An Act to amend the Public Health Service Act to revise and extend the authorities under that Act relating to health services research and health statistics and to establish a National Center for Health Care Technology, and for other purposes.
PL 95-623 (S.2466), enacted 11/09/1978

PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. SMS 
Public Law 95-623 
95th Congress 
An Act 
Health Services 
Research, Health 
Statistics, and 
Health Gire 
Technology Act 
of 1978. 
42 u s e 201 note. 
42 u s e 201 note. 
42 u s e 242m. 
To amend the Public Health Service Act to revise and extend the authorities 
Nov. 9, 1978 
under that Act relating to health services research and health statistics and 
[S. 2466] 
to establish a National Center for Health Care Technology, and for other 
purposes. 
Be it encLcted hy the Senate and House of Representatives of the 
United States of America in Congress assembled, 
SHORT TITLE, REFERENCE TO ACT 
SECTION 1. (a) This Act may be cited as the "Health Services 
Kesearch, Health Statistics, and Health Care Technology Act of 
1978". 
(b) Whenever in this Act (other than in sections 12 and 13) an 
amendment or repeal is expressed in terms of an amendment to, or 
repeal of, a section or other provision, the reference shall be considered 
to be made to a section or other provision of the Public Health Service 
Act. 
EXTENSION OF AUTHORIZATIONS 
SEC. 2, (a) Section 308 (i) (1) is amended— 
(1) in the first sentence (A) by striking out "and" after "1976,", 
and (B) by inserting before the period a comma and the follow-
ing: "$35,000,000 for the fiscal year ending September 30, 1979, 
$40,000,000 for the fiscal year ending September 30, 1980, and 
$45,000,000 for the fiscal year ending September 30,1981"; and 
(2) by striking out the second sentence and inserting in lieu 
thereof the following: "At least 20 per centum of the amount 
appropriated under the preceding sentence for any fiscal year or 
$6,000,000, whichever is less, shall be available only for health 
services research, evaluation and demonstration activities directly 
undertaken through the National Center for Health Services 
Research, and at least 5 per centum of such amount or $1,000,000, 
whichever is less, shall be available only for dissemination activ-
ities directly undertaken through such Center.". 
(b) Section 308 (i) (2) is amended (1) by inserting "and epidemio-
logical" after "statistical", (2) by striking out "and" after "1976,", 
and (3) by inserting before the period a comma and the following: 
"$50,000,000 for the fiscal year ending September 30,1979, $65,000,000 
for the fiscal year ending September 30, 1980, and $70,000,000 for the 
fiscal year ending September 30,1981". 
GENERAL AUTHORITY 
SEC. 3. (a) Subsection (a) of section 304 is amended to read as 42 USe 242b. 
follows: 
"(a)(1) The Secretary, acting through the National Center for 
Health Services Eesearch, 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 effective-
ness, efficiency, and quality of health services m the United States. 
92 STAT. 3444 
PUBLIC LAW 95-623—NOV. 9, 1978 
" (2) In carrying out paragraph (1), the Secretary shall give appro-
priate emphasis to research, demonstrations, evaluations, and statisti-
cal 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 statis-
tical 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 con-
cerning 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. 
Training 
"(3) The Secretary shall, through the National Center for Health 
programs. 
Services Research, the National Center for Health Statistics, and the 
National Center for Health Care Technology and using National 
Research Service Awards and other appropriate authorities, undertake 
and support training programs to provide for an expanded and con-
tinuing supply of individuals qualified to perform the research, evalua-
tion, and demonstration projects set forth in sections 305, 306, and 
42 use 242c, 
309.". 
242k. 
(b) Paragraph (1) of section 304(b) is amended (1) by inserting ", 
Post, p. 3447. 
when appropriate," before "enter into contracts", and (2) by striking 
42 use 242b. 
Q^^ ^11 after "entities and individuals" the second time it appears and 
inserting in lieu thereof a period. 
(c) Subsection (c) of section 304 is amended to read as follows: 
"(c) (1) The Secretary shall coordinate all health services research, 
evaluations, and demonstrations, all health statistical and epidemio-
logical activities, and aill research, evaluations, and demonstrations 
respecting the assessment of health care technology undertaken and 
supported throug'h 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. 
4 
> 
"(2) The Secretary shall coordinate the health services research, 
evaluations, and demonstrations, the health statistical and (where 
appropriate) epidemiological actiAdties, and the research, evaluations, 
and demonstrations respecting the assessment of health care tech-
nology 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.". 
(d) Section 304(d) (3) is amended (1) by striking out "experts 
and", (2) by inserting "but in accordance with section 3109 of title 5, 
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3^145 
United States Code" after "advisable", and (3) by adding at the end 
the following: "The Secretary may for the purpose of carrying out the 
functions set forth in sections 305, 306, and 309, obtain (in accordance 
with section 3109 of title 5 of the United States Code, but without 
regard to the limitation in such section on the number of days or the 
period of service) for each of the centers the services of not more than 
fifteen experts who have appropriate scientific or professional quali-
fications.". 
(e) The heading for section 304 is amended to read as follows: 
42 use 242c, 
242k. 
Post, p. 3447. 
42 use 242b. 
GENERAL AUTHORITY RESPECTING RESEARCH, EVALUATIONS, AND DEMON-
STRATIONS IN HEALTH STATISTICS, HEALTH SERVICES AND HEALTH CARE 
TECHNOLOGY". 
NATIONAL CENTER FOR HEALTH SERVICES RESEARCH 
SEC 4. Subsection (b) of section 305 is amended— 
(1) by striking out "may undertake and support" and insert-
ing in lieu thereof "shall undertake and support"; 
(2) by striking out "construction," in paragraph (3); 
(3) striking "and" at the end of paragraph (2); 
(4) striking the period in paragraph (3) and inserting in lieu 
thereof ", and"; and 
; 
(5) adding at the end thereof the following new paragraph: 
" (4) the uses of computer science in health services delivery and 
medical information systems.". 
NATIONAL CENTER FOR HEALTH STATISTICS 
SEC. 5. (a) Subsection (b) of section 306 is amended (1) by striking 
out "may", (2) by inserting "shall" after "(1)" and after "(2)", (3) 
by striking out "and" at the end of paragraph (1), (4) by striking out 
the period at the end of paragraph (2) and inserting in lieu thereof 
a semicolon, and (5) by adding after paragraph (2) the following: 
"(3) may undertake and support (by grant or contract) epi-
demiological 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 arrange-
ments under which the entities will pay the cost of the service 
provided. 
Amounts appropriated to the Secretary from payments made under 
arrangements made under paragraph (4) shall be available to the 
Secretary for obligation until expended.". 
(b) Section 306 (c) is amended by— 
(1) inserting "and epidemiological" after "statistical" each 
place it occurs; and 
(2) striking "Labor and Public Welfare" and inserting in lieu 
thereof "Human Resources". 
(c) (1) Subsection (e) of section 306 is amended to read as follows: 
"(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; 
Cooperative 
Health Statistics 
System, 
establishment. 
92 STAT. 3446 
PUBLIC LAW 95-623—NOV. 9, 1978 
"(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 participating in the system produce uniform 
and timely data and assure appropriate access to such data.". 
42 use 242k. 
(2) Paragraph (4) (D) of subsection (i) of section 306 is amended 
by inserting before the semicolon the following: ", with respect to the 
Cooperative Health Statistics System established under subsection 
(e), and with respect to the standardized means for the collection of 
health information and statistics to be established by the Secretary 
under subsection (j) (1)". 
(d) The first sentence of subsection (f) of section 306 is amended by 
inserting ", acting through the Center," after "the Secretary". 
(e)(i) Section 306(i)(l) is amended by striking out "United 
States". 
(2) Paragraph (2) (A) of section 306 (i) is amended by inserting 
"health planning," after "health statistics,". 
(f) Section 306 is amended by redesignating subsection (i) as sub-
section (k) and by inserting after subsection (h) the following new 
subsections: 
" (i) The Center may provide to public and nonprofit private entities 
engaged in health planning activities technical assistance in the effec-
tive use in such activities of statistics collected or compiled by the 
Center. 
42 use 242b. 
"(j) In carrying out the requirements of section 304(c) and para-
graph (1) of subsection (e) of this section, the Secretary shall coordi-
nate 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) (1); 
"(3) after consultation with the National Committee on Vital 
and Health Statistics, establishing standards to assure the quality 
of health statistical and epidemiological data collection, process-
ing, 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) 
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3447 
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 imder 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 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.". 
NATIONAL CENTER FOR HEALTH CARE TECHNOLOGY; NATIONAL COUNCIL 
ON HEALTH CARE TECHNOLOGY 
SEC. 6. (a) Section 309 is amended— 
(1) by amending the section heading to read as follows: 
42 use 242m. 
"HEALTH CONFERENCES AND HEALTH EDUCATION INFORMATION' ; 
(2) by inserting " (a)" before "A conference"; and 
(3) by striking out "309" and inserting in lieu thereof "310". 42 USC 242,9. 
(b) Section 310 (as in effect before the date of the enactment of this 
Act) is amended— 
(1) by striking out the section heading; and 
(2) by striking out "SEC. 310." and inserting in lieu thereof 
"(b)". 
(c) Part A of title III is amended by adding after section 308 the 
following new section: 
"NATIONAL CENTER FOR HEALTH CARE TECHNOLOGY; NATIONAL COUNCIL 
ON HEALTH CARE TECHNOLOGY 
"SEC. 309. (a) There is established in the Department of Health, 
Education, and Welfare the National Center for Health Care Technol-
ogy (hereinafter in this section referred to as the 'Center') which shall 
be under the direction of a Director who shall be appointed by the Sec-
retary and supervised by the Assistant Secretary for Health (or such 
other officer of the Department as may be designated by the Secretary 
as the principal adviser to him for health programs). 
"(b) (1) The Secretary, acting through the Center, shall undertake 
and support (by grant or contract) assessments of health care tech-
nology. Such assessments shall take into account the safety, effective-
ness, 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, demonstra-
tions, 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. 
Establishment. 
42 USC 242ii. 
Grants and 
contracts. 
92 STAT. 3448 
PUBLIC LAW 95-623—NOV. 9, 1978 
Grants and 
contracts. 
42 u s e 242m. 
Limitations. 
Requirements. 
Review 
requirements for 
certain grants and 
contracts. 
" (3) The Secretary, acting through the Center, shall encourage and 
support (by grant or contract) research, evaluations, and demonstra-
tions 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 tech-
nology 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. 
"(5) The Center may make recommendations to the Secretary 
respecting health care technology issues in the administration of the 
laws under the Secretary's jurisdiction, including recommendations 
with respect to reimbursement policy. 
"(c) (1) The Secretary, acting through the Center, shall, by grant 
or contract, assist public and private nonprofit entities in meeting the 
costs of planning and establishing new centers, and operating existing 
and new centers, for assessments, multidisciplinary research, evalua-
tions, and demonstrations respecting the matters referred to in para-
graphs (1) and (2) of subsection (b). To the extent practicable, the 
Secretary shall take such actions, in accordance with the requirements 
of this subsection and section 308, to assure that three such centers sliall 
be operational by September 1,1981. 
"(2) (A) No grant or contract may be made under this subsection 
for planning and establishing a center unless the Secretary, acting 
through the Center, determines that when it is operational it will meet 
the requirements listed in subparagraph (B), and no payment shall 
be made under a grant or contract for operation of a center unless the 
center meets such requirements. 
"(B) Each center shall meet the following requirements: 
"(i) There shall be a full-time director of the center who pos-
sesses a demonstrated capacity for sustained productivity and 
leadership in assessments, research, demonstrations, and evalua-
tions respecting the matters referred to in paragraphs (1) and (2) 
of subsection (D), and there shall be such additional professional 
staff as may be appropriate. 
"(ii) The staff of the center shall have expertise in the various 
disciplines needed to conduct assessments, multidisciplinary 
research, evaluations and demonstrations respecting the matters 
referred to in paragraphs (1) and (2) of subsection (b). 
" (iii) The center shall be located within an established academic 
or research institution with departments and resources appro-
priate to the programs of the center. 
"(iv) Each center shall meet such additional requirements as 
the Secretary may by regulation prescribe. 
"(d) Any grant or contract under subsection (b) or (c), the direct 
cost of which will exceed $35,000, may be made or entered into only 
after appropriate review for scientific merit by peer review groups 
composed of experts in the relevant fields and only after the National 
Council on Health Care Technology has had an opportunity to review 
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3449 
National Council 
on Health Care 
Technology. 
Establishment. 
the project with respect to which the grant or contract is to be made 
or entered into. 
"(e) To assist in carrying out this section, the Secretary, acting 
through the Center, shall cooperate and consult with the National 
Institutes of Health, the Veterans' Administration, and any other 
interested Federal departments or agencies and with State and local 
health departments and agencies. 
"(f) (1) There is established the National Council on Health Care 
Technology (hereinafter in this subsection referred to as the 'Council'). 
The Council shall— 
"(A) advise the Secretary and the Director of the Center with 
respect to the performance of the functions prescribed by this 
section; 
"(B) review applications for grants and contracts under this 
section in excess of $35,000 and provide the Secretary its recom-
mendation respecting the approval of such applications; 
"(C) after consultation with appropriate public and private 
entities, advise the Secretary respecting the safety, efficacy, effec-
tiveness, cost effectiveness, and the social and economic impacts 
of particular health care technologies; 
"(D) after consultation with appropriate public and private 
entities, develop, when appropriate and to the extent practicable, 
exemplary standards, norms, and criteria concerning the use of 
particular health care technologies; and 
"(E) promptly publish, disseminate, and otherwise make avail-
able, through the National Library of Medicine, standards, norms, 
and criteria developed under subparagraph (D). 
" (2) The Council shall consist of— 
"(A) the Director of the National Institutes of Health, the 
Chief Medical Officer of the Veterans' Administration, the Assist-
ant Secretary for Health and Environment of the Department of 
Defense, the Chairman of the National Professional Standards 
Review Council, a member of the National Council on Health 
Planning and Development (established under section 1503), the 42 USC 300k-3 
Director of the Office of Science and Technology Policy, the head 
of the Food and Drug Administration (or the successor to such 
entity), the head of the Center for Disease Control (or the suc-
cessor to such entity), and the head of the Health Care Financing 
Administration (or the successor to such entity) who (or their 
designees') shall be ex officio members, and 
"(B) eighteen members appointed by the Secretary. 
The Secretary shall make his initial appointments to the Council 
within one hundred and twenty days of the date of the enactment of 
this section. Six of the appointed members shall be selected from indi-
viduals who are distinguished in the fields of medicine, engineering, 
or science (including social science). Of such six members, at least two 
shall be selected from individuals who are representatives of business 
entities engaged in the development or production of health care tech-
nology. Two of the appointed members shall be physicians, two of 
the appointed members shall be selected from individuals who are 
hospital administrators, two of the appointed members shall be selected 
from individuals who are distinguished in the field of economics, two 
of the appointed members shall be selected from individuals who are 
distinguisihed in the field of law, one of the appointed members shall be 
selected from individuals who are distinguished in the field of ethics, 
Membership. 
39-194 O—80—pt. 3 
52 : QL3 
92 STAT. 3450 
PUBLIC LAW 95-623—NOV. 9, 1978 
Council 
members, terms 
of office. 
Compensation. 
5 u s e 5332 note. 
"Health care 
technology." 
Appropriation 
authorization. 
and three of the appointed members shall be selected from members 
of the general public who represent the interests of consumers of health 
care. 
"(3) (A) Each appointed member of the Council shall be appointed 
for a term of four years, except that— 
"(i) any member appointed to fill a vacancy occurring prior 
to the expiration of the term for which his predecessor was 
appointed shall be appointed for the remainder of such term; and 
(ii) of the members first appointed after the date of the enact-
ment of this section, four shall be appointed for a term of four 
years, four shall be appointed for a term of three years, four shall 
be appointed for a term of two years, and four s'haill be appointed 
for a term of one year, as designated by the Secretary at the time 
of appointment. 
Appointed members may serve after the expiration of their terms until 
their successors have taken office. 
"(B) Members of the Council who are not officers or employees of 
the United States shall receive for each day they are engaged in the 
performance of the functions of the Council compensation at rates not 
to exceed the daily equivalent of the annual rate in effect for grade 
GS-18 of the General Schedule, including traveltime; and all mem-
bers, while so serving away from their homes or regular places of busi-
ness, may be allowed travel expenses, including per diem in lieu of 
subsistence, in the same manner as such expenses are authorized by 
section 5703 of title 5, United States Code, for persons in the Govern-
ment service employed intermittently. 
"(4) The Council shall annually elect one of its appointed members 
to serve as Chairman until the next election. 
" (5) The Council shall meet at the call of the Chairman, but not less 
often than four times a year. 
" (6) The Director of the Center shall (1) designate a member of the 
staff of the Center to act as Executive Secretary of the Council, and 
(2) make available to the Council such staff, information, and other 
assistance as it may require to carry out its functions. 
"(7) The Council shall be subject to the Federal Advisory Commit-
tee Act, except that the Council shall terminate September 30,1981. 
"(g) The Director of the National Institutes of Health, the head of 
the Food and Drug Administration (or the successor to such entity), 
the head of the Center for Disease Control (or the successor to such 
entity), the head of the Health Care Financing Administration (or 
the successor to such entity), and the head of any other entity of the 
Department of Health, Education, and Welfare designated by the 
Secretary shall each make available annually to the Center and the 
Council a listing of all health care technologies of which he is aware 
that are under development and appear likely to be used in the practice 
of medicine. 
"(h) For purposes of this section, the term 'health care technology' 
means any discrete and identifiable regimen or modality used to diag-
nose and treat illness, prevent disease, maintain patient well-being, 
or facilitate the provision of health care services. 
"(i) There are authorized to be appropriated to carry out this sec-
tion $15,000,000 for the fiscal vear ending September 30, 1979, 
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3451 
$25,000,000 for the fiscal year ending September 30, 1980, and 
$33,000,000 for the fiscal year ending September 30,1981. Not less than 
15 per centum of the amount appropriated for the fiscal year ending 
September 30, 1981, shall be obligated for assessments, research, 
demonstrations, and evaluations directly undertaken through the Cen-
ter under paragraph (1) or (2) of subsection (b).". 
(d) (1) Subsection (a) (1) of section 308 is amended (A) by insert- 42 USC 242m. 
ing "and section 309" after "307'*, and (B) by striking out "health 
statistics" and inserting in lieu thereof ", health statistics, and health 
care technology". 
(2) Subsection (b) (1) of such section is amended by striking out 
"or 307" and inserting in lieu thereof "307, or 309". 
(3) Subsection (d) of such section is amended (A) by striking out 
"or 307" and inserting in lieu thereof "307, or 309", and (B) by insert-
ing "or epidemiological" after "statistical" in clause (1). 
(4) Subsection (e) of such section is amended by striking out "or 
307" each place it occurs and inserting in lieu thereof "307, or 309". 
(5) Subsection (f) of such section is amended by striking out "or 
306" and inserting in lieu thereof "306, or 309". 
(6) Subsection (g) (2) of such section is amended by striking out 
"and 306" and inserting in lieu thereof "306, and 309". 
(7) Subsection (h) (1) of such section is amended by striking out 
"or 306" each place it occurs and inserting in lieu thereof "306, or 309". 
(8) The heading for such section is amended by striking out "AND 
30 7" and inserting in lieu thereof "so?, AND 309". 
STUDY OF COSTS OF DISEASES AND ADVERSE EFFECTS ON HUMANS WHICH 
ARE ENVIRONMENTALLY RELATED 
SEC. 7. Section 304 (as amended by section 3(d)) is amended by 42 USC 242b. 
adding at the end the following: 
"(e) (1) The Secretary and the National Academy of Sciences (act-
ing 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 Con-
sumer Product Safety Commission, the Council of Economic Advisers, 
the Council on Wage and Price Stability, the Council on Environ-
mental 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), 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, responsible for causing, con-
tributing to, increasing susceptibility to, or aggravating human 
diseases and adverse effects on humans; 
"(B) identify each such disease and adverse effect on humans 
92 STAT. 3452 
PUBLIC LAW 95-623—NOV. 9, 1978 
Reports to 
congressional 
committees. 
"Health costs of 
pollution and other 
environmental 
conditions." 
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 con-
dition which can be traced to a specific type of source; 
"(D) ascertain (i) the extent to which the pollutants and con-
ditions identified under subparagraph (A) are, or may reasonably 
be anticipated to be, responsible, individually or collectively, for 
causing, contributing to, increasing susceptibility to, or aggra-
vating 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). 
"(2) The Secretary shall enter into appropriate arrangements with 
the Academy under which the Secretary shall be responsible for 
expenses incurred by the Academy in connection with the study pre-
scribed by paragraph (1). 
"(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 limitations, (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 (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 (1) 
(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 pollu-
tion 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 rehabilita-
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3453 
tion 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 pi'o-
grams 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.". 
42 use 1395, 
1396. 
Plan. 
Submittal to 
Congress. 
Guidelines. 
INFORMATION 
ON 
EFFECTS 
ON 
HEALTH 
OF THE 
ENVIRONMENT 
AND 
EMPLOYMENT CONDITIONS 
SEC. 8. (a) Section f306 (as amended by section 5) is amended by 42 USC 242k. 
inserting after subsection (k) the following new subsection: 
"(1) (1) The Secretary, acting through the Center, shall develop a 
plan for the collection and coordination of statistical and epidemiologi-
cal 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 the date of the enactment of this 
subsection, guidelines for the collection, compilation, analysis, pub-
lication, 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. Guidelines 
established under this subparagraph shall not (i) authorize or require 
the disclosure of any matter described in section 552(b) (6) of title 5, 
United States Code, and (ii) authorize or require the disclosure of any 
statistics or other information which is exempt from disclosure piu'-
suant to subsection (a) of section 552 of title 5, United States Code, by 
reason of subsection (b) (4) of such section. 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 admin-
istration of laws relating to the protection of the public health 
and safety or the environment; 
"(iii) to encourage the more effective use by executive depart-
ments of such studies, statistics, and information; 
"(iv) to improve the statistical validity and reliability of such 
studies, statistics, and information; and 
92 STAT. 3454 
PUBLIC LAW 95-623—NOV. 9, 1978 
Guidelines, 
compliance. 
Exemptions. 
'Guidelines. 
Study. 
Report to 
Congress. 
"(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. 
"(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 admin-
istering laws under their jurisdiction relating to environmental health 
protection or the safety and health of employees. 
"(E) (i) Each executive department shall comply with the substan-
tive and procedural requirements of the guidelines. 
"(ii) The President shall by Executive order require each executive 
department to comply with requests, made in accordance with the 
guidelines, by the Secretary, the Administrator of the Environmental 
Piotection Agency, the Consumer Product Safety Commission, or the 
Secretary of Labor for statistics and information. 
"(iii) The President may by Executive order exempt any executive 
department from compliance with a requirement of the guidelines 
respecting specific statistics or other information if the President 
determines that the exemption is necessary in the interest of national 
security. 
"(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. 
"(G) For purposes of this paragraph, the term 'guidelines' means 
the guidelines, either as initially established or as revised, in effect 
under this paragraph. 
" (3) The Secretary, acting through the Center, shall conduct a study 
of the issues respecting, and the recommendations for, establishing a 
Federal system to assist, in a manner designed to avoid invasion of 
personal privacy, Federal, State, and other entities in locating individ-
uals who have been or many have been exposed to hazardous substances 
to determine the effect on their health of such exposure and to assist 
them in obtaining appropriate medical care and treatment. In con-
ducting such study, the Secretary may consult with any public and 
private entity which it determines has expertise on any matter to be 
considered in the study. Not later than one year after the date of the 
enactment of this subsection, the Secretary shall complete the study and 
report to the Congress the results of the study and any recommenda-
tions for legislation or administrative action. 
"(4) In carrying out paragraphs (1), (2), and (3), the Secretary 
shall consult with and take into consideration any recommendations 
of the Task Force on Environmental Cancer and Heart and Lung 
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3455 
Disease, the Administrator of the Environmental Protection Agency, 
the Secretary of Labor, the Consumer Product Safety Commission, the 
Council on Environmental Quality, the National Committee on Vital 
and Health Statistics, and the National Academj of Sciences (includ-
ing the Institute of Medicine and any other unit of the Academy).". 
(b) The first sentence of subsection (d) of section 308 is amended 42 USC 242m. 
by inserting after "unless authorized" the following: "by guidelines 
in effect under section 306(1) (2) or". 
42 USC 242k. 
TASK FORCE ON ENVIRONMENTAL CANCER AND HEART AND LUNG DISEASE 
SEC. 9. The Director of the National Center for Health Statistics 42 USC 4362a. 
and the head of the Center for Disease Control (or the successor to 
such entity) shall each serve as members of the Task Force on Envi-
ronmental Cancer and Heart and Lung Disease established under sec-
tion 402 of Public Law 95-95. 
42 USC 4362. 
MINE WORKERS STUDY 
SEC. 10. The Secretary, acting through the National Center for 
Health Services Research, shall arrange for the conduct of a study to 
evaluate the impact upon the utilization of health services by and the 
health status of members of the United Mine Workers and their 
dependents as a result of changes in the United Mine Workers' collec-
tive-bargaining agreements of March 1978, that require copayments 
for health services. Such study and a report thereon shall be completed 
and submitted to the Secretary, the Committee on Human Resources, 
the Committee on Appropriations, and the Committee on Finance of 
the Senate, and the Committee on Ways and Means, the Committee on 
Appropriations, and the Committee on Interstate and Foreign Com-
merce of the House of Representatives no later than thirty months 
after the date of enactment of this section. Not more than $1,000,000 
of the sums authorized to be appropriated for health services research, 
evaluation, and demonstration activities by section 308(i) (1) of the 
Public Health Service Act shall be made available for such study. 
42 USC 242m 
note. 
Report to 
congressional 
committees. 
AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT 
SEC 11. (a) Subsection (g) of section 208 is amended (1) by strik- 42 USC 210. 
ing out "one hundred and fifty-five" and inserting in lieu thereof "one 
hundred and seventy-nine", (2) by striking out "and not less than" 
and inserting in lieu thereof ", not less than", and (3) by inserting 
after "alcoholism," the following: "not less than ten shall be for the 
National Center for Health Services Research, not less than twelve 
shall be for the National Center for Health Statistics, and not less 
than seven shall be for the National Center for Health Care 
Technology,". 
^b) Part K of title I I I is repealed. 
Repeal. 
(c) Section 453 is amended by adding at the end the following: 42 USC 280c. 
"The Secretary, through the Institute, may, effective October 1,1978, 42 USC 289k. 
and without regard to section 405, carry out a program of grants for 42 USC 285. 
public and nonprofit private vision research facilities.". 
(d) (1) Section 472(a) (1) (A) is amended— 
42 USC 289/-1. 
92 STAT. 3456 
PUBLIC LAW 95-623—NOV. 9, 1978 
42 use 289/-1. 
42 use 219. 
(A) by striking out "and" at the end of clause (iii), 
(B) by redesignating clause (iv) as clause (vii), 
(C) by inserting after clause (iii) the following: 
"(iv) research at the National Center for Health Services 
Research, the National Center for Health Statistics, and the 
National Center for Health Care Technology, 
"(v) training at such Centers to undertake such research, 
"(vi) research on the matters set forth in section 304(a) 
(2) at public institutions and at nonprofit private institu-
tions, and", and 
(D) by striking out "such research" in clause (vii) (as so 
redesignated) and inserting in lieu thereof "biomedical and 
behavioral research and the research described in clause (vi)". 
(2) Section 472(a)(1)(B) is amended by striking out "such 
research" and inserting in lieu thereof "biomedical and behavioral 
research and the research described in subparagraph (A) (vi)". 
(e) Title V is amended by adding at the end the following: 
u 
42 u s e 229c. 
Record 
maintenance. 
42 u s e 292e. 
Biennial financial 
audit. 
Waiver. 
42 u s e 295f-l. 
CONTRACT AUTHORITY 
"SEC. 514. The authority of the Secretary to enter into contracts 
under this Act shall be effective for any fiscal year only to such extent 
or in such amounts as are provided in advance by appropriation 
Acts.". 
(f)(1) The second sentence of subsection (a) of section 705 is 
amended to read as follows: "Such records shall include records which 
fully disclose (A) the amount and disposition by such entity of the 
funds paid to it under such grant, loan, loan guarantee, interest sub-
sidy, or contract, (B) the total cost of the project or undertaking for 
which such grant, loan, loan guarantee, interest subsidy, or contract is 
made, (C) the amount of that portion of the cost of the project or 
undertaking received by or allocated to such entity from other sources, 
and (D) such other records as will facilitate an audit conducted in 
accordance with generally accepted auditing standards.". 
(2) Subsection (b) of section 705 is amended to read as follows: 
"(b) Each entity which received a grant or entered into a contract 
under this title shall provide for a biennial financial audit of any 
books, accounts, financial records, files, and other papers and property 
which relate to the disposition or use of the funds received under such 
grant or contract and such other funds received by or allocated to the 
project or undertaking for which such grant or contract was made. 
For purposes of assuring accurate, current, and complete disclosure 
of the disposition or use of the funds received, each such audit shall be 
conducted in accordance with such requirements concerning the 
individual or agency which conducts the audit, and such standards 
applicable to the performance of the audit, as the Secretary may by 
regulation provide. A report of each such audit shall be filed with 
the Secretary at such time and in such manner as he may require.", 
(g) Section 771(d) is amended by adding at the end the following: 
"(5) The Secretary may waive (in whole or in part) application to 
a school of dentistry of the requirement of any paragraph of this 
subsection if the Secretary determines, after receiving the written 
recommendation of the appropriate accreditation body or bodies 
PUBLIC LAW 95-623—NOV. 9, 1978 
92 STAT. 3457 
(approved for such purpose by the Commissioner of Education) that 
compliance by such school with such requirement will prevent it from 
maintaining its accreditation.". 
HEALTH PROFESSIONS REPORTS AND PROGRAMS 
SEC. 12. (a) Section 708(d) of the Public Health Service Act is 42 USC 292h. 
amended (1) by striking out "not later than September 1 of each 
year", and (2) by inserting at the end the following: "Such report 
shall be submitted biennially, and the first such report shall be due 
not later than October 1,1979.". 
(b) Section 709(b) of such Act is amended by striking out "Janu- 42 USC 292i. 
ary 1, 1979" and inserting in lieu thereof "February 1,1980". 
(c) Section 751 (i) of such Act is amended by striking out "Decem- 42 USC 294t. 
ber" and inserting in lieu thereof "March". 
(d) Section 771(b) (2) (B) of such Act is amended by striking out 42 USC 295f-l. 
"45 days after the date for which the determination is made" and 
inserting in lieu thereof "the first December 31 occurring after the date 
for which the determination is made". 
(e) Section 782(c) of such Act is amended by striking out "Sep- 42 USC 295g-2. 
tember 30, 1979" and inserting in lieu thereof "March 1, 1980". 
(f) Section 788(b) (6) of such Act is amended by striking out "Sep- 42 USC 295g-8. 
tember 30, 1978" and inserting in lieu thereof "October 1, 1979". 
(g) Section 793(c) of such Act is amended (1) by striking out 42 USC 295h-2. 
"annually" and inserting in lieu thereof "biennially", and (2) by 
striking out "December 1, 1978" and inserting in lieu thereof "Octo-
ber 1,1979". 
(h) Section 951(b) of the Nurse Training Act of 1975 is amended 42 USC 296 note, 
by striking out "Not later than February 1, 1977, and February 1 of 
each succeeding year" and inserting in lieu thereof "Not later than 
October 1,1979, and October 1 of each odd-numbered year thereafter". 
(i)(l) Section 702(d) of the Health Professions Educational 
Assistance Act of 1976 is amended by striking out "not later than two 42 USC 295h-4 
years after the date of enactment of this Act" and inserting in lieu note, 
thereof "not later than October 1,1979". 
(2) Section 903(a)(2) of the Health Professions Educational 42 USC 292h 
Assistance Act of 1976 is amended by striking out "January 1, 1979" note, 
and inserting in lieu thereof "April 1,1979". 
(j) Section 772(e) of the Public Health Service Act is amended by 42 USC 295f-2. 
inserting before the period a comma and the following: "except that 
a student Avho, for other than academic reasons, withdraws from a year 
class before the end of an academic year or does not complete an aca-
demic year shall not be considered as having been enrolled in a year 
class in that academic year". 
MISCELLANEOUS 
SEC. 13. (a)(1) Section 111(h) (42 U.S.C. 7411) of the Act of 
July 14,1955, as amended by Public Law 95-95, is amended by adding 
the following at the end thereof: 
" (5) Any design, equipment, work practice, or operational standard, 
or any combination thereof, described in this subsection shall be treated 
as a standard of performance for purposes of the provisions of this 
Act (other than the provisions of subsection (a) and this subsection).". 
92 STAT. 3458 
PUBLIC LAW 95-623—NOV. 9, 1978 
(2) Subsections (d) (1) (A) and (g) (4) (B) of such section are each 
amended by striking out "under suosection (b)" and inserting in lieu 
thereof "under this section". 
(3) Subsection (j) of such section is amended by striking out "sub-
section (b) of" in paragraphs (1) (A) and (2) (A) thereoiT 
(b) Section 112(e) of such Act (42 U.S.C. 7412) is amended by 
'' 
adding the following at the end thereof: 
" (5) Any design, equipment, work practice, or operational standard, 
or any combination thereof, described in this subsection shall be treated 
as an emission standard for purposes of the provisions of this Act 
(other than the provisions of this subsection)." 
(c) Section 117(c) (3) of such Act (42 U.S.C. 7417) is amended by 
striking out "(b) (1) (B)" in each place it appears. 
(d) Section 317(a) (1) of such Act (42 U.S.C. 7617) is amended by 
striking out "(b)". 
Approved November 9, 1978. 
LEGISLATIVE HISTORY: 
HOUSE REPORTS: No. 95-1190 accompanying H.R. 12584 (Comm. on Interstate and 
Foreign Commerce) and No. 95-1783 (Comm. of Conference). 
SENATE REPORT No. 95-839 (Comm. on Human Resources). 
CONGRESSIONAL RECORD, Vol. 124 (1978): 
June 26, considered and failed of passage in Senate. 
Aug. 9, considered and passed Senate. 
Sept. 25, H.R. 12584 considered and passed House; passage vacated, and 
S. 2466, amended, passed in lieu. 
Oct. 13, House agreed to conference report. 
Oct. 15, Senate agreed to conference report.