A bill to amend the Public Health Service Act to revise and extend the program under the National Heart and Lung Institute, to revise and extend the program of National Research Service Awards, and to establish a national program with respect to genetic diseases; and to require a study and report on the release of research information.
PL 94-278 (H.R.7988), enacted 04/22/1976

PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 401 
Public Law 94-278 
94th Congress 
An Act 
To amend the Public Health Service Act to revise and extend the program 
under the National Heart and Lung Institute, to revise and extend the pro-
gram of National Research Service Awards, and to establish a national pro-
gram with respect to genetic diseases; and to require a study and report on 
the release of research information. 
Be it enacted hy the Senate and House of Representatives of the 
United States of America in Congress assembled^ 
SECTION 1. (a) This Act may be cited as the "Health Research and 
Health Services Amendments of 1976"'. 
(b) Whenever in this Act (other than in titles III, V, VI, VII, and 
XI) 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. 
Apr. 22, 197(3 
[H.R. 7988] 
Health Research 
and Health 
Services 
Amendments of 
1976. 
42 u s e 201 note. 
42 u s e 201 note. 
TITLE I—KEVISION OF NATIONAL HEART AND LUNG 
INSTITUTE PROGRAMS 
SEC. 101. (a) Congress finds and declares that— 
(1) diseases of the heart, blood, and blood vessels collectively 
cause more than half of all the deaths each year in the United 
States and the combined effect of the disabilities and deaths from 
such diseases is having a major social and economic impact on 
the Nation; 
(2) elimination of heart and blood vessel diseases as significant 
causes of disability and death could increase the average Ameri-
can's life expectancy by about eleven years and could provide for 
annual savings to the economy in lost wages, productivity, and 
cost of medical care of more than $40,000,000,000 per year ; 
(3) chronic lung diseases have been gaining steadily in recent 
years as important causes of disability and death, vrith emphysema 
being among the fastest rising causes of death in the United 
States; 
(4) chronic respiratory diseases affect an estimated ten million 
Americans, emphysema an estimated one million, chronic bron-
chitis an estimated four million, and asthma an estimated five 
million; 
(5) thrombosis (the formation of blood clots in the vessels) 
may cause, directly or in combination with other problems, many 
deaths and disabilities from heart disease and stroke which can 
now be prevented; 
(6) blood and blood products are essential human resources 
whose value in saving life and promoting health cannot be 
assessed in terms of dollars; 
(7) the provision of prompt and effective emergency medical 
services utilizing to the fullest extent possible advances in trans-
portation and communications and other electronic systems and 
specially trained professional and paraprofessional health care 
personnel can reduce substantially the number of fatalities and 
42 u s e 287 note. 
90 STAT. 402 
PUBLIC LAW 94-278—APR. 22, 1976 
severe disabilities due to critical illnesses in connection with heart, 
blood vessel, lung, and blood diseases; 
(8) blood diseases, including nutritional anemia, anemia due to 
inherited abnormalities (such as sickle cell anemia and Cooley's 
anemia (thalassemia), anemias resulting from failure of the bone 
marrow, hemorrhagic defects (a common cause of death in patients 
with leukemia and other malignancies, and of disability from 
inherited diseases such as hemophilia)), and malignancies of the 
lymph nodes and bone marrow, such as leukemia, have a devastat-
ing impact in spite of recent advances, and constitute an impor-
tant category of illness that requires major attention; and 
(9) the greatest potential for advancement against heart, blood 
vessel, lung, and blood diseases lies in the National Heart, Lung, 
and Blood Institute, but advancement against such diseases 
f 
depends not only on the research programs of that Institute but 
also on the research programs of other research institutes of the 
National Institutes of Health, 
(b) It is the purpose of this title to enlarge the authority of the 
National Heart, Lung, and Blood Institute in order to advance the 
national attack upon heart, blood vessel, lung, and blood diseases and 
to enlarge its authority with respect to blood resources. 
National Heart, 
SEC. 102. Sections 411, 418(a) (6), and 419A(c) are each amended 
Lung, and Blood 
by striking out "National Heart and Lung Institute" and inserting in 
Institute. 
][Q^ thereof "National Heart, Lung, and Blood Institute". 
^2 use 287, 
gj,^_ 103. (a) Section 412 is amended— 
42 use 287a 
^^"^ ^ inserting "and with respect to the use of blood and blood 
products and the management of blood resources" after "diseases" 
in the matter preceding paragraph (1) ; 
(2) by inserting "and to the use of blood and blood products 
and the management of blood resources" before the semicolon at 
the end of paragraph (1); 
(3) by inserting "and to the use of blood and blood products 
and the management of blood resources" after "diseases" in para-
graph (4) 
_; 
(4) by inserting "and on the use of blood and blood products 
and the management of blood resources" after "diseases" in para-
graph (5); 
_ 
(5) by striking out "heart diseases" in paragraph (6) and 
inserting in lieu thereof "heart, blood vessel, lung, and blood 
diseases and the management of blood resources"; 
(6) by inserting "and to the use of blood and blood products 
and the management of blood resources" after "diseases" in para-
graph (7); and 
(7) by inserting at the end of the section heading "AND IN THE 
MANAGEMENT OF BLOOD RESOURCES". 
National Heart, 
(b) Section 412 is amended by striking out "National Heart and 
Lung, and Blood 
Lung Advisory Council" and inserting in lieu thereof "National Heart, 
Advisory Council, ^ ^ ^ g , and Blood Advisory Council". 
42 use 287b. 
SEC. 104 (a) Section 413(a) is amended— 
(1) by striking out "Disease" in the first sentence and insert-
ing in lieu thereof "Diseases and Blood Resources"; and 
(2) by inserting "and blood resources" after "diseases" in such 
sentence and in paragraph (7). 
(b) Section 413(b) is amended— 
(1) by striking out "calendar" each place it occurs in paragraph 
(2) and inserting in lieu thereof "fiscal"; and 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 403 
(2) by adding at the end of such paragraph the following: "Each 
such plan shall contain (A) an estimate of the number and type 
of personnel which will be required by the Institute to carry out 
the Program during the five years with respect to which the plan 
is submitted, and (B) recommendations for appropriations to 
carry out the program during such five years". 
(c) Section 413(c)(1) is amended by striking out "fifty" and 
inserting in lieu thereof "one hundred". 
(d) Section 413(c) (2) is amended— 
(1) by striking out "operate" and inserting in lieu thereof 
"operate, alter, renovate"; and 
(2) by inserting "and blood resource" after "disease". 
(e) Section 413(d) is amended— 
(1) by striking out "Assistant Director for Health Informa-
tion Programs" each place it occurs and inserting in lieu thereof 
"Assistant Director for Prevention Education, and Control"; 
(2) by striking out "and pulmonary" in the second sentence and 
inserting in lieu thereof ", blood, and pulmonary" and by inserting 
"and blood" after "pulmonary" in the third sentence; and 
(3) by inserting "and blood resources" after "diseases" in the 
second sentence. 
(f) The section heading of section 413 is amended by striking out 
"DISEASE" and inserting in lieu thereof "DISEASES AND BLOOD RESOURCES". 
SEC. 105. Section 414(b) is amended (1) by striking out "and" after 
"1974,", and (2) by inserting before the period a comma and the fol-
lowing : "$10,000,000 for fiscal year 1976, and $30,000,000 for fiscal year 
1977". 
SEC. 106. (a) (1) Subsection (a) (1) (A) of section 415 is amended 
b y -
(A) striking out "fifteen" and inserting in lieu thereof "ten", 
and 
(B) striking out ", blood vessel, and blood diseases" and insert-
ing in lieu thereof "diseases". 
(2) Subsection (a) (1) (B) of such section is amended by striking 
out "fifteen" and inserting in lieu thereof "ten". 
(3) Subsection (a) (1) of such section is amended—-
(A) by striking out "and" at the end of subparagraph ( A ) , 
(B) by striking out the period at the end of subparagraph (B) 
and inserting in lieu thereof ", and", and 
(C) by inserting after subparagraph (B) the following new 
subparagraph: 
"(C) ten new centers for basic and clinical research into, train-
ing in, and demonstration of, advanced diagnostic, prevention, 
and treatment methods (including methods of providing emer-
gency medical services) for blood, blood vessel diseases, research 
in the use of blood products, and research in the management of 
blood resources.", 
(b) Section 415 (a) is further amended— 
(1) by inserting "and for research in the use of blood and blood 
products and in the management of blood resources" after 
"diseases" in paragraph (1) ( A ) ; 
(2) by striking out "chronic" in paragraph (1) ( B ) ; 
(3) by striking out "paragraph (1) ( A ) " in paragraph (2) and 
inserting in lieu thereof "paragraph ( 1 ) " ; 
42 use 287b. 
Assistant 
Director for 
Prevention 
Education, and 
Control. 
42 use 287c. 
National research 
and 
demonstration 
centers. 
42USC287d. , 
90 STAT. 404 
PUBLIC LAW 94-278—APR. 22, 1976 
42 use 287d. 
Aggregate of 
[>ayments, 
imitation. 
42 use 287f. 
42 use 287g. 
Report to 
Secretary for 
transmittal to 
President and 
Congress. 
42 u s e 287g 
note. 
Effective date. 
42 u s e 287g 
note. 
(4) by inserting ", pulmonary, and blood" before "diseases" in 
paragraph (2) ; 
(5) by striking out "cardiovascular disease" in paragraph (2) 
(A) and inserting in lieu thereof "cardiovascular, pulmonary, and 
blood diseases"; and 
(6) by striking out "such disease" in subparagraphs (B), (C), 
and (D) of paragraph (2) and inserting in lieu thereof "such 
diseases". 
(c) Section 415 (b) is amended— 
(1) by inserting "the management of blood resources and" 
before "advanced"; and 
(2) by amending the first sentence after paragraph (4) to read 
as follows: "The aggregate of payments (other than payments for 
construction) made to any center under such an agreement for its 
costs (other than indirect costs) described in the first sentence may 
not exceed $5,000,000 in any year, except that the aggregate of 
such payments in any year may exceed such amount to the extent 
that the excess amount is attributable to increases in such year in 
appropriate costs as reflected in the Consumer Price Index pub-
lished by the Bureau of Labor Statistics.". 
(d) The section heading of section 415 is amended by inserting "AND 
B
L
O
O
D RESOURCES" after "DISEASES". 
SEC. 107. (a) Section 417(a) (1) is amended by striking out "Director 
of the Office of Science and Technology" and inserting in lieu thereof 
"Director of the National Science Foundation". 
(b) Section 417 is amended by striking out "National Heart and 
Lung Advisory Council" in subsection (a) and in subsection (b) (3) 
and inserting in lieu thereof "National Heart, Lung, and Blood 
Advisory Council". 
(c) The section heading of section 417 is amended by striking out 
"AND LUNG" and inserting in lieu thereof ", LUNG, AND BLOOD". 
SEC. 108. Section 418 is amended— 
(1) by inserting "and to the use of blood and blood products and 
the management of blood resources" after "diseases" in para-
graphs (1), (2), (3), and (4) of subsection (a) ; 
(2) by redesignating paragraphs (4), (5), and (6) of subsec-
tion (a) as paragraphs (5), (6), and (7),respectively, and by add-
ing after paragraph (3) the following new paragraph: 
"(4) recommend to the Secretary (A) areas of research in 
heart, blood vessels, lung, and blood diseases and in the use of 
blood and blood products and the management of blood resources 
which it determines should be supported by the awarding of con-
tracts in order to best carry out the purposes of this part, and (B) 
the percentage of the budget of the Institute which should be 
expended for such contracts;"; and 
(3) (A) by amending paragraph (2) of subsection (b) to read 
as follows: 
"(2) The Council shall submit a report to the Secretary for simul-
taneous transmittal, not later than November 30 of each year, to the 
President and to the Congress on the progress of the Program toward 
the accomplishment of its objectives during the preceding fiscal year.". 
(B) For purposes of section 418(b) (2) of the Public Health 
Service Act (as amended by subparagraph (A)), the period 
beginning July 1, 1975, and ending September 30, 1976, shall be 
considered a fiscal year. 
(C) The amendment made by subparagraph (A) shall take 
effect as of January 1,1976. 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 405 
SEC. 109. Section 419A is amended— 
(1) by inserting "and projects with respect to the use of blood 
and blood products and the management of blood resources" after 
"training projects" in subsection (a); 
(2) by inserting "and into the use of blood and blood products 
and the management of blood resources" after "diseases" in sub-
section (b); 
(3) by inserting "and for research and training in the use of 
blood and blood products and the management of blood resources" 
after "diseases" in subsection (c); 
(4) by striking out "in amounts not to exceed $35,000" in para-
graph (1) of subsection (c) and inserting in lieu thereof "if the 
direct costs of such research and training do not exceed $35,000, 
but only"; and 
(5) by striking out "in amounts exceeding $35,000" in para-
graph (2) of subsection (c) and inserting in lieu thereof "if the 
direct costs of such research and training exceed $35,000, but only". 
SEC. 110. Section 419B is amended— 
(1) by striking out "and" after "1974," and by inserting before 
the period at the end of the first sentence a comma and the fol-
lowing : "$339,000,000 for fiscal year 1976, and $373,000,000 for fis-
cal year 1977"; and 
(2) by striking out "diseases of the blood" and inserting in lieu 
thereof "blood diseases and blood resources". 
SEC. 111. (a) Section 301 is amended by striking out "heart diseases" 
in paragraphs (c) and (h) and inserting in lieu thereof "heart, blood 
vessel, lung, and blood diseases and blood resources". 
(b) Section 301 is amended by striking out "National Heart and 
Lung Advisory Council" in paragraphs (c) and (h) and inserting in 
lieu thereof "National Heart, Lung, and Blood Advisory Council". 
SEC. 112. The title of Part B of title IV is amended to read as 
follows: 
Administration. 
42 use 287h. 
42 use 287i. 
42 use 241. 
"PART B—NATIONAL HEART, LUNG, AND BLOOD INSTITUTE". 
TITLE II—NATIONAL RESEARCH SERVICE AWARDS 
SEC. 201. (a) (1) Subsection (a) (1) (A) (i) of section 472 is amended 42 USe 289/-:L. 
(A) by striking out "in matters" and inserting in lieu thereof "or 
under programs administered by the Division of Nursing of the Health 
Resources Administration, in matters", and (ii) by inserting before 
"are directed" the following: "or Division of Nursing". 
(2) Subsections (a) (1) (A) (iii) and (a) (1) (B) of such section are 
each amended by striking out "non-Federal". 
(b) Subsection (c) (1) (A) (i) of such section is amended by striking 
out "health research or teaching" and inserting in lieu thereof "health 
research or teaching or any combination thereof which is in accord-
ance with usual patterns of academic employment". 
(c) Subsection (c) (2) (A) of such section is amended by striking 
out "health research or teaching" and inserting in lieu thereof "health 
research or teaching or any combination thereof which is in accord-
ance with the usual patterns of academic employment". 
(d) The first sentence of subsection (d) of such section is amended 
by inserting a comma before the period and the following: 
"$165,000,000 for fiscal year 1976, and $185,000,000 for fiscal year 
1977". 
90 STAT. 406 
PUBLIC LAW 94-278—APR. 22, 1976 
42 use 289Z-1. 
42 use 289/-1. 
Biomedical and 
behavioral 
research 
personnel, 
studies. 
42 use 289/-2. 
Report to 
congressional 
committees. 
42 use 289/-2. 
SEC. 202. (a) Subsection (a) (1) (A) (i) of section 472 is amended by 
striking out "the disease or (diseases) or other health problems to 
which the activities of the Institutes and Administration are directed" 
and inserting in lieu thereof "diseases or other health problems". 
(b) Subsection (b) (2) of section 472 is amended by striking out "to 
the entities of the National Institutes of Health and the Alcohol, Drug 
Abuse, and Mental Health Administration" and inserting in lieu 
thereof "within the Department of Health, Education, and Welfare". 
SEC. 203. (a)(1) Subparagraph (A) of the first paragraph (4) of 
subsection (c) of section 472 is amended by striking out "and the inter-
est on such amount" down through and including "was made". 
(2) The last sentence of subparagraph (B) of such paragraph is 
amended by striking out "at the same rate as that fixed by the Secre-
tary of the Treasury under subparagraph (A) to determine the amount 
due the United States" and inserting in lieu thereof "at a rate fixed by 
the Secretary of the Treasury after taking into consideration private 
consumer rates of interest prevailing on the date the United States 
becomes entitled to such amount". 
(b) The amendments made by subsection (a) shall apply with 
respect to National Research Awards under section 472 which are 
made from appropriations for fiscal years ending on or after June 30, 
1975. 
SEC. 204. Section 473(b) is amended by adding after paragraph (2) 
the following new paragraph: 
"(3) The National Academy of Sciences or other group or associa-
tion conducting the study required by subsection (a) shall conduct 
such study in consultation with the Director of the National Institutes 
of Health.". 
SEC. 205. Subsection (c) of section 473 is amended by striking out 
"March 31" and inserting in lieu thereof "September 30". 
TITLE III—DISCLOSURE OF RESEARCH INFORMATION 
Investigations 
and study. 
42 use 289/-1 
note. 
42 use 289/-1 
note. 
42 u s e 201 note. 
SEC. 301. (a) (1) The President's Biomedical Research Panel (estab-
lished by section 201(a) of the National Cancer Act Amendments of 
1974 (Public Law 93-352)) and the National Commission for the Pro-
tection of Human Subjects of Biomedical and Behavioral Research 
(established by section 201 of the National Research Act (Public Law 
93-348)) shall each conduct an investigation and study of the impli-
cation of the disclosure to the public of information contained in 
research protocols, research hypotheses, and research designs obtained 
by the Secretary of Health, Education, and Welfare (hereinafter in 
the subsection referred to as the "Secretary") in connection with an 
application or proposal submitted, during the period beginning Jan-
uary 1, 1975, and ending December 31, 1975, to the Secretary for a 
grant, fellowship, or contract under the Public Health Service Act. 
In making such investigation and study the Panel and the Commission 
shall each determine the following: 
(A) The number of requests made to the Secretary for the 
disclosure of information contained in such research protocols, 
hypotheses, and designs and the interests represented by the per-
sons for whom such requests were made. 
(B) The purposes for which information disclosed by the Sec-
retary pursuant to such requests was used. 
(C) The effect of the disclosure of such information on— 
(i) proprietary interests in the research protocol, hypoth-
esis, or design ft*om which such information was disclosed 
and on patent rights; 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 407 
(ii) the ability of peer review systems to insure high qual-
ity federally funded research; and 
(iii) the (I) protection of the public against research 
which presents an unreasonable risk to human subjects of 
such research and (II) the adequacy of informed consent 
procedures. 
(2) (A) Not later than May 31, 1976, the Panel shall complete the 
investigation and study required to be made by the Panel by paragraph 
(1), and, not later than June 30, 1976, the Panel shall submit to the 
Committee on Interstate and Foreign Commerce of the House of 
Eepresentatives and the Committee on Labor and Public Welfare of 
the Senate a report on such investigation and study. The report shall 
contain such recommendations for legislation as the Panel deems 
appropriate. 
(B) Not later than November 30, 1976, the Commission shall com-
plete the investigation and study required to be made by the Commis-
sion by paragraph (1), and, not later than December 31, 1976, the 
Commission shall submit to the Committee on Interstate and Foreign 
Commerce of tlie House of Representatives and the Committee on 
Labor and Public Welfare of the Senate a report on such investigation 
and study. The report shall contain such recommendations for legisla-
tion as the Commission deems appropriate. 
(b) Section 211(b) of the National Eesearch Act (Public Law 
93-348) is amended by striking out "July 1,1976" and inserting in lieu 
thereof "January 1,1977". 
Report to 
congressional 
committees. 
Report to 
congressional 
committees. 
42 u s e 218 note. 
TITLE IV—GENETIC DISEASES 
SEC. 401. This title may be cited as the "National Sickle Cell Anemia, 
Cooley's Anemia, Tay-Sachs, and Genetic Diseases Act". 
SEC. 402. In order to preserve and protect the health and welfare of 
all citizens, it is the purpose of this title to establish a national program 
to provide for basic and applied research, research training, testing, 
counseling, and information and education programs with respect to 
genetic diseases, including sickle cell anemia, Cooley's anemia, Tay-
Sachs disease, cystic fibrosis, dysautonomia, hemophilia, retinitis pig-
mentosa, Huntington's chorea, and muscular dystrophy. 
SEC. 403. (a) Title XI is amended by striking out parts A and B and 
inserting in lieu thereof the following : 
"PART A—GENETIC DISEASES 
National Sickle 
Cell Anemia, 
Cooley's Anemia, 
Tay-Sachs, and 
Genetic Diseases 
Act 
42 u s e 300b 
note. 
42 u s e 300b 
note. 
TESTING AND COUNSELING PROGRAMS AND INFORMATION 
AND EDUCATION PROGRAMS 
"SEC. 1101. (a) (1) The Secretary, through an identifiable admin- 42 USC 300b. 
istrative unit within the Department of Health, Education, and Wel-
fare, may make grants to public and nonprofit private entities, and may 
enter into contracts with public and private entities, for projects to 
establish and operate voluntary genetic testing and counseling pro-
grams primarily in conjunction with other existing health programs, 
including programs assisted under title V of the Social Security Act. 42 USC 701. 
"(2) The Secretary shall carry out, through an identifiable admin-
istrative unit within the Department of Health, Education, and Wel-
fare, a program to develop information and educational materials 
90 STAT. 408 
PUBLIC LAW 94-278—APR. 22, 1976 
Appropriation 
authorization. 
relating to genetic diseases and to disseminate such information and 
materials to persons providing health care, to teachers and students, 
and to the public generally in order to most rapidly make available the 
latest advances in the testing, diagnosis, counseling, and treatment of 
individuals respecting genetic diseases. The Secretary may, under such 
program, make grants to public and nonprofit private entities and 
enter into contracts with public and private entities and individuals 
for the development and dissemination of such materials. 
"(b) For the purpose of making payments pursuant to grants and 
contracts under this section, there are authorized to be appropriated 
$30,000,000 for fiscal year 1976, $30,000,000 for fiscal year 1977, and 
$30,000,000 for fiscal year 1978. 
u 
RESEARCH PROJECT GRANTS AND CONTRACTS 
42 u s e 300b-l. 
42 u s e 241. 
Sickle cell 
anemia and 
eooley's anemia 
research, priority. 
"SEC. 1102. In carrying out section 301, the Secretary may make 
grants to public and nonprofit private entities, and may enter into con-
tracts with public and private entities and individuals, for projects for 
(1) basic or applied research leading to the understanding, diagnosis, 
treatment, and control of genetic diseases, (2) planning, establishing, 
demonstrating, and developing special programs for the training of 
genetic counselors, social and behavioral scientists, and other health 
professionals, (3) the development of programs to educate practicing 
physicians, other health professionals, and the public regarding the 
nature of genetic processes, the inheritance patterns of genetic dis-
eases, and the means, methods, and facilities available to diagnose, 
control, counsel, and treat genetic diseases, and (4) the development of 
counseling and testing programs and other programs for the diagnosis, 
control, and treatment of genetic diseases. In making grants and enter-
ing into contracts for projects described in clause (1) of the preceding 
sentence, the Secretary shall give priority to applications for such 
grants or contracts which are submitted for research on sickle cell 
anemia and for research on Cooley's anemia. 
'VOLUNTARY PARTICIPATION 
42 use 300b-2. 
"SEC. 1103. The participation by any individual in any program or 
portion thereof under this part shall be wholly voluntary and shall not 
be a prerequisite to eligibility for or receipt of any other service or 
assistance from, or to participation in, any other program. 
u 
A P P L I C A T I O N S ; ADMINISTRATION 
OF GRANTS AND CONTRACT PROGRAMS 
42 use 300b-3. 
"SEC. 1104. (a) A grant or contract under this part may be made 
upon application submitted to the Secretary at such time, in suCh 
manner, and containing and accompanied by such information, as the 
Secretary may require. Each applicant shall— 
"(1) provide that the programs and activities for which assist-
ance under this part is sought will be administered by or under 
the supervision of the applicant; 
"(2) provide for strict confidentiiality of all test results, medi-
cal records, and other information regarding testing, diagnosis, 
counseling, or treatment of any person treated, except for (A) 
such information as the patient (or his guardian) gives informed 
consent to be released, or (B) statistical data compiled without 
reference to the identity of any such patient; 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 409 
"(3) provide for community representation where appropriate 
in the development and operation of vohmtary genetic testing or 
counseling programs funded by a grant or contract under this 
part; 
"(4) in the case of an applicant for a grant or contract under 
section 1101(a) (1) for the delivery of services, provide assurances 
siatisfactory to the Secretary that (A) the services for community-
wide testing and counseling to be provided under the program 
for which the application is made (i) will take into consideration 
widely prevalent diseases with a genetic component and high-risk 
population groups in which certain genetic diseases occur, and 
(ii) where appropriate will be directed especially but not exclu-
sively to persons who are entering their child-producing years, 
and (B) appropriate arrangements will be made to provide coun-
seling to persons found to have a genetic disease and to persons 
found to carry a gene or chromosome which may cause a deleteri-
ous effect in their offspring; and 
"(5) establish fiscal control and fund accounting procedures as 
may be necessary to assure proper disbursement of and accounting 
of Federal funds paid to the applicant under this part. 
"(b) In making any grant or entering into any contract for testing 
and counseling programs under section 1101, the Secretary shall (1) 
take into a,ccount the number of persons to be served by the program 
supported by such grant or contract and the extent to which rapid 
and effective use will be made of funds under the grant or contract; 
and (2) give priority to programs operating in areas which the Secre-
tary determines have the greatest number of persons who will benefit 
from and are in need of the services provided under such programs. 
"(c) In making grants and entering into contracts for any fiscal 
year under section 301 for projects described in section 1102 or under 
section 1101 the Secretary shall give special consideration to applica-
tions from entities that received grants from, or entered into contracts 
with, the Secretary for the preceding fiscal year for the conduct of 
comprehensive sickle cell center-s or sickle cell screening and educa-
tion clinics. 
"PUBLIC HEALTH SER^^CE FACILITIES 
"SEC. 1105. The Secretary sliall establish a program within the 
Service to provide voluntary testing, diagnosis, counseling, and treat-
ment of individuals respecting genetic diseases. Services under such 
program shall be made available through facilities of the Service to 
persons requesting such services, and the program shall proA^ide appro-
priate publicity of the availability and voluntary nature of such 
services. 
"REPORTS 
"SEC. 1106. (a) The Secretary shall prepare and submit to the Pres-
ident for transmittal to the Congress on or before April 1 of each year 
a comprehensive report on the administration of this part. 
"(b) The report required by this section shall contain such rec-
ommendations for additional legislation as the Secretary deems 
necessary.". 
(b)(1) Section 1121(b)(5) is amended by striking out "ending 
June 30," each place it occurs. 
(2) Parts C and D are redesignated as parts B and C, respectively. 
(3) The heading of such title is amended to read as follows: 
42 use 241. 
42 use 300b-4. 
Report to 
President for 
transmittal to 
eongress. 
42 use 300b-5. 
42 use 300C-11. 
42 use SOOc-ll, 
300C-21. 
90 STAT. 410 
PUBLIC LAW 94-278—APR. 22, 1976 
Effective date. 
42 use 300b 
note. 
21 use 350. 
21 use 321, 341, 
343. 
"Children." 
Food labeling. 
"Food to which 
this section 
applies." 
"TITLE XI—GENETIC DISEASES, HEMOPHILIA PRO-
GRAMS, AND SUDDEN INFANT DEATH SYNDROME." 
(c) The amendments made by subsections (a) and (b) shall take 
effect July 1,1976. 
TITLE V—FEDERAL FOOD, DRUG, AND COSMETIC ACT 
AMENDMENTS 
SEC. 501 (a) Chapter IV of the Federal Food, Drug, and Cosmetic 
Act is amended by adding after section 410 (21 U.S.C. 349) the follow-
ing new section: 
"VITAMINS AND MINERALS 
"SEC. 411. (a) (1) Except as provided in paragraph (2) — 
"(A) the Secretary may not establish, under section 201 (n), 
401, or 403, maximum limits on the potency of any synthetic or 
natural vitamin or mineral within a food to which this section 
applies; 
"(B) the Secretary may not classify any natural or synthetic 
vitamin or mineral (or combination thereof) as a drug solely 
because it exceeds the level of potency which the Secretary deter-
mines is nutritionally rational or useful; 
"(C) the Secretary may not limit, imder section 201 (n), 401, 
or 403, the combination or number of any synthetic or natural— 
"(i) vitamin, 
"(ii) mineral, or 
" (iii) other ingredient of food, 
within a food to which this section applies. 
"(2) Paragraph (1) shall not apply in the case of a vitamin, 
mineral, other ingredient of food, or food, which is represented for 
use by individuals in the treatment or management of specific diseases 
or disorders, by children, or by pregnant or lactating women. For 
purposes of this subparagraph, the term 'children' means individuals 
who are under the age of twelve years. 
"(b) (1) A food to which this section applies shall not be deemed 
under section 403 to be misbranded solely because its label bears, in 
accordance with section 403 (i) (2), all the ingredients in the food 
or its advertising contains references to ingredients in the food which 
are not vitamins or minerals. 
"(2) (A) The labeling for any food to which this section applies 
may not list its ingredients which are not vitamins or minerals (i) 
except as a part of a list of all the ingredients of such food, and (ii) 
imless such ingredients are listed in accordance with applicable regu-
lations under section 403. To the extent that compliance with clause 
(i) of this subparagraph is impracticable or results in deception or 
unfair competition, exemptions shall be established by regulations 
promulgated by the Secretary. 
"(R) Notwithstanding the provisions of subparagraph (A), the 
labeling and advertising for any food to which this section applies may 
not give prominence to or emphasize ingredients which are not— 
"(i) vitamins, 
"(ii) minerals, or 
"(iii) represented as a source of vitamins or minerals. 
"(c) (1) For purposes of this section, the term 'food to which this 
section applies' means a food for humans which is a food for special 
dietary use— 
"(A) which is or contains any natural or synthetic vitamin or 
mineral, and 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 411 
"(B) which— 
"(i) is intended for ingestion in tablet, capsule, or liquid 
form, or 
"(ii) if not intended for ingestion in such a form, does not 
simulate and is not represented as conventional food and is 
not represented for use as a sole item of a meal or of the diet. 
"(2) For purposes of paragraph (1) (B) (i), a food shall be con-
sidered as intended for ingestion in liquid form only if it is formulated 
in a fluid carrier and it is intended for ingestion in daily quantities 
measured in drops or similar small units of measure. 
"(3) For purposes of paragraph (1) and of section 403(j) insofar 
as that section is applicable to food to which this section applies, the 
term 'special dietary use' as applied to food used by man means a 
particular use for which a food purports or is represented to he, used, 
including but not limited to the following: 
" ( A ) Supplying a special dietary need that exists by reason of 
a physical, physiological, pathological, or other condition, includ-
ing but not limited to the condition of disease, convalescence, 
pregnancy, lactation, infancy, allergic hypersensitivity^ to food, 
underweight, overweight, or the need to control the intake of 
sodium. 
"(B) Supplying a vitamin, mineral, or other ingredient for 
use by man to supplement his diet by increasing the total dietary 
intake. 
"(C) Supplying a special dietary need by reason of being a 
food for use as the sole item of the diet.", 
(b) The Secretary of Health, Education, and Welfare shall amend 
any regulation promulgated under the Federal Food, Drug, and 
Cosmetic Act which is inconsistent with section 411 of such Act (as 
added by subsection (a)) and such amendments shall be promulgated 
in accordance with section 553 of title 5, United States Code. 
SEC. 502. (a) (1) Section 403(a) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(a)) is amended (A) by inserting " ( 1 ) " 
after "If", and (B) by inserting before the period at the end a comma 
and the following: "or (2) in the case of a food to which section 411 
applies, its advertising is false or misleading in a material respect or 
its labeling is in violation of section 411 (b) (2)". 
(2) (A) Section 201 (n) of such Act is amended by inserting "or 
advertising" after "labeling" each time it occurs. 
(B) Section 303 of such Act is amended by adding at the end 
the following new subsection: 
"(d) No person shall be subject to the penalties of subsection (a) 
of this section for a violation of section 301 involving misbranded food 
if the violation exists solely because the food is misbranded under 
section 403(a) (2) because of its advertising, and no person shall be 
subject to the penalties of subsection (b) of this section for such a 
violation unless the violation is committed with the intent to defraud 
or mislead.". 
(C) Section 304(a) of such Act (21 U.S.C. 334(a)) is amended by 
adding after paragraph (2) the following new paragraph: 
"(3) (A) Except as provided in subparagraph (B), no libel for 
condemnation may be instituted under paragraph (1) or (2) against 
any food which— 
"(i) is misbranded under section 403 (a) (2) because of its adver-
tising, and 
" (ii) is being held for sale to the ultimate consumer in an estab-
lishment other than an establishment owned or operated by a 
manufacturer, packer, or distributor of the food. 
"Special dietary 
use." 
21 use 343. 
21 use 350 note. 
21 use 301. 
Ante, p. 410. 
21 use 321. 
21 use 333. 
Misbranded food, 
penalties, 
exemption. 
21 use 331. 
Libel for 
condemnation. 
Supra. 
90 STAT. 412 
PUBLIC LAW 94-278—APR. 22, 1976 
"(B) A libel for condemnation may be instituted under paragraph 
(1) or (2) against a food described in subparagraph (A) if— 
"(i) (I) the food's advertising which resulted in the food being 
Ante, f. 4>11. 
misbranded under section 403(a)(2) was disseminated in the 
establishment in which the food is being held for sale to the 
ultimate consumer, 
"(II) such advertising was disseminated by, or under the direc-
tion of, the owner or operator of such establishment, or 
"(III) all or part of the cost of such advertising was paid by 
such owner or operator; and 
"(ii) the owner or operator of such establishment used such 
advertising in the establishment to promote the sale of the food.", 
(b) Chapter VII of such Act is amended by adding after section 706 
(21 U.S.C. 376) the following new section: 
'ADVERTISING OF CERTAIN FOODS 
21 use 378. 
21 use 331. 
Ante, p. 411. 
Notice to FTC. 
15 use 58. 
15 use 45, 53, 
57b. 
15 use 56. 
"SEC. 707. (a) (1) Except as provided in subsection (c), before the 
Secretary may initiate any action under chapter III— 
"(A) with respect to any food which the Secretary determines 
is misbranded under section 403(a) (2) because of its advertising. 
or "(B) with respect to a food's advertising which the Secretary 
determines causes the food to be so misbranded, 
the Secretary shall, in accordance with paragraph (2), notify in writ-
ing the Federal Trade Commission of the action the Secretary proposes 
to take respecting such food or advertising. 
" (2) The notice required by paragraph (1) shall— 
"(A) contain (i) a description of the action the Secretary pro-
poses to take and of the advertising which the Secretary has 
determined causes a food to be misbranded, (ii) a statement of 
the reasons for the Secretary's determination that such advertis-
ing has caused such food to be misbranded, and 
"(B) be accompanied by the records, documents, and other 
written materials which the Secretary determines supports his 
determination that such food is misbranded because of such 
advertising. 
"(b)(1) If the Secretary notifies the Federal Trade Commission 
under subsection (a) of action proposed to be taken under chapter III 
with respect to a food or food advertising and the Commission notifies 
the Secretary in writing, within the 30-day period beginning on the 
date of the receipt of such notice, that— 
"(A) it has initiated under the Federal Trade Commission Act 
an investigation of such advertising to determine if it is prohibited 
by such Act or any order or rule under such Act, 
"(B) it has commenced (or intends to commence) a civil action 
under section 5, 13, or 19 with respect to such advertising or the 
Attorney General has commenced (or intends to commence) a 
civil action under section 5 with respect to such advertising, 
"(C) it has issued and served (or intends to issue and serve) a 
complaint under section 5(b) of such Act respecting such adver-
tising, or 
"(D) pursuant to section 16(b) of such Act it has made a 
certification to the Attorney General respecting such advertising, 
the Secretary may not, except as provided by paragraph (2), initiate 
the action described in the Secretary's notice to the Federal Trade 
Commission. 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 413 
"(2) If, before the expiration of the 60-day period beginning on 
the date the Secretary receives a notice described in paragraph (1) 
from the Federal Trade Commission in response to a notice of the 
Secretary under subsection (a)— 
" ( A ) the Commission or the Attorney General does not com-
mence a civil action described in subparagraph (B) of paragraph 
(1) of this subsection respecting the advertising described in the 
Secretary's notice, 
"(B) the Commission does not issue and serve a complaint 
described in subparagraph (C) of such paragraph respecting 
such advertising, or 
"(C) the Commission does not (as described in subparagraph 
(D) of such paragraph) make a certification to the Attorney 
General respecting such advertising, or, if the Commission does 
make such a certification to the Attorney General respecting such 
advertising, the Attorney General, before the expiration of such 
period, does not cause appropriate criminal proceeding's to be 
brought against such advertising, 
the Secretary may, after the expiration of such period, initiate the 
action described in the notice to the Commission pursuant to subsec-
tion (a). The Commission shall promptly notify the Secretary of the 
commencement by the Commission of such a civil action, the issuance 
and service by it of such a complaint, or the causing by the Attorney 
General of criminal proceedings to be brought against such adver-
tising. 
"(c) The requirements of subsections (a) and (b) do not apply with 
respect to action under chapter I I I with respect to any food or food 
advertising if the Secretary determines that such action is required 
to eliminate an imminent hazard to health. 
"(d) For the purpose of avoiding unnecessary duplication, the Sec-
retary shall coordinate any action taken under chapter I I I because 
of advertising which the Secretary determines causes a food to be 
misbranded with any action of the Federal Trade Commission under 
the Federal Trade Commission Act with respect to such advertising." 
(c) The amendments made by subsection (a) shall take effect 180 
days after the date of the enactment of this Act. 
21 use 331. 
15 use 58. 
Effective date. 
21 use 334 note. 
T I T L E V I — A K T H R I T I S ACT AMEN^DMENTS 
SEC. 601. This title may be cited as the "National Arthritis Act 
Technical Amendments of 1976". 
^ SEC. 602. (a) Section 2 of the National Arthritis Act of 1974 (Pub-
lic Law 93-640) (hereinafter in this section referred to as the "Act") 
is amended by— 
(1) inserting " ( a ) " after "SEC. 2."; 
(2) inserting a comma and "including $2,500,000,000 in medical 
expenses," after "$9,200,000,000" in paragraph (3); and 
(3) inserting a new subsection (b) at the end thereof as 
follows: 
"(b) It is therefore the purpose of this Act to provide for— 
"(1) the formulation of a long-range plan— 
"(A) to expand and coordinate the national research, treat-
ment, and control effort against arthritis; 
" ( B ) to advance educational activities for patients, pro-
fessional and allied health personnel, and the public? which 
will alert the citizens of the United States to the early indi-
cations of arthritis: and 
National Arthritis 
Act Technical 
Amendments of 
1976. 
42 use 289c-]. 
note. 
42 use 289C-1 
note. 
90 STAT. 414 
PUBLIC LAW 94-278—APR. 22, 1976 
"(C) to emphasize the significance of early detection and 
proper control of these diseases and of the complications 
f 
which may evolve from them; 
"(2) the establishment and support of programs to develop 
new and improved methods of arthritis screening, detection, pre-
vention, and referral; 
" (3) the establishment of a central arthritis screening and detec-
tion data bank; and 
"(4) the development, modernization, and operation of centers 
for arthritis screening, detection, diagnosis, prevention, control, 
treatment, education, rehabilitation, and research and training 
programs.". 
42 use 289c-l 
(b) Section 3 of the Act is amended by striking out "chief medical 
°°*®' 
officer" and inserting in lieu thereof "Chief Medical Director" in sub-
section (b) (4). 
(c) The section heading for section 4 of the Act is amended by 
striking out "DEMONSTRATION" after "COMMITTEE,". 
42 use 289a. 
SEC. 603. (a) (1) Section 431(c) of the Public Health Service Act 
is amended by inserting " (hereinafter in this part collectively referred 
to as 'arthritis')" after "musculoskeletal diseases". 
42 use 289c-l 
(2) The fourth sentence of section 434(b) of such Act is amended 
by striking out "and related musculoskeletal diseases". 
(3) Section 434(e) of such Act is amended by striking out "and 
related musculoskeletal diseases (hereinafter in this part collectively 
referred to as 'arthritis')". 
42 use 289C-5, 
(b) Section 438 of such Act is amended by— 
(1) inserting "the" before "health" the first time it appears in 
the first sentence of subsection ( a ) ; and 
(2) inserting "established" after "bank" in the second sentence 
of subsection (a). 
42 use 289C-6. 
(c) Section 439 of such Act is amended by— 
(1) inserting "new and existing" before "centers" in the first 
sentence of subsection ( a ) ; 
(2) striking out "$13,000,000" and inserting in lieu thereof 
"$8,000,000", and striking out "$15,000,000" and inserting in lieu 
thereof "$20,000,000" in subsection (h) ; and 
(3) redesignating subsections (e), (f), (g), and (h) as subsec-
tions (d), (e), (f),and (g),respectively. 
T I T L E V I I — D I A B E T E S P L A N 
42 use 289C-2 
SEC, 701. Section 3 (i) (2) of the National Diabetes Mellitus Research 
note- 
and Education Act (42 U.S.C. 289c-2) is amended to read as follows: 
" (2) The Commission shall cease to exist after September 30,1976.". 
T I T L E V I I I — H E A L T H S E R V I C E S 
AMBULATORY SURGICAL SERVICES 
42 use 247d. 
SEC. 801. (a) Section 319 (a) (7) is amended by— 
(1) inserting after subparagraph (K) the following new 
subparagraph: 
"(L) ambulatory surgical services;" and 
(2) redesignating subparagraphs (L) and (M) as subpara-
graphs (M) and (N), respectively. 
PUBLIC LAW 94-278—APR. 22, 1976 
90 STAT. 415 
(b) Section 330 (b) (2) is amended by— 
^ 
42 USC 254c. 
(1) inserting after subparagraph 
(K) the following new 
subparagraph: 
" (L) ambulatory surgical services;" and 
(2) redesignating subparagraphs (L) and (M) as subpara-
graphs (M) and (N),respectively. 
T I T L E I X — I N D I A N H E A L T H 
S E E V I C E 
SEC. 901. Section 225 is amended by adding at the end thereof the ^^ USC 234. 
following new subsection— 
"(j) Notwithstanding any other provision of law, the Secretary 
, J'**> 
may, where he deems advisable, allow the Indian Health Service to 
utilize nonprofit recruitment agencies to assist in obtaining personnel 
for the Public Health Service.". 
T I T L E X — A P P O I N T M E N T O F A D V I S O R Y C O M M I T T E E S 
SEC. 1001. All appointments to advisory committees established to ^.2 USC 217a-l. 
assist in implementing the Public Health Service Act, the Mental 42 USC 201 note. 
Retardation Facilities and Community Mental Health Centers Con- 42 USC 2661 
struction Act of 1963, and the Comprehensive Alcohol Abuse and ^°^^-
Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970, 42 USC 4551 
shall be made without regard to political affiliation. 
°^*®-
T I T L E X I — M I S C E L L A N E O U S P R O V I S I O N S 
. , 
SEC. 1101. Section 212 of the Public Health Service Act is amended 42 USC 213. 
by adding after subsection (d) the following new subsection: 
"(e) Active service of commissioned officers of the Service shall be 
deemed to be active military service in the Armed Forces of the United 
States for the purposes of all rights, privileges, immunities, and bene- 
' 
fits now or hereafter provided under the Soldiers' and Sailors' Civil 
Relief Act of 1940 (50 App. U.S.C. 501 et seq.).". 
SEC. 1102. (a) The second paragraph (4) of subsection (c) of section 
472 of the Public Health Service Act is redesignated as paragraph (5). 42 USC 289/-1, 
(b) Section 507 of the Public Health Service Act is amended by 42 USC 225a. 
striking out "hospitals of the Service, of the Veterans' Administration, 
or of the Bureau of Prisons of the Department of Justice, and to 
Saint Elizabeths Hospital, except that grants to such" and insert in 
lieu thereof "Federal institutions, except that grants to". 
SEC. 1103. Title I V of the Public Health Service Act is amended by 
adding after section 475 the following new section: 
"VISITING SCIENTIST AWARDS 
"SEC. 476. (a) The Secretary may make awards (referred to as 42 USC 289/-5. 
'Visiting Scientist Awards') to outstanding scientists who agree to 
serve as visiting scientists at institutions of post-secondary education 
which have significant enrollments of disadvantaged students. Visiting 
Scientist Awards shall be made by the Secretary to enable the faculty 
and students of such institutions to draw upon the special talents of 
scientists from other institutions for the purpose of receiving guidance, 
advice, and instruction with regard to research, teaching, and curric-
ulum development in the biomedical and behavioral sciences and such 
other aspects of these sciences as the Secretary shall deem appropriate. 
89-194 O—78—Dt. 1 
30 
90 STAT. 416 
PUBLIC LAW 94-278—APR. 22, 1976 
"(b) The amount of each Visiting Scientist Award shall include 
such sum as shall be commensurate with the salary or remuneration 
which the individual receiving the award would have been entitled to 
receive from the institution with which the individual has, or had, a 
Eligibility 
permanent or immediately prior affiliation. Eligibility for and terms 
requirements. 
of Visiting Scientist Awards shall be determined in accordance with 
regulations the Secretary shall prescribe." 
42 use 295g-23. 
SEC. 1104. Section 786 of the Public Health Service Act is amended 
by inserting before the period at the end of the first sentence "and 
$3,500,000 for the fiscal year ending June 30, 1975 and $2,000,000 for 
the fiscal year ending June 30,1976", 
42 use 294b. 
SEC. 1105. (a) Section 742(a) of the Public Health Service Act is 
amended by striking out "and" after "1974," and by inserting after 
"1975" the following: ", and $60,000,000 for the fiscal year ending June 
30, 1976". 
42 use 294. 
(b) Section 740(b)(4) of such Act is amended by striking out 
"1975" and inserting in lieu thereof "1976". 
42 use 300/. 
SEC. 1106. Section 1511(b) (5) of the Public Health Service Act is 
amended by striking out "1535" and inserting in lieu thereof "1536". 
42 use 300p-3. ^ (b) Section 1613 of such Act is amended by striking out "1510" and 
inserting in lieu thereof "1610". 
Repeal. 
(c) The last sentence of section 1631 of such Act is repealed. 
42USe300s-l. 
SEC. 1107. (a) Section 132(a)(1)(A) of the Developmental Dis-
abilities Services and Facilities Construction Act (42 U.S.C. 6062) 
(hereinafter in this section referred to as the "Act") is amended by 
striking out "134" and inserting in lieu thereof "133". 
42 use 6064. 
(b) Section 134(b) (1) of the Act is amended by striking out "134" 
and inserting in lieu thereof "133". 
(c) Section 134(b) (1) of the Act is amended by striking out "136" 
and inserting in lieu thereof "135". 
(d) Section 301 (a) of the Developmentally Disabled Assistance and 
42 use 6001 
Bill of Eights Act is amended by striking out "101 (7)" and inserting 
note. 
in lieu thereof "102(7)". 
Approved April 22, 1976. 
LEGISLATIVE HISTORY: 
HOUSE REPORTS: No. 94-498 (eomm. on Interstate and Foreign Commerce) and No. 
94-1005 (Comm. of eonference). 
SENATE REPORTS: No. 94-509 accompanying S. 988 (Comm. on Labor and Public 
Welfare) and No. 94-743 (Comm. of Conference). 
CONGRESSIONAL RECORD: 
Vol. 121 (1975): Oct. 20, considered and passed House. 
Dec. 11, considered and passed Senate, amended, in lieu of 
S. 988. 
Vol. 122 (1976): Apr. 12, House and Senate agreed to conference report.