An Act to amend the Community Mental Health Centers Act to revise and extend the programs under that Act, to amend the Public Health Service Act to revise and extend the programs of assistance for libraries of medicine, the programs of the National Heart, Lung, and Blood Institute, and of the National Cancer Institute, and the program for National Research Service Awards, to establish the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, and for other purposes.
PL 95-622 (S.2450), enacted 11/09/1978

92 STAT. 3412 
PUBLIC LAW 95-622—NOV. 9, 1978 
Public Law 95-622 
95th Congress 
Nov. 9, 1978 
[S. 2450] 
Community 
Mental Health 
Centers Act, 
amendments. 
Community 
Mental Health 
Centers 
Extension Act of 
1978. 
42 u s e 2689 
note. 
42 use 2689 
note. 
42 u s e 2689a. 
42 u s e 2689b. 
42 u s e 2689c. 
42 u s e 2689d. 
42 u s e 2689g. 
42 u s e 2689h. 
42 u s e 2689q. 
An Act 
To amend the Community Mental Health Centers Act to revise and extend the 
programs under that Act, to amend the Public Health Service Act to revise and 
extend the programs of assistance for libraries of medicine, the programs of 
the National Heart, Lung, and Blood Institute, and of the National Cancer 
Institute, and the program for National Research Service Awards, to establish 
the President's Commission for the Study of Ethical Problems in Medicine and 
Biomedical and Behavioral Research, and for other purposes. 
Be it enacted hy the Senate and House of Representatives of the 
United States of America in Congress assembled, 
TITLE I—COMMUNITY MENTAL HEALTH CENTERS 
EXTENSION 
SHORT T I T L E : REFERENCE TO ACT 
SEC. 101. (a) This title may be cited as the "Community Mental 
Health Centers Extension Act of 1978". 
(b) Whenever in this title (other than in sections 109 and 110(d)) 
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 Community Mental 
Health Centers Act. 
, 
EXTENSIONS OF AUTHORIZATIONS 
SEC. 102. (a) Section 202(d) is amended by striking out "and" after 
"1977,", and inserting before the period a comma and the fol-
lowing : "$1,500,000 for the fiscal year ending September 30,1979, and 
$1,000,000 for the fiscal year ending September 30,1980". 
(b) (1) Section 203(d) (1) is amended by striking out "and" after 
"1977,", and inserting before the period a comma and the fol-
lowing : "$34,500,000 for the fiscal year ending September 30,1979, and 
$35,000,000 for the fiscal year ending September 30,1980". 
(2) Section 203(d) (2) is amended (A) by striking out "1978" and 
inserting in lieu thereof "1980", and (B) by striking out "two fiscal 
years" and inserting in lieu thereof "four fiscal years". 
(c) Section 204(c) is amended by striking out "and" after "1977,", 
and inserting before the period a comma and the following: 
"$20,000,000 for the fiscal year ending September 30, 1979, and 
$3,000,000 for the fiscal year ending September 30,1980". 
(d) Section 205(c) is amended by striking out "and" after "1977," 
and inserting before the period a comma and the following: 
"$30,000,000 for the fiscal year ending September 30, 1979, and 
$25,000,000 for the fiscal year ending September 30,1980". 
(e) Section 212(c) is amended by striking out "three" and inserting 
in lieu thereof "five". 
(f) Section 213 is amended by striking out "and" after "1977,", 
and inserting after "1978," the following: "and $25,000,000 for the 
fiscal year ending September 30,1979,". 
(g) Section 231(d) is amended by striking out "and" after "1977,", 
and inserting before the period a comma and the following: 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3413 
"$8,000,000 for the fiscal year ending September 30, 1979, and 
$9,000,000 for the fiscal year ending September 30,1980". 
USE OF UNOBLIGATED FUNDS 
SEC. 103. (a) (1) Subsection (b) (1) of section 203 is amended by Grants, 
adding before the period a comma and the following: "except that if 42 U
S
C 2689b. 
at the end of such period a center or entity has not obligated all the 
funds received by it under a grant, the center or entity may use the 
unobligated funds under the grant in the succeeding year for the same 
purposes for which such grant was made but only if the center or 
entity is eligible to receive a grant under subsection (a) for such 
succeeding year". 
(2) Subsection (c) of such section is amended by adding at the end 
the following: "The amount of a grant prescribed by paragraph (1) 
or (2) for a community mental health center for any year shall be 
reduced by the amount of unobligated funds from the preceding year 
which the center is authorized, under subsection (b) (1), to use in that 
year. If in a fiscal year the sum of (i) the total of State, local, and 
other funds, and of the fees, premiums, and third-party reimburse-
ments collected in that year, and (ii) the amount of the grant received 
under this section, by a center or entity exceeds its costs of operation 
for that year because such total collected was greater than expected, 
and if the center or entity is eligible to receive a grant under subsec-
tion (a) in the succeeding year, an adjustment in the amount of that 
grant shall be made in such a manner that the center or entity may 
retain such an amount (not to exceed 5 per centum of the amount by 
which such sum exceeded such costs) as the center or entity can 
demonstrate to the satisfaction of the Secretary will be used to enable 
the center or entity (I) to expand and improve its services, (II) to 
increase the number of persons (eligible to receive services from such 
a center or entity) it is able to serve, (III) to modernize its facilities, 
(IV) to improve the administration of its service programs, and (V) 
to establish a financial reserve for the purpose of offsetting the decrease 
in the percentage of Federal participation in program operations in 
future years.". 
(b)(1) Paragraph (1) (A) of subsection (e) of such section is 
amended (A) by striking out "and" at the end of clause (i), (B) by 
redesignating clause (ii) as clause (iii), and (C) by inserting after 
clause (i^ the following: 
"(ii) the amount prescribed for a grant under the applicable 
repealed section for an entity for any year shall be reduced by 
the amount of unobligated funds from the preceding fiscal year 
which the entity is authorized, under subparagraph (B) of this 
paragraph, to use in that year, and". 
(2) Paragraph (1) (B) of such subsection is amended by inserting 
before the period a comma and the following: "except that if at the 
end of any period for which such a grant is made an entity has not 
obligated all of the funds received by it under the grant, the entity 
may use the unobligated funds under such grant in the succeeding 
grant period for the same purposes for which such grant was made 
but only if the entity is eligible to receive such a grant for such grant 
period". 
(3) Paragraph (1) of such subsection is amended by adding at the 
end the following new sentence: "If in a fiscal year the sum of (I) the 
92 STAT. 3414 
PUBLIC LAW 95-622—NOV. 9, 1978 
total of State, local, and other funds, and of the fees, premiums, and 
third-party reimbursements collected in that year, and (II) the 
amount of the grant received under the applicable repealed section, 
by an entity exceeds its costs of operation for that year because such 
total collected was greater than expected, and if the entity is eligible 
, 
to receive a grant under such an applicable repealed section in the 
• ' 
succeeding year, an adjustment in the amount of that grant shall be 
made in such a manner that the entity may retain such an amount 
(not to exceed 5 per centum of the amount by which such sum 
exceeded such costs) as the entity can demonstrate to the satisfaction 
of the Secretary will be used to enable the entity (I) to expand and 
improve its services, (II) to increase the number of persons (eligible 
to receive services from such an entity) it is able to serve, (III) to 
modernize its facilities, (IV) to improve the administration of its 
service programs, and (V) to establish a financial reserve for the 
purpose of offsetting the decrease in the percentage of Federal par-
ticipation in program operations in future years.". 
COMMUNITY MENTAL HEALTH CENTERS REQUIREMENTS 
42 use 2689. 
SEC. 104. (a) (1) Section 201(b) (1) is amended to read as follows: 
"(b) (1) The comprehensive mental health services which shall be 
provided through a community mental health center are as follows: 
"(A) Beginning on the date the community mental health cen-
ter is established for purposes of this title, the services provided 
through the center shall include— 
"(i) inpatient services, emergency services, and outpatient 
services; 
"(ii) assistance to courts and other public agencies in 
screening residents of the center's catchment area who are 
bein^ considered for referral to a State mental health facility 
for inpatient treatment to determine if they should be so 
referred and provision, where appropriate, of treatment for 
such persons through the center as an alternative to inpatient 
treatment at such a facility; 
" (iii) provision of foUowup care for residents of its catch-
ment area who have been discharged from inpatient treat-
ment at a mental health facility; 
"(iv) consultation and education services which— 
"(I) are for a wide range of individuals and entities 
involved with mental health services, including health 
professionals, schools, courts, State and local law 
enforcement and correctional agencies, members of the 
clergy, public welfare agencies, health services delivery 
agencies, and other appropriate entities; and 
"(II) include a wide range of activities (other than 
the provision of direct clinical services) designed to 
develop effective mental health programs in the center's 
catchment area, promote the coordination of the pro-
vision of mental health services among various entities 
serving the center's catchment area, increase the aware-
ness of the residents of the center's catchment area of 
the nature of mental health problems and the types of 
mental health services available, and promote the preven-
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3415 
tion and control of rape and the proper treatment of the 
victims of rape; and 
"(v) the services described in subparagraph (B) or, in lieu 
of such services, providing a plan approved by the Secretary 
under which the center will, during the three-year period 
beginning on such establishment date, assume in increments 
the provision of the services described in subparagraph (B) 
and will upon the expiration of such three-year period pro-
vide all the services described in subparagraph (B). 
"(B) After the expiration of such three-year period, a com-
munity mental health center shall provide, in addition to the 
services required by subparagraph (A), services which include— 
"(i) day care and other partial hospitalization services; 
"(ii) a program of specialized services for the mental 
health of children, including a full range of diagnostic, treat-
ment, liaison, and followup services (as prescribed by the 
Secretary); 
"(iii) a program of specialized services for the mental 
health of the elderly, including a full range of diagnostic, 
treatment, liaison, and followup services (as prescribed by 
the Secretary); 
"(iv) a program of transitional half-way house services for 
mentally ill individuals who are residents of its catchment 
area and who have been discharged from inpatient treatment 
in a mental health facility or would without such services 
require inpatient treatment in such a facility; and 
"(v) provision of each of the following service programs 
(other than a service program for which there is not sufficient 
need (as determined by the Secretary) in the center's catch-
ment area, or the need for which in the center's catchment 
area the Secretary determines is currently being met) : 
"(I) A program for the prevention and treatment of 
alcoholism and alcohol abuse and for the rehabilitation 
of alcohol abusers and alcoholics.. 
"(II) A j)rogram for the prevention and treatment of 
drug addiction and abuse and for the rehabilitation of 
drug addicts, drug abusers, and other persons with drug 
dependency problems.". 
(2) Section 204 is amended by striking out "section 201 (b) (1) (D)" 
each place it appears and inserting in lieu thereof "section 
201(b)(1) (A) (iv)". 
(b) Clause (A) of section 201(b) (2) is amended by inserting after 42 USC 2689 
"in the center's catchment area" the following:", or, with the approval 
of the Secretary, in the case of inpatient services, emergency services, 
and transitional half-way house services, through appropriate arrange-
ments with health professionals and others serving tne residents of the 
catchment area". 
(c) (1) Section 201(c) (1) is amended— 
(A) by striking out "The governing board of a community 
mental health center (other than a center described in subpara-
graph (B))" and inserting in lieu thereof "Except as provided 
in subparagraph (B), the governing board of a community mental 
health center"; and 
(B) by amending subparagraph (B) to read as follows: 
" 
' 
"(B) In the case of a community mental health center which is 
operated by a governmental agency or a hospital, such center may, in 
Alcohol abuse 
program. 
Drug abuse 
program. 
42 USC 2689c. 
92 STAT. 3416 
PUBLIC LAW 95-622—NOV. 9, 1978 
42 
use 
2689e. 
42 
use 
2689b, 
2689c, 
2689d. 
42 
use 
2689. 
42 use 2689 
note. 
eontract 
authority. 
National 
Advisory Mental 
Health Council, 
grant approval. 
lieu of meeting the requirements of subparagraph (A), appoint a com-
mittee which advises it with respect to the operations of the center and 
which is composed of individuals who reside in the center's catchment 
area, who are representative of the residents of the area as to employ-
ment, age, sex, place of residence, and other demographic character-
istics, and at least one-half of whom are not providers of health care.". 
(2) Section 206(e) is amended by inserting "(1)" after "(e)" and 
by adding at the end the following new paragraph: 
" (2) (A) Except as provided in subparagraph (B), not more than 5 
per centum of the total amount appropriated under sections 203, 204, 
and 205 for any fiscal year shall be used by the Secretary to provide 
grants under those sections to community mental health centers which 
do not 
meet the 
governing board 
requirements of 
section 
201(c)(1)(A). 
. 
. 
, 
"(B) Subparagraph (A) shall not apply, during the fiscal year end-
ing September 30, 1979, and during the fiscal year ending Septem-
ber 30, 1980, to any community mental health center which received 
a grant under this title in a fiscal year beginning before the date of 
the enactment of the Community Mental Health Centers Amendments 
of 1975.". 
OPERATIONS GRANTS TECHNICAL ASSISTANCE AND MONITORING 
SEC. 105. Section 206(e), as amended by section 104(c) (2) of this 
title, is amended by adding at the end the following new paragraph: 
"(3) Not more than 1 per centum of the total amount appropriated 
under section 203, 204, and 205 for any fiscal year shall be used by 
the Secretary to enter into contracts with State mental health authori-
ties under which the authorities (A) would monitor activities of com-
munity mental health centers (other than centers operated by such 
authorities) receiving grants under this title to determine if the 
requirements of this title applicable to the receipt of such grants are 
being met, and (B) would be provided funds to meet the expenses of 
conducting such monitoring. The authority of the Secretary to enter 
into contracts under this paragraph shall be effective for any fiscal 
year only to such extent or in such amounts as are provided in advance 
in appropriation Acts.". 
APPLICATIONS 
: SEC. 106. Section 206 (c) (2) is amended— 
(1) by amending the matter preceding subparagraph (A) to 
read as follows: "The Secretary may approve an application for a 
grant under section 203, 204, or 205 only if the application meets 
the requirements of paragraph (1) and, except as provided in 
paragraph (3)—"; 
(2) by inserting "the Secretary" before "determines" in sub-
paragraphs (A) and (B) ; and 
(3) by striking out "and" at the end of clause (iii) of subpara-
graph (B), by striking out the period at the end of clause (iv) of 
such subparagraph and inserting in lieu thereof a semicolon, and 
by 
adding 
after 
such subparagraph 
the following 
new 
subparagraphs: 
"(C) in the case of an application for the first grant under sec-
tion 203, 204, or 205, or an application for a grant under such 
section which requests a grant in an amount greater than the 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3417 
amount specified by the applicant in its plan and budget sub- 
>
> 
mitted in accordance with paragraph (1) (A) (i), the application 
is recommended for approval by the National Advisory Mental 
Health Council; and 
"(D) in the case of an application of a community mental 
health center which does not meet the governing board require-
ments of section 201 (c) (1) (A), the ccanmittee appointed pursuant 42 USC 2689. 
to section 201(c) (1) (B) has approved the application or, if such 
committee has not approved the application, the Secretary deter-
mines that the committee's failure to approve the application was 
unreasonable.". 
CATCHMENT AREAS 
SEC. 107. Section 238(2) is amended by inserting "health service 42 USC 2689u. 
areas," after "political subdivisions,". 
RAPE CONTROL 
SEC. 108. Section 231(c) is amended hj inserting after the first 42 USC 2689q. 
sentence the following: "The recommendations of the committee shall 
be submitted directly to the Secretary without review or revision by 
any person without the consent of the committee.". 
STATE MENTAL HEALTH PROGRAMS 
SEC. 109. Subsection (g) of section 314 of the Public Health Service 42 USC 246. 
Act is amended to read as follows: 
"STATE MENTAL HEALTH PROGRAMS 
"(g)(1) From allotments made pursuant to paragraph (4), the Grants. 
Secretary shall make grants tp State mental health authorities to 
assist them in meeting the costs of carrying out their functions under 
title XV of this Act and under section 237 of the Community Mental 42 USC 300k-l. 
Health Centers Act and, after September 30,1979, in meeting the costs 42 U
S
C 2689t. 
of providing mental health services. 
"(2) No grant may be made under paragraph (1) unless an appli-
cation 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 Secre-
tary that— 
"(A) the mental health services provided within the State 
under the grant applied for will be provided in accordance with 
the State health plan in effect for such State under section 1524 (c); 42 USC 300m-3. 
"(B) funds received under the grant applied for will (i) be 
used to supplement and, to the extent practical, to increase the 
level of non-Federal funds that would otherwise be made avail-
able for the purposes for which the grant funds are provided, and 
(ii) not be used to supplant such non-Federal funds; 
"(C) the State mental health authority will— 
"(i) provide for such fiscal control and fund accounting 
procedures as may be necessary to assure the proper disburse-
ments of and accounting for funds received under grants 
i 
under paragraph (1); 
39-194 O—80—pt. 3 
50 : QL3 
92 STAT. 3418 
PUBLIC LAW 95-622—NOV. 9, 1978 
Reports. 
State mental 
health authority, 
duties. 
42 use 2689t. 
Consultation with 
Labor Secretary. 
State authority, 
annual review of 
activities. 
"' 
'••• 
"(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 the amount of funds obligated in such fiscal year 
for the provision of each such category of services; 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; 
"(D) the State mental health authority will— 
"(i) perform the duties prescribed by section 237 of the 
Community Mental Health Centers Act; 
"(ii) prescribe and provide for the enforcement of mini-
mum standards for the maintenance and operation of mental 
health programs and facilities (including community mental 
health centers) within the State; 
"(iii) provide for assistance to courts and other public 
'- 
agencies and to appropriate private agencies to facilitate (I) 
screening by community mental health centers (or, if there are 
no such centers, other appropriate entities) of residents of 
the State who are being considered for inpatient care in a 
mental health facility to determine if such care is necessary, 
and (II) provision of followup care by community mental 
health centers (or, if there are no such centers, oy other 
appropriate entities) for residents of the State who have been 
discharged from mental health facilities; and 
" (iv) establish and carry out a plan which— 
"(I) is designed to eliminate inappropriate placement 
in institutions of persons with mental health problems, 
to insure the availability of appropriate noninstitutional 
services for such persons, and to improve the quality of 
care for those with mental health problems for whom 
institutional care is appropriate, and 
"(II) shall include fair and equitable arrangements 
(as determined by the Secretary after consultation with 
the Secretary of Labor) to protect the interests of 
, . 
employees affected by actions described in subclause (I), 
including arrangements designed to preserve employee 
,.;r ' - 
rights and benefits and to provide training and retrain-
ing of such employees where necessary and arrangements 
under which maximum effort will be made to guarantee 
the employment of such employees. 
"(3) (A) The Secretary shall review annually the activities under-
taken by each State mental health authority with an approved appli-
cation to determine if it complied with the assurances provided with 
the application. The Secretary may not approve an application sub-
mitted under paragraph (2) if the Secretary determines— 
" (i) the State for which the application was submitted did not 
comply with assurances provided with a prior application under 
paragraph (2), and 
"(ii) he cannot be assured that the State will comply with the 
assurances provided with the application under consideration. 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3419 
"(B) Whenever the Secretary, after reasonable notice and opportu- Grant payments, 
nity for a hearing to the State mental health authority of a State, finds termination, 
that, with respect to funds paid to the authority under a grant under 
paragraph (1), there is a failure to comply substantially with assur-
ances provided under paragraph (2) with respect to the receipt of such 
grant, the Secretary shall notify the authority that further payments 
will not be made to it under such grant (or, in his discretion, that 
further payments will not be made to it from such grant for activities 
in which there is such failure), until he is satisfied that there will no 
longer be such failure. Until he is so satisfied, the Secretary shall make 
no payment to such authority from such grant, or shall limit payment 
under such grant to activities in which there is no such failure. 
" (4) For the purpose of determining the total amount of grants that 
may be made to the State mental health authorities of each State, the 
Secretary shall, in each fiscal year and in accordance with regulations, 
allot the sums appropriated for such year under paragraph (7) among 
the States on the basis of the population and the financial need of the 
' '-' 
respective States. The populations of the States shall be determined on 
the basis of the latest figures for the population of the States available 
from the Department of Commerce. 
» 
"(5) (A) The Secretary shall determine the amount of any grant 
under paragraph (1); but the amount of grants made in any fiscal 
year to the mental health authorities of any State may not exceed the 
amount of the State's allotment available for obligation in such fiscal 
year. Payments under such grants may be made in advance or by way 
of reimbursement, and at such intervals and on such conditions, as 
the Secretary finds necessary. 
"(B) The Secretary, at the request of a State mental health author-
ity, may reduce the amount of the grant to the authority under para-
graph (1) by— 
"(i) the fair market value of any supplies or equipment furn-
ished the State mental health authority, and 
"(ii) the amount of the pay, allowances, and travel expenses of 
any officer or employee of the Government when detailed to the 
State mental health authority and the amount of any other costs 
incurred in connection with the detail of such officer or employee, 
when the furnishing of such supplies or equipment or the detail of such 
an officer or employee is for the convenience of and at the request of 
the State mental health authority and for the purpose of carrying 
out any project with respect to which its grant under paragraph (1) 
is made. The amount by which any such grant is so reduced shall be 
available for payment by the Secretary of the costs incurred in furnish-
ing the supplies or equipment, or in detailing the personnel, on which 
the reduction of such grant is based, and such amount shall be deemed 
as part of the grant and shall be deemed to have been paid to the State 
mental health authority. 
"(6) In any fiscal year not less than 70 per centum of the amount 
of a State's grant shall be available only for the provision of mental 
..• 
,» f 
health services and for.the conduct of mental health planning activities 
in communities of the State. 
"(7) For the purpose of making grants under this subsection there Appropriation 
are authorized to be appropriated $5,000,000 for the fiscal year ending authorization. 
September 30, 1979, $20,000,000 for the fiscal year ending September 
30,1980, and $25,000,000 for the fiscal year ending September 30,1981. 
"(8) Kegulations (including substantive amendments to regula- Regulations. 
92 STAT. 3420 
PUBLIC LAW 95-622—NOV. 9, 1978 
tions) under this subsection shall be promulgated by the Secretary 
after consultation with a conference of State mental health authorities. 
The Secretary shall consult with such conference before the publication 
of proposals for such regulations or amendments.". 
MISCELLANEOUS 
42 use 2689f. 
SEC. 110. (a) Section 211(1) (A) is amended (1) by inserting "for 
compensation of personnel for its initial operation" after "1975)", and 
(2) by inserting "for such compensation of personnel" after "under 
that section". 
42 use 2689b. 
(b) Section 203(e) (1) (A) (i) is amended by striking out "unless it 
42 use 2689. 
meets the requirements of section 201" and inserting in lieu thereof the 
42 use 2688u. 
following: "(other than section 271) unless it provides at least the 
comprehensive mental health services described in clauses (i) through 
(iv) of section 201(b) (1) (A)". 
42 use 2689m. 
(c) Effective July 29, 1975, section 225 is amended by striking out 
"this part" and inserting in lieu thereof "this title". 
(d) Section 504(a) of the Comprehensive Alcohol Abuse and 
42 use 4588. 
Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 is 
amended by adding after and below paragraph (2) the following: 
"Insofar as practicable, the Secretary shall approve applications under-
this subsection in a manner which results in an equitable geographic 
distribution of Centers.". 
EFFECTIVE DATE 
v, 
SEC. 111. The amendments made by this title (other than by section 
42 use 2689 
110 (c)) to the Community Mental Health Centers Act shall apply witli 
note. 
respect to grants made under the Community Mental Health Centers 
Act from appropriations for fiscal years ending after September 30. 
1978. 
Biomedical 
Research and 
Research 
Training 
Amendments of 
1978. 
42 u s e 201 note. 
42 u s e 201 note. 
TITLE II—BIOMEDICAL RESEARCH EXTENSION 
AMENDMENTS 
SHORT TITLE; REFERENCE TO ACT 
SEC. 201. (a) This title may be cited as the "Biomedical Research 
and Research Training Amendments of 1978". 
(b) Whenever in this title (other than in sections 267 and 268) 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. 
PART A—^LIBRARIES OF MEDICINE 
EXTENSION OF AUTHORIZATIONS 
42 use 280b. 
SEC. 211. Section 390(c) is amended by striking out "and" after 
"1976," and by inserting before the period the following: ", $15,000,000 
for the fiscal year ending September 30,1979, $16,500,000 for the fiscal 
year ending September 30, 1980, and $18,500,000 for the fiscal year 
ending September 30,1981". 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3421 
BOARD OF R E G E N T S ' APPOINTMENTS 
SEC. 212. Section 383 is amended (1) by striking out "by the 42USC277. 
President, by and with the advice and consent of the Senate" in the 
first sentence of subsection (a) and inserting in lieu thereof "by the 
Secretary", and (2) by striking out "by the President" in the first 
sentence of subsection (c) and inserting in lieu thereof "by the 
Secretary". 
PART B—PROGRAMS OF THE NATIONAL HEART, LUNG, AND BLOOD 
INSTITUTE 
EXTENSION O F AUTHORIZATIONS 
SEC. 221. (a) Section 414(b) is amended by striking out "and" after 42 USC 287c. 
"1977," and by inserting before the period the following: 
", $40,000,000 for the fiscal year ending September 30, 1979, and 
$45,000,000 for the fiscal year ending September 30,1980". 
(b) Section 419B is amended in the first sentence by striking out 42 USC 287i. 
"and" after "1977," and by inserting before the period the following: 
", $470,000,000 for the fiscal year ending September 30, 1979, and 
$515,000,000 for the fiscal year ending September 30,1980". 
SUBMISSION OF REPORTS 
SEC. 222. (a) Section 413(b) (2) is amended by striking out "submit 42 USC 287b. 
to the President for transmittal to the Congress a report" and inserting 
in lieu thereof "submit a report to the Secretary, for simultaneous 
transmittal by the Secretary, not later than November 30 of each year, 
to the President and to the Congress,". 
(b) Section 418(b) (2) is amended by inserting "by the Secretary" 42 USC 287g. 
after "transmittal". 
INFORMATION PROGRAMS 
SEC. 223. (a) Section 412 (5) is amended by striking out "make avail- 42 USC 287a. 
able" and inserting in lieu thereof "make available on a timely basis". 
(b) Section 413(d) is amended (1) by striking out "to provide" in 42 USC 287b, 
the second sentence and inserting in lieu thereof "to provide on a 
timely basis", and (2) by striking out "diet" in the third sentence and 
inserting in lieu thereof "diet and nutrition, environmental pollutants". 
EDUCATION AND INFORMATION PROGRAMS OF CENTERS 
SEC. 224. Section 415(a) (2) is amended by adding after subpara- 42 USC 287d. 
graph (D) the following: 
"(E) Programs of continuing education for health and allied 
health professionals in the diagnosis, prevention, and treatment 
of such diseases and information programs for the public respect-
ing the prevention and early diagnosis and treatment of such 
diseases." 
92 STAT. 3422 
PUBLIC LAW 95-622—NOV. 9, 1978 
PART C—PROGRAMS OF THE NATIONAL CANCER INSTITUTE 
• 
Subpart I—Extension of and Substantive Changes in Programs of the 
National Cancer Institute 
EXTENSION OF AUTHORIZATIONS 
42 use 286c. 
SEC. 231. (a) Section 409(b) is amended by striking out "and" after 
"1977," and by inserting before the period the following: ", $90,500,000 
for the fiscal year ending September 30, 1979, and $103,000,000 for the 
fiscal year ending September 30,1980". 
42 USC286g. 
(b) Section 410C is amended by striking out "and" after "1977;" 
and by inserting before the period the following: "$924,500,000 for the 
fiscal year ending September 30, 1979; and $927,000,000 for the fiscal 
' 
year ending September 30,1980". 
NATIONAL CANCER ADVISORY BOARD 
42USC286f. 
SEC. 232. (a)(1)(A) Subsection (a) of section 410B is amended 
by striking out "twenty-three" and inserting in lieu thereof "twenty-
nine". 
(B) Paragraph (1) of such subsection is amended by inserting after 
"Veterans' Administration" the following: ", the Director of the 
National Institute for Occupational Safety and Health, the Director 
of the National Institute of Environmental Health Sciences, the Sec-
retary of Labor, the Commissioner of the Food and Drug Administra-
tion, the Administrator of the Environmental Protection Agency, the 
Chairman of the Consumer Product Safety Commission". 
(2) The first sentence of such subsection following paragraph (2) 
is amended (A) by striking out "and not more" and inserting in lieu 
' 
thereof ", not more", and (B) by inserting before the period ", and 
not less than five of the appointed members shall be individuals knowl-
edgeable in environmental carcinogenesis (including carcinogenesis 
involving occupational and dietary factors)". 
,,, 
^
_
, , 
(3) The second sentence of such subsection following paragraph (2) 
is amended by inserting before the period a comma and the following: 
,; 
. 
"and at least two of the physicians appointed to the Board shall be 
physicians primarily involved in treating individuals who have 
cancer". 
(4) Such subsection is amended by adding at the end the following: 
"The ex officio members of the Board shall be nonvoting members.". 
Reports. 
(5) Section 410B(g) is amended by striking out "a report to the 
President for transmittal to the Congress not later than January 31 
of each year on the progress" and inserting in lieu thereof "a report 
to the Secretary, for simultaneous transmittal by the Secretary, not 
later than November 30 of each year, to the President and to the Con-
gress, on the progress during the preceding fiscal year". 
42 use 286f 
(b) The amendments made by subsection (a) of this section respect-
note, 
ing the manner of appointing members of the National Cancer Advi-
sory Board and the composition of such Board shall apply with respect 
to appointments made to the Board after the date of the enactment of 
this Act, and the President shall make appointments to such Board 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3423 
after such date in a manner which will bring about, at the earliest fea-
sible time, the composition prescribed by such amendments. 
SUBMISSION OF REPORTS 
SEC. 233. Section 410A(b) is amended (1) by striking out "end of 42 USC 286e. 
each calendar year" and inserting in lieu thereof "end of each fiscal 
year", (2) by striking out "submit to the President for transmittal to 
the Congress" and inserting in lieu thereof "submit to the Secretary, 
for simultaneous transmittal by the Secretary, not later than Novem-
ber SO of each year, to the President and to the Congress,", and (3) by 
striking out "the preceding calendar year" and inserting in lieu thei^eof 
"the preceding fiscal year". 
FUNCTIONS OF CENTERS 
SEC. 234. (a) Subsections (a) and (b) of section 408 are each 42 USC 286b. 
amended by striking out "clinical research, training, and demonstra-
tion of advanced diagnostic and treatment methods relating to cancer" 
and inserting in lieu thereof "basic and clinical research into, training 
in, and demonstration of, advanced diagnostic, prevention, and treat-
ment methods for cancer". 
(b) Clause (3) of the second sentence of section 408(b) is amended 
v i 
by inserting after the comma the following: "continuing education for 
health professionals and allied health professions personnel, and 
information programs for the public respecting cancer,". 
NATIONAL CANCER PROGRAM 
SEC. 235. (a) Paragraph (1) of subsection (b) of section 407 is 42 USC 286a. 
amended by striking out ", plan and develop" and inserting in lieu 
thereof "(A) plan and develop", and by inserting before the period 
the following: "; and (B) implement an expanded and intensified 
research program for the prevention of cancer caused by occupational 
or environmental exposure to carcinogens". 
(b) Paragraph (7) of such subsection is amended to read as follows: 
"(7) Support appropriate programs of education (including 
continuing education) and training in fundamental sciences and 
clinical disciplines for investigators, physicians, and allied health 
professionals for participation in clinical programs relating to 
cancer, including the use of training stipends, fellowships, and 
career awards." 
(c) The first sentence of subsection (c) (3) of such section is 
amended by striking out "twelve times" and inserting in lieu thereof 
"four times". 
CANCER CONTROL PROGRAMS 
SEC. 236. (a) Subsection (a) of section 409 is amended to read as 42 USC 286c. 
follows: 
"(a) The Director of the National Cancer 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 subsection shall include— 
"(1) locally initiated education and demonstration programs 
(and regional networks of such programs) to transmit research 
92 STAT. 3424 
PUBLIC LAW 95-622—NOV. 9, 1978 
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; 
, 
"(2) the demonstration of and the education of health profes-
sionals in— 
"(A) effective methods for the early detection of cancer 
and the identification of individuals with a high risk of 
developing cancer, and 
"(B) improved methods of patient referral to appropriate 
centers for early diagnosis and treatment of cancer; and 
"(3) the demonstration of new methods for the dissemination 
of information to the general public concerning the early detec-
tion and treatment of cancer and information concerning unap-
proved and ineffective methods, drugs, and devices for the 
diagnosis, prevention, treatment, and control of cancer.". 
Subpart II—Technical Revision of the Authority of the National 
Cancer Institute 
TECHNICAL REVISION 
42 use 281. 
SEC. 241. (a) (1) Part A of title IV (as amended by subpart I of 
this part) is amended to read as follows: 
"PART A—NATIONAL CANCER INSTITUTE 
A DIVISION OF THE NATIONAL INSTITUTES OF HEALTH 
u 
42 use 281. 
"SEC. 400. The National Cancer Institute (in this part referred to 
as the 'Institute') is a division of the National Institutes of Health. 
"CANCER RESEARCH AND OTHER ACTIVITIES 
42 use 282. 
"SEC. 401. (a) In carrying out the purposes of section 301 with 
42 use 241. 
respect to cancer, the Secretary, through the Institute and in coopera-
tion with the National Cancer Advisory Board, shall— 
"(1) conduct, assist, and foster research, investigations, experi-
ments, and studies relating to the cause, prevention, and methods 
of diagnosis and treatment of cancer; 
"(2) promote the coordination of research conducted by the 
Institute and similar research conducted by other agencies and 
organizations and by individuals; 
"(3) provide clinical training and instruction in technical 
matters relating to the diagnosis and treatment of cancer; 
"(4) secure for the Institute consultation services and advice of 
cancer experts from the United States and abroad; 
; 
I 
"(5) cooperate with State health agencies in the prevention, 
control, and eradication of cancer; and 
"(6) procure, use, and lend radium as provided in subsection 
"(b)In 
(b)In carrying out subsection (a), all appropriate provisions of 
section 301 shall be applicable to the authority of the Secretary, and 
the Secretary is authorized— 
"(1) to purchase radium, from time to time and without regard 
41 use 5. 
to section 3T09 of the Revised Statutes, and to make such radium 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3425 
available for the purposes of this part, both to the Service and 
by loan to other agencies and institutions for such consideration 
and subject to such conditions as he maj^ prescribe; and 
"(2) to provide the necessary facilities where training and 
instruction may be given in all technical matters relating to the 
diagnosis and treatement of cancer to persons found by the Sec-
retary to have pjroper technical qualifications and designated by 
him for such training or instruction and to fix and pay them a per 
diem allowance during such training or instruction. 
"NATIONAL CANCER PROGRAM 
"SEC. 402. The National Cancer Program shall consist of (1) an 42 USC 283. 
expanded, intensified, and coordinated cancer research program 
encompassing the research programs conducted and supported by the 
Institute and the related research programs of the other research insti-
tutes and including an expanded and intensified research program 
for the prevention of cancer caused by occupational or environmental 
exposure to carcinogens, and (2) the other programs and activities 
of the Institute. 
"CANCER CONTROL PROGRAMS 
"SEC. 403. The Director of the Institute shall establish and support 42 USC 284. 
demonstration, education, and other programs for the detection, diag-
nosis, 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; 
" (2) the demonstration of and the education of health profes-
sionals in— 
" (A) effective methods for the early detection of cancer and 
the identification of individuals with a high risk of developing 
cancer, and 
"(B) improved methods of patient referral to appropriate 
centers for early diagnosis and treatment of cancer; and 
" (3) the demonstration of new methods for the dissemination of 
information to the general public concerning the early detection 
and treatment of cancer and information concerning unapproved 
and ineffective methods, drugs, and devices for the diagnosis, 
prevention, treatment, and control of cancer. 
((. 
DUTIES AND FUNCTIONS or THE DIRECTOR 
"SEC. 404. (a) The Director of the Institute in carrying out the 42 USC 285. 
National Cancer Program shall— 
"(1) collect, analyze, and disseminate information (including 
information 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 
92 STAT. 3426 
PUBLIC LAW 95-622—NOV. 9, 1978 
Report to 
President and 
Congress. 
Report to 
President and 
Congress. 
-.iX 
results of cancer research undertaken in any country for the use of 
any person involved in cancer research in any country; 
"(2) establish or support the large-scale production or distribu-
tion of specialized biological materials and other therapeutic sub-
stances for research and set standards of safety and care for 
persons using such materials; 
"(3) support research in the cancer field outside the United 
States by highly qualified foreign nationals which research can 
be expected to inure to the benefit of the American people; support 
\ 
collaborative research involving American and foreign partici-
pants; and support the training of American scientists abroad 
and foreign scientists in the United States; 
"(4) support appropriate programs of education (including 
continuing education) and training in fundamental sciences and 
clinical disciplines for investigators, physicians, and allied health 
professionals for participation in clinical programs relating to 
cancer, including the use of training stipends, fellowships, and 
career awards; 
"(5) expeditiously utilize existing research facilities and per-
sonnel of the National Institutes of Health for accelerated explo-
ration of opportunities in areas of special promise; 
"(6) encourage and coordinate cancer research by industrial 
concerns where such concerns evidence a particular capability 
for such research; 
"(7) provide and contract for a program to disseminate and 
interpret, on a current basis, for practitioners and other health 
professionals, scientists, and the general public scientific and other 
information respecting the cause, prevention, diagnosis, and treat-
ment of cancer; 
"(8) (A) prepare and submit, directly to the President for 
review and transmittal to Congress, an annual budget estimate 
(including an estimate of the number and type of personnel 
needed for the National Cancer Institute) for the National Cancer 
Program, after reasonable opportunity for comment (but without 
— 
change) by the Secretary, the Director of the National Institutes 
of Health, and the National Cancer Advisory Board; and (B) 
receive from the President and the Office of Management and 
Budget directly all funds appropriated by Congress for obligation 
/ 
and expenditure by the Institute; and 
"(9) as soon as practicable after the end of each fiscal year, 
prepare in consultation with the National Cancer Advisory Board 
and submit to the Secretary, for simultaneous transmittal, not 
later than November 30 of each year, to the President and to the 
Congress, a report on the activities, progress, and accomplishments 
under the National Cancer Program during the preceding fiscal 
year, which shall include a report on the progress, activities, and 
accomplishments of, and expenditures for, the information serv-
ices of the Program, and a plan for the Program during the next 
five years. 
"(b) The Director of the Institute (after consultation with the 
National Cancer Advisory Board) in carrying out his functions in 
administering the National Cancer Program and without regard to 
any other provision of this Act is authorized— 
" (1) to obtain (in accordance with section 3109 of title 5, United 
States Code and if authorized by the National Cancer Advisory 
PUBLIC LAW 95-622—NOV. 9, 1978 
' 
92 STAT. 3427 
Board, but without regard to the limitation in such section on the 
number of days or the period of such service) the services of not 
more than one hundred and fifty-one experts or consultants who 
have scientific or professional qualifications; 
"(2) to acquire, construct, improve, repair, operate, and main- 
' • 
tain cancer centers, laboratories, research, and other necessary 
facilities and equipment, and related accommodations as may be 
necessary, and such other real or personal propertj^ (including 
patents) as the Director deems necessary; to acquire, without 
regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or 
otherwise through the Administrator of General Services, build-
ings or parts of buildings in the District of Columbia or com-
munities located adjacent to the District of Columbia for the use 
of the Institute for a period not to exceed ten years; 
"(3) to appoint one or more advisory committees composed of 
such private citizens and officials of Federal, State, and local gov-
ernments as he deems desirable to advise him with respect to his 
functions; 
/ 
, ". '[' 
" (4) to utilize, with their consent, the services, equipment, per-
sonnel, information, and facilities of other Federal, State, or local 
public agencies, with or without reimbursement therefor; 
"(5) to accept voluntary and uncompensated services; 
"(6) to accept unconditional gifts, or donations of services, 
money, or property, real, personal, or mixed, tangible or 
intangible; 
"(7) to enter into such contracts, leases, cooperative agree-
ments, or other transactions, without regard to sections 3648 and 
3709 of the Revised Statutes of the United States (31 U.S.C. 529, 
41 U.S.C. 5), as may be necessary in the conduct of his functions, 
with any public agency, or with any person, firm, association, 
corporation, or educational institution; 
"(8) to take necessary action to insure that all channels for the 
dissemination and exchange of scientific knowledge and informa-
tion are maintained between the Institute and the other scientific, 
medical, and biomedical disciplines and organizations nationally 
,'» 
and internationally; 
"(9) to award grants for new construction as well as altera- Grants, 
tions and renovations for improvement of basic research labora-
tory facilities, including those related to biohazard control, as 
deemed necessary for the National Cancer Program; and 
"(10) to call special meetings of the National Cancer Advi-
sory Board at such times and in such places as the Director 
deems necessary in order to consult with, obtain advice from, 
or to secure the approval of projects, programs, or other actions 
to be undertaken without delay in order to gain maximum benefit 
from a new scientific or technical finding. 
u 
SCIENTIFIC REVIEW 
"SEC. 405. (a) The Director of the Institute shall, by regulation, 42 USC 286. 
provide for proper scientific review of all research grants and pro-
grams over which he has authority (1) by utilizing, to the maximum 
extent possible, appropriate peer review groups established within 
the National Institutes of Health and composed principally of non-
Federal scientists and other experts in the scientific and disease fields, 
92 STAT. 3428 
PUBLIC LAW 95-622—NOV. 9, 1978 
Grants. 
42 u s e 286a. 
and (2) when appropriate, by establishing, with the approval of the 
National Cancer Advisory Board and the Director of the National 
Institutes of Health, other formal peer review groups as may be 
required. 
'(b) Under procedures approved by the Director of the National 
Institutes of Health, the Director of the National Cancer Institute 
may approve grants under this Act for cancer research or training— 
"(1) if the direct costs of such research and training do not 
exceed $35,000, but only after appropriate review for scientific 
merit, and 
"(2) if the direct costs of such research and training exceed 
$35,000, but only after appropriate review for scientific merit 
and recommendation for approval by the National Cancer 
Advisory Board under section 407(b) (3). 
u 
NATIONAL CANCER RKSEARCH AND DEMONSTRATION 
CENTERS 
Establishment. 
"SEC. 406. (a) The Director of the Institute is authorized to provide 
42 use 286a. 
for the establishment of new centers for basic and clinical research 
into, training in, and demonstration of, advanced diagnostic, preven-
tion, and treatment methods for cancer. Such centers may be sup-
ported under subsection (b) or under any other applicable provision 
of law. 
Cooperative 
" (b) The Director of the Institute, under policies established by the 
agreements. 
Director of the National Institutes of Health and after consultation 
with the National Cancer Advisory Board, is authorized to enter into 
cooperative agreements with public or private nonprofit agencies or 
institutions to pay all or part of the cost of planning, establishing, or 
strengthening, and providing basic operating support for existing or 
new centers (including, but not limited to, centers established under 
subsection (a)) for basic and clinical research into, training in, and 
demonstration of advanced diagnostic, prevention, and treatment 
methods for cancer. Federal payments under this subsection in support 
of such cooperative agreements may be used for (1) construction (not-
Post, p. 3432. 
withstanding any limitation under section 477), (2) staffing and other 
basic operating costs, including such patient care costs as are required 
for research, (3) clinical training (including clinical training for 
allied health professionals, continuing education for health profes-
sionals and allied health professions personnel, and information pro-
grams for the public respecting cancer, and (4) demonstration 
purposes. The aggregate of payments (other than payments for 
construction) made to any center in support of such an agreement 
for its costs (other than indirect costs) described in the first sentence 
may not exceed $5,000,000 in any fiscal year, except that if in any fiscal 
year there is an increase, as reflected in the Consumer Price Index 
published by the Bureau of Labor Statistics, in the cost of a center 
for which payments may be made under such an agreement, the aggre-
gate of payments in such year for such center may exceed $5,000,000 
to include such increase and any such increase in any preceding fiscal 
year for which payments were made to such center under such an 
agreement to the extent that such increase resulted in payments in 
excess of $5,000,000. As used in this section, the term 'construction' 
does not include the acquisition of land, and the term 'training' does 
not include research training for which fellowship support may be 
42 use 289/-1. 
provided under section 472. Support of a center under this section may 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3429 
be for a period of not to exceed three years and may be extended by 
the Director of the Institute for additional periods of not more than 
three years each, after review of the operations of such center by an 
appropriate scientific review group established by the Director of the 
Institute. 
"NATIONAL CANCER ADVISORY BOARD 
"SEC. 407. (a) (1) There is established in the Institute a National Establishment. 
Cancer Advisory Board (hereinafter in this section referred to as the 42 USC 286b. 
'Board') to be composed of twenty-nine members as follows: 
"(A) The Secretary, the Director of the Office of Science and 
Technology Policy, the Director of the National Institutes of 
Health, the chief medical officer of the Veterans' Administration, 
the Director of the National Institute for Occupational Safety 
and Health, the Director of the National Institute of Environ-
mental Health Sciences, the Secretary of Labor, the Commissioner 
of the Food and Drug Administration, the Administrator of the 
Environmental Protection Agency, the Chairman of the Con-
sumer Product Safety Commission (or their designees), and a 
medical officer designated by the Secretary of Defense shall be 
ex officio members of the Board. 
"(B) Eighteen members appointed by the President. 
Not more than twelve of the appointed members of the Board shall 
be scientists or physicians, not more than eight of the appointed mem-
bers shall be representatives from the general public, and not less than 
five of the appointed members shall be individuals knowledgeable in 
environmental carcinogenesis (including carcinogenesis involving 
occupational and dietary factors). The scientists and physicians 
appointed to the Board shall be appointed from persons who are 
among the leading scientific or medical authorities outstanding in the 
study, diagnosis, or treatment of cancer or in fields related thereto, 
and at least two of the pihysicians appointed to the Board shall be 
physicians primarily involved in treating individuals who have cancer. 
Each appointed member of the Board shall be appointed from among 
persons who by virtue of their training, experience, and background 
are especially qualified to appraise the programs of the Institute. The 
ex officio members of the Board shall be nonvoting members. 
"(2) (A) Appointed members shall be appointed for six-year terms, 
except that of the members first appointed six shall be appointed for 
a term of two years, and six shall be appointed for a term of four 
years, as designated by the President at the time of appointment, 
"(B) Any member appointed to fill a vacancy occurring prior to 
expiration of the term for which his predecessor was appointed shall 
serve only for the remainder of such term. Appointed members shall 
be eligible for reappointment and may serve after the expiration of 
their terms until their successors have taken office. 
"(C) A vacancy in the Board shall not affect its activities, and 
twelve members thereof shall constitute a quorum. 
" (3) The President shall designate one of the appointed members to 
serve as Chairman for a term of two years. 
" (4) The Board shall meet at the call of the Director of the Institute 
or the Chairman, but not less often than four times a year and shall 
advise and assist the Director of the Institute with respect to the 
National Cancer Program. 
"(5) The Director of the Institute shall designate a member of the 
staff of the Institute to act as Executive Secretary of the Board. 
92 STAT. 3430 
PUBLIC LAW 95-622—NOV. 9, 1978 
Hearings. 
Reports. 
Compensation. 
5 use 5332 
note. 
Ante, p. 3424. 
Ante, p. 3427. 
42 use 219. 
"(6) The Board may hold such hearings, take such testimony, and 
sit and act at such times and places as the Board deems advisable to 
investigate programs and activities of the National Cancer Program. 
"(7) The Board shall submit a report to the Secretary for simulta-
neous transmittal by the Secretary, not later than November 30 of 
each year, to the President and the Congress, on the progress during 
the preceding fiscal year of the National Cancer Program toward the 
accomplishment of its objectives. 
"(8) Members of the Board who are not officers or employees of the 
United States shall receive for each day they are engaged in the per-
formance of the duties of the Board compensation at rates not to exceed 
the daily equivalent of the annual rate in effect for GS-18 of the 
General Schedule, including traveltime; and all members, while so 
serving away from their homes or regular places of business, may be 
allowed travel expenses, including per diem in lieu of subsistence, in 
the same manner as such expenses are authorized by section 5703, title 
5, United States Code, for persons in the Government service employed 
intermittently. 
"(9) The Director of the Institute shall make available to the Board 
such staff, information, and other assistance as it may require to carry 
out its activities. 
"(b) The Board is authorized— 
"(1) to review research projects or programs conducted or 
authorized to be conducted under section 401 relating to the study 
of the cause, prevention, or methods of diagnosis and treatment 
of cancer, and recommend to the Secretary any such projects which 
it believes show promise of making valuable contributions to 
human knowledge with respect to the cause, prevention, or meth-
ods of diagnosis and treatment of cancer; 
"(2) to collect information as to studies which are being carried 
on in the United States or any other country as to the cause, pre-
vention, and methods of diagnosis and treatment of cancer, by 
correspondence or by personal investigation of such studies, and 
with the approval of the Secretary make available such infor-
mation through the appropriate publications for the benefit of 
health agencies and organizations (public or private), physicians, 
or any other scientists, and for the information of the general 
public; 
"(3) to review applications for grants for research projects re-
lating to cancer and to recommend to the Director for approval 
under section 405(b) (2) those applications which show promise 
of making valuable contributions to human knowledge with re-
spect to the cause or prevention of cancer or to methods of 
diagnosis or treatment of cancer; 
" (4) to recommend to the Secretary for acceptance conditional 
gifts pursuant to section 501 of this Act; and 
"(5) to make recommendations to the Secretary with respect to 
carrying out the provisions of this part. 
li PRESIDENT'S CANCER PANEL 
Establishment. 
"SEC. 408. (a) (1) There is established the President's Cancer Panel 
42 use 286c. 
(hereinafter in this section referred to as the 'Panel') which shall be 
composed of three persons appointed by the President, who by virtue 
of their training, experience, and background are exceptionally qual-
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3431 
ified to appraise the National Cancer Program. At least two of the 
members of the Panel shall be distinguished scientists or physicians. 
"(2) (A) Members of the Panel shall be appointed for three-year 
terms, except that (i) in the case of two of the members first appointed, 
one shall be appointed for a term of one year and one shall be 
appointed for a term of two years, as designated by the President at 
the time of appointment, and (ii) any member appointed to fill a 
vacancy occurring prior to the expiration of the term for which his 
predecessor was appointed shall be appointed only for the remainder 
of such term. 
"(B) The President shall designate one of the members to serve as 
Chairman for a term of one year. 
"(C) Members of the Panel shall each be entitled to receive the daily 
equivalent of the annual rate of basic pay in effect for ^rade GS-18 
of the General Schedule for each day (including traveltime) during 
which they are engaged in the actual performance of duties vested in 
the Panel, and shall be allow^ed travel expenses (including a per diem 
allowance) under section 5703(b) of title 5, United States Code. 
"(3) The Panel shall meet at the call of the Chairman, but not less 
often than four times a year. A transcript shall be kept of the pro-
ceedings of each meeting of the Panel, and the Chairman shall make 
such transcript available to the public. 
"(b) The Panel shall monitor the development and execution of the 
National Cancer Program, and shall report directly to the President. 
Any delays or blockages in rapid execution of the Program shall imme-
diately be brought to the attention of the President. The Panel shall 
submit to the President periodic progress reports on the Program and 
annually an evaluation of the efficacy of the Program and suggestions 
for improvements, and shall submit such other reports as the President 
shall direct. 
"GIFTS 
"SEC. 409. The Secretary shall recommend acceptance of conditional 
gifts pursuant to section 501 for study, investigation, or research into 
the cause, prevention, and methods of diagnosis and treatment of can-
cer, or for the acquisition of real property or the erection, equipment, 
or maintenance of premises, buildings, or equipment of the Institute, 
only after consultation with the National Cancer Advisory Board. 
Donations of $50,000 or over in aid of research under this part may 
be acknowledged by the establishment within the Institute of suitable 
memorials to the donors. 
5 use 5332 
note. 
Information 
available to 
public. 
Report to 
President. 
42 use 286d. 
42 use 219. 
u 
AUTHORIZATION OF APPROPRIATIONS 
"SEC. 410. (a) For the purpose of carrying out this part (other than 42 USe 286e. 
section 403), there are authorized to be appropriated $400,000,000 for 
the fiscal year ending June 30, 1972; $500,000,000 for the fiscal year 
ending June 30, 1973; $600,000,000 for the fiscal year ending June 30, 
1974; $750,000,000 for the fiscal year ending June 30,1975; $830,000,000 
for the fiscal year ending June 30,1976; $985,000,000 for the fiscal year 
ending September 30, 1977; $923,590,000 for the fiscal year ending 
September 30,1978; $924,500,000 for the fiscal year ending September 
30, 1979; and $927,000,000 for the fiscal year ending September 30, 
92 STAT. 3432 
PUBLIC LAW 95-622—NOV. 9, 1978 
"(b) There are authorized to be appropriated to carry out section 
403 $20,000,000 for the fiscal year ending June 30,1972; $30,000,000 for 
the fiscal year ending June 30,1973; $40,000,000 for thfe fiscal year end-
ing June 30,1974; $53,600,000 for the fiscal year ending June 30,1975 ; 
$68,500,000 for the fiscal year ending June 30,1976; $88,500,000 for the 
fiscal year ending September 30, 1977; $84,560,000 for the fiscal year 
ending September 30,1978; $90,500,000 for the fiscal year ending Sep-
tember 30, 1979; and $103,000,000 for the fiscal year ending Septem-
ber 30,1980. 
Contract 
"(c) The authority of the Secretary to enter into any contract for 
authority. 
the conduct of a program under section 404 (a) (7) shall be effective for 
Ante, p. 3425. 
any fiscal year only to such extent or in such amounts as are provided 
in advance in appropriation Acts.". 
42 use 286b 
(2) The change in the manner of appointing members of the 
note. 
National Cancer Advisory Board and in the composition of such Board 
prescribed by the amendment made by paragraph (1) shall apply with 
respect to appointments made to the Board after the date of the enact-
ment of this Act, and the President shall make appointments to such 
Board after such date in a manner which will oring about, at the 
earliest feasible time, the composition prescribed by such amendment, 
(b) Part I of title IV is amended by adding at the end the following: 
"APPROPRIATIONS 
42 use 289/-6. 
"SEC. 477. Appropriations to carry out the purposes of this title 
shall be available for the acquisition of land or the erection of build-
ings only if so specified, but in the absence of express limitation therein 
may be expended in the District of Columbia for personal services, 
stenographic recording and translating services, by contract if deemed 
41 use 5. 
necessary, without regard to section 3709 of the Revised Statutes; 
traveling expenses (including the expenses of attendance at meetings 
when specifically authorized hj the Secretary); rental, supplies and 
equipment, purchase and exchange of medical books, books of refer-
ence, directories, periodicals, newspapers, and press clippings; 
purchase, operation, and maintenance of motor-propelled passenger-
carrying vehicles; printing and binding (in addition to that otherwise 
provided by law); and for all other necessary expenses in carrying 
out the provisions of this title. 
"OTHER AUTHORITY 
42 use 289/-7. 
"SEC. 478. This title shall not be construed as limiting (1) the func-
tions or authority of the Secretary under any other title of this Act, 
or of any officer or agency of the United States, relating to the study 
of the prevention, diagnosis, and treatment of any disease or diseases 
for which a separate institute is established under this Act; or (2) the 
expenditure of money therefor.". 
CONFORMING AMENDMENTS 
42 use 287d. 
SEC. 242. (a) Section 415 (b) (1) is amended by striking out "section 
405" and inserting in lieu thereof "section 477". 
42 use 289/. 
(b) Section 471 is amended by striking out "section 407 (b) (9)" and 
inserting in lieu thereof "section 404 (a) (8)". 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3433 
PART D—NATIONAL RESEARCH SERVICE AWARDS 
EXTENSION OF AUTHORIZATIONS 
SEC. 251. (a) Subsection (d) of section 472 is amended by striking 42 USC 289/-1. 
out "and" after "1977," and by inserting before the period at the end 
of the first sentence the following: ", $197,500,000 for the fiscal year 
ending September 30, 1979, $210,000,000 for the fiscal year ending 
September 30, 1980, and $222,500,000 for the fiscal year ending 
September 30,1981". 
(b) Subsection (d) of such section is amended (1) by striking out 
"25 per centum" in the second sentence and inserting in lieu thereof 
"15 per centum", and (2) by inserting before the period "and not less 
than 50 per centum shall be made available for grants under subsection 
(a)(1)(B) for National Research Service Awards". 
(c) Subsection (d) of such section is amended by adding at the end 
thereof the following new sentence: "In any fiscal year not more than 
4 per centum of the amount obligated to be expended under this section 
may be obligated for National Research Service Awards for periods 
of three months or less.". 
APPROVAL o r AWARDS 
SEC. 252. Paragraph (2) of subsection (b) of such section is amended 
by striking out '^Ihe award of National Research Service Awards by 
the Secretary under subsection (a) and the making of grants for such 
Awards" and inserting in lieu thereof "The making of grants under 
subsection (a) (1) (B) for National Research Service Awards". 
PERIOD OF AWARDS 
SEC. 253. Paragraph (4) of subsection (b) of such section is amended 
to read as follows: 
"(4) The period of any National Research Service Award made to 
any individual under subsection (a) may not exceed— 
"(A) five years in the aggregate for predoctoral training, and 
"(B) three years in the aggregate for postdoctoral training, 
unless the Secretary for good cause shown waives the application of 
such limit to such individual." 
ADJUSTMENTS IN ALLOWANCES 
SEC. 254. The first sentence of subsection (b) (5) of such section is 
amended by inserting after "dependency allowances)" the following: 
", adjusted periodically to reflect increases in the cost of living". 
SERVICE OBLIGATION 
SEC. 255. (a) Subparagraph (B) of subsection (c) (1) of such sec-
tion is amended (1) by inserting "or" in clause (i) after "Corps,"^ (2) 
by striking, out clause (ii), and (3) by redesignating clause (iii) as 
clause (ii). 
(b) (1) Paragraph (2) of subsection (c) of such section is amended 
to read as follows: 
"(2) For each month for which an individual receives a National 
Research Service Award which is made for a period in excess of three 
months, such individual shall— 
39-194 O—80—pt. 3 
51 : QL3 
92 STAT. 3434 
PUBLIC LAW 95-622—NOV. 9, 1978 
"(A) for one month engage in health research or teaching or 
any combination thereof which is in accordance with the usual 
patterns of academic employment, or, if so authorized, serve as a 
member of the National Health Service Corps, or 
"(B) if authorized under paragraph (1) (B) or (l)(C),for 
one month serve in the individual's specialty or engage in a 
health-related activity." 
(2) Paragraph (4) (A) of such subsection is amended by striking 
out 
and inserting in lieu thereof 
. 
,_;, 
" • ^ = * ( ^ ) " -
(3) Paragraph (5) (B) of such subsection amended by striking out 
"extreme hardship" and inserting in lieu thereof 
"substantial 
hardship". 
42 use 289^-1 
(b) The amendments made by subsection (a) shall apply only with 
note. 
respect to National Research Service Awards made under section 472 
42 use 289/-1. 
of the Public Health Service Act after the date of the enactment of 
this Act. 
REPORTS ON STUDIES 
f 
-
42 use 289/-2. 
SEC. 256. Section 473(c) is amended by striking out "not later than 
September 30 of each year" and inserting in lieu thereof "at least once 
every two years". 
PART E—MISCELLANEOUS AMENDMENTS 
SUBSTANCES AND ORGANISMS FOR RESEARCH 
42 use 241. 
SEC 261. Effective October 1,1978, section 301 is amended by adding 
after and below paragraph (h) the following: "The Secretary may 
make available to individuals and entities, for biomedical and behav-
ioral research, substances and living organisms. Such substances and 
organisms shall be made available under such terms and conditions 
(including payment 
for 
them) 
as the Secretary 
determines 
appropriate." 
EXPANSION OF RESEARCH AND TESTING AUTHORITY 
42 use 241. 
SEC. 262. Effective October 1,1978, section 301 (as amended by sec-
tion 261 of this title) is amended (1) by striking out "Surgeon Gen-
eral" each place it appears and inserting in lieu thereof "Secretary", 
(2) by striking out "Collect" in paragraph (a) and inserting in lieu 
thereof "collect", (3) by striking out "Make" in paragraphs (b), (c), 
and (f) and inserting in lieu thereof "make", (4) oy striking out 
"Secure" in paragraph (d) and inserting in lieu thereof "secure , (5) 
by striking out "For" in paragraph (e) and inserting in lieu thereof 
"for", (6) by striking out "Enter" in paragraph (g) and inserting in 
lieu thereof "enter", (7) by striking out "Adopt" m paragraph (h) 
and inserting in lieu thereof "adopt", (8) by striking out "and" at 
the end of paragraph (f), (9) by redesignating paragraphs (a) 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3435 
ionizing 
radiation. 
through (h) as paragraphs (1) through (8), respectively, and (10) by 
inserting "(a)" after "301." and by adding at the end the following: 
"(b)(1) The Secretary shall conduct and may support through Grants, 
grants and contracts studies and testing of substances for carcinogen-
icity, 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, terato-
genicity, mutagenicity, and other harmful biological effects. 
"(2) (A) The Secretary shall establish a comprehensive program of Low-level 
research into the biological effects of low-level ionizing radiation under 
which program the Secretary shall conduct such research and may 
support such research by others through grants and contracts. 
"(B) The Secretary shall conduct a comprehensive review of Fed-
eral programs of research on the biological effects of ionizing radiation. 
"(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 prevention and treatment of 
disease and on the maintenance and promotion of health, and pro-
grams for the dissemination of information respecting human nutri-
tion 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 Depart-
ment 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. 
"(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 estab-
lished by a Federal agency with respect to a substance contained 
in the list under subparagraph (A), the ex^tent 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— 
"(I) 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 sub-
Annual report, 
publication. 
92 STAT. 3436 
PUBLIC LAW 95-622—NOV. 9, 1978 
stances or to provide information described in clause (ii) of sub-
paragraph (C), and (ii) how the Secretary and each such other 
entity, respectively, have responded to each such request. 
Contract 
"(5) The authority of the Secretary to enter into any contract for 
authority. 
the conduct of any study, testing, program, research, or review, or 
assessment under this subsection shall be effective for any fiscal year 
only to such extent or in such amounts as are provided in advance in 
appropriation Acts.". 
NEW ARTHRITIS CENTERS 
42 use 289c-6. 
SEC. 263. Section 439 (g) is amended by striking out the last sentence. 
PEER REVIEW OF RESEARCH GItANTS UNDER THE DIVISION OF NURSING 
42 use 289/-4. 
SEC 264. Section 475(a) is amended (1) by inserting before ", shall 
by regulation" the following: "and the head of the Division of Nursing 
of the Health Resources Administration (or the successor to either 
such entity)", (2) by inserting after "research" in paragraph (1) the 
following: "(including research under programs of such Division of 
Nursing)", and (3) by striking out "or the" in paragraph (2) and 
inserting in lieu thereof "the" and by inserting before the period in 
that paragraph a comma and the following: "or the Division of Nurs-
ing of the Health Resources Administration (or the successor to either 
such entity)". 
EXPERTS AND CONSULTANTS FOR THE 
INSTITUTES 
Ante, p. 3432. 
SEC 265. Title IV is amended by inserting after section 478 (as 
added by section 241(b) of this title) the following new section: 
42 use 289/-8. 
eompensation. 
42 use 284, 
287b. 
"EXPERTS AND CONSULTANTS 
"SEC. 479. (a) The Director of the National Institutes of Health 
may obtain (in accordance with section 3109 of title 5, United States 
Code, but without regard to the limitation in such section on the 
number of days or the period of service) the services of not more than 
two hundred experts or consultants who have scientific or professional 
qualifications, for the National Institutes of Health and for each of 
the research institutes (other than the National Cancer Institute and 
the National Heart, Lung, and Blood Institute). 
" (b) (1) Experts and consultants whose services are obtained under 
subsection (a) or under section 404(b) (1) or 413(c) (1) shall be paid 
or reimbursed for their expenses associated with traveling to and from 
their assignment location in accordance with sections 5724, 5724a(a) 
(1), 5724a(a) (3), and 5726(c) of title 5, United States Code. 
"(2} Expenses specified in paragraph (1) may not be allowed in 
connection with the assignment of an expert or consultant whose 
services are obtained under this subsection, unless and until the expert 
or consultant agrees in writing to complete the entire period of his 
assignment or 1 year, whichever is shorter, unless separated or 
reassigned for reasons beyond his control that are acceptable to the 
Secretary. If the expert or consultant violates the agreement, the money 
spent by the United States for these expenses is recoverable from him 
as a debt due the United States. The Secretary may waive in whole 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3437 
or in part a right of recovery under this subsection with respect to an 
expert or consultant on assignment with the Secretary.". 
PUBLIC HEALTH SERVICE HOSPITALS 
SEC. 266. Section 321 (a) is amended by striking out ", and tobacco". 42 USC 248. 
EXTENSION o r DEADLINE FOR FINAL REPORT OF NATIONAL COMMISSION ON 
DIGESTIVE DISEASES 
SEC. 267. Section 301 (i) (1) of the Arthritis, Diabetes, and Digestive 
Disease Amendments of 1976 (Public Law 94-562) is amended by 42 USC 289a 
striking out "Within eighteen months following its initial meeting (as note, 
prescribed by subsection (d))," and inserting in lieu thereof "Not 
later than February 1,1979,". 
PROGRAMS FOR FAMILIES OF ALCOHOLICS AND ALCOHOL ABUSERS 
SEC. 268. (a) Section 2(a) of the Comprehensive Alcohol Abuse and 
Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 is 42 USC 4541. 
amended— 
(1^ by striking out "and" at the end of paragraph (5), 
(2) by redesignating paragraph (6) as paragraph (7), and 
(3) by inserting after paragraph (5) the following new 
paragraph: 
"(6) alcohol abuse and alcoholism have a substantial impact 
on the families of alcohol abusers and alcoholics; and". 
(b) Section 303(a)(4)(B) of such Act is amended by inserting 42 USC 4573. 
"and for education, counseling, and treatment of the families of 
alcoholic abusers and alcoholics" after "under the age of eighteen". 
(c) Section 501 (a) of such Act is amended— 
42 USC 4585. 
(1) by striking out "of" each place it appears in paragraphs 
(1) through (4) and inserting "of" before "alcohol abuse and 
alcoholism"; 
(2) by striking out "and" at the end of paragraph (3) and 
inserting "and" after the comma at the end of paragraph (4); and 
(3) by inserting after paragraph (4) the following new 
paragraph: 
"(5) the impact on families,". 
(d) Section 501(b)(5) of such Act is amended by inserting "or 
those of their families" after "individuals suffering from alcoholism 
or alcohol abuse". 
TITLE III—PRESIDENT'S COMMISSION FOR THE STUDY 
OF ETHICAL PROBLEMS IN MEDICINE AND BIO-
MEDICAL AND BEHAVIORAL RESEARCH 
P R E S I D E N T ' S COMMISSION FOR THE STUDY OF ETHICAL PROBLEMS I N 
MEDICINE AND BIOMEDICAL AND BEHAVIORAL RESEARCH 
SEC 301. The Public Health Service Act is amended by adding after 
title XVII the following new title: 
92 STAT. 3438 
PUBLIC LAW 95-622—NOV. 9, 1978 
"TITLE XVIII—PKESIDENT'S COMMISSION FOR 
THE 
STUDY OF ETHICAL PROBLEMS IN MEDICINE AND 
BIOMEDICAL AND BEHAVIORAL RESEARCH 
''ESTABLISHMENT OF COMMISSION 
42 use 300v. 
"SEC. 1801. (a) ESTABLISHMENT.—(1) There is established the 
President's Commission for the Study of Ethical Problems in Medicine 
and Biomedical and Behavioral Research (hereinafter in this title 
referred to as the 'Commission') which shall be composed of eleven 
members appointed by the President. The members of the Commission 
shall be appointed as follows: 
" (A) Three of the members shall be appointed from individuals 
who are distinguished in biomedical or behavioral research. 
"(B) Three of the members shall be appointed from individuals 
who are distinguished in the practice of medicine or otherwise 
distinguished in the provision of health care. 
i 
"(C) Five of the members shall be appointed from individuals 
who are distinguished in one or more of the fields of ethics, 
theology, law, the natural sciences (other than a biomedical or 
behavioral science), the social sciences, the humanities, health 
administration, government, and public affairs. 
"(2) No individual who is a full-time officer or employee of the 
United States may be appointed as a member of the Commission. The 
Secretary of Health, Education, and Welfare, the Secretary of 
Defense, the Director of Central Intelligence, the Director of the 
* :;>. • ' 
Office of Science and Technology Policy, the Administrator of 
Veterans' Affairs, and the Director of the National Science Foundation 
shall each designate an individual to provide liaison with the 
;. [i:, •• 
Commission. 
"(3) No individual may be appointed to serve as a member of the 
Commission if the individual has served for two terms of four years 
each as such a member. 
"(4) A vacancy in the Commission shall be filled in the manner in 
which the original appointment was made. 
"(b) TERMS.— (1) Except as provided in paragraphs (2) and (3), 
members shall be appointed for terms of four years. 
"(2) Of the members first appointed— 
" (A) four shall be appointed for terms of three years, and 
"(B) three shall be appointed for terms of two years, 
as designated by the President at the time of appointment. 
"(^3) Any member appointed to fill a vacancy occurring before the 
expiration of the term for which his predecessor was appointed shall 
be appointed only for the remainder of such term. A member may 
serve after the expiration of his term until his successor has taken 
office. 
"(c) 
CHAIRMAN.—The Chairman of the Commission shall be 
appointed by the President, by and with the advice and consent of the 
Senate, from members of the Commission. 
"(d) MEETINGS.—(1) Seven members of the Commission shall 
constitute a quorum for business, but a lesser number may conduct 
hearings. 
"(2) The Commission shall meet at the call of the Chairman or at 
the call of a majority of its members. 
•
.
*
*
»
%
• 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3439 
"(e) COMPENSATION.— (1) Members of the Commission shall each 
be entitled to receive the daily equivalent of the annual rate of basic 
pay in effect for grade GS-18 of the General Schedule for each day 
(including travel time) during which they are engaged in the actual 
performance of duties vested in the Commission. 
"(2) While away from their homes or regular places of business in 
the performance of services for the Commission, members of the 
Commission shall be allowed travel expenses, including per diem in lieu 
of subsistence, in the same manner as persons employed intermittently 
in the Government service are allowed expenses under section 5703 of 
title 5 of the United States Code. 
5 use 5332 
note. 
u 
DUTIES OF THE COMMISSION 
"SEC. 1802. (a) STITDIES.— (1) The Commission shall undertake 
42 USC 300v-l. 
studies of the ethical and legal implications of— 
"(A) the requirements for informed consent to participation in 
research projects and to otherwise undergo medical procedures; 
"(B) the matter of defining death, including the advisability of 
s
- developing a uniform definition of death; 
"(C) 
voluntary testing, counseling, and information 
and 
education 
programs 
with 
respect 
to 
genetic 
diseases 
and 
conditions, taking into account the essential equality of all human 
beings, born and unborn; 
"(D) the differences in the availability of health services as 
determined by the income or residence of the persons receiving the 
services; 
" ( E ) current procedures and mechanisms designed (i) to safe-
guard the privacy of human subjects of behavioral and biomedical 
research, (li) to ensure the confidentiality of individually identi-
fiable patient records, and (iii) to ensure appropriate access of 
.
> 
patients to information continued in such records, and 
" ( F ) such other matters relating to medicine or biomedical or 
• > 
behavioral research as the President may designate for study by 
the Commission. 
The Commission shall determine the priority and order of the studies 
required under this paragraph. 
"(2) The Commission may undertake an investigation or study of 
any other appropriate matter which relates to medicine or biomedical 
or behavioral research (including the protection of human subjects of 
biomedical or behavioral research) and which is consistent with the 
purposes of this title on its own initiative or at the request of the head 
of a Federal agency. 
"(3) In order to avoid duplication of effort, the Commission may, 
in lieu of, or as part of, any study or investigation required or other-
wise conducted under this subsection, use a study or investigation 
conducted by another entity if the Commission sets forth its reasons 
for such use. 
"(4) Upon the completion of each investigation or study under- Report to 
taken by the Commission under this subsection (including a study 
President and 
or investigation which merely uses another study or investigation), it Congress, 
shall report its findings (including any recommendations for legisla-
tion or administrative action) to the President and the Congress and 
to each Federal agency to which a recommendation in the report 
, , 
applies. 
y • 
,--.., 
;• _ 
92 STAT. 3440 
PUBLIC LAW 95-622—NOV. 9, 1978 
Publication in 
Federal Register. 
Report to 
President, 
Congress, and 
Federal agencies. 
Publication in 
"(b) RECOMMENDATIONS TO AGENCIES.—(1) Within 60 days of the 
Federal Register, date a Federal agency receives a recommendation from the Commission 
that the agency take any action with respect to its rules, policies, guide-
lines, or regulations, the agency shall publish such recommendation 
in the Federal Register and shall provide opportunity for interested 
persons to submit written data, views, and arguments with respect to 
adoption of the recommendation. 
"(2) Within the 180-day period beginning on the date of such pub-
lication, the agency shall determine whether the action proposed by 
such recommendation is appropriate, and, to the extent that it deter-
mines that— 
"(A) such action is not appropriate, the agency shall, within 
such time period, provide the Commission with, and publish in 
the Federal Register, a notice of such determination (including 
an adequate statement of the reasons for the determination), or 
"(B) such action is appropriate, the agency shall undertake 
such action as expeditiously as feasible and shall notify the Com-
mission of the determination and the action undertaken. 
"(c) 
REPORT ON PROTECTION OF H U M A N SUBJECTS.—The Commis-
sion shall biennially report to the President, the Congress, and 
appropriate Federal agencies on the protection of human subjects of 
biomedical and behavioral research. Each such report shall include a 
review of the adequacy and uniformity (1) of the rules, policies, guide-
lines, and regulations of all Federal agencies regarding the protection 
of human subjects of biomedical or behavioral research which such 
agencies conduct or support, and (2) of the implementation of such 
rules, policies, guidelines, and regulations by such agencies, and may 
include such recommendations for legislation and administrative 
action as the Commission deems appropriate. 
"(d) ANNUAL REPORT.—Not later than December 15 of each year 
(beginning with 1979) the Commission shall report to the President, 
the Congress, and appropriate Federal agencies on the activities of the 
Commission during the fiscal year ending in such year. Each such 
report shall include a complete list of all recommendations described 
in subsection (b) (1) made to Federal agencies by the Commission 
during the fiscal year and the actions taken, pursant to subsection 
(b) (2), by the agencies upon such recommendations, and may include 
such recommendations for legislation and administrative action as the 
Commission deems appropriate. 
" (e) PUBLICATIONS.—The Commission may at any time publish and 
disseminate to the public reports respecting its activities. 
"(b) DEEINITIONS.—For purposes of this section: 
"(1) The term 'Federal agency' means an authority of the gov-
ernment of the United States, but does not include (A) the Con-
gress, (B) 
the courts of the United States, and 
(C) 
the 
government of the Commonwealth of Puerto Rico, the govern-
ment of the District of Columbia, or the government of any terri-
tory or possession of the United States. 
"(2) The term 'protection of human subjects' includes the pro-
tection of the health, safety, and privacy of individuals. 
"ADMINISTRATIVE PROVISIONS 
Hearings. 
"SEC. 1803. (a) HEARINGS.—The Commission may for the purpose 
42 use 300v-2. 
of carrying out this title hold such hearings, sit and act at such times 
Report to 
President, 
Congress, and 
Federal agencies. 
PUBLIC LAW 95-622—NOV. 9, 1978 
92 STAT. 3441 
and places, take such testimony, and receive such evidence, as the Com-
mission may deem advisable. 
"(b) STAFF.— (1) The Commission may appoint and fix the pay of 
such staff personnel as it deems desirable. Such personnel shall be 
appointed subject to the provisions of title 5, United States Code, gov-
erning appointments in the competitive service, and shall be paid in 
accordance with the provisions of chapter 51 and subchapter I I I of 
chapter 53 of such title relating to classification and General Schedule 5 USC 5101 et 
pay rates. 
*^9' ^331. 
"(2) The Commission may procure temporary and intermittent 
services to the same extent as is authorized by section 3109(b) of title 
5 of the United States Code, but at rates for individuals not to exceed 
the daily equivalent of the annual rate of basic pay in effect for grade 
GS-18 of the General Schedule. 
5 USC 5332 
"(3) Upon request of the Commission, the head of any Federal 
"ote. 
agency is authorized to detail, on a reimbursable basis, any of the per-
sonnel of such agency to the Commission to assist it in carrying out 
its duties under this title. 
"(c) CONTRACTS.—The Commission, in performing its duties and 
functions under this title, may enter into contracts with appropriate 
public or nonprofit private entities. The authority of the Commission 
to enter into such contracts is effective for any fiscal year only to such 
extent or in such amounts as are provided in advance in appropria-
tion Acts. 
"(d) INFORMATION.— (1) The Commission may secure directly from 
any Federal agency information necessary to enable it to carry out this 
title. Upon request of the Chairman of the Commission, the head of 
such agency shall furnish such information to the Commission. 
"(2) The Commission shall promptly arrange for such security 
clearances for its members and appropriate staff as are necessary to 
obtain access to classified information needed to carry out its duties 
under this title. 
"(3) The Commission shall not disclose any information reported 
to or otherwise obtained by the Commission which is exempt from 
disclosure under subsection (a) of section 552 of title 5, United States 
Code, by reason of paragraphs (4) and (6) of subsection (b) of such 
section. 
"(e) SUPPORT SERVICES.—^The Administrator of General Services 
shall provide to the Commission on a reimbursable basis such admin-
istrative support services as the Commission may request. 
"AUTHORIZATION or 
APPROPRIATIONS; TERMINATION OF COMMISSION 
"SEC. 1804. (a) AUTHORIZATIONS.—To carry out this title there are 42 USC 300v-3. 
authorized to be appropriated $5,000,000 for the fiscal year ending Sep-
tember 30, 1979, $5,000,000 for the fiscal year ending September 30, 
1980, $5,000,000 for the fiscal year ending September 30, 1981, and 
$5,000,000 for the fiscal year ending September 30,1982. 
"(b) 
FEDERAL ADVISORY COMMITTEE A C T ; TERMINATION.—The Com-
mission shall be subject to the Federal Advisory Committee Act, 5 USC app. 
except that, under section 14(a) (1) (B) of such Act, the Commission 
shall terminate on December 31,1982.". 
92 STAT. 3442 
PUBLIC LAW 95-622—NOV. 9, 1978 
' 
MISCELLANEOUS PROVISIONS 
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SEC. 302. (a) The President shall initially appoint members to the 
note. 
President's Commission for the Study of Ethical Problems in Medicine 
and Biomedical and Behavioral Kesearch (established under the 
amendment made by section 301) not later than 90 days after the date 
of the enactment of this title. 
Repeal. 
(b) Effective November 1, 1978, part A of title I I of the National 
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Research Act, section 213 of such Act, and subsection (f) of section 
°o*«- 
217 of the Public Health Service Act are repealed. 
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Approved November 9, 1978. 
LEGISLATIVE HISTORY: 
HOUSE REPORT No. 95-1192 accompanying H.R. 12347 (eomm. on Interstate and 
Foreign eommerce). 
SENATE REPORT No. 95-838 (eomm. on Human Resources). 
eONGRESSIONAL REeORD, Vol. 124 (1978): 
June 26, considered and passed Senate. 
Oct. 15, considered and passed House, amended; Senate concurred in House 
amendments.