of the health of the

residents of its health service area,

(B) the status of the health care delivery system in the

area and the use of that system by the residents of the area,

(C) the effect the area’s health care delivery system has

on the health of the residents of that area,

(D) the number, type, and location of the area’s health

resources, including health services, manpower, and facilities,

(E) the patterns of utilization of the area’s health resources, and

(F) the environmental and occupational exposure factors affecting immediate and longterm health conditions.

* * *

In carrying out this paragraph, the agency shall to the maximum extent practicable use existing data (including data developed under Federal health programs) and coordinate its activities with the cooperative system provided for under section

242k(e) of . . . title [42 of the United States Code].

(2) The agency shall, after appropriate consideration of

the recommended national guidelines for health planning
V, Health Resources Administration ● 155

C. Bureau of Health Planning—continued

Type of

Legal citation authority Legislative text

policy issued by the Secretary under section 300k-1 of . . . title

[42] the priorities set forth in section 300k-2 of . . . title [42],

and the data developed pursuant to paragraph (1), establish,

annually review, and amend as necessary a health systems

plan (hereinafter in this subchapter referred to as the

“HSP”) . . .

Implied (c) A health systems agency shall implement its HSP and

AIP, and in implementing the plans it shall perform at least

the following functions: . . .

(2) The agency may provide, in accordance with the

priorities established in the AIP, technical assistance . . . for

the development of projects and programs which the agency

determines are necessary to achieve the health systems

described in the HSP, . . .

(d) Each health systems agency shall coordinate its activities

with—

(1) each Professional Standards Review Organization

(designated under section 1320c-1 of . . . titlee [42]),

(2) entities referred to in paragraphs (1) and (2) of section

3334(a) of this title and regional and local entities the views of

which are required to be considered under regulations

prescribed . . . to carry out section 4231(b) of this title,

(3) other appropriate general or special purpose regional

planning or administrative agencies, and

General (4) any other appropriate entity, in the health system

agency’s health service area. The agency shall, as appropriate, secure data from them for use in the agency’s planning and development activities, . . .

Implied (g)(l) Except as provided in paragraph (2), each health

systems agency shall review on a periodic basis (but at least

every five years) all institutional health services offered in the

health service area of the agency and shall make recommendations to the State health planning and development agency . . . respecting the appropriateness in the area of such services.

(2) A health systems agency shall complete its initial

review of existing institutional health services within three

years after the date of the agency’s designation under section

300 l-4(c) of this title.

[Jointly administered with the National Center for Health

Statistics (OASH). ]
156 ● Part IZ—Directory of Statutory Authorities

C. Bureau of Health Planning—continued

—

Type of

Legal citation authority Legislative text

b) Public Health General

Service Act

● P.L. 78-410$1522,

as added by P.L.

93-641 §3 (1975)

● 42 USC §300m-1

Implied

General

c) Public Health Implied

Service Act

● P.L. 78-410$1523

as added by P.L.

93-641 §3 (1975)

● 42 USC §300m-2

(a) “A State administrative program (hereinafter in this

section referred to as the “State Program”) is a program for the

performance within the State by its State Agency of the functions prescribed by section 300m-2 of . . . title [42]. . . .

(b) The State Program of a State must–

(7)(A) provide for the coordination . . . with the cooperative system provided for under section 242k(e) . . . title

[42] of the activities of the State Agency for the collection,

retrieval, analysis, reporting and publication of statistical and

other information related to health and health care, and

(B) require providers of health care doing business in

the State to make statistical and other reports of such information to the State Agency;

(8) provide, in accordance with methods and procedures

prescribed or approved by the Secretary, for the evaluation,

at least annually, of the performance by the State Agency of

its functions and of their economic effectiveness;

(9) provide that the State Agency will from time to time,

and in any event not less often than annually, review the State

Program and submit to the Secretary required modifications;

(10) require the State Agency to make such reports, in

such form and containing such information, concerning . . .,

performance of functions, and other matters as the Secretary

may from time to time require, and keep such records . . . as

the Secretary may find necessary to verify such reports;”

[Jointly administered with the National Center for Health

Statistics (OASH). ]

(a) “Each State Agency Of a State designated under section

300m(b)(3) of . . . title [42] shall, except as authorized under

subsection (b) of this section, perform within the State the

following functions; . . .

(3) Assist the Statewide Health Coordinating Council of

the State in the review of the State medical facilities plan

required under section 3000-2 of . . . title [42] . . .

(4) . . . (B) administer a State certificate of need program

which applies to new institutional health services proposed to

be offered or developed within the State and which is satisfactory to the Secretary. Such program shall provide for review

and determination of need prior to the time such services, facilities, and organizations are offered or developed or substantial expenditures are undertaken in preparation for such offering or development, and provide that only those services,
V. Health Resources Administration ● 157

C. Bureau of Health Planning—continued

Type of

Legal citation authority Legislative text

d) Public Health

Service Act

● P.L. 78-410$1524,

as added by P.L.

93-641$3 (1975)

● 42 USC §300m-3

e) Public Health

Service Act

● P.L. 78-410 ~1533,

as added by P.L.

93-641$3 (1975)

● 42 USC §300n-2

facilities, and organizations found to be needed shall be offered or developed in the State . . .

(6) Review on a periodic basis (but not less often than

every five years) all institutional health services being offered

in the State and, after consideration of recommendations submitted by health systems agencies under section 3001-2(g) of

. . . title [42] respecting the appropriateness of such services,

make public its findings. . . .“

Implied (c) “A SHCC [Statewide Health Coordinating Council]

shall perform the following functions: . . .

(2)(A) Prepare and review and revise as necessary (but at

least annually) a State health plan which shall be made up of

the HSP’S of the health systems agencies within the

States. . . .

(B) In the preparation and revision of the State health

plan, the SHCC shall review and consider the preliminary

State health plan submitted by the State agency under section

300m-2(a)(2) . . .“

Specific (b)(l) “The Secretary shall include in the materials

provided under subsection (a) of this section [e.g., technical

assistance by the Secretary of HEW to the designated health

service agencies] the following:

(A) Specification of the minimum data needed to determine the health status of the residents of a health service area

and the determinants of such status.

(B) Specification of the minimum data needed to

determine the status of the health resources and services of a

health service area.

(C) Specification of the minimum data needed to

describe the use of health resources and services within a

health service area.

(2) Planning approaches, methodologies, policies, and

standards . . .

Implied (c) In order to facilitate the exchange of information

concerning health services, health resources, and health planning and resources development practice and methodology,

the Secretary shall establish a national health planning information center to support the health planning and resources

development programs of health systems agencies, State

Agencies, and other entities concerned with health planning

and resources development; to provide access to current information on health planning and resources development; and

to provide information for use in the analysis of issues and
—

158 ● Part 11—Directory of Statutory Authorities

C. Bureau of Health Planning—continued

Type of

Legal citation authoritv Legislative text

f) Public Health Specific

Service Act

● P.L. 78-410 §1535,

as added by P.L.

93-641$3 (1975)

● 42 USC §300n-4

problems related to health planning and resource developmerit. ”

(b) “The Secretary shall prescribe performance standards

covering the structure, operation, and performance of the

functions of each designated health systems agency and State

Agency, and he shall establish a reporting system based on the

performance standards that allows for continuous review of

the . . . functions of such agencies.

(c) The Secretary shall review in detail at least every three

years the structure, operation and performance of the functions of each designated health systems agency to determine—

(1) the adequacy of the HSP of the agency for meeting the

needs of the residents of the area for a healthful environment

and for accessible, acceptable and continuous quality health

care at reasonable costs, and the effectiveness of the AIP in

achieving the system described in the HSP;

* * *

(5) the appropriateness of the data assembled pursuant to

section 3002-2 (b)(l) of this title and the quality of the analyses

of such data; . . .

(7) the extent to which it may be demonstrated that–

(A) the health of the residents in the agency’s health

service area has been improved;

.

(B) the accessibility, acceptability, continuity, and

quality of health care in such area has been improved; and

(C) increases in costs of the provision of health care

have been restrained.

(d) The Secretary shall review in detail at least every three

years the structure, operation and performance of the functions of each designated State Agency to determine—

(1) the adequacy of the State health plan of the Statewide

Health Coordinating Council prepared under section 300m3(c)(2) of this title in meeting the needs of the residents of the

State for a healthful environment and for accessible, acceptable, and continuous quality health care at reasonable

costs; . . .

(6) the extent to which it may be demonstrated that–

(A) the health of the residents of the State has been improved;

(B) the accessibility, acceptability, continuity, and

quality of health care in the State has been improved; and

(C) increases in costs of the provision of health care

have been restrained.”
W. Health Services Administration 159

V1. HEALTH SERVICES ADMINISTRATION

Type of

Legal Citation authority Legislative text

A. Bureau of Community Health Service

1. Community Health Centers

a) Public Health Implied

●

●

Service Act

P.L. 78-410$330, as

added by P.L. 94-63

$501(a), (1975) and

amended

42 USC §254c

Specific

(c)(1) “The Secretary may make grants to public

and nonprofit private entities for projects to plan and develop

community health centers which will serve medically undeserved populations. A project for which a grant may be made

under this subsection . . . shall include—

(A) an assessment of the need that the population proposed to be served by the community health center for which

the project is undertaken has for primary health services, supplemental health services, and environmental health

services; . . .

(e)(2) h application for a grant [for the operating costs of

community health centers serving medically underserved

areas] . . . shall include—

(A) a description of the need in the center’s catchment

area . . .

(e)(3) Except as provided in subsection (d)(l)(B) Of this

section, the Secretary may not approve an application for a

grant under subsection (d) of this section [e.g., for costs of

operation of public and nonprofit private community health

centers which serve medically underserved populations]

unless the Secretary determines . . . that— . . .

(H) the center has developed, . . .

(ii) an effective procedure for compiling and reporting to the Secretary such statistics and other information as

the Secretary may require relating to

(I) the costs of its operations,

(11) the patterns of use of its services,

(III) the availability, accessibility, and acceptability of its services,

(IV) such other matters relating to operations of

the applicant as the Secretary may, by regulation, require,

and

(V) expenditures made from any amount the

center was permitted to retain under subsection (d)(4) (B).”
160 . Part n-Directory of Statutory Authorities

A. Bureau of Community Health Service

2. Fam/ly Planning

Type of

Legal citation authority Legislative text

2. Family Planning

a) Public Health General (a) “The Secretary may—

Service Act (1) conduct, and

(2) make grants . . . and enter

● P.L. 78-41051004, projects for research in biomedical,

into contracts . . . for

contraceptive developImplied (a) “The Secretary is authorized to make grants to public or

nonprofit private entities and to enter into contracts . . . to

assist in developing and making available family planning and

population growth information (including educational

materials) to all persons desiring such information (or

materials). . . . “

as added by P.L. ‘merit, behavioral, and program implementatio~ fields related

91-572 §6(c), to family planning and population . . . “

(1970), and [Jointly administered with the National Institute of Child

amended Health and Human Development (NIH). ]

● 42 USC §300a-2

b) Public Health

Service Act

● P.L. 78-410$1005,

as added by P.L.

91-572 §6(c),

(1970), and

amended

Q 42 USC §300a-3

c) Public Health Specific (a) “Not later than seven months after the close of each

Service Act fiscal year, the Secretary shall make a report to the Congress

setting forth a plan to be carried out over the next five fiscal

 P.L. 78-420 1009y§09, years for—

as added by P.L. (1) extension of family planning services to all persons de94-63 §203(a), siring such services,

(1975) (2) family planning and population research programs,

(3) training of necessary manpower for the programs au-

. 42 USC §300a-6a thorized by this subchapter and other Federal laws for which

the Secretary has responsibility and which pertain to family

planning, and

(4) carrying out the other purposes set forth in this subchapter and the Family Planning Services and Population Research Act of 1970.

(b) Such a plan shall, at a minimum, indicate on a phased

basis—

(1) the number of individuals to be served by family planning programs under this subchapter and other Federal laws

for which the Secretary has responsibility, the types of family

planning and population growth information and educational

materials to be developed under such laws and how they will
VI. Health Services Administration ● 161

A. Bureau of Community Health Service

2. Family P/arming—continued

Type of

Legal citation authority Legislative text

be made available, the research goals to be reached under such

laws, and the manpower to be trained under such laws;

(2) an estimate of the costs and personnel requirements

needed to meet the purposes of this subchapter and other

Federal laws for which the Secretary has responsibility and

which pertain to family planning programs; and

(3) the steps to be taken to maintain a systematic reporting system capable of yielding comprehensive data on which

service figures and program evaluations for the Department of

Health, Education, and Welfare shall be based.

(c) “Each report submitted under subsection (a) of this section shall—

(1) compare results achieved during the preceding fiscal

year with the objectives established for such year under the

plan contained in the previous such report;

(2) indicate steps being taken to achieve the objectives

during the fiscal years covered by the plan contained in such

report and any revisions to plans in previous reports necessary

to meet these objectives; and

(3) make recommendations with respect to any additional

legislative or administrative action necessary or desirable in

carrying out the plan contained in such report. ”

3. Genetic Diseases, Hemophilia, and Sudden Infant Death Syndrome (SIDS)

a) Public Health General

Service Act

● P.L. 78-410$1101,

as added by P.L.

94-278$403,

(1976)

● 42 USC §300b

b) Public Health General

Service Act

● P.L. 78-410$1102,

as added by P.L.

94-278 $403(a),

(1976)

● 42 USC §300b-1

(a)(2) “The Secretary shall carry out, through a r t

identifiable administrative unit within the Department of

Health, Education, and Welfare, a program to develop

information and educational materials relating to genetic

diseases and to disseminate such information and materials to

persons providing health care, to teachers and students, and

to the public generally in order to most rapidly make available

the latest advances in the testing, diagnosis, counseling, and

treatment of individuals respecting genetic diseases. . . . “

“In carrying out section 241 of . . . title [42] the Secretary

may make grants to public and nonprofit private entities, and

may enter into contracts with public and private entities and

individuals, for projects for

(1) basic or applied research leading to the understanding, diagnosis, treatment, and control of geneti c

diseases, . . . In making grants and entering into contracts for

projects described in clause (1) of the preceding sentence, the

Secretary shall give priority to applications for such grants or
162 Part 11—Directory of Statutory Authorities

A. Bureau of Community Health Service

3. Genetic Diseases, Hemophilia, and Sudden InfanttnfantNFANT/nfant Death syndrome (SIDs)—continued

Type of

Legal citation authority Legislative text

c) Public Health

Service Act

● P.L. 78-410 § 1107,

as added by P.L.

95-626 §205 (1978)

● 42 USC §300b-6

d) Public Health

Service Act

c P.L. 78-410$1121,

as added by P.L.

93-270 $3(a) (1974)

and amended

● 42 USC §300c-11

contracts which are submitted for research on sickle cell

anemia and research on Cooley’s anemia.”*

[Jointly administered with the National Institute of General

Medical Sciences (NIH). ]

Specific “The Secretary, acting through an identifiabl e

administrative unit, shall—

(1) conduct epidemiological assessments and surveillance

of genetic diseases to define the scope and extent of such

diseases and the need for programs for the diagnosis, treatment, and control of such diseases, screening for such

diseases, and the counseling of persons with such diseases;

(2) On the basis of the assessments and surveillance

described in paragraph (1), develop for use by the States programs which combine in an effective manner diagnosis, treatment, and control of such diseases, screening for such

diseases, and counseling of persons with such diseases, . . . “

[Jointly administered with the Center for Disease Control. ]

General (a) “The Secretary, through the Assistant Secretary for

Health, shall carry out a program to develop public information and professional educational materials relating to sudden

infant death syndrome and to disseminate such information

and materials to persons providing health care, to public safety officials, and to the public generally.

(b)(l) The Secretary may make grants to public and nonprofit private entities, and enter into contracts with public and

private entities, for projects which include both—

(A) the collection, analysis, and furnishing of information (derived from post mortem examinations and other

means) relating to the causes of sudden infant death syndrome; and

(B) the provision of information and counseling to

families affected by sudden infant death syndrome. . . .

(b)(2) No grant maybe made or contract entered into under

this subsection unless an application therefor has been submitted to and approved by the Secretary. . . . Each application shall—

(D) provide for making such reports in such form and

containing such information as the Secretary may reasonably

require.

*Section 301 of the Public Health Service Act, 42 USC $241, is the general data collection authority for the Secretary of HEW,
VI. Health Services Administration Q 163

A. Bureau of Community Health Service

3. Genetic Diseases, Hemophilia, and Sudden Infant Death Syndrome (SIDs)—continued

Type of

Legal citation authority Legislative text

(c) The Secretary shall submit, not later than January 1,

1976, a comprehensive report to [Congress] respecting the administration of this section and the results obtained from the

programs authorized by it. ”

4. Health Underserved Rural Areas

a) Public Health General (a) “The Secretary may make grants to, and enter into

Service Act contracts with, public and private entities which provide

health services—

● P.L. 78-410 §340, (1) to demonstrate new and innovative methods for the

as added by P.L. provision of primary health services and dental health serv95-626$115 (1978) ices, or

(2) to conduct research on such methods or on existing

● 42 USC §256 methods for the provision of primary health services and dental health services, to medical underserved populations or to

such other populations as the Secretary determines are

necessary to demonstrate or conduct research on particular

methods.

(b) Grants and contracts may be made under subsection (a)

to demonstrate and conduct research on—

(1) methods of attracting and retaining primary care

physicians, dentists, physician assistants, nurse practitioners,

and other health professionals, both individually and as

teams, to train and practice among medical underserved

populations;

(2) differing types of organizational models and relationships, including federations of health service centers, designed

to meet unique primary health and dental health service

needs;

(3) management and technological improvements

(including new or improved methods for biomedical communication and medical and financial recordkeeping and billing

systems) to increase the productivity, effectiveness, efficiency,

and financial stability of primary health and dental health

service providers;

(4) methods of providing health promotion, disease prevention, and health education programs, including school

health programs;

(5) methods of identifying, coordinating, and integrating

existing primary health and dental health service programs

with mental health and social service programs to maximize
164 . Part ZZ—Directory of Statutory Authorities

A. Bureau of Community Health Service

4. Health Underserved Rural Areas—continued

Type of

Legal citation authority Legislative text

b) Social Security

Act

● P.L. 74-241 §1112,

as added by P.L.

86-778$705,

(1960) and amended

● 42 USC §1312

use of available resources, avoid duplication of effort, and ensure a coordinated, comprehensive care system;

(6) specific services or mixtures of services appropriate

for a given area, including ambulatory care, home health care,

environmental health services (described in section 330(a)(4)),

community outreach activities, transportation services, and

other supplemental health services (as defined in section

330(b)(2));

(7) the effect of availability of primary health and home

health services in terms of reduction of emergency room visits,

hospitalizations, and institutionalization in long-term care

facilities;

(8) the use of mobile health screening clinics to provide

preventive health care services to meet the needs of medical

underserved populations; and

(9) such other projects as the Secretary determines to be

necessary to further the purposes of this section.

(c)(2) The Secretary shall,to the extent feasible, coordinate

demonstration and research projects carried out under this

section with any demonstration and research projects carried

out under the Social Security Act for the reimbursement of

services which are the subject of projects under this section.

(d)(l) No grant may be made under this section unless an

application therefor is submitted to, and approved by, the

Secretary. Such an application shall be submitted in such form

and manner and shall contain such information as the

Secretary shall prescribe. . . .

General “In order to assist the States to extend the scope and

content, and improve the quality, of medical care and medical

services for which payments are made to or on behalf of needy

and low-income individuals under this chapter and in order to

promote better public understanding about medical care and

medical assistance for needy and low-income individuals, the

Secretary shall develop and revise from time to time guides or

recommended standards as to the level, content, and quality

of medical care and medical services for the use of the States in

evaluating and improving their public assistance medical care

programs and their programs of medical assistance, shall secure periodic reports from the States on items included in, and

the quantity of, medical care and medical services for which

expenditures under such programs are made; and shall from
W. Health Services Administration ● 165

A. Bureau of Community Health Service

4. Health Underserved Rural Areas—continued

Type of

Legal citation authority Legislative text

time to time publish data secured from these reports and other

information necessary to carry out the purposes of this section. ”

5. Maternal

a) Social Security

Act

and Child Health

● P.L. 74-241$505,

as added by P.L.

90-248 §~301,

304(a), (1968),

and amended

● 42 USC §705

b) Social Security

Act

● P.L. 74-241 §512,

as added by P.L.

90-248 §301,

(1968)

● 42 USC §712

General

Implied

(a) “In order to be entitled to payments from allotments

under section 702 of . . . title [42], a State must have a State

plan for maternal and child health services and services for

crippled children which— . . .

(4) provides that the State agency will make such reports,

in such form and containing such information ,

as the Secretary may from time to time require, and comply

with such provisions as he may from time to time find

necessary to assure the correctness verification of such

reports; . . . “

(7) provides, with respect to the portion of the plan

relating to services for crippled children, for early identification of children in need of health care and services, and for

health care and treatment needed to correct or ameliorate

defects or chronic conditions discovered thereby, through

provision of such periodic screening and diagnostic services, . . . “

“From the sums available under . . . section 702 of . . . title [42], the Secretary is authorized to make grants to or jointly financed cooperative arrangements with public or other

nonprofit institutions of higher learning, and public or nonprofit private agencies and organizations engaged in research

or in maternal and child health or crippled children’s programs, and contracts with public or nonprofit private agencies

and organizations engaged in research or in such programs,

for research projects relating to maternal and chiId health

services or crippled children’s services which show promise of

substantial contribution to the advancement thereof. Effective

with respect to grants made and arrangements entered into

after June 30, 1968, (1) special emphasis shall be accorded to

projects which will help in studying the need for, and the feasibility, costs, and effectiveness of, comprehensive health care

programs in which maximum use is made of health personnel

with varying levels of training, and in study methods of training for such progams . . . “ u A u

r

46-643 0- 79 - 12
166 s Part n-Directory of Statutory Authorities

A. Bureau of Community Health Service

5. Maternal and Child Healt h

Type of

Legal citation authority Legislative text

c) Social Security General (a) “The Secretary of Health, Education, and Welfare

●

●

Act shall make such studies and investigations as will promote the

efficient administration of this subchapter. ”

P.L. 74-241 §513,

as added by P.L.

90-248 §301, (1968)

42 USC §713

6. Migrant Health

a) Public Health General

Service Act

● P.L. 78-410 y§319

formerly §310 as

added by P.L.

94-63 §401(a)

(1976), and

amended

● 42 USC §247d

Specific

(c)(l)(A) “The Secretary may, in accordance with the

priorities assigned under subsection (b)(l) of this section,

make grants to public and non-profit private entities for projects to plan and develop migrant health centers which will

serve migratory agricultural workers, seasonal agricultural

workers, and the members of the families of such migratory

and seasonal workers, in high impact areas. A project for

which a grant may be made under this subparagraph . . .

shall include—

(i) an assessment of the need that the workers (and

the members of the families of such workers) proposed to be

served by the migrant health center for which the project is

undertaken have for primary health services, supplemental

health services, and environmental health services; . . .

(e) “The Secretary may enter into contracts with public and

private entities to—

* * *

(2) conduct projects and studies to assist the several States

and entities which have received grants or contracts under this

section in the assessment of problems related to camp and field

sanitation, pesticide hazards, and other environmental health

hazards to which migratory agricultural workers, seasonal

agricultural workers, and members of their families are exposed. . . .

(f)(2) The Secretary may not approve an application for a

grant under subsection (d)(l)(A) of this section [e.g. for the

costs of operation of public and nonprofit private migrant

health centers in certain cases] unless the Secretary determines

that— . . .
W. Health Services Administration ● 167

A. Bureau of Community Health Service

6. Migrant Health—continued

Type of

Legal citation authority Legislative text

(H) the Center has developed

(ii) an effective procedure for compiling and reporting to the Secretary such statistics and other information as

the Secretary may require relating to (I) the costs of its operations, (II) the patterns of use of its services, (III) the availability, accessibility, and acceptability of its services, and (IV)

such other matters relating to operations of the applicant as

the Secretary may, by regulation require; . . . “

7. National

a) Public Health

Service Act

Health Service Corps

Implied (b) “The Secretary shall establish by regulation

promulgated not later than May 1, 1977, criteria for the

designation of areas, population, groups, medical facilities,

P.L. 78-410$332, and other public facilities, in the States, as health manpower

as added by P.L. shortage areas. In establishing such criteria, the Secretary

94-484, §407(b)(3) shall take into consideration the following:

(1976) (1) The ratio of available health manpower to the number

of individuals in an area or population group, or served by a

42 USC §254e medical facility or other public facility under consideration for

designation.

(2) Indicators of a need, notwithstanding the supply of

health manpower, for health services for the individuals in an

area or population group or served by a medical facility or

other public facility with special consideration to indicators

of —

(A) infant mortality,

(B) access to health services, and

(C) health status.

(3) The percentage of physicians serving an area, population group, medical facility, or other public facility under consideration for designation who are employed by hospitals and

who are graduates of foreign medical schools. . . .

(d) In accordance with the criteria established under subsection (b) of this section and the considerations listed in subsection (c) of this section, the Secretary shall designate, not later

than November 1, 1977, health manpower shortage areas in

the States, publish a descriptive list of the areas, population

groups, medical facilities, and other public facilities so

designated, and at least annually review and, as necessary,

revise such designations. . . . “
168 ● Part n-Directory of Statutory Authorities

A. Bureau of Community Health Service

7. National Health Service Corps—continued

Type of

Legal citation authority Legislative text

[Jointly administered with the Bureau of Health Manpower

(HRA). ]

b) Public Health

Service Act

● P.L. 78-4105333,

as added by P.L.

94-484 $407(b)(3),

(1976)

 42 USC 254f

c) Public Health

Service Act

● P.L. 78-410$336,

as added by P.L.

94-484 &107 (b)(3),

(1976)

● 42 USC ¦254i

Specific (g) “The Secretary shall conduct, or enter into contracts for

the conduct of, studies of the methods of assignments of Corps

members to health manpower shortage areas. Such studies

shall include studies of—

(1) the characteristics of physicians, dentists, and other

health professionals who are more likely to remain in practice

in health manpower shortage areas;

(2) the characteristics, including utilization and reimbursement patterns, of areas which have been able to retain

health manpower personnel, and

(3) the appropriate conditions for the assignment and use

of nurse practitioners, physician assistants, and expanded

function dental auxiliaries in health manpower shortage

areas. ”

[Jointly administered with the Bureau of Health Manpower

(HRA). ]

Implied The Secretary shall submit an annual report to Congress on

May 1 of each year, and shall include in such report with

respect to the previous calendar year—

(1) the number, identity, and priority of all health manpower shortage areas designated in such year and the number

of health manpower shortage areas which the Secretary

estimates will be designated in the subsequent year;

(2) the number of applications filed under section

254f . . . title [42] in such year for assignment of Corps

members and the action take on each application;

(3) the number and types of Corps members assigned in

such year to health manpower shortage areas, the number and

types of additional Corps members which the Secretary

estimates will be assigned to such areas in the subsequent year,

and the need for additional members for the Corps;

(4) the recruitment efforts engaged in for the Corps in

such year and the number of qualified individuals who applied

for service in the Corps in such year;

Specific (s) the number of patients seen and the number of patient

visits recorded during such year with respect to each health

manpower shortage area to which a Corps member was

assigned during such year; .

(6) the number of Corps members who elected, and the

number of Corps members who did not elect, to continue to

provide health services in health manpower shortage areas
W. Health Services Administration ● 169

A. Bureau of Community Health Service

7. National Heallth Service Corps—continued

Type of

Legal citation authority Legislative text

after termination of their service in the Corps and the reasons

(as reported to the Secretary) of members who did not elect

for not making such election;

(7) the results of evaluations and determinations made

under section 254 f(a)(l)(D) of this title during such year; and

(8) the amount charged during such year for health services provided by Corps members, the amount which was collected in such year by entities in accordance with agreements

under section 254g of this title, and the amount which was

paid to the Secretary in such year under such agreements. ”

[Jointly administered with the Bureau of Health Manpower

(HRA).]

8. Office of State Program Coordination: Grants to States

a) Public Health Specific (d)(l) “The Secretary shall make grants to State health

Service Act authorities to assist in meeting the costs of providing comprehensive public health services.

 P.L. 78-410 §314, (2) No grant may be made under paragraph (1) to the

as added by P.L. State health authority of any State unless an application there94-63 §102, (1975) fore has been submitted to and approved by the Secretary.

and amended Such an application shall be submitted in such form and manner and shall contain such information as the Secretary may

● 42 USC §246 require, and shall contain or be supported by assurances

satisfactory to the Secretary that—

(A) the comprehensive public health services which

will be provided within the State with funds under a grant

under paragraph (1) will be provided in accordance with the

State health plan in effect under section 1524(c);

* * *

(C)(ii) from time to time, as prescribed by t he

Secretary, report to the Secretary (through a uniform national

reporting system and by such categories as the Secretary may

prescribe) a description of the comprehensive public health

services provided in the State in the fiscal year for which the

grant applied for is made and the amount and source of funds

expended in that fiscal year and in the preceding fiscal year for

the provision of each such category of services; and

(iii) make such other reports (in such form and containing such information as the Secretary may prescribe) as

the Secretary may reasonably require and keep such records

and afford such access thereto as the Secretary may find
170 ● Part 11—Directory of Statutory Authorities

A. Bureau of Community Health Service

8. Office of State Program Coordination: Grants to States—continued

Type of

Legal citation authority Legislative text

necessary to assure the correctness of, and to verify, such

reports;

* * *

b) Public Health

Service Act

● P.L. 78-410$317,

as added by P.L.

87-868 §2 (1962),

and amended

● 42 USC $247b

Implied (4)(A) . . . In determining the amount of a grant to a

State health authority under subclause (I), the Secretary shall

take into account the financial need of such State and the level

of State and local expenditures for comprehensive public

health services (as defined in subparagraph (C)). In determining the financial need of a State, the Secretary shall consider, as major factors, the proportion of the State’s population whose income level is below the poverty income level

established by the Secretary and the proportion of its population which is living in medical underserved areas. ”

[Jointly administered with the Center for Disease Control. ]

General -

(a) “The Secretary may make grants—

(1) to State health authorities to assist them in meeting the

costs of establishing and maintaining preventive health service

programs for screening for, the detection, diagnosis, prevention, and referral for treatment of, and follow-up on compliance with treatment prescribed for hypertension; and

(2) to States and, . . . to political subdivisions of States

and to other public entities to assist them in meeting the costs

of establishing and maintaining preventive health service programs (other than programs described in paragraph (1)).

(b) No grant may be made under section (a) unless an application therefor has been submitted to, and approved by,

the Secretary. Such an application shall be in such form and

be submitted in such manner as the Secretary shall by regulation prescribe and shall provide—

(1) a complete description of the type and extent of the

program for which the applicant is seeking a grant under

subsection (a);

(2) with respect to each such program, . . .

(B) a description of the services provided by the applicant in such program in such period, . . . and,

(D) if the applicant proposes changes in the provision

of the services in such program, the priorities of such proposed changes, reasons for such changes, and the amount of

Federal funds needed by the applicant to make such changes;

* * *

(5) assurances satisfactory to the Secretary that the applicant will provide for periodic evaluation of its program or

programs;
iiiW. Health Services Administration ● 171

A. Bureau of Community Health Service

8. Office of State Program Coordination: Grants to States—continued

Type of

Legal citation authority Legislative text

(6) assurances satisfactory to the Secretary that the applicant will make such reports (in such form and containing such

information as the Secretary may by regulation prescribe) as

the Secretary may reasonably require and keep such records

and afford such access thereto as the Secretary may find

necessary to assure the correctness of, and to verify, such

reports; . . .

(h) The Secretary shall include, as part of the report required by section 1705 [42 USC 300u-4], a report on the extent

of the problems presented by the diseases and conditions referred to in subsection (j) [concerning preventive health service programs to immunize children against immunizable

diseases, and influenza]; . . . and on the effectiveness of the

activities assisted under grants under subsection (a) in controlling such diseases and conditions.

[Center for Disease Control administers all but the authority

concerning hypertension; the Bureau of Community Health

Services (HSA) administers the hypertension program. ]

c) Social Security

Act

● P.L. 74-241$1861

note, as added by

P.L. 94-63$602

(1975), and

amended

● 42 USC §1395x

note 2

Implied (a)(1) “For the purpose of demonstrating the establishment

and initial operation of public and nonprofit private agencies . . . which will provide home health services . . . in areas

in which such services are not otherwise avaiIable, the

Secretary of Health, Education, and Welfare may . . . make

grants to meet the initial costs of establishing and operating

such agencies and expanding the services available through existing agencies, and to meet the costs of compensating professional and paraprofessional personnel during the initial operation of such agencies or the expansion of services of existing

agencies.

(2) In making grants under this subsection, the Secretary

shall consider the relative needs of the several States for home

health services and preference shall be given to areas within a

state in which a high percentage of the population proposed to

be served is composed of individuals who are elderly, medically indigent, or both.

(3) Application for grants under this subsection shall be

in such form and contain such information as the Secretary

shall prescribe by regulation. . . . “
172 ● Part 1l—Directory of Statutory Authorities

iB. Bureau of Medical Services

1. Emergency Medical Services

Type of

Legal citation authority Legislative text

B. Bureau of Medical Services

1. Emergency Medical Services

a) Public Health General

Service Act

● P.L. 78-410 §1205

as added by P.L.

93-154 §2(a) (1973),

and amended

● 42 USC §300d-4

b) Public Health Specific

Service Act

● P.L. 78-410 §1206,

added by P.L.

93-154, §2(a),

(1973), and

amended

● 42 USC §300d-5

(a) “The Secretary may make grants . . . and enter into

contracts . . . for the support of research in emergency

medical techniques, methods, devices, and delivery. The

Secretary shall give special consideration to applications for

grants or contracts for research relating to the delivery of

emergency medical services in rural areas and especially

research which emphasizes the identification and utilization of

techniques and methods to apply the results of such research

to improve the delivery of emergency medical services in such

areas.

* * *

(c) The recipient of a grant or contract under this section

shall make such reports to the Secretary as the Secretary may

require. Such reports shall contain recommendations and a

plan of action for applying the results of the research assisted

by such grantor contract to improve the delivery of emergency medical services. ”

(b)(4)(C) “An emergency medical services system

shall— . . .

(xi) provide for a coordinated patient recordkeeping

system meeting appropriate standards established by the

Secretary, which records shall cover the treatment of the patient from initial entry into the system through his discharge

from it, and shall be consistent with ensuing patient records

used in follow-up care and rehabilitation of the patient; . . .

(xiii) provide the Secretary with such information as

he may require to conduct periodic, comprehensive, and independent reviews and evaluations of the extent and quality

of the emergency health care services provided in the system’s

service area, and submit to the Secretary the results of any

review or evaluation which may be conducted by such system

of the extent and quality of the emergency health care services

provided in the system’s service area;”
VI. Health Services Administration ● 173

B. Bureau of Medical Services

1. Emergency Medical Services—continued

Type of

Legal citation authority Legislative text

c) Public Health Specific (a) The Secretary shall administer the program of grants

●

●

Service Act and contracts . . . authorized by this part through an identifiable administrative unit specializing in emergency medical

P.L. 78-410$1208, services within the Department of Health, Education and

as added by P.L. Welfare.

93-154 §2(a), (b) Such administrative unit shall–

(1973) and (1) be responsible for collecting, analyzing, cataloging,

amended and disseminating all data . . . derived from reviews and

evaluations of emergency medical services systems assisted

42 USC §300d-7 under sections 300d-1, 300d-2, and 300d-3 of . . . title [42];

(2) publish suggested criteria for collecting necessary ind) Public Health

Service Act

● P.L. 78-410$1210,

as added by P.L.

93-15462 (1973)

● 42 USC §300d-9

formation for the evaluation of projects and programs funded

under this subchapter; . . .

(7) provide for periodic, independent evaluations of the

effectiveness of, and coordination between, the programs carried out under this part and the programs carried out under

section 295g-9 of . . . title [42].

(c) In addition, such administrative unit shall, through the

Interagency Committee on Emergency Medical Services

(established under section 300d-8 of this title)–

(1) study on a continuing basis (including evaluating the

adequacy, technical soundness, and redundancy of) the roles,

resources, and responsibilities of all Federal programs and activities relating to emergency medical services.

Such unit shall report to the Congress the results of

studies made under paragraph (1). The . . . reports shall be

made not later than February 1 of each year after 1978. ”

Implied The Secretary shall prepare and submit annually to the

Congress a report on the administration of this subchapter.

Each report shall include an evaluation of the adequacy of the

provision of emergency medical services in the United States

during the period covered by the report, and evaluation of the

extent to which the needs for such services are being adequately met through assistance provided under this subchapter . . . “
———

174 ● Part Ii—Directory of Statutory Authorities

B. Bureau of Medical Services

1. Emergency Medical Services—continued

Type of

Legal citation authority Legislative text

e) Public Health General (a)(l) “The Secretary may make grants to, and enter into

●

●

Service Act contracts with, public- or private non-profit entities for the

support of, and may conduct programs for the establishment,

P.L. 78-410$1221 operation, and improvement of activities to

as added by P.L. (A) demonstrate the effectiveness of different methods

94-573 $14(3), for the treatment and rehabilitation of individuals injured by

(1976) and burns,

amended (B) conduct research in the treatment and rehabilitation

of such individuals . . .

42 USC §300d-21 (2) The Secretary may enter into contracts . . . for the

support of research in the treatment and rehabilitation of individuals injured by burns.”

[Jointly administered with the National Institute of General

Medical Sciences (NIH). ]

2. Public Health Service Hospitals

a) Public Health Implied “The Surgeon General, pursuant to regulations, shall—

Service Act (a) Control, manage, and operate all institutions, hospitals

and stations of the service, . . . and provide for the care,

● P.L. 78-410$321 treatment, and hospitalization of patients . . . “

(1944) and amended

● 42 USC §248

C. Indian Health Service

a) Indian Health Care Specific (a) “The Secretary, acting through the Service, shall place

Improvement Act such conditions as he deems necessary to effect the purpose

of . . . title [25] in any contract which he makes with any urQ P.L. 94-437 §503 ban Indian organization pursuant to this title. Such conditions

(1976) shall include, but are not limited to, requirements that the

organization successfully undertake the following activities:

● 25 USC §1653 (1) determine the population of urban Indians which are

or could be recipients of health referral or care services;

(2) identify all public and private health service resources

within the urban center in which the organization is.situated

which are or may be available to urban Indians;

* * *

(7) identify gaps between unmet health needs of urban Indians and the resources available to meet such needs;
W. Health Services Administration ● 175

C. Indian Health Service—continued

Type of

Legal citation authority Legislative text

Implied

b) Indian Health Care General

Improvement Act

● P.L. 94-437$505

(1976)

● 25 USC §1655

(8) make recommendations to the Secretary and Federal,

State, local, and other resource agencies on methods of improving health service programs to meet the needs of urban

Indians; . . .

(b) The Secretary, acting through the Service, shall by

regulation prescribe the criteria for selecting urban Indian

organizations with which to contract pursuant to this title.

Such criteria shall, among other factors, take into consideration:

(1) the extent of the unmet health care needs of urban Indians in the urban center involved;

(2) the size of the urban Indian population which is to

receive assistance;

(3) the relative accessibility which such population has to

health care services in such urban center; . . . “

“For each fiscal year during which an urban Indian

organization receives or expends funds pursuant to a contract

under . . . title [25], such organization shall submit to the

Secretary a report including information gathered pursuant to

section 503(a)(7) and (8) [25 USC §1653(a)(7), (8)] . . . and

such other information as the Secretary may request. . . . “
176 ● Part IZ1—Directory of Statutory Authorities

V11. NATIONAL INSTITUTES OF HEALTH

Type of

Legal citation authority Legislative text

A. General Authority Applicable to all NIH Institutes

a) Public Health General (b)(2)(A) “The secretary shall establish a comprehensive

●

●

Service Act program of research into the biological effects of low-level

ionizing radiation under which program the Secretary shall

P.L. 78-410 §301 conduct such research and may support such research by

(1944), as amended others through grants and contracts.

by P.L. 95-622 (B) The Secretary shall conduct a comprehensive

§262 (1978) review of Federal programs of research on the biological effects of ionizing radiation.

42 USC §241 (3) The Secretary shall conduct and may support through

grants and contracts research and studies on human nutrition,

with particular emphasis on the role of nutrition in the prevenb) Public Health

Service Act

● P.L. 78-410$431,

as added by P.L.

81-692 §2(b)

(1950)

● 42 USC §289a

tion and treatmentof disease and on the maintenance a-rid promotion of health, and programs for the dissemination of information respecting human nutrition to health professionals

and the public. In carrying out activities under this paragraph,

the Secretary shall provide for the coordination of such of

these activities as are performed by the different divisions

within the Department of Health, Education, and Welfare and

shall consult with entities of the Federal Government, outside

of the Department of Health, Education, and Welfare, engaged in comparable activities. The Secretary, upon request of

such an entity and under appropriate arrangements for the

payment of expenses, may conduct and support such activities

for such entity. . . . “

Implied (b) “The Surgeon General is authorized with the approval of

the Secretary to establish in the Public Health Service one or

more additional institutes to conduct and support scientific

research and professional training relating to the cause,

prevention, and methods of diagnosis and treatment of other

particular diseases or groups of diseases . . . whenever the

Surgeon General determines that such action is necessary to

effectuate fully the purposes of section 241 of . . . title [42]

with respect to such disease or diseases . . . “*

*Section 301 of the Public Health Service Act, 42 USC $241, is the general data collection authority for the Secretary of HEW.
VIZ. National Institutes of Health “ 177

A. General Authority Applicable to All NIH Institutes—continued

Type of

Legal citation authority Legislative text

c) Public Health Implied (a) “Where an institute has been established under this part,

●

●

Service Act the Surgeon General shall carry out the purposes of se&ion

241 of . . . title [42] with respect to the conduct and support

P.L. 78-410$433, of research relating to the disease or diseases to which the acas added by P.L. tivities of the institute are directed, through such institute and

81-692 §2(b) in cooperation with the national advisory council or commit-

(195o), and tee established or expanded by reason of the establishment of

amended such institute. The provisions of this subsection shall also be

applicable to any institute established by any other provision

42 USC §289c of this chapter to the extent that such institute does not

already have the authority conferred by this subsection.”*

B. Fogarty International Center

a) International General

Health Research

Act

● P.L. 86-610$5

(1960), and

amended

● 22 USC §2103

(b) “To carry out the purposes of section 2101 of . . . title

[22], the President, in cooperation with participating foreign

countries, is authorized to encourage, support, and promote

the planning and conduct of, , . . research investigations, experiments, and studies in the United States and in participating foreign countries relating to the causes, diagnosis,

treatment, control and prevention of diseases and impairments of mankind (including nutritional and other health

deficiencies) or to the rehabilitation of the handicapped.

* * *

(f) The President may delegate any authority vested in him

by this section to the Secretary of Health, Education, and

Welfare.

(h) The President shall transmit to the Congress at the

beginning of each regular session, a report summarizing activities under this section and making such recommendations

as he may deem appropriate. ”

● Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
278 ● Part iI]—Directory of Statutory Authorities

C. National Cancer Institute

Type of

Legal citation authority Legislative text

C. National Cancer Institute

a) Public Health General

Service Act

● P.L. 78-410 ~301

(1944), as amended

by P.L. 95-622

$262 (1978)

● 42 USC §241

(b)(l) “The Secretary shall conduct and may support

through grants and contracts studies and testing of substances

for carcinogenicity, teratogenicity, mutagenicity, and other

harmful biological effects. In carrying out this paragraph, the

Secretary shall consult with entities of the Federal Government, outside of the Department of Health, Education, and

Welfare, engaged in comparable activities. The Secretary,

upon request of such an entity and under appropriate arrangements for the payment of expenses, may conduct for such entity studies and testing of substances for carcinogenicity, teratogenicity, mutagenicity, and other harmful biological effects.

Specific (4) The Secretary shall’ publish an annual report which

contains—

(A) a list of all substances

(i) which either are known to be carcinogens or may

reasonably be anticipated to be carcinogens and

(ii) to which a significant number of persons residing

in the United States are exposed;

(B) information concerning the nature of such exposure

and the estimated number of persons exposed to such substances;

(C) a statement identifying

(i) each substance contained in the list under subparagraph (A) for which no effluent, ambient, or exposure

standard has been established by a Federal agency, and

(ii) for each effluent, ambient, or exposure standard

established by a Federal agency with respect to a substance

contained in the list under subparagraph (A), the extent to

which, on the basis of available medical, scientific, or other

data, such standard, and the implementation of such standard

by the agency, decreases the risk to public health from exposure to the substance; and

(D) a description of

(i) each request received during the year involved–

(1) from a Federal agency outside the Department

of Health, Education, and Welfare for the Secretary, or

(II) from an entity within the Department of

Health, Education, and Welfare to any other entity within the

Department, to conduct research into, or testing for, the carcinogenicity of substances or to provide information described

in clause (ii) of subparagraph (C), and
VIZ. National Institutes of Health 179

C. National Cancer institute—continued

Type of

Legal citation authority Legislative text

(ii) how the Secretary and each such other entity, .

respectively, have responded to each such request.

b) Public Health

Service Act

● P.L. 78-410$401 ,

(1944) formerly

§402, renumbered

and amended by

P.L. 95-622, §241

(1978)

● 42 USC §282

c) Public Health

Service Act

● P.L. 78-410, §403

formerly y§409,

renumbered and

amended by P.L.

95-622 (1978)

● 42 USC §284

d) Public Health

Service Act

● P.L. 78-410$404,

as added by P.L.

92-218, $3(a),

(1971), formerly

§407, renumbered

and amended and

amended by P.L.

95-622 §241 (1978)

● 42 USC §285

General (a) “In carrying out the purposes of section 301 [42 USC

y$241] with respect to cancer, the Secretary, through the Institute and in cooperation with the National Cancer Advisory

Board, shall–

(1) conduct, assist, and foster research, investigations,

experiments, and studies relating to the cause, prevention, and

methods of diagnosis and treatment of cancer; . . . “*

Implied “The Director of the Institute shall establish and support

demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for

rehabilitation and counseling respecting cancer. Programs

established and supported under this section shall include—

(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit

research results and to disseminate information respecting the

detection, diagnosis, prevention, and treatment of cancer and

rehabilitation and counseling respecting cancer to physicians

and other health professionals who provide care to individuals

who have cancer; . . .

Specific (a) “The Director of the Institute in carrying out the

National Cancer Program shall—

(1) collect analyze, and disseminate information

(including information~mation respecting nutrition programs for

cancer patients and the relationship between nutrition and

cancer) useful in the prevention, diagnosis, and treatment of

cancer, including the establishment of an international cancer

research data bank to collect, catalog, store, and disseminate

insofar as feasible the results of cancer research undertaken in

any country for the use of any person involved in cancer

research in any country; . . . “

*Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
180 s Part II—Directory of Statutory Authorities

C. National Cancer Institute—continued

Type of

Legal citation authority Legislative text

e) Clean Air Act

● P.L. 88-206 §154,

as added by P.L.

95-95, §125 (1977)

● 42 USC §7454

Implied (e) “The Secretary of Health, Education, and Welfare shall

encourage and support continuing research programs that will

increase scientific knowledge of the effects of changes in the

ozone in the stratosphere upon human health. Such Secretary

shall transmit reports by January 1, 1978, and biennially

thereafter, to the Administrator and the Congress on the

results of such programs, together with any appropriate

recommendations for legislation or regulation (or both). ”

[Environmental Protection Agency has primary responsibility

for this authority, but EPA coordinates with the National

Cancer Institute and the National Institute of Environmental

Health Sciences. ]

D. National Eye Institute

a) Public Health

Service Act

● P.L. 78-410 §451

as added by P.L.

90-489 §1 (1968)

● 42 USC §289i

b) Public Health

Service Act

● P.L. 78-410 §453

as added by P.L.

90-489$1 (1968)

and amended

 42 USC §289k

Implied “The Secretary is authorized to establish in the Public

Health Service an institute for the conduct and support of

research for new treatment and cures and training relating to

blinding eye diseases and visual disorders, including research

and training in the special health problems and requirements

of the blind and in the basic and clinical sciences relating to the

mechanism of the visual function and preservation of sight.

The Secretary is also authorized to plan for research and training, especially against the main causes of blindness and loss of

visual function. ”

General The Secretary shall, through the National Eye Institute

established under this part, carry out the purposes of section

241 of . . . title [42], with respect to the conduct and support

of research with respect to blinding eye diseases and visual

disorders associated with general health and well-being,

including the special health problems and requirements of the

blind and the mechanism o f sight and visual

function, except that the Secretary shall determine the areas in

which and the extent to which he will carry out such purposes

of section 241 of this title through such Institute or an institute

established by or under other provisions of this chapter, or

both of them, when both such institutes have functions with

respect to the same subject matter. . . . “*

.

*Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
Vll, National Institutes of Health ● 181

E. National Heart, Lung, and Blood Institute

Type of

Legal citation authority Legislative text

E. National Heart, Lung, and Blood Institute

a) Public Health General “In carrving out the purposes of section 241 of . . . title

●

●

Service Act [42] with respect to heart, blood vessel, lung, and blood

diseases and with respect to the use of blood and blood prodP.L. 78-410 §412 ucts and the management of blood resources the Secretary,

as added by P.L. through the Institute and in cooperation with the National

80-655 $3(b) Heart, Lung, and Blood Advisory Council (hereinafter in this

(1948), and part referred to as the “Council”), shall—

amended (1) conduct, assist, and foster researches, investigations,

experiments , and demonstration s relating t o

42 USC §287a the cause, prevention and methods of diagnosis and treatment

of heart, blood vessel, lung, and blood diseases and to the use

b) Public Health

Service Act

● P.L. 78-410$413,

as added by P.L.

92-423 §3(3)

(1972) and amended

 42 USC §287b

of blood and blood prod~cts and the management of blood

resources; . . .

(5) establish an information center on research, prevention, diagnosis, and treatment of heart, blood vessel, lung,

and blood diseases and on the use of blood and blood products and the management of blood resources, and collect and

make available on a timely basis, through publications and

other appropriate means, information as to, and the practical

application of, research and other activities carried on pursuant to this part; . . . “*

General (a) “The Director of the Institute, with the advice of the

Council, shall develop a plan for a National Heart, Blood

Vessel, Lung, and Blood Diseases and Blood Resources Program (hereafter in this part referred to as the “Program”) to

expand, intensify, and coordinate the activities of the Institute

respecting heart, blood vessel, lung, and blood diseases and

blood resources (including its activities under section 287a of

this title) and shall carry out the Program in accordance with

such plan. The Program shall . . . provide for—

(1) investigation into the epidemiology, etiology, and

prevention of all forms and aspects of heart, blood vessel,

lung, and blood diseases, including investigations into the

social, environmental, behavioral, nutritional, biological, and

genetic determinants and influences involved in the

epidemiology, etiology, and prevention of such diseases;

(2) studies and research into the basic biological processes

and mechanisms involved in the underlying normal and abnormal heart, blood vessel, lung, and blood phenomena;

● Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.

46-643 0 - ’79 - 13
182 ● Part l&Directory of Statutory Authorities

E. National Heart, Lung, and Blood Institute—continued

Type of

Legal citation authority Legislative text

(3) research into the development, trial, and evaluation of

techniques, drugs, and devices (including computers) used in,

and approaches to, the diagnosis, treatment (including

emergency medical service), and prevention of heart, blood

vessel, lung, and blood diseases and the rehabilitation of patients suffering from such diseases; . . .

Implied

(5) establishment of programs for the conduct and direction of field studies, large-scale testing and evaluation, and

demonstration of preventive, diagnostic, therapeutic, and

rehabilitative approaches to, and emergency medical services

for, such diseases;

(6) studies and research into blood diseases and blood,

and into the use of blood for clinical purposes and all aspects

of the management of its resources in this country, including

the collection, preservation, fractionalization, and distribution of it and its products; . . .

(9) establishment of programs for study and research into

heart, blood vessel, lung, and blood diseases of children

(including cystic fibrosis, hyaline membrane, and hemolytic

and hemophilia diseases) for the development and demonstration of diagnostic, treatment, and preventive approaches to

these diseases; and

(10) establishment of programs for study, research,

development, demonstrations and evaluation of emergency

medical services for people who become critically ill in connection with heart, blood vessel, lung or blood diseases, . . .

(d) . . . The Director of the Institute, acting through the

Assistant Director for Prevention Education, and Control,

shall conduct a program to provide on a timely basis the

public and the health professions with health information with

regard to cardiovascular, blood and pulmonary diseases and

blood resources. In the conduct of such program, special emphasis shall be placed upon dissemination of information

regarding diet and nutrition, environmental pollutants, exercise, stress, hypertension, cigarette smoking, weight control,

and other factors affecting the prevention of arteriosclerosis

and other cardiovascular diseases and of pulmonary and

blood diseases. ”
V11National Institutes of Health ● 183

E. National Heart, Lung, and Blood institute—continued

Type of

Legal citation authority Legislative text

c) Public Health

Service Act

● P.L. 78-410$418,

formerly §414, as

added by P.L.

80-655 $3(b)

(1948), and

amended

● 42 USC §287g

d) Public Health

●

●

Service Act

P.L.78-41O §419A

formerly §413, as

added by P.L.

80-655 $3(b)

(1948), and

amended

42 USC §287h

Implied (a)(5) “The [National Heart, Lung, and Blood Advisory]

Council is authorized to— . . . collect information as to

studies which are being carried on in the United States or any

other country as to the cause, prevention, or methods of

diagnosis or treatment of heart, blood vessel, lung and blood

diseases and to the use of blood and blood products and the

management of blood resources, . . . and . . . make available

such information through appropriate publication for the

benefit of health and welfare agencies and organizations . . . ,

physicians, or any other scientists, and for the information of

the general public; . . .

General (a) “In carrying out the provisions of section 287a of this

title all appropriate provisions of section 241 of . . . title [42]

shall be applicable to the authority of the Secretary . . . “*

F. National Institute on Aging

a) Public Health General (a) “The Secretary (1)

Service Act the purposes of section

research investigation,

shall, through the Institute, carry out

241 of . . . title [42] with respect to

experiments, demonstrations, and

● P.L. 78-410 §463, studies related to- the aging process and the diseases and other

as added by P.L. special problems and needs of the aged, except that the

93-296, §3 (1974) Secretary shall determine the area in which and the extent to

which he will carry out such activities in furtherance of the

● 42 USC §289k-4 purposes of section 241 of . . . title [42] through the Institute

or another institute established by or under other provisions

of this chapter, or both of them, when both such institutes

have functions with respect to the same subject matter, . . .

Specific (b) The Secretary shall, through the Institute, conduct

scientific studies to measure the impact on the biological,

medical, and psychological aspects of aging of all programs

and activities assisted or conducted by the Department of

Health, Education, and Welfare.

*Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
184 ● Part ZZ—Directory of Statutory Authorities

F. National Instltute on Aging—continued

Type of

Legal citation authority Legislative text

Implied (c) The Secretary, through the Institute, shall carry out

public information and education programs designed to

disseminate as widely as possible the findings of Institutesponsored and other relevent aging research and studies and

other information about the process of aging which may assist

elderly and near-elderly persons in dealing with, and all

Americans in understanding, the problems and processes

associated with growing older.”*

G. National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID) relies on the general authority

of the Secretary of HEW applicable to all Institutes within NIH, specifically 42 USC 289a(b) and

289c(a).

H. National Institute of Arthritis,

a) Public Health Implied

●

●

Service Act

P.L. 78-410 §431

as added by P.L.

81-692 §2(b)

(1950) and amended

42 USC Y§289a

b) Public Health

●

●

Service Act

P.L. 78-410 §434,

as added by P.L.

92-305$1 (a)

(1972), and

amended

42 USC §289c-1

General

Metabolism, and Digestive Diseases

“(a) The Surgeon General shall establish in the Public

Health Service an institute for research on arthritis, rheumatism, digestive diseases, and metabolism, and an institute for

research on neurological diseases (including epilepsy, cerebral

palsy, and multiple sclerosis) and blindness, and he shall also

establish a national advisory council or committee for each

such institute to advise, consult with, and make recommendations to him with respect to the activities of the institute with

which each council or committee is concerned. ”

[Jointly administered with the National Institute of Neurological and Communicative Disorders and Stroke (NIH). ]

(c) “The Director of the Institute, acting through the

Associate Director for Digestive Diseases, shall (1) carry out,

at the facilities of the Institute, a program of research in the

diagnosis, prevention, and treatment of digestive diseases;

and (2) carry out programs of support for research and training . . . in the diagnosis, prevention, and treatment of

digestive diseases, including support for . , . epidemiology

studies, clinical trials, and interdisciplinary research programs.

(d) The Director of the National Institute of Arthritis,

‘Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
V11. National Institutes of Health 185

H. National Institute of Arthritis, Metabolism, and Digestive Diseases—continued

Type of

Legal citation authority Legislative text

b) Public Health

●

●

Service Act

P.L. 78-410$435,

as added by P.L.

93-354 $5(a)

(1974)

42 USC §289c-2

d) Public Health

General

. General

●

●

Service Act

P.L. 78-410 §436A,

as added by P.L.

94-562 §201(a)

(1976)

42 USC §289c-3a

Implied

Metabolism, and Digestive Diseases, working through the

Associate Director for Diabetes . . . shall—

(1) carry out programs of support for research and training in the diagnosis, prevention, and treatment of diabetes

mellitus and related endocrine and metabolic diseases, and (2)

establish programs of evaluation, planning, and dissemination of knowledge related to research and training in diabetes

mellitus and related endocrine and metabolic diseases. ”

(a) “Consistent with applicable recommendations of the

National Commission on Diabetes, the Secretary shall provide

for the development, or substantial expansion, of centers for

research and training in diabetes mellitus and related endocrine and metabolic disorders. Each center developed or expanded under this section shall . . .

(2) conduct (A) research in the diagnosis and treatment of

diabetes mellitus and related endocrine and metabolic

disorders and the complications resulting from such disease or

disorders, . . . (C) information programs for physicians and

allied health personnel who provide primary care for patients

with such disease, disorders, or complications . . . “

(f) “The [National Diabetes Advisory] Board shall–

(1) review and evaluate the implementation of the long

range plan to combat diabetes mellitus (hereinafter in this section referred to as the “Diabetes Plan”) formulated by the National Commission on Diabetes under section 3(e) of the National Diabetes Mellitus Research and Education Act, . . .

(g) The Board may collect such data as it deems advisable

and necessary to enable it to perform the functions required

by subsection (f) of this section.

* * *

(j) One year after the date of its establishment and each year

thereafter the Board shall submit to the Secretary and to the

Congress a report—

(2) which describes and evaluates the progress made in

such year in diabetes research, . . . “
186 ● Part 11—Directory of Statutory Authorities

H. National Institute of Arthritis, Metabolism, and Digestive Diseases—continued

Type of

Legal citation authority Legislative text

e) Public Health

Service Act

● P.L. 78-410$438,

as added by P.L.

93-640$4 (1975),

and amended

● 42 USC §289c-5

f) Public Health

Service Act

 P.L. 78-410 §439,

as added by P.L.

93-640 §4 (1975)

and amended

● 42 USC §289c-6

Specific (c)(1) “As soon as practicable after January 4, 1975, the

Secretary, through the Assistant Secretary for Health, shall

establish the Arthritis Data System for the collection, storage,

analysis, retrieval, and dissemination of data derived from patient populations with asymptomatic and symptomatic types

of arthritis, including where possible, data involving general

populations for the purpose of detection of individuals with a

risk of developing arthritis.

(2) The Secretary shall provide for standardization of patient data and recordkeeping for the collection, storage,

analysis, retrieval, and dissemination of such data in cooperation with projects under this section and centers assisted under

section 289c-6 of this title, and other persons engaged in arthritis programs. ”

General (b) Each [comprehensive arthritis] center assisted under this

section shall— . . .

(2) conduct–

(A) basic and clinical research into the cause,

diagnosis, early detection, prevention, control, and treatment

of, arthritis and complications resulting from arthritis, including research into implantable biomaterials and

biomechanical and other orthopedic procedures and in the

development of other diagnostic and treatment methods; . . .

(C) information and continuing education programs

for physicians and other health and allied health professional

who provide care for patients with arthritis; and

(D) programs for the dissemination to the general

public of information—

(i) on the importance of early detection of arthritis,

of seeking prompt treatment, and of following an appropriate

regimen; and

(ii) to discourage the promotion and use of unapproved and ineffective diagnostic, preventive, treatment, and

control methods and unapproved and ineffective drugs and

devices.

(c) Each center assisted under this section may conduct programs to—

(1) develop new and improved methods of screening and

early detection, referral, and diagnosis of individuals with a

risk of developing arthritis, asymptomatic arthritis,. or symptomatic arthritis,

Implied (2) disseminate the results of research, screening, and

other activities, and develop means of standardizing patient

data and recordkeeping . . . “
VI1. National Institutes of Health ● 187

H. National Institute of Arthritis, Metabolism, and Digestive Diseases—continued

Type of

Legal citation authority Legislative text

g) Public Health General (g) “The [National Arthritis Advisory] Board may collect

Service Act such data as it deems advisable and necessary to enable it to

perform the functions required by subsection (f) of this sec-

. P.L. 78-410 §440, tion. [respecting review and evaluation of the implementation

as added by P.L.

94-562 §~103(a)

(1976)

● 42 USC §289c-7

of the Arthritis Plan ]“

1. National Institute of Child Health and Human Development

a) Public Health Implied (a) “The Surgeon General is authorized, with the approval

Service Act of the Secretary, to establish in the Public Health Service the

National Institute of Child Health and Human Development

 P.L. 78-410$441 , for the conduct and support of research and training relating

as added by P.L. to maternal health, child health, and human development, in87-838$1 (1962) eluding research and training in the special health problems

and amended and requirements of mothers and children and in the basic

sciences relating to the processes of human growth and

 42 USC §289d development, including prenatal development.

General (b) The Secretary shall carry out through the National

Institute of Child Health and Human Development the purposes of section 241 of . . . title [42] with respect to the conduct and support of research which specifically relates to sudden infant death syndrome.”*

General (a) “The Secretary may–

(1) conduct, and

(2) make grants . . . and enter into contracts . . . for

projects for, research in the biomedical, contraceptive development, behavioral, and program implementation fields related to family planning and population . . . “

[Jointly administered with Family Planning, Bureau of Community Health Services (HSA). ]

b) Public Health

Service Act

 P.L. 78-410$100 4

as added by P.L.

91-572 §6(c),

(1970), and

amended

● 42 USC §300a-2

*Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
188 ● Part 11—Directory of Statutory Authorities

J. National Institute of Dental Research

Type of

Legal citation authority Legislative text

J. National Institute of Dental Research

a) Public Health

Service Act

● P.L. 78-410 §422,

as added by P.L.

80-755 §3(b),

(1948), and

amended

● 42 USC §288a

b) Public Health

●

●

Service Act

P.L. 78-410$423,

as added by P.L.

80-755 §3(b),

(1948), and

amended

42 USC §288b

c) Public Health

●

●

Service Act

P.L. 78-410 §424,

as added by P.L.

80-755 §3(b),

(1948)

42 USC §288c

General “In carrying out the purposes of section 241 of . . . title [42]

with respect to dental diseases and conditions the Surgeon

General, through the Institute and in cooperation with the National Advisory Dental Research Council (hereafter in this

part referred to as the “Council”), shall—

(a) Conduct, assist, and foster researches, [sic], investigations, experiments, and studies relating to the cause, prevention, and methods of diagnosis and treatment of dental diseases and conditions; . . . “*

General (a) “In carrying out the provisions of section 288a of this

title all appropriate provisions of section 241 of . . . title [42]

shall be applicable to the authority of the Surgeon

General, . . . “*

Implied “The Council is authorized to—

* * *

(b) Collect information as to studies which are being carried

on in the United States or any other country as to the cause,

prevention, or methods of diagnosis or treatment of dental

diseases and conditions, . . . and with the approval of the

Surgeon General make available such information through

appropriate publications for the benefit of health agencies and

organizations (public or private), physicians, dentists, or any

other scientists, and for the information of the general

public; . . . “

*Section 301 of the Public Health Service Act, 42 USC §241, is the general data collection authority for the Secretary of HEW.
VII. National Institutes ofl+ealth ● 189

K. National Institute of Environmental Health Sciences

Type of

Legal citation authority Legislative text

K. National Institute of Environmental Health Sciences

a) Energy Supply and

Environmental

Coordination Act

of 1974

● P.L. 93-319$7

(1974)

● 15 USC §793

b) Health Services

●

●

and Centers

Amendments of

1978

P.L. 95-626$209

(1978)

42 USC §247a note

c) Clean Air Act

● P.L. 88-206 §154,

as added by P.L.

95-95, §125 (1977)

● 42 USC §7454

Specific (b) “In order to determine the health effects of emissions of

sulfur oxides to the air resulting from any conversions to

burning coal to which section I857c-10 of Title 42 applies, the

Department of Health, Education, and Welfare shall, through

the National Institute of Environmental Health Sciences and in

cooperation with the Environmental Protection Agency, conduct a study of chronic effects among exposed populations. . . . “

[Jointly administered with the Environmental Protection

Agency (EPA). ]

Specific “The Secretary of Health, Education, and Welfare shall

conduct a study to determine the long-term effect on child

development of various levels of lead in blood. The Secretary

shall report the results of such study to the Congress together

with recommendations for such legislation as the Secretary

determines is appropriate.”

Implied (e) “The Secretary of Health, Education, and Welfare shall

encourage and support continuing research programs that will

increase scientific knowledge of the effects of changes in the

ozone in the stratosphere upon human health. Such Secretary

shall transmit reports by January 1, 1978, and biennially

thereafter, to the Administrator and the Congress on the

results of such programs, together with any appropriate

recommendations for legislation or regulation (or both). ”

[Environmental Protection Agency has primary responsibility

for this authority, but EPA coordinates with the National

Cancer Institute and the National Institute of Environmental

Health Sciences (NIH). ]
190 ● Part 11—Directory of Statutory Authorities

L. National Institute of General Medical Science

Type of

Legal citation authority Legislative text

L. National Institute of General Medical Science

a) Public Health

Service Act

● P.L. 78-410 §442,

as added by P.L.

87-838$1 (1962),

and amended

● 42 USC §289e

b) Public Health

Service Act

● P.L. 78-410$1102,

as added by P.L.

94-278 §403(a)

(1976)

● 42 USC §300b-1

c) Public Health

Service Act

● P.L. 78-410$1221,

as added by P.L.

94-573 §14(3),

(1976)

● 42 USC §300d-21

Implied “The Surgeon General is authorized, with the approval of

the Secretary, to establish in the Public Health Service an institute for the conduct and support of research and training in

the general or basic medical sciences and related natural or

behavioral sciences which have significance for two or more

other institutes, or are outside the general area of responsibility of any other institute, established under or by this chapter. ”

General “In carrying out section 241 of . . . title [42], the Secretary

may make grants to public and nonprofit private entities, and

may enter into contracts with public and private entities and

individuals, for projects for (1) basic or applied research

leading to the understanding, diagnosis, treatment, and control of genetic diseases, . . . In making grants and entering

into contracts for projects described in clause (1) of the

preceding sentence, the Secretary shall give priority to applications for such grants or contracts which are submitted for

research on sickle cell anemia and for research on Cooley’s

anemia. ” *

[Jointly administered with the Genetic Disease, Hemophilia

and SIDS program, Bureau of Community Health Services

(HSA).]

General (a)(l) “The Secretary may make grants to, and enter into

contracts with, public or private nonprofit entities for the support of, and may conduct, programs for the establishment,

operation, and improvement of activities to

(A) demonstrate the effectiveness of different methods

for the treatment and rehabilitation of individuals injured by

burns,

(B) conduct research in the treatment and rehabilitation

of such individuals, . . . “

[Jointly administered with the Emergency Medical Services

Bureau of Medical Services (HSA). ]

*Section 301 of the Public Health Service Act, 42 USC§241, is the general data collection authority for the Secretary of HEW.
VII. National Institutes of Health ● 191

M. National Institute of Neuroiogical and Communicative Disorders and Stroke

Type of

Legal citation authority Legislative text

M. National Institute of Neurological and Communicative Disorders and Stroke

a) Public Health Implied (a) “The Surgeon General shall establish in the Public

●

●

Service Act Health Service an institute for research on arthritis,

rheumatism, digestive diseases, and metabolism, and an inP.L. 78-410$431 stitute for research on neurological diseases (including epilepas added by P.L. sy, cerebral palsy, and multiple sclerosis) and blindness, and

81-692 $2(b) he shall also establish a national advisory council or commit-

(195o) and amended tee for each such institute to advise, consult with, and make

recommendations to him with respect to the activities of the

42 USC §289a institute with which each council or committee is concerned. ”

[Jointly administered with the National Institute of Arthritis,

Metabolism and Digestive Diseases (NIH). ]

N. National Library of Medicine

a) Public Health Implied

Service Act

● P.L. 78-410$390,

as added by P.L.

89-291 $2(1965),

and amended

● 42 USC §280b

(a) “The Congress hereby finds and declares that (1) the

unprecedented expansion of knowledge in the health sciences

within the past two decades has brought about a massive

growth in the quantity, and major changes in the nature of,

biomedical information, materials, and publications; (2) there

has not been a corresponding growth in the facilities and

techniques necessary adequately to co-ordinate and

disseminate among health scientists and practitioners the everincreasing volume of knowledge and information which has

been developed in the health science field; (3) much of the

value of the ever-increasing volume of knowledge and information which has been, and continues to be, developed in

the health science field will be lost unless proper measures are

taken in the immediate future to develop facilities and techniques necessary to collect, preserve, store, process, retrieve,

and facilitate the dissemination and utilization of, such knowledge and information.

(b) It is therefore the policy of this part to–

(2) assist through grants physicians and other practitioners in the sciences related to health, to scientists, and to

public or nonprofit private institutions on behalf of such

physicians, other practitioners, and scientists, in the compilation of existing, and the creation of additional, written matter

which will facilitate the distribution and utilization of knowl-
192 ● Part Z]—Directory of Statutory Authorities

N. National Library of Medicine—continued

Type of

Legal citation authority Legislative text

b) Public Health

Service Act

P.L. 78-410 ¦§394,

formerly §395, as

added by P.L.

89-291 §2 (1965)

and amended

42 USC §280b-5

c) Public Health

●

●

Service Act

P.L. 78-410 §~397,

formerly §399, as

added by P.L.

89-291 §2 (1965),

renumbered §398

and amended

42 USC §280b-9

edge and information relating to scientific, social, and cultural

advancements in sciences related to health;

(3) assist in the conduct of research, investigations, and

demonstrations in the field of medical library science and related activities, and in the development of new techniques,

systems, and equipment for processing, storing, retrieving,

and distributing information in the sciences related to

health; . . .

(5) assist in the development of a national system of

regional medical libraries each of which would have facilities

of sufficient depth and scope to supplement the services of

other medical libraries within the region served by it; . . . “

Implied (a) “To carry out the purposes of section 280b(b)(2) of this

title, the Secretary shall make grants to physicians and other

practitioners in the sciences related to health, to scientists, and

to public or nonprofit private institutions on behalf of such

physicians, other practitioners, and scientists for the compilation of existing, or writing of original, contributions relating

to scientific, social, or cultural, advancements in sciences

related to health.”

Implied (a) “To carry out the purposes of section 280b(b)(6) of this

title, the Secretary, . . . shall make grants to, and enter into

appropriate contracts . . . for the purpose of supporting

biomedical scientific publications of a non-profit nature and

to procure the compilation, writing, editing, and publication

of reviews, abstracts, indices, handbooks, bibliographies, and

related matter

developments.

pertaining to scientific works and scientific

. .
Viii. Health Care Financing Administration

Vlll. HEALTH CARE FINANCING ADMINISTRATION

● 193

Type of

Legal citation authority Legislative text

A. Office of the Administrator

1. Office of Policy, Planning, and Research

a) Public Health Specific (d) “The Secretary shall establish the following within one

Service Act year of January 4, 1975:

(1) A uniform system for calculating the aggregate cost of

● P.L. 78-410$1533, operation and the aggregate volume of services provided by

as added by P.L. health services institutions as defined by the Secretary in

93-641, §3 (1974), regulations. Such system shall provide for the calculation of

and amended the aggregate volume to be based on:

(A) The number of patient days;

● 42 USC §300n-2 (B) The number of patient admissions;

(C) The number of outpatients visits; and

(D) Other relevant factors as determined by the

Secretary.

(2) A uniform system for cost accounting and calculating

the volume of services provided by health services

tions. Such system shall:

(A) Include the establishment of specific cost

and, where appropriate, subcost centers.

(B) Include the designation of an appropriate

factor for each cost center.

(C) Provide for an appropriate application

institucenters

volume

of such

system in the different types ‘of institutions (including

hospitals, nursing homes, and other types of health services

institutions), and different sizes of such types of institutions.

(3) A uniform system for calculating rates to be charged

to health insurers and other health institutions payers by

health service institutions. Such system shall:

(A) Be based on all-inclusive rate for various categories

of patients (including, but not limited to individuals receiving

medical, surgical, pediatric, obstetric, and psychiatric institutional health services).

(B) Provide that such rates reflect the true cost of providing services to each such category of patients. The system

shall provide that revenues derived from patients in one

category shall not be used to support the provision of services

to patients in any other category.

(C) Provide for an appropriate application of such

system in the different types of institutions (incIuding

hospitals, nursing homes, and other types of health service institutions) and different sizes of such types of institutions.

(D) Provide that differences in rates to various classes

of purchasers (including health insurers, direct service payers,
194 ● Part 11—Directory of Statutory Authorities

A. Office of the Administrator

1. Office of Policy, Planning, and Research—continued

Type of

Legal citation authority Legislative text

b) Social Security Specific

Act

● P.L. 74-241,

§1121, as added by

P.L. 95-142,

$19(a) (1977)

● 42 USC §1320a

and other health institution payers) be based on justified and

documented differences in the costs of operation of health

service institutions made possible by the actions of such purchasers.

(4) A classification system for health services institutions.

Such classification system shall quantitatively describe and

group health services institutions of the various types. Factors

included in such classification system shall include—

(A) the number of beds operated by an institution;

(B) the geographic location of an institution;

(C) the operation of a postgraduate physician training

program by an institution; and

(D) the complexity of services provided by an institution.

(5) A uniform system for the reporting by health services

institutions of—

(A) the aggregate cost of operation and the aggregate

volume of services, as calculated in accordance with the

system established by the Secretary under paragraph (l);

(B) the costs and volume of services at various cost

centers, and subcost centers, as calculated in accordance with

the system established by the Secretary under paragraph (2);

and

(C) rates, by category of patient and class of purchaser,

as calculated in accordance with the system established by the

Secretary under paragraph (3).

Such system shall provide for an appropriate application of

such system in the different types of institutions (including

hospitals, nursing homes, and other types of health services

institutions) and different sizes of such institutions. ”

(a) “For the purposes of reporting the cost of services

provided by, of planning, and of measuring and comparing

the efficiency of and effective use of services in hospitals,

skilled nursing facilities, intermediate care facilities, home

health agencies, health maintenance organizations, and other

types of health services facilities and organizations to which

payment may be made under this Act, the Secretary shall

establish by regulation, for each such type of health services

facility or organization, a uniform system for the reporting by

a facility or organization of that type of the following information:

(I) The aggregate cost of operation and the aggregate

volume of services.
VIII. Health Care Financing Administration ● 195

A. Office of the Administrator

1. Office of Policy, Planning, and Research—continued

Type of

Legal citation authority Legislative text

(2) The costs and volume of services for various functional accounts and subaccounts.

(3) Rates, by category of patient and class of purchaser.

(4) Capital assets, as defined by the Secretary, including

(as appropriate) capital funds, debt service, lease agreements

used in lieu of capital funds, and the value of land, facilities,

and equipment.

(5) Discharge and bill data.

The uniform reporting system for a type of health services

facility or organization shall provide for appropriate variation

in the application of the system to different classes of facilities

or organizations within that type and shall be established, to

the extent practicable, consistent with the cooperative system

for producing comparable and uniform health information

and statistics described in section 306(e)(l) of the Public

Health Service Act. In reporting under such a system,

hospitals shall employ such chart of accounts, definitions,

principles, and statistics as the Secretary may prescribe in

order to reach a uniform reconciliation of financial and

statistical data for specific uniform reports to be provided to

the Secretary.

(b) The Secretary shall–

(1) monitor the operation of the systems established

under subsection (a);

(2) assist with and support demonstration and evaluations of the effectiveness and cost of the operation of such

systems and encourage State adoption of such system; and

(3) periodically revise such systems to improve their effectiveness and diminish their cost.

(c) The Secretary shall provide information obtained

through use of the uniform reporting systems described in

subsection (a) in a useful manner and format to appropriate

agencies and organizations, including health systems agencies

(designated under section I515 of the Public Health Service

Act) and State health planning and development agencies

(designated under section 1521 of such Act), as may be

necessary to carry out such agencies’ and organizations’ functions. ”

[This authority is delegated to the Health Care Financing Administration, and HCFA is directed to coordinate with the National Center for Health Statistics (OASH). ]
196 • Part I1—Directory of Statutory Authorities

A. Office of the Administrator

1. Office of Policy, Pianning, and Research—continued

Type of

Legal citation authority Legislative text

c) Social Security Implied (a)(l) “The Secretary of Health, Education, and

●

●

Act Amendments Welfare is authorized, either directly or through

of 1967 grants . . . or contracts . . . to develop and engage in experiments and demonstration projects for the following

P.L. 90-248, purposes:

$402(a), (1967) (A) to determine whether, and if so which,

and amended changes in methods of payment or reimbursement (other

than those dealt with in section 222 (a) of the Social Security

42 USC §1395b-1 Amendments of 1972) for health care and services under

health programs established by this chapter, including a

change to methods based on negotiated rates, would have the

effect of increasing the efficiency and economy of health services under such programs through the creation of additional

incentives to these ends without adversely affecting the quality of such services;

(B) to determine whether payments for services other

than those for which payment may be made under such programs (and which are incidental to services for which payment

may be made under such programs) would, in the judgment of

the Secretary, result in more economical provision and more

effective utilization of services for which payment may be

made under such program, where such services are furnished

by organizations and institutions which have the capability of

providing—

(i) comprehensive health care services,

(ii) mental health care services (as defined by section

2691(c) of this title),

(iii) ambulatory health care services (includes

surgical services provided on an outpatient basis), or

(iv) institutional services which may substitute, at

lower cost, for hospital care;

(C) to determine whether the rates of payment or reimbursement for health care services, approved by a State for

purposes of the administration of one or more of its laws,

when utilized to determine the amount to be paid for services

furnished in such State under the health programs established

by this chapter, would have the effect of reducing the costs of

such programs without adversely affecting the quality of such

services;

(D) to determine whether payments under such programs based on a single combined rate of reimbursement or

charge for the teaching activities and patient care which

residents, interns, and supervising physicians render in connection with a graduate medical education program in a pa-
VI1l. Health Care Financing Administration ● 197

A. Office of the Administrator

1. Office of Policy, Planning, and Research—continued

Type of

Legal citation authority Legislative text

tient facility would result in more equitable and economical

patient care arrangements without adversely affecting the

quality of such care;

(E) to determine whether coverage of intermediate care

facility services and homemaker services would provide

suitable alternatives to posthospital benefits presently provided under subchapter XVIII of this chapter; such experiment

and demonstration projects may include:

(i) counting each day of care in an intermediate care

facility as one day of care in a skilled nursing facility, if such

care was for a condition for which the individual was

hospitalized,

(ii) covering the services of homemakers for a maximum of 21 days, if institutional services are not medically appropriate,

(iii) determining whether such coverage would

reduce long-range costs by reducing the lengths of stay in

hospitals and skilled nursing facilities, and

(iv) establishing alternative eligibility requirements

and determining the probable cost of applying each alternative, if the project suggests that such extension of coverage

would be desirable;

(F) to determine whether, and if so which types of,

fixed price or performance incentive contract would have the

effect of inducing to the greatest degree effective, efficient, and

economical performance of agencies and organizations making payment under agreements or contracts with the Secretary

for health care and services under health programs established

by this chapter;

(G) to determine under what circumstances payment

for services would be appropriate and the most appropriate,

equitable, and noninflationary methods and amounts of reimbursement under health care programs established by this

chapter for services, which are performed independently by

an assistant to a physician including a nurse practitioner

(whether or not performed in the office of or at a place at

which such physician is physically present), and—

(i) which such assistant is legally authorized to perform by the State or political subdivision wherein such services are performed, and

(ii) for which such physician assumes full legal and

ethical responsibility as to the necessity, propriety, and quality thereof;

(H) to establish an experimental program to provide

day-care services, which consist of such personal care, super46-643 0-79 - 1 4
.—

198 ● Part 11—Directory of Statutory Authorities

A. Office of the Administrator

1. Office of Policy, Planning, and Research—continued

Type of

Legal citation authority Legislative text

vision, and services as the Secretary shall by regulation

prescribe, for individuals eligible to enroll in the supplemental

medical insurance program established under part B of this

subchapter and subchapter XIX of this chapter, in day-care

centers which meet such standards as the Secretary shall by

regulation establish; and

(I) to determine whether the services of clinical

psychologists may be made more generally available to persons eligible for services under this subchapter and subchapter

XIX of this chapter in a manner consistent with quality of care

and equitable and efficient administration. . . . “

d) Social Security

Act

● P.L. 74-241,

51861(v)(1)(F), as

added by P.L.

95-142, §19(b)

(1977)

● 42 USC §1395 X

e) Social Security

●

●

Act Amendments

of 1972

P.L. 92-603

§245 (a)(c) (1972),

and amended

42 USC $1395x

note 1

Specific (v)(l)(F) “Such regulations [e.g. to determine the definition

of reasonable costs for health service facilities] shall require

each provider of services . . . to make reports to the Secretary

of information described in section l121(a) [42 USC §1320a]

in accordance with the uniform reporting system (established

under such section) for that type of provider. ”

Implied (a) “The Secretary is authorized to conduct reimbursement

experiments designed to eliminate unreasonable expenses

resulting from prolonged rentals of durable medical equipment described in section 1861(s)(6) of the Social Security Act

[subsec. (s)(6) of this section].

(c) The Secretary is authorized, at such time as he deems appropriate, to implement on a nationwide basis any such reimbursement procedures which he finds to be workable,

desirable and economical and which are consistent with the

purposes of this section. ”
VIII. Health Care Financing Administration ● 199

Type of

Legal citation authority Legislative text

B. Health Standards and Quality Bureau

a) Public Health

Service Act

● P.L. 78-410, §353,

as added by P.L.

90-174, $5(a),

(1967)

● 42 USC §263a

b) Social Security

Act

● P.L. 74-241 §1106

as added by Act

of Aug. 10, 1939,

§802 and

amended

● 42 USC §1306

General (d)(l) “A license shall not be issued in the case of any

clinical laboratory unless

(A) the application therefore contains or is accompanied by such information as the Secretary finds

necessary, and

(B) the applicant agrees and the Secretary determines

that such laboratory will be operated in accordance with

standards found necessary by the Secretary to carry out the

purposes of this section. Such standards shall be designed to

assure consistent performance by the laboratories of accurate

laboratory procedures and services, and shall include, among

others, standards to assure—

(i) maintenance of a quality control program adequate and appropriate for accuracy of the laboratory procedures and services;

(ii) maintenance of records, equipment, and facilities

necessary to proper and effective operation of the laboratory;

(iii) qualifications of the director of the laboratory

and other supervisory professional personnel necessary for

adequate and effective professional supervision of the operation of the laboratory (which shall include criteria relating to

the extent to which training and experience shall be

substituted for education); and

(iv) participation in a proficiency testing program

established by the Secretary. ”

[Jointly administered with the Center for Disease Control. ]

Implied (d) “Notwithstanding any other provision of this section the

Secretary shall make available to each State agency operating

a program under subchapter XIX of this chapter and

shall, . . . make available for public inspection in readily accessible form and fashion, the following official reports . . .

dealing with the operation of the health programs established

by subchapters XVIII and XIX of this chapter— . . .

(3) program validation survey reports and other formal

evaluations of the performance of providers of services, including the reports of follow-up reviews except that such

reports shall not identify individual patients, individual health

care practitioners, or other individuals. ”

[Jointly administered with Medicare, and Medicaid (HCFA). ]
200 ● Part ll—Directory of Statutory Authorities

B. Health Standards and Quality Bureau—continued

Type of

Legal citation authority Legislative text

c) Social Security

Act

● P.L. 74-241 §1155,

as added by P.L.

92-603 §249F (b),

(1972), and

amended

● 42 USC §1320c-4

d) Social Security

Act

● P.L. 74-241 §1156,

as added by P.L.

92-603 §249F

(1972), and

amended

• 42 USC §1320c-5

General

Specific

Implied

(f)(l) “An agreement entered into under this part between

the Secretary and any organization . . . designated as the Professional Standards Review Organization for any area shall

provide that such organization will—

(B) collect such data relevant to its functions and such

information and keep and maintain such records in such form

as the Secretary may require to carry out the purposes of this

part and to permit access to and use of any such records as the

Secretary may require for such purposes.”

(a) “Each Professional Standards Review Organization shall

apply professionally developed norms of care, diagnosis, and

treatment based upon typical patterns of practice in its regions

(including typical lengths-of-stay for institutional care by age

and diagnosis) as principal points of evaluation and review.

The National Professional Standards Review Council and the

Secretary shall provide such technical assistance to the

organization as will be helpful in utilizing and applying such

norms of care, diagnosis, and treatment.

* * *

(c)(l) The National Professional Standards Review Council

shall provide for the preparation and distribution, to each

Professional Standards Review Organization and to each

other agency or person performing review functions . . . of

appropriate materials indicating the regional norms to be

utilized pursuant to this part. Such data concerning norms

shall be reviewed and revised from time to time. The approval

of the National Professional Standards Review Council of

norms of care, diagnosis, and treatment shall be based on its

analysis of appropriate and adequate data. . . .

(d)(l) Each Professional Standards Review Organization

shall—

(B) require that there be included in any such certification [of medical necessity for in-patient treatment] with

respect to any patient such information as may be necessary to

enable such organization properly to evaluate the medical

necessity of the further institutional health care recommended

by the physician executing such certification.

(2) The points in time at which any such certification will

be required . . . shall be consistent with and based on professionally developed norms of care and treatment and data

developed with respect to length of stay in health care institutions of Patients having various illnesses, iniuries. or health . . . ,
Vlll. Health Care Financing Administration • 201

B. Health Standards and Quality Bureau—continued

Type of

Legal citation authority Legislative text

conditions, and requiring various types of health care services

or procedures. ”

e) Social Security

Act

● P. L.74-241 §1163,

as added by P.L.

92-603 §249F(b)

(1972) and

amended

● 42 USC §1320c-12

General

f) Social Security General

Act

● P.L. 74-241 §1171,

as added by P.L.

95-142, §5 (1977)

● 42 USC §1320 c-20

g) Social Security Specific

Act

● P.L. 74-241$1172,

as added by P.L.

95-142, §5 (1977)

● 42 USC §1320c-21

(a)(l) “There shall be established a National Professional

Standards Review Council (hereinafter in this section referred

to as the “Council”).

(e) It shall be the duty of the Council to–

* * *

(2) provide for the development and distribution, among

Statewide Professional Standards Review Councils and Professional Standards Review Organizations of information and

data which will assist such review Councils and organizations

in carrying out their duties and functions; . . .

(4) make or arrange for the making of studies and investigations with a view to developing and recommending to

the Secretary and to the Congress measures designed more effectively to accomplish the purposes and objectives of this

part.”

(e)(2) “Each Professional Standards Review Organization

shall provide to the State agency for the State in which it is

located, upon request, data or information which the

Secretary requires such organizations to report to him routinely on a periodic basis, and such other data or information as

the Secretary authorizes to be disclosed. ”

“The Secretary shall submit to the Congress not later than

April 1, 1978, and not later than April 1 of each year

thereafter, a full and complete report on the administration,

impact, and cost of the program under this part during the

preceding fiscal year, including data and information on—

* * *

(2) the number of health care institutions and practitioners whose services are subject to review by Professional

Standards Review Organizations, and the number of

beneficiaries and recipients who received services subject to

such review during such year;

(5) changes in utilization rates and patterns, and changes

in medical procedures and practices, attributable to the activities of Professional Standards Review Organizations;
— ——— —

202 ● Part 11—Directory of Statutory Authorities

B. Health Standards and Quality Bureau—continued

Type of

Legal citation authority Legislative text

(6) the results of program evaluation activities, including

the operation of data collection systems and the status of Professional Standards Review Organization data policy and implementation; . . . “

C. Medicaid

a) Social Security

Act

● P.L. 74-241 §1106,

as added by Act

of Aug. 10, 1939,

§802 and amended

● 42 USC §1306

b) Social Security

Act

● P.L. 74-241 ~1902,

as added by P.L.

89-97 $121(a),

(1965), and

amended by P.L.

95-142 ~19,

(1977)

● 42 USC ~1396a

Implied (d) “Notwithstanding any other provision of this section the

Secretary shall make available to each State Agency operating

a program under subchapter XIX of this chapter and

shall, . . . make available for public inspection in readily accessible form and fashion, the following official

reports . . . dealing with the operation of the health programs

established by subchapters XVIII and XIX of this

chapter— . . .

(3) program validation survey reports and other formal

evaluations of the performance of providers of services, including the reports of follow-up reviews, except that such

reports shall not identify individual patients, individual health

care practitioners, or other individuals. ”

[Jointly administered with Medicare and the Health Standards

and Quality Bureau (HCFA). ]

General (a) “A State plan for medical assistance must— . . .

(6) provide that the State agency will make such reports,

in such form and containing such information, as the Secretary may from time to time require, and comply with such

provisions as the Secretary may from time to time find necessary to assure the correctness and verification of such

reports . . .

(27) provide for agreements with every person or institution providing services under the State plan under which such

person or institution agrees

(A) to keep such records as are necessary fully to

disclose the extent of the services provided to individuals

receiving assistance under the State plan, and

(B) to furnish the State agency or the Secretary with

such information, regarding any payments claimed by such

persons or institution for providing services under the State

plan, as the State agency or the Secretary may from time to

time request; . . .
V]Il. Health Care Financing Administration ● 203

C. Medicaid—continued

Type of

Legal citation authority Legislative text

Specific (4o) require each health services facility or organization

which receives payments under the plan and of a type for

which a uniform reporting system has been established under

section l121(a) [42 USC $1320a] to make reports to the

Secretary of information described in such section in accordance with the uniform reporting system (established

under such section) for that type of facility or organization. ”

c) Social Security

Act

● P.L. 74-241

$1903 (a)(3) as

added by P.L.

92-603 $$235(a),

249B, 299 E(a),

(1972) and amended

● 42 USC $1396b

d) Social Security

Act

● P.L. 74-241,

~1908, as added

by P.L. 90-248

~236(b) (1968),

and amended

● 42 USC ~1396g

Implied (a) “The Secretary . . . shall pay to each State which has a

plan approved under this subchapter, for each quarter, beginning with the quarter commencing January 1, 1966—

(3) an amount equal to–

(A)(i) 90 per centum of so much of the sums expended

during such quarter as are attributable to the design, development, or installation of such mechanized claims processing

and information retrieval systems as the Secretary determines

are likely to provide more efficient, economical, and effective

administration of the plan and to be compatible with the

claims processing and information retrieval systems utilized in

the administration of subchapter XVIII of this chapter,

. . . and

(B) 75 per centum of so much of the sums expended

during such quarter as are attributable to the operation of

systems . . . of the type described in subparagraph

(A)(i) ., . “

Implied (c) “It shall be the function and duty of such agency or

board [responsible for the licensing of administrators of

nursing homes] to— . . .

(2) develop and apply appropriate techniques, including

examinations and investigations, for determining whether an

individual meets such standards [e.g. standards to ensure that

nursing home administrators are of good character]; . . .

(6) conduct a continuing study and investigation of nursing homes and administrators of nursing homes within the

State with a view to the improvement of the standards imposed for the licensing of such administrators and of procedures and methods for the enforcement of such standards

with respect to administrators of nursing homes who have

been licensed as such.”
204 ● Part ZZ—Directory of Statutory Authorities

D. Medicare

Type of

Legal citation authority Legislative text

D. Medicare

a) Social Security Implied (d) “Notwithstanding any other provision of this section the

Act Secretary shall make available to each State agency operating

a program under subchapter XIX of this chapter and

● P.L. 74-241$1106, shall . . . make available for public inspection in readily acas added by Act cessible for m and fashion, the following official

of Aug. 10, 1939, reports . . . dealing with the operation of the health programs

$802 and amended established by subchapters XVIII and XIX of this chapter—

● 42 USC ~1306

(3) program validation ~ur~e~ reports and other formal

evaluations of the performance of providers of services, including the reports of follow-up reviews, except that such

reports shall not identify individual patients, individual health

care practitioners, or other individuals. ”

[Jointly administered with Medicaid and the Health Standards

and Quality Bureau (HCFA). ]

b) Social Security

Act

● P.L. 74-241 ~1816,

as added by P.L.

89-97 $102(a)

(1965), and

amended

● 42 USC ~1395h

c) Social Security

●

●

Act

P.L. 74-241 ~1842,

as added by P.L.

89-97 $102(a),

(1965), and

amended

42 USC ~1395u

General (b) “The Secretary shall not enter into or renew an

agreement with any agency or organization under this section

unless—

(2) such agency or orga~iz~t~on agrees–

(A) to furnish to the Secretary such of the information

acquired by it in carrying out its agreement under this section,

and

(B) to provide the Secretary with access to all such

data, information, and claims processing operations, as the

Secretary may find necessary in performing his functions

under this part; . . . “

General (b)(3) “Each such contract [with carriers to provide for

administration of benefits under subchapter XVIII—Health Insurance for the Aged and Disabled] shall provide that the

carrier— . . .

(D) will furnish to the Secretary such timely information and reports as he may find necessary in performing his

functions under this part; and

(E) will maintain such records and afford such access

thereto as the Secretary finds necessary to assure the correctness and verification of the information and reports under
VIII. Health Care Financing Administration ● 205

D. Medicare—continued

Type of

Legal citation authority Legislative text

subparagraph (D) and otherwise to carry out the purposes of

this part; . . . “

d) Social Security

Act

● P.L. 74-241,

$1874, as added by

P.L. 89-97

~$102(a), ill(a),

(1965) and

amended

● 42 USC $1395kk

e) Social Security

Act

● P.L. 74-241$1875,

as added by P.L.

89-97 ~102(a)

(1965) and

amended

● 42 USC $13951/

General (b) “The Secretary may contract with any person, agency,

or institution to secure on a reimbursable basis such special

data, actuarial information, and other information as may be

necessary in the carrying out of his functions under this subchapter. ”

General (a) “The Secretary shall carry on studies and develop

recommendations to be submitted from time to time to the

Congress relating to health care of the aged and disabled, including studies and recommendations concerning

(1) the adequacy of existing personnel and facilities for

health care for purposes of the programs under parts A and B

of this subchapter;

(2) methods for encouraging the further development of

efficient and economical forms of health care which are a constructive alternative to inpatient hospital care; and

(3) the effects of the deductibles and coinsurance provisions upon beneficiaries, persons who provide health services,

and the financing of the program.

(b) The Secretary shall make a continuing study of the

operation and administration of the insurance programs under

parts A and B of this subchapter (including a validation of the

accreditation process of the Joint Commission on the Accreditation of Hospitals, the operation and administration of

health maintenance organizations authorized by section

1395mm of this title, the experiments and demonstration projects authorized by section 1395b-1 of this title, and the experiments and demonstration projects authorized by Section

222(a) of the Social Security Amendments of 1972), and shall

transmit to the Congress annually a report concerning the

operation of such programs. ”
206 ● Part Z]—Directory of Statutory Authorities

D. Medicare—continued

Type of

Legal citation authority Legislative text

f) Social Security General (b)(4) “pursuant to agreements with approved providers of

Act services and renal dialysis facilities, the Secretary may make

payments to such px’oviders and facilities for the cost of home

● P.L. 74-24151881, dialysis supplies and equipment and self-care home dialysis

as added by P.L. support services furnished to patients whose self-care home

95-292 ~2 (1978) dialysis is under the direct supervision of such provider or

facility . . .

● 42 USC $1395rr (s) An agreement under paragraph (4) shall require . . . that the provider or facility will—

* * *

(B) perform all such administrative functions and

maintain such information and records as the Secretary may

require to verify the transactions and arrangements described

in subparagraph (A);

(0 submit such cost reports, data, and information as

the Secretary may require with respect to the costs incurred

for equipment supplies and services furnished to the facility’s

home dialysis patient population; and

(D) provide for full access for the Secretary to all such

records, data, and information as he may require to perform

his functions under this section . . .

Specific (c)(l)(A) For the purpose of assuring effective and efficient

administration of the benefits provided under this section, the

Secretary shall establish, in accordance with such criteria as

he finds appropriate, renal disease network areas, such network organizations . . . as he finds necessary to accomplish

such purpose, and a national end stage renal disease medical

information system. The Secretary may by regulations provide for such coordination of network planning and quality

assurance activities and such exchange of data and information among agencies with responsibilities for health planning

and quality assurance activities under Federal law as is

consistent with the economical and efficient administration of

this section and with the responsibilities established for network organization under this section . . .

(2) The network organizations of each network shall be

responsible, in addition to such other duties and function as

may be prescribed by the Secretary for— . . .

(E) submitting an annual report to the Secretary on July

1 of each year which shall include a full statement of the network’s goals, data on the network’s performance in meeting

its goals (including data on the comparative performance of

facilities and providers with respect to the identification and

placement of suitable candidates in self-care settings and
VIII. Health Care Financing Administration “ 207

D. Medicare—continued

Type of

Legal citation authority Legislative text

transplantation), identification of those facilities that have

consistently failed to cooperate with network goals, and

recommendations with respect to the need for additional or

alternative services or facilities in the network in order to meet

the network goals, including self-dialysis training, transplantation, and organ procurement facilities

General (e)(1) Notwithstanding an; ~t~er provision of this title, the

Secretary may, pursuant to agreements with approved providers of services and renal dialysis facilities, reimburse such

providers and facilities . . . for the reasonable cost of the pui--

chase, installation, maintenance and reconditioning for subsequent use of artificial kidney and automated dialysis

peritoneal machines . . . which are to be used exclusively by

entitled individuals dialyzing at home.

(2) An agreement under this subsection shall require that

the provider or facilit y will—

* * *

(C) provide for full access for the Secretary to all

records and information relating to the purchase,

maintenance, and use of the equipment; and

(D) submit such reports, data, and information as the

Secretary may require with respect to the cost, management,

and use of the equipment.

* * *

Specific (g) The Secretary shall submit to the Congress on April 1,

1979, and April 1 of each year thereafter a report on the end

stage renal disease program, including but not limited to—

(1) the number of patients, nationally and by renal

disease network, on dialysis (self-dialysis or otherwise) at

home and in facilities;

(2) the number of new patients entering dialysis at home

and in facilities during the year;

(3) the number of facilities providing dialysis and the

utilization rates of those facilities;

(4) the number of kidney transplants by source of donor

organ;

(5) the number of patients awaiting organs for transplant;

(6) the number of transplant failures;

(7) the range of costs of kidney acquisitions, by type of

facility and by region;

(8) the number of facilities providing transplants and the

number of transplants performed per facility;

(9) patient mortality and morbidity rates;

(10) the average annual cost of hospitalization for an-
———.

208 ● Part ZZ—Directory of Statutory Authorities

D. Medicare—continued

Type of

Legal citation authority Legislative text

cillary problems in dialysis and transplant patients, and drug

costs for transplant patients;

(11) medicare payment rates for dialysis, transplant procedures, and physician services, along with any changes in

such rates during the year and the reasons for those changes;

(12) the results of cost-saving experiments;

(13) the results of basic kidney disease research conducted

by the Federal Government, private institutions, and foreign

governments;

(14) information on the activities of medical review

boards and other networks organizations; and

(15) estimated program costs over the next five years.”
Index ● 209

INDEX

Typeof

U.S. Code authority Administering agency Page

Citation (Specific, General, Implied) numbe r

15 Usc ~793 . . . . .

15 Usc ~1337 . . . .

21 USC ~346a . . . .

21 USC $348 . . . . .

21 Usc ~355 . . . . .

21 Usc ~357 . . . . .

21 USC $360b . . . .

21 USC ~360c . . . .

21 USC $360i. . . . .

21 USC $360j . . . . .

21 Usc ~375 . . . . .

21 USC ~376 . . . . .

21 USC ~1164 . . . .

21 USC ~1172 . . . .

21 Usc ~1173 . . . .

21 USC $1176 . . . .

21 Usc ~1177 . . . .

21 Usc $1191 . . . .

21 USC $1192 . . . .

22 USC $2103 . . . .

25 USC ~1653 . . . .

25 USC ~1655 . . . .

29 USC ~657 . . . . .

29 USC 6669 . . . . .

29 USC ~671 . . . . .

29 USC ~673 . . . . .

29 USC $675 . . . . .

30 USC $811 . . . . .

30 USC ~813 . . . . .

30 USC ~843 . . . . .

30 USC ~936 . . . . .

30 Usc ~951 . . . . .

30 USC $958 . . . . .

42 USC ~218(c)(2) .

42 USC $218(d) . . .

42 USC ~218(e)(2) .

42 USC ~241(a) . . .

42 USC $241(b)(l) .

42 USC

~241(b), (2), (3) .

42 USC ~241 (b)(4).

42 USC ~242 . . . . .

42 USC ~242 note .

42 USC $242a . . . .

s

I

s

s

S/G

G

G

I

G

G/I

I

I

G

G

s

S/G

I

I

I

G

S/1

G

s

G/S

G

s

I

I

S/G

s

I

s

I

I

I

G

G

G

G

s

G

I

G

NIH (NIEHS)

OASH (OSH)

FDA (BF) & EPA

FDA (BF)

FDA (BD)

FDA (BD)

FDA (BVD)

FDA (BMD)

FDA (BMD)

FDA (BMD)

FDA (General)

FDA (BF)

ADAMHA (NIDA)

ADAMHA (NIDA)

ADAMHA (NIDA)

ADAMHA (NIDA)

ADAMHA (NIDA)

ADAMHA (NIDA)

ADAMHA (NIDA)

NIH (Fogarty International Center)

HSA (IHS)

HSA (IHS)

CDC (NIOSH) & DOL

CDC (NIOSH) & DOL

CDC (NIOSH)

CDC (NIOSH) & DOL

CDC (NIOSH) & DOL

CDC (NIOSH) & DOL

CDC (NIOSH) & DOL

CDC (NIOSH) & DOL

CDC (NIOSH)

CDC (NIOSH) & DOI

CDC (NIOSH)

ADAMHA (NIMH)

ADAMHA (NIAAA)

ADAMHA (NIDA)

OASH (General)

NIH (NCI)

NIH (Director’s Office)

NIH (NCI)

189

88

138

139

135

136

146

140

141

141

135

140

110

111

111

112

112

113

113

177

174, 175

175

126, 127

127, 128

129

129

129, 130

130, 131

132

133

133

133

134

115

109

114

81

178

176

178

ADAMHA (NIDA) & FDA (BD) & DEA 114, 137

ADAMHA (NIDA) 114

ADAMHA (NIDA) & (NIMH) &

FDA 115, 138
——....——

210 ● Part I]—Directory of Statutory Authorities

Index—continued

Type of

U.S. Code authority Administering agency Page

Citation (Smcifk, General, Implied) number

42 USC ~242b (a-c)

42 USC $242b(e) . .

42 USC ~242c . . . .

42 USC $242k . . . .

42 USC ~2421 . . . . .

42 USC $242m(a). .

42 USC ~242m(g). .

42 USC ~242n . . . .

42 USC ~2420 . . . .

42 USC $242p . . . .

42 USC $246(d) . . .

42 USC $246(g) . . .

42 USC

$247a note . . . . .

42 USC $247b . . . .

42 USC $247b-2 . . .

42 USC S247C . . . .

42 USC ~247d . . . .

42 USC $248 . . . . .

42 USC $254c . . . .

42 USC ~254e . . . .

42 USC ~254f . . . . .

42 USC $254i. . . . .

42 USC ~256 . . . . .

42 USC ~262 . . . . .

42 USC ~263a . . . .

42 USC $263b . . . .

42 USC ~263d . . . .

42 USC ~263e . . . .

42 USC $263i. . . . .

42 USC ~2631 . . . . .

42 USC $268 . . . . .

42 USC ~280b . . . .

42 USC ~280b-5 . . .

42 USC ~280b-9 . . .

42 USC ~282 . . . . .

42 USC $284 . . . . .

42 USC ~285 . . . . .

42 USC $287a . . . .

42 USC ~287b . . . .

42 USC $287g . . . .

42 USC ~287h . . . .

s

s

G

s

G

1/ s

I

G

I

s

s

s

s

G

G

s

G / S

I

1/S

I

s

1/S

G

I

G

I

G

s

G

s

G

I

I

I

G

I

s

G

G / I

I

G

OASH (NCHS) &

(NCHSR) & (NCHCT)

OASH (NCHS)

OASH (NCHSR)

OASH (NCHS)

CDC

OASH (NCHS) & (NCHSR)

OASH (NCHSR)

OASH (NCHCT)

OASH (General)

OASH (NCHS)

CDC tk HSA (BCHS)

ADAMHA (NIMH)

NIH (NIEHS)

CDC & HSA (BCHS)

OASH (OSH) & ADAMHA

(NIAAA)

CDC

HSA (BCHS)

HSA (BMS)

HSA (BCHS)

HRA (BHM) & HSA (BCHS)

HRA (BHM) & HSA (BCHS)

HRA (BHM) & HSA (BCHS)

HSA (BCHS)

FDA (BOB)

HCFA (HSQB) & CDC

FDA (BRH)

FDA (BRH)

FDA (BRH)

FDA (BRH)

FDA (BRH)

CDC

NIH (NLM)

NIH (NLM)

NIH (NLM)

NIH (NCI)

NIH (NCI)

NIH (NCI

NIH (NHLBI)

NIH (NHLBI)

NIH (NHLBI)

NIH (NHLBI)

88, 91, 94

95

92

97

119

93, 101

93

90

81

102

119, 169

116

189

120, 170

88, 109

121

166

174

159

148, 167

149, 168

149, 168

163

135

121, 199

142

142

143

144

144, 145

122

191

192

192

179

179

179

181

181, 182 “

183

183
Index “ 211

Index—continued

Typeof

U.S. Code authority Administering agency Page

Citation (Specific, General, Implied) number

42 USC ~288a . . . .

42 USC ~288b . . . .

42 USC ~288c . . . .

42 USC ~289a(a) . .

42 USC $289a(b) . .

42 USC $289c . . . .

42 USC $289c-1 . . .

42 USC ~289c-2 . . .

42 USC $289c-3a . .

42 USC $289c-5 . . .

42 USC ~289c-6 . . .

42 USC ~289c-7 . . .

42 USC $289d . . . .

42 USC ~289e . . . .

42 USC $289i . . . . .

42 USC $289k . . . .

42 USC ~289k-1 . . .

42 USC $289k-4 ., .

42 USC $291d . . . .

42 USC ~292h . . . .

42 USC ~295g-1 . . .

42 USC ~295h-2 . . .

42 USC ~295h-4 . . .

42 USC ~296 note .

42 USC $300a-2 . . .

42 USC $300a-3 . . .

42 USC ~300a-6a . .

42 USC ~300a-26 . .

42 USC ~300b . . . .

42 USC ~300b-1 . . .

42 USC $300b-6 . . .

42 USC ~300c-11 . .

42 USC $300d-4 . . .

42 USC $300d-5 . . .

42 USC $300d-7 . . .

42 USC $300d-9 . . .

42 USC ~300d-21 . .

42 USC $300e , . . .

42 USC ~300e-14 . .

42 USC ~3001-2 . . .

42 USC ~300m-1 . .

42 USC ~300m-2 . .

42 USC $300m-3 . .

42 USC ~300n-2. . .

G

G

I

I

I

I

G

G

G/I

s

G/I

G

I/G

I

I

G

I

G/S/I

S/G

s

G

s

s

s

G

I

s

s

G

G

s

G

G

s

s

I

G

s

G

S/I/G

G/I

I

I

S/r

NIH (NIDR)

NIH (NIDR)

NIH (NIDR)

NIH (NIAMDD) & (NINCDS)

NIH (GeneraI)

NIH (General)

NIH (NIAMDD)

NIH (NIAMDD)

NIH (NIAMDD)

NIH (NIAMDD)

NIH (NIAMDD)

NIH (NIAMDD)

NIH (NICHD)

NIH (NIEHS)

NIH (NEI)

NIH (NEI)

ADAMHA (NIMH)

NIH (NIA)

HRA (BHF)

OASH (NCHS) & HRA (BHM)

HRA (BHM)

OASH (NCHS) & HRA (BHM)

OASH (NCHS) & HRA (BHM)

HRA (BHM)

HSA (BCHS) & NIH (NICHD)

HSA (BCHS)

HSA (BCHS)

OASH (OAPP)

HSA (BCHS)

HSA (BCHS) & NIH (NIGMS)

CDC & HSA (BCHS)

HSA (BCHS)

HSA (BMS)

HSA (BMS)

HSA (BMS)

HSA (BMS)

HSA (BMS) & NIH (NIGMS)

OASH (HMO)

OASH (HMO)

OASH (NCHS) & HRA (BHP)

OASH (NCHS) & HRA (BHP)

HRA (BHP)

HRA (BHP)

HRA (BHP)

188

188

188

184, 191

176

177

184

185

185

186

186

187

187

190

180

180

116

183, 184

147

102, 150

152

104, 152

104, 152

153

160, 187

160

160

82

161

161, 190

122, 162

162

172

172

173

173

174, 190

82

82

105, 154, 155

106, 156

156

157

157, 193
— .

212 ● Part 11—Directory of Statutory Authorities

Index—continued

Type of

U.S. Code authority Administering agency Page

Citation (Specific, General, Implied) number

42 USC §300n-2(d).

42 USC §300n-4. . .

42 USC §3000-2 . . .

42 USC §300u . . . .

42 USC §300u-l(a).

42 USC §300u-l(b).

42 USC §300u-3 . . .

42 USC §300u-4 . . .

42 USC §300u-5 . . .

42 USC §300u-8 . . .

42 USC §705 . . . . .

42 USC §712 . . . . .

42 USC §713 . . . . .

42 USC §1306 . . . .

42 USC §1312 . . . .

42 USC §1320a . . .

42 USC y§1320c-4 . .

42 USC §1320c-5 . .

42 USC §1320c-12 .

42 USC §1320c-20 .

42 USC §1320c-21 .

42 USC §1395b-1 . .

42 USC §¦395h . . .

42 USC §1395u . . .

42 USC §1395x . . .

42 USC ¦§1395x

note 1. . . . . . . . . . .

42 USC §1395x

note 2. . . . . . . . . . .

42 USC §1395kk . .

42 USC §1395/1 . . .

42 USC §1395rr . . .

42 USC §1396a . . .

42 USC §1396b . . .

42 USC §1396g . . .

42 USC §2689 . . . .

42 USC §2689e. . . .

42 USC §2689q . . .

42 USC §4551 . . . .

42 USC §4552 . . . .

42 USC §4585 . . . .

42 USC §4821 . . . .

42 USC §7454 . . . .

s

s

s

G/I

G/I

s

I/G

1/S

I/G

G/I

G

I

G

I

G

s

G

S/1

G

G

s

I

G

G

s

I

I

G

G

G/S

G/S

I

I

s

s

S/1

I/G

I

s

G

I

HCFA (OPPR)

HRA (BHP)

HRA (BHF)

OASH (ODPHP) & CDC

OASH (ODPHP) & CDC

OASH (ODPHP) & CDC

OASH (ODPHP) & CDC

OASH (ODPHP) & CDC

OASH (ODPHP) & CDC

OASH (ODPHP)

HSA (BCHS)

HSA (BCHS)

HSA (BCHS)

HCFA (Medicare)& (Medicaid)

& (HSQB)

HSA (BCHS)

OASH (NCHS) & HCFA

HCFA (HSQB)

HCFA (HSQB)

HCFA (HSQB)

HCFA (HSQB)

HCFA (HSQB)

HCFA (OPPR)

HCFA (Medicare)

HCFA (Medicare)

HCFA (OPPR)

HCFA (OPPR)

HSA (BCHS)

HCFA (Medicare)

HCFA (Medicare)

HCFA (Medicare)

HCFA (Medicaid)

HCFA (Medicaid)

HCFA (Medicaid)

ADAMHA (NIMH)

ADAMHA (NIMH)

ADAMHA (NIMH)

ADAMHA (NIAAA)

ADAMHA (NIAAA)

ADAMHA (NIAAA)

CDC & HUD

NIH (NCI) & (NIEHS) & EPA

193

158

147

83, 123

84, 123

124

85, 124

86, 125

86,87

87

165

165

166

199,202,204

164

107, 194

200,201

200

201

201

201

196

204

204

198

198

171

205

205

206

202

203

203

116

117

117,118

109

110

110

126

180, 189

U. S. GOVERNMENT PRINTING OFFICE : 1979 0-46-643