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The original documents are located in Box 43, folder "4/22/76 HR7988 Health Research
and Health Services Amendments of 1976 (2)" of the White House Records Office:
Legislation Case Files at the Gerald R. Ford Presidential Library.
Copyright Notice
The copyright law of the United States (Title 17, United States Code) governs the making of
photocopies or other reproductions of copyrighted material. Gerald R. Ford donated to the United
States of America his copyrights in all of his unpublished writings in National Archives collections.
Works prepared by U.S. Government employees as part of their official duties are in the public
domain. The copyrights to materials written by other individuals or organizations are presumed to
remain with them. If you think any of the information displayed in the PDF is subject to a valid
copyright claim, please contact the Gerald R. Ford Presidential Library.
Exact duplicates within this folder were not digitized.
Digitized from Box 43 of the White House Records Office Legislation Case Files
at the Gerald R. Ford Presidential Library
94TH CONGRESS
1st Session
}
{
REPORT
HOUSE OF REPRESENTATIVES
No. 94-498
HEART, LUNG AND BLOOD RESEARCH,
RESEARCH TRAINING, AND GENETIC
DISEASES AMENDMENTS OF 1975
REPORT
BY THE
COMMITTEE ON INTERSTATE AND
FOREIGN COMMERCE
[To accompany H.R. 7988]
SEPTEMBER 22, 1975.-Committed to the Committee of the Whole House
on the State of the Union and ordered to be printed
U.S. GOVERNMENT PRINTING OFFICE
57-006
WASHINGTON : 1975
94TH CONGRESS
HOUSE OF REPRESENTATIVES
REPORT
1st Session
No. 94-498
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE
HARLEY O. STAGGERS, West Virginia, Chairman
TORBERT H. MACDONALD, Massachusetts SAMUEL L. DEVINE, Ohio
JOHN E. MOSS, California
JAMES T. BROYHILL, North Carolina
JOHN D. DINGELL, Michigan
TIM LEE CARTER, Kentucky
PAUL G. ROGERS, Florida
CLARENCE J. BROWN, Ohio
LIONEL VAN DEERLIN, California
JOE SKUBITZ, Kansas
FRED B. ROONEY, Pennsylvania
JAMES F. HASTINGS, New York
HEART, LUNG, AND BLOOD RESEARCH, RESEARCH
JOHN M. MURPHY, New York
JAMES M. COLLINS, Texas
TRAINING, AND GENETIC DISEASES AMENDMENTS
DAVID E. SATTERFIELD III, Virginia
LOUIS FREY, JR., Florida
BROCK ADAMS, Washington
OF 1975
JOHN Y. McCOLLISTER, Nebraska
W. S. (BILL) STUCKEY, JR., Georgia
NORMAN F. LENT, New York
BOB ECKHARDT, Texas
H. JOHN HEINZ III, Pennsylvania
RICHARDSON PREYER, North Carolina
EDWARD R. MADIGAN, Illinois
JAMES W. SYMINGTON, Missouri
CARLOS J. MOORHEAD, California
CHARLES J. CARNEY, Ohio
MATTHEW J. RINALDO, New Jersey
SEPTEMBER 22, 1975.-Committed to the Committee of the Whole House on the
RALPH H. METCALFE, Illinois
State of the Union and ordered to be printed
GOODLOE E. BYRON, Maryland
JAMES H. SCHEUER, New York
RICHARD L. OTTINGER, New York
HENRY A. WAXMAN, California
ROBERT (BOB) KRUEGER, Texas
Mr. STAGGERS, from the Committee on Interstate and Foreign
TIMOTHY E. WIRTH, Colorado
Commerce, submitted the following
PHILIP R. SHARP, Indiana
WILLIAM M. BRODHEAD, Michigan
W. G. (BILL) HEFNER, North Carolina
REPORT
JAMES J. FLORIO, New Jersey
ANTHONY TOBY MOFFETT, Connecticut
JIM SANTINI, Nevada
[To accompany H.R. 7988]
ANDREW MAGUIRE, New Jersey
W. E. WILLIAMSON, Clerk
The Committee on Interstate and Foreign Commerce, to whom was
KENNETH J. PAINTER, Assistant Clerk
referred the bill (H.R. 7988) to amend the Public Health Service Act
Professional Staff
ROBERT F. GUTHRIE
JAMES M. MENGER, Jr.
to revise and extend the program under the National Heart and Lung
CHARLES B. CURTIS
WILLIAM P. ADAMS
Institute, to revise and extend the program of National Research Serv-
LEE S. HYDE
ROBERT R. NORDHAUS
ice Awards, and to establish a national program with respect to genetic
ELIZABETH HARRISON
BRIAN R. MOIR
diseases; and to require a study and report on the release of research
JEFFREY H. SCHWARTZ
WILLIAM G. PHILLIPS
KAREN G. NELSON
information, having considered the same, report favorably thereon
with an amendment and recommend that the bill as amended do pass.
The amendment strikes out all after the enacting clause and inserts
MINORITY STAFF
in lieu thereof a substitute text which appears in italic type in the
LEWIS E. BERRY, Minority Counsel
reported bill.
H. THOMAS GREENE, JAN VLCEK, JOHNNIE L. GALLEMORE, and RONALD D. COLEMAN,
SUMMARY OF LEGISLATION
Assistant Minority Counsels
SUBCOMMITTEE ON HEALTH AND THE ENVIRONMENT
H.R. 7988 would amend the Public Health Service Act to revise and
PAUL G. ROGERS, Florida, Chairman
extend for fiscal years 1976 and 1977 the program under the National
DAVID E. SATTERFIELD III, Virginia
Heart and Lung Institute; revise and extend for fiscal years 1976 and
RICHARDSON PREYER, North Carolina
TIM LEE CARTER, Kentucky
JAMES W. SYMINGTON, Missouri
JAMES T. BROYHILL, North Carolina
1977 the program of National Research Service Awards; require the
JAMES H. SCHEUER, New York
JAMES F. HASTINGS, New York
President's Biomedical Research Panel to conduct an investigation of
HENRY A. WAXMAN, California
H. JOHN HEINZ III, Pennsylvania
the implications of disclosure of research information obtained by the
W. G. (BILL) HEFNER, North Carolina
SAMUEL L. DEVINE, Ohio (Ex Officio)
Secretary of Health, Education, and Welfare in connection with an ap-
JAMES J. FLORIO, New Jersey
plication for a research grant, fellowship or contract; and replace the
CHARLES J. CARNEY, Ohio
ANDREW MAGUIRE, New Jersey
existing authority for screening, counseling, treatment, research and in-
HARLEY O. STAGGERS, West Virginia (Ex Officio)
formation programs, and education programs for sickle cell anemia
STEPHAN E. LAWTON, Counsel
and Cooley's anemia with a new general authority authorizing a na-
Jo ANNE GLISSON, Staff Assistant
tional program with respect to all genetic diseases, including, but not
STEPHEN J. CONNOLLY, Staff Assistant
limited to, sickle cell anemia, Cooley's anemia and Tay-Sachs disease.
DONALD DALRYMPLE, Assistant Counsel
(1)
(II)
2
3
COST OF LEGISLATION
of the National Heart and Lung Institute to the National Heart,
As reported by the Committee, H.R. 7988 provides for authoriza-
Lung and Blood Institute, provide explicit authority for the Institute
to conduct programs with respect to the use of blood products and
tions of appropriations for two fiscal years, 1976 and 1977, for pro-
the management of blood resources, and authorize the Institute to hire
grams under the National Heart and Lung Institute, for National Re-
an additional fifty experts and consultants.
search Service Awards, and for a national program with respect to
The title would authorize $20 million for fiscal year 1976 and $30
genetic diseases as shown in the following table.
million for fiscal year 1977 for prevention and control programs, and
NEW OBLIGATIONAL AUTHOR ITY FOR FISCAL YEARS 1976-77 UNDER H.R. 7988
would authorize $340 million for fiscal year 1976 and $375 million
for fiscal year 1977 for the National Heart, Blood Vessel, Lung and
[In millions of dollars]
Blood Diseases and Blood Resources Program.
Fiscal year-
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
Program
1976
1977
Total
This title extends, with only technical modifications, for fiscal years
Title I-Heart, lung and blood programs:
1976 and 1977, the explicit authority of the Secretary of Health, Edu-
Control program
20
30
50
Research program
340
375
715
cation, and Welfare to provide awards to individuals and institutions
Title II-National research service awards
175
200
375
Title IV-Genetic diseases
20
25
45
for biomedical research training. It would authorize $175 million for
fiscal year 1976 and $200 million for fiscal year 1977.
Total
555
630
1,185
TITLE IHI-DISCLOSURE OF RESEARCH INFORMATION
This new obligational authority may be compared with a fiscal year
1975 obligational authority of $781.647 million, a fiscal year 1975 ap-
This title would require the President's Biomedical Research Panel
propriation of $526.2 million, and a fiscal year 1976 budget request of
to conduct an investigation of the implications of disclosure of re-
$447.5 million.
search information obtained by the Secretary of Health, Education,
LEGISLATIVE BACKGROUND
and Welfare in connection with applications or proposals for grants,
fellowships or contracts submitted during calendar year 1975.
The legislative authorities for the National Heart, Blood Vessel,
Lung and Blood Act of 1972, the National Research Service Award
TITLE IV-GENETIC DISEASES
Act, the National Sickle Cell Anemia Control Act, and the National
This title would substitute for the existing programs of research,
Cooley's Anemia Control Act expired on June 30, 1975. The legislative
services, and information relating to sickle cell anemia and Cooley's
authorities for these programs are presently being funded under Pub-
anemia a new Part A of title XI of the Public Health Service Act di-
lic Law 94-41, a continuing resolution making funding available for
recting the Secretary of Health, Education, and Welfare to support
fiscal year 1976.
research in genetic diseases and to establish an identifiable administra-
On May 15, 1975, most members of the Subcommittee on Health and
tive unit charged with administering new, noncategorical authorities
the Environment introduced H.R. 7039, legislation which would revise
for testing, counseling, and information programs with respect to ge-
and extend the program under the National Heart and Lung Institute,
netic diseases, primarily through existing health programs. The bill
revise and extend the program of National Research Service Awards,
would authorize $20 million for fiscal year 1976 and $25 million for
control disclosure of research information, and establish a national
fiscal year 1977 for the testing, counseling and information programs.
program with respect to genetic diseases. Hearings were conducted on
It would also direct HEW to establish within the Public Health Serv-
H.R. 7039 on May 20 through 22, 1975; H.R. 7039 was subsequently
ice, a program for the testing, diagnosis, counseling and treatment of
considered in open executive session by the Subcommittee on Health
individuals respecting genetic diseases.
and the Environment, amended, reported, and reintroduced as a clean
bill, H.R. 7988, on June 17, 1975. H.R. 7988 was subsequently consid-
TITLE V-MISCELLANEOUS
ered and ordered reported with amendments by voice vote of the Com-
mittee on Interstate and Foreign Commerce on September 4, 1975.
This title amends section 507 of the Public Health Service Act to
expand the authority of the Secretary of Health, Education, and Wel-
PRINCIPAL PROVISIONS OF H.R. 7988
fare to award grants for research, training and demonstration proj-
ects to Federal institutions. Existing provisions of section 507 limit
TITLE I-REVISION OF NATIONAL HEART AND LUNG INSTITUTE PROGRAMS
this authority to awards to hospitals of the Public Health Service, of
the Veterans Administration and of the Bureau of Prisons, and to
This title extends for fiscal years 1976 and 1977 the authority of
Saint Elizabeths Hospital. Title V would expand this authority to
the Department of Health, Education, and Welfare to conduct re-
authorize the Secretary to make grants for research, training and
search, experiments and demonstration programs with respect to
demonstration projects under the Public Health Service Act and cer-
heart, lung, blood and blood vessel diseases. The only major sub-
tain other grants under that Act and the Community Mental Health
stantive revisions to existing law are provisions that change the title
Centers Act to any Federal institution.
4
5
COMMITTEE PROPOSAL
programs dealing with heart, blood vessels and blood diseases,
and fifteen in programs dealing with lung diseases, although
TITLE I-REVISION OF NATIONAL HEART AND LUNG INSTITUTE PROGRAMS
the activities of any center could relate to more than one
Legislative Background
disorder)
The National Heart Institute was established by Public Law 655 of
Approve grants of under $35,000 without review by the
June 16, 1948, in order "to improve the health of the people of the
National Heart and Lung Advisory Council but with review
United States
[with respect to] diseases of the heart and circula-
and approval by the appropriate study section and
tion". Public Law 89-239 signed on October 6, 1965, provided funds
Submit an annual report to the President for transmittal to
for implementing the President's Commission on Heart Disease, Can-
Congress on the progress of the Program and plans for the
cer, and Stroke; over $5 million was provided for an expanded heart
next five years.
disease program. In November 1969, the Secretary of Health, Edu-
Public Law 92-423 also required the Director of the National Heart
cation, and Welfare designated the Institute as the National Heart and
and Lung Institute to establish a program of education for the public
Lung Institute to reflect expansion of its functions in the lung disease
and health professionals with respect to heart, blood vessel, lung and
area.
blood diseases. Special emphasis was placed on informing the public
Specific authority for the development and implementation of a
of the effect of reduction of known risk factors in preventing these
national program to combat heart, blood vessel, lung, and blood dis-
disorders.
eases with separate authorizations for the program was first enacted
In order to coordinate all Federal programs dealing with cardio-
in 1972 (Public Law 92-423). The 1972 Act required the Direc-
vascular, pulmonary and blood disorders, the 1972 law required that
tor of the National Heart and Lung Institute, with the advice of the
the Secretary of HEW establish an Interagency Technical Committee
National Heart and Lung Advisory Council, to develop and carry out
on Heart, Blood Vessel, Lung and Blood Diseases and Blood Re-
a ten-point plan for a National Heart, Blood Vessel, Lung and Blood
sources. Membership on the Committee includes representatives of all
Disease Program. The plan was required to cover a wide range of
agencies SO involved.
activities, including research into the epidemiology, etiology and pre-
The law also established the National Heart and Lung Advisory
vention of all forms of heart, blood vessel, lung and blood diseases. In
Council and charged it with responsibility to oversee development and
addition, the plan was to provide for the evaluation of methods of ther-
implementation of the Program and to approve grant requests in excess
apy, research into the effective use of the Nation's blood resources, edu-
of $35,000. The Council consists of five ex-officio members and eighteen
cation of the public and health professionals, training of scientists and
members appointed by the Secretary of HEW. Eleven of the ap-
clinicians, and establishment of programs for the study and evaluation
pointed members are scientific or medical authorities; two are enrolled
of emergency medical services. The 1972 Act specifically provided for
in residency programs; and five are leaders in public affairs. The
coordination of the program with the activities of other Institutes to
Council submits an annual report to the President for transmittal to
the extent that they conducted research in these areas. Authoriza-
Congress on the progress of the Program in accomplishing its
tions for the Program were established at $1.38 billion to be appropri-
objectives.
ated over a three year period (fiscal years 1973-1975).
Implementation of the 1972 Act
The Act provided the Director of the National Heart and Lung In-
The Committee is generally pleased with the accomplishments under
stitute, in accordance with policies established by the Director of NIH
and after consultation with the National Heart and Lung Advisory
the National Heart, Blood Vessel, Lung, and Blood Disease Program
since the passage of Public Law 92-423 in 1972. In response to this
Council, with authority to:
legislation, the National Heart and Lung Institute was reorganized
Obtain the services of not more than fifty experts or con-
into five divisions: the Division of Heart and Vascular Diseases, the
sultants who have scientific or professional qualifications
Division of Lung Diseases, the Division of Blood Diseases and Re-
without regard to the time limitations imposed by section
sources, the Division of Intramural Research (which conducts the lab-
3109 of title 5, United States Code;
oratory and clinical research at the National Institutes of Health),
Acquire, construct, improve, repair, operate and maintain
and the Division of Extramural Affairs (which is responsible for the
heart, blood vessel, lung and blood disease laboratories, re-
services associated with scientific and technical merit peer review of
search and other necessary facilities and equipment;
applications for grant and contact support and grant and contact man-
Enter into contracts, leases and cooperative agreements;
agement functions). In addition, an Office of Prevention, Control, and
Establish, as necessary, Heart, Blood Vessel, Lung and
Education was established. This Office was charged with implementing
Blood Disease Control Programs in cooperation with Federal,
the prevention, control, and education programs provided for in the
State and other health agencies;
Act.
Establish and participate in the support of thirty new re-
Of the thirty research and development centers authorized in 1972,
search, training and demonstration centers and support exist-
only three have been designated one in each of the three disease areas
ing centers (fifteen of the new centers were to be engaged in
emphasized in the legislation. The Cardiovascular Center is located in
6
7
Houston, Texas; the Pulmonary Center in Burlington, Vermont; and
Clinical trials of blood oxygenators for temporary support of the
the Blood Resources Center in Seattle, Washington. The programs of
lung are underway, and two important trials in the blood area have
these centers include both basic and clinical research and demonstra-
just been completed. Trials to evaluate urea as an anti-sickling agent
tion as well as educational projects designed to hasten the application
have demonstrated that it is not effective in the treatment of the sickle
of research findings.
cell crisis. A clinical trial has been completed indicating that the en-
Significant scientific and medical knowledge has been achieved
zyme streptokinase (a relatively inexpensive and available prepara-
through research fostered under the 1972 Act. For example, recent
tion) dissolves blood clots in the lung just as effectively as the more
research has contributed greatly to the understanding of the roles of
widely publicized urokinase (another enzyme preparation), which is
different risk factors for heart attacks, such as high blood pressure,
difficult to obtain.
cigarette smoking, high blood lipids, obesity, and diabetes, as well as
Consistent with its statutory responsibilities, the National Heart and
those risk factors which act simultaneously. Of special significance
Lung Institute is promoting the dissemination of knowledge through
is the development of methods for accurate and precise determination
prevention, control and education programs. The National High Blood
of blood lipids for effective risk factor detection and management.
Pressure Education Program is aimed at bringing individuals with
New therapy for heart attacks has resulted from research sponsored
hypertension under effective treatment programs. The establishment
by the Institute. Recent investigations have demonstrated that a heart
of a National Research and Demonstration Center at the University of
attack victim's prognosis is directly related to the amount of dead heart
Vermont will tie together and intensify efforts and resources for the
muscle. Drugs, oxygen therapy, and mechanical circulatory assistance
control of respiratory disease in Vermont, a state with one of the high-
are promising new therapies for limiting the amount of heart muscle
est respiratory ailment rates in the country. A primary goal of this
damage from heart attacks. Recent studies in animals show that nitro-
Center will be to hasten the application of new research results. The
glycerin, one of the oldest and best drugs for relief of the chest pain of
Institute also supports twenty-six sickle cell disease screening and
angina pectoris, may also be valuable in the treatment of acute heart
education clinics which are designed to evaluate new screening tech-
attacks by reducing heart damage. New noninvasive methods have been
niques and demonstrate counseling and education methodologies.
developed which will be important in determining the benefits of vari-
Thus, encouraging progress has been made over the last three years
ous therapies in reducing heart muscle damage.
by the National Heart and Lung Institute, not only in obtaining re-
Considerable advances have been demonstrated in early detection of
search results with respect to diseases of the heart, blood vessel, lung,
chronic bronchitis and emphysema, the major obstructive pulmonary
and blood but also in evaluating these results and in disseminating
diseases. A new and potentially more sensitive method has been de-
knowledge gained through research. It is clear that the Program needs
veloped to detect changes in lung function and structure, which appear
to be continued to advance the Nation's efforts to combat the diseases
to be the first sign of chronic obstructive lung disease.
that together are responsible for over half the deaths each year in the
Finally, important developments have occurred with respect to blood
United States.
research and the use of blood. A procedure has been developed which
Proposed Legislation
will improve production of Factor VIII, used to stop bleeding in
hemophiliac patients. This procedure will enable blood banks and
The purpose of title I of H.R. 7988 is to extend the authority of the
laboratories throughout the country to obtain more potent and
National Heart, Blood Vessel, Lung, and Blood Act of 1972 for two
more uniform Factor VIII from donor blood. Important progress has
fiscal years, with substantive changes and revised authorization levels.
been made in developing techniques to impart blood compatibility to
The Committee is particularly concerned that the activities of the Na-
materials for artificial organs which come in contact with blood.
tional Program-which appear to be developing well-continue with-
Evaluation of new knowledge has been fostered under the authority
out interruption. The two-year continuation is felt to be appropriate
of the 1972 Act. Examples of evaluation of new findings with respect
in this instance because this timing would cause the legislation to be
to heart disease include a study being carried out in twelve Extra-
reviewed again shortly after the President's Biomedical Research
mural Lipid Research Clinics to test whether or not lipid low-
Panel has completed its work, and its recommendations on these and
ering can prevent or delay the onset of coronary heart disease; a
related program areas may then be taken into account.
large-scale clinical trial conducted in twenty clinics throughout the
The principal change made in the 1972 Act by the reported bill
country which will determine the impact on cardiovascular disease of
involves a series of amendments designed to provide increased em-
controlling, simultaneously, high levels of blood lipids, high blood
phasis on the need for a coordinated effort between programs in blood
research and the use of blood resources. Thus, the reported bill contains
pressure, and cigarette smoking; a Coronary Drug Project which has
studied the effects of five lipid-lowering drug regimens in patients who
provisions which would change the name of the National Heart and
have already had heart attacks; and initiation of a collaborative na-
Lung Institute to the National Heart, Lung and Blood Institute, make
tional program to determine the indications for and the long-term
a comparable change in the name of the Institute's advisory council,
effects of coronary artery surgery in the management of coronary heart
and make it clear that the authority of the Institute extends to the
disease.
use of blood products and the management of blood resources.
H. Rept. 94-498-2
8
9
The reported bill also expands the scope of prevention programs
taneous transmission to the President and the Congress not later than
in the national research and demonstration centers to include all heart,
November 30 of each year.
lung, blood and related diseases in lieu of the existing, more limited
Although the Committee is proposing authorization levels for the
requirement that centers be utilized for prevention programs relating
next two fiscal years which are lower than those in the 1972 Act, this
to heart disease. Recent research advances have demonstrated that
does not indicate a desire to lower the operating levels of the National
techniques are available to make prevention programs a worthwhile
Heart, Lung and Blood Institute. The proposed authorization levels
part disease. of control for pulmonary and blood diseases as well as heart
are consistent with the appropriations figures for the first three years
of the National Program, with room for some growth. If it is deter-
A minor change proposed in the reported bill has been made as a
mined that unexpected expenses cause the cost of continuation at cur-
result of the dissolution of the Office of Science and Technology in
rent operating levels to exceed these authorizations, such information
1973. Existing law designates the Director of the Office of Science
should be immediately transmitted to the Committee.
and Technology, who at the time of enactment of P.L. 92-423 was the
There are some additional aspects of the implementation of the 1972
President's principal science advisor, as an ex-officio member of the
National Heart and Lung Advisory Council. The legislation would
Act and the amendments proposed in the reported bill that the Com-
substitute membership for the Director of the National Science Foun-
mittee wishes to emphasize.
dation, since the Director of the NSF now serves as the science advisor
The Committee is disappointed that only three of the thirty research
to the President. Should a new office, such as an Office of Science and
and development centers authorized by the 1972 Act have become oper-
Technology Policy, be established in the executive office of the Presi-
ational, although it is pleased that the centers cover the three categories
dent, the Committee intends to immediately consider substitution of
of diseases addressed by the Act-heart, lung and blood. While it is
the chief executive of that office for the Director of the National
aware that monetary and personnel limitations have stalled center de-
Science Foundation.
velopment, the Committee wishes to state again its support for a
The Committee feels the duties of the National Heart, Lung, and
broader distribution of centers across the country. The centers are a
Blood Advisory Council should include the making of recommenda-
most promising setting for research and the dissemination of the re-
tions concerning those portions of the National Program that are
sults of research into the health care delivery system. Underfunding
conducted under contract awards. Since the membership includes
this vital mechanism is false economy.
public representatives as well as scientists with diverse areas of ex-
In adopting amendment providing increased emphasis on research
pertise, the council has a wide perspective from which to provide
on the use of blood and the management of blood resources, the Com-
advice regarding broad principles of program balance in extramural
mittee has demonstrated its belief that the National Heart, Lung and
activities. Thus, the reported bill specifically includes as mandated
Blood Institute would be an appropriate locus of coordination for all
functions of the advisory council the development of recommendations
blood resources activities of the Department, and recommends that
regarding general areas of research and development suitable for
necessary delegations of authority be given to the Institute for this
award under contracts, and suggestions as to portions of the Institute
purpose. It is intended, however, that HEW agencies with specific
budget to be devoted to such research and development areas. It should
capabilities implement activities in their area of expertise. The Na-
be noted, however, that the council responsibility in the area of grants
tional Heart, Lung and Blood Institute-in addition to its general
is to review and recommend approval or disapproval for funding of
coordinating role-should be the locus for studies and research into
the science and management of the Nation's blood resources. Regula-
grant applications; in the area of contracts, the council is not au-
thorized to review individual contract proposals.
tory activity should remain with the Food and Drug Administration,
The Committee has become concerned about the length of time that
and the new authority afforded the Institute regarding the use of
blood and the management of blood resources is not intended to affect,
has been taken in the past for the annual report of the advisory coun-
prevent, or deter the Food and Drug Administration, through its
cil to become available to the Committee after its completion. For ex-
Bureau of Biologics, from conducting similar research relevant to
ample, the report required to be submitted by the council to the Presi-
its regulatory programs. Implementation of new methodology and
dent for submission to the Congress by January 31, 1975 did not reach
techniques. after they have been evaluated as effective, should be the
the Congress until May 15, 1975, although it was submitted by the
responsibility of the health services arm of the Department of Health,
council to the President in December of 1974. This report, which de-
Education, and Welfare-the Center for Disease Control, the Health
scribes the progress made by the National Heart and Lung Institute
Resources Administration, or the Health Services Administration.
in accomplishing Program objectives, must be received by the Com-
The fivefold increase in support for research in lung disease between
mittee in a timely manner if effective oversight of the National Heart,
fiscal years 1970 and 1975 has been encouraging to the Committee. The
Lung and Blood Institute is to be accomplished. The Committee is
achievements in the pulmonary disease area over the past few years
unaware of the reasons for the five month delay in the submission of
have been significant, but many questions remain unanswered. The
the report to the President and his transmission of it to the Con-
Committee wishes to be assured that this support continues So that
gress. For this reason, H.R. 7988 requires that the report be trans-
the goal of understanding the basic processes that underlie pulmonary
mitted to the Secretary of Health, Education, and Welfare for simul-
disease may be realized.
10
11
The Committee is generally pleased by the activities of the Inter-
needs of an ever-expanding national biomedical research effort, the Ad-
agency Technical Committee established by section 416 of the Act, and,
ministration proposed phasing out the research training grant and fel-
thus, has proposed no amendments to that section. It does feel, however,
lowship programs of the NIH and ADAMHA. The Congress, while
that the coordination of Federal activities relating to heart, blood
agreeing with the Administration's contention that certain modifica-
vessel, lung, and blood diseases and to blood resources would be better
tions in the programs were in order, strongly disagreed with the de-
facilitated by the establishment of subcommittees to the Interagency
cision to terminate the programs. The Congress then enacted, in July
Technical Committee in each of the subject areas, and would urge the
1974, the National Research Service Award Act of 1974, Title I of
Secretary to establish such subgroupings. The subcommittee on lung
Public Law 93-348.
programs, for example, might include representatives from the
This new authority abolished the previous broad research training
Lung Program of the National Heart, Lung, and Blood Institute, the
authorities under the Public Health Service Act and consolidated
National Institute on Allergy and Infectious Diseases, the Maternal
them in a new mechanism called the National Research Service Award.
and Child Health program, the National Institute on Occupational
Under this, the Secretary of Health, Education, and Welfare was di-
Safety and Health, and the Center for Disease Control. In the Com-
rected to provide pre- and post-doctoral support to individuals, and
mittee's view, such a reorganization would result in an improved
additional support to institutions training such individuals. In addi-
coordination of programmatic activities and a valuable exchange of in-
tion, the National Research Service Award authority provided that
formation in each of the subject areas.
recipients of support be required to fulfill a service obligation as a con-
As is true with all areas of NIH research, the Committee is con-
dition of receiving support; and further, that research training sup-
cerned that the results of research be put into the health care system
port be directed to and made available to persons in specific areas in
as rapidly as possible. It is of utmost importance that the knowledge
which a need for additional researchers had been determined. Public
obtained through the National Heart, Blood Vessel, Lung, and Blood
Law 93-348 provided a one-year appropriation authorization.
Disease Program be effectively evaluated and demonstrated in the
Implementation of the 1974 Act
community.
The Committee is concerned that the National Research Service
The utilization of research results in community medical practice
Awards authority has been and continues to be misconstrued by the
is dependent on health education of the public. Much of the current
Administration and, further, that the Administration appears to be
knowledge which increases man's ability to control diseases necessi-
unwilling to commit the resources necessary to support the vigorous
tates changes in human behavior to actually effect changes in morbidity
biomedical and behavioral research training programs mandated in
and mortality. The Committee feels that effective health education is
the law. Indeed, many of the actions of the Administration during the
crucial to this effort. It is important to know what educational tech-
first year of the authority appear to be consistent with its previous
niques will work in inducing beneficial changes in perspective and
attempts to abandon the program.
values-and thus ultimately in the behavior of the public. Therefore,
Despite the clear intent of Congress in enacting the National Re-
the Committee is supportive of programs designed to measure the
search Service Award Act of 1974, the Administration proposed, in its
effectiveness of health education techniques and wishes to encourage
1975 budget request to eliminate predoctoral and institutional support
the National Heart, Lung and Blood Institute to pursue these
and to severely limit the number of new postdoctoral individual
activities.
awards. The fiscal year 1976 budget request was based on a fiscal year
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
1975 rescission proposal and would have allocated only $136 million
Legislative Background
for the funding of all research training for the NIH and ADAMHA.
It was estimated that in fiscal year 1976 only 1,000 new postdoctoral
Since 1930, when authority for the training of biomedical research-
individual awards could be granted by the National Institutes of
ers was first provided to the National Cancer Institute, the National
Health and 100 by the Alcohol, Drug Abuse, and Mental Health Ad-
Institutes of Health (and later the Alcohol, Drug Abuse, and Mental
ministration. The rationale for this decision was ostensibly to keep the
Health Administration) have supported significant and highly success-
number of new awardees in each year in proportion to the number of
ful research training programs. The original research training author-
new research grants awarded each year. No facts or figures were cited
ity has been reaffirmed and expanded by legislation on at least a dozen
to provide a basis for the rationale.
occasions, and programs for the support of training of biomedical and
The Congress rejected the 1975 rescission proposal, which included
behavioral scientists have grown greatly both in size and scope-par-
the proposed cutback of research training activities, and the Commit-
ticularly since 1955. By 1971, NIH training grants and fellowships
tee notes with approval that in fiscal year 1975 the NIH and
supported or assisted 37.5 percent of the Nation's full-time graduate
ADAMHA awarded an estimated $177 million in individual and insti-
students in the medical sciences and 21 percent in the life sciences. Dur-
tutional research training awards. This figure included new starts
ing the several decades these programs have existed, the United States
under the National Research Service Awards authority as well as con-
has become the acknowledged world leader in biomedical and be-
tinuing commitments under previous research training authorities.
havioral research.
In order for the NIH and ADAMHA to honor their continuing re-
In 1973, despite the tremendous success of the research training pro-
search training commitments in fiscal year 1976 as well as to make new
grams in preparing highly qualified biomedical scientists to meet the
12
13
awards, it is estimated that $175 million will be required. Since the
No matter how great an individual's potential for becoming a re-
Administration, as reflected in its 1976 budget request of only $136
search scientist might be, the quality of the training the individual re-
million, persists in its attempts to underfund and therby undermine
ceives remains a key determinant of his or her future productivity.
research training activities, the Committee finds it necessary to state
For this reason, institutional awards are a vital adjunct to the indi-
again certain fundamental premises with respect to biomedical and be-
vidual award mechanism, and the Committee intends that the granting
havioral research training programs.
of institutional awards be continued as an integral part of the
A National Research Service Award can take several forms-all of
ADAMHA and NIH research training programs.
which the Committee intends should be used as appropriate. These
On a related matter, the Committee notes that the National Insti-
forms or mechanisms consist of both individual and institutional
tutes of Health has revised its program of General Research Support
awards for research training at both the predoctoral and postdoctoral
grant awards to enable institutions which have not as yet established
levels.
substantial research programs to develop research environments capa-
The conference report accompanying H.R. 7724 which became Pub-
ble of supporting such programs. It is the Committee's understanding
lic Law 93-348 [H. Rept. 93-1148] stated that the conferees used the
that, after interaction with Congressional Committees, the NIH has
existing training grant programs of the National Institutes of Health
reserved 10 percent of its GRS award funding for institutions which
as the basis for the provision of the Act authorizing grants to non-
receive less than $200,000 in Federal biomedical research monies. While
federal public and nonprofit private institutions in order for those
the Committee shares the concern reflected in the new proposed guide-
institutions to select and support their own trainees. The Committee
lines that new emerging institutions should participate in the GRS
reiterates its intention that institutional support be given. Similarly,
program and believes that this is an improvement over past policy
it was and still is the intent of the Committee that research training
which restricted GRS support to those institutions which had re-
support be afforded to predoctoral students as well as individuals at
ceived more than $200,000 in awards, the Committee plans to look into
the postdoctoral level.
the entire concept of GRS support and the administration of the pro-
The Committee disagrees with the position of the Administration
gram in the near future.
that no institutional awards be granted. Institutional awards are a
The Administration's reluctance to support predoctoral-level re-
vital mechanism in the overall national biomedical and behavioral re-
search training has also caused the Committee great concern. It is from
search training effort. It is through such awards that institutions are
the predoctoral ranks that postdoctoral-level research scientists
able to build up and maintain excellent environments in which to train
emerge. The Committee believes it is vitally important to support
future scientists. In addition, the institutional award is made to the
graduate students seeking the Ph. D. or a combined degree with a view
training institution which selects the people to be trained and which is
to engaging in careers in biomedical or behavioral research. Not only
in the best position to weigh an applicant's merits and potential for a
should the supply of highly qualified Ph. D. candidates be maintained,
productive research career within the environment of that paricular
but vigorous steps should be taken to attract bright young persons to
institution.
careers as research scientists through programs of support for pre-
The individual award, on the other hand, is made on the basis of a
doctoral training. In the case of the research training program of
national competition in which a selection committee makes awards
ADAMHA, 80 percent of the program is directed to providing assist-
after assessing the academic transcripts and potential of applicants
ance for research training to individuals pursuing doctoral degrees.
who have not yet had the opportunity to establish research records on
At the National Institutes of Health, the figure is smaller, approxi-
which to be judged. The recipient of an individual award then goes to
mately 35 percent, but significant nonetheless. With the exception of
an institution which he or she feels will provide the best training en-
the Administration, every witness questioned on this matter at the
vironment. Although the individual award carries with it some funds
hearings stated that predoctoral training should be maintained.
allotted to the institution selected by the awardee to cover costs of
The Committee never intended that predoctoral support nor institu-
support services and other expenses, the individual award mechanism
tional support be abandoned. Indeed, the continuation of such support
does not enable the institution to build up its training capacity in any
was one of the primary reasons that research training legislation was
significant or coherent manner. The institutional award does, and it is
enacted last year. The Committee believes strongly that a rational mix
the Committee's intention that such awards provide sufficient support
of pre- and post-doctoral individual awards and institutional awards
SO as to allow institutions to plan training programs on a prospective
is essential for the maintenance of the high quality training of our
basis. The Committee is aware of and opposes the arbitrary ceiling of
Nation's biomedical and behavioral research scientists.
25 percent imposed by the Administration to cover institutional costs
The Committee notes with disappointment that nowhere in the Ad-
in each training grant and expects that each institutional award will
ministration's statement on research training can it find an instance in
include appropriate funding levels which adequately reflect institu-
which the word excellence is mentioned. The worldwide preeminence of
tional costs based on such factors as the nature of the training program
this Nation's biomedical and behavioral research community was not
and types of trainees in the particular program, and not an arbitrary
attained by ignoring this essential element of our research training
percentage figure that may bear no relationship to costs.
programs. The maintenance of scientific excellence is not only desir-
14
15
able, it is necessary with regard to research which is a vital part of our
the study be conducted in consultation with the Director of NIH. The
national health enterprise. The various research training support
Committee believes it is important that the National Institutes of
mechanisms authorized by the National Research Service Awards Act
Health be able to cousult with those conducting the study and be
were designed to continue and to expand this tradition of excellence.
afforded the opportunity to comment on any reports submitted pur-
It is the Committee's intent that this mandate be fully carried out
suant to section 473 before these reports are transmitted. The Com-
according to the spirit as well as the letter of the law.
mittee has a high degree of confidence in the ability of NIH program
Proposed Legislation
managers to contribute to the various facets of the study, and wishes
The Committee remains firmly committed to Federal support for
those conducting the study to have the full benefit of such contribu-
biomedical and behavioral research training programs. The Committee
tions in drawing their conclusions. The final recommendations should,
believes that successful research depends upon the availability of scien-
of course, be the sole responsibility of those conducting the study.
tists and institutions capable of producing superior research and per-
A considerable amount of concern has been voiced about the feature
sonnel. The amendments effected by H.R. 7988 are directed at extend-
of the Act which requires monetary payback in the case of an individ-
ing programs and making some relatively small but important modifi-
ual who has not completed the service payback requirement. The for-
mula in the existing law specifies that the individual must reimburse
cations to them.
H.R. 7988 would broaden the authority for research training au-
the United States for all support funds received plus interest, and
thorized by section 472 to include biomedical and behavioral research
that, if there has been partial fulfillment of the service obliga-
training programs of entities other than the NIH and ADAMHA,
tion, such time as has been served shall be given one half credit in
such as the research training programs of the Health Resources Ad-
the computation of the monetary debt. The present law states that in-
terest shall accrue at the time the award is made to the individual.
ministration. The Committee did not intend to restrict authority for
biomedical and behavioral research strictly to the NIH and ADA-
Originally, this provision was included to further encourage recipi-
ents of research training support to follow careers in research
MHA, and this technical change should remove any doubt about that
or teaching or both or provide some other health-related service. The
point.
Committee still intends that this be SO. However, on reconsideration of
The proposed legislation would also delete the words "non-Federal"
the interest factor in the payback formula, the Committee has deter-
in section 472(a) (1) which sets forth the kinds of institutions at which
mined that to mandate interest accrual from the time the award is
research training may take place under National Research Service
received results in inordinately high debt accumulation to the indi-
Award support. Since many Federal institutions such as the Public
Health Service and Veterans Administration hospitals can provide
vidual. Consequently, the Committee has modified the computation
excellent environments for research training, the Committee does not
of the formula to specify that interest accrues only from the time the
individual fails to complete the service obligation and the United
wish to exclude individuals training at such Federal institutions from
States becomes entitled to receive repayment. Thus, for example, under
receiving awards.
A further amendment corrects an apparent misunderstanding with
the present law an individual who had received $36,000 of support for
three years of training would have been obligated to repay $32,500
respect to the kinds of activities a National Research Services Award
had he or she served two of the three years of the service obligation.
recipient might engage in as part of the service payback requirement
Under the revised method of interest computation, the individual in
under subsection 472(c). While the original legislation specified
the same circumstance would be obligated to repay only $18,500.
"health research or teaching" the Committee intended that this pro-
Because of the undue harshness of the interest computation in the
vision be interpreted broadly to include research or teaching or a com-
original law, the Committee has also provided that the effects of this
bination of research and teaching. To make this intent clear, the
Committee has added the phrase, "or any combination thereof which
amendment respecting interest be retroactively applied to fiscal year
1975 recipients of Awards.
is in accordance with usual patterns of academic employment." The
Finally, the Committee has provided for authorizations of appro-
Committee intends that the regulations respecting this aspect of service
priations for fiscal years 1976 and 1977 of $175 million and $200 mil-
payback be amended promptly to reflect this broader view.
lion, respectively. The Committee does not believe that the biomedical
In addition, the Committee intends that the teaching and research
and behavioral research training programs of the NIH and ADAMHA
requirement be construed broadly SO as to apply to a variety of settings
can be maintained at monetary levels any lower than these. The fiscal
and types of activities and not be limited solely to the university or
academic setting. Particularly in the event an awardee is unable to
year 1976 figure, in fact, provides for maintenance of the program at
fiscal year 1975 levels.
secure employment in the areas of endeavor specified in the law, the
Committee intends the Secretary have flexibility in setting forth
TITLE IHI-DISCLOSURE OF RESEARCH INFORMATION
reasonable standards for fulfillment of the service obligation.
Section 473 relates to the studies to be undertaken by either the Na-
Background
tional Academy of Sciences or another appropriate organization to de-
Biomedical and behavioral research of the type sponsored by the
termine the overall need for biomedical and behavioral research per-
Department of Health, Education, and Welfare is often highly sophis-
sonnel and the subject areas in which such personnel are needed. H.R.
ticated and specialized. In order to assure competent evaluation of
7988 would add a further specification to this provision to require that
H. Rept. 94-498-3
16
17
applications for biomedical and behavioral research awards, HEW has
The bases for this determination by the Secretary were that the
established a "peer review" system using panels of nongovernmental
creative concepts embodied in research designs were analogous to trade
consultants to investigate and evaluate grant applications. These
secrets, that the applications contained financial information and that
panels, called "initial review groups" (IRGs), are organized around
they were submitted to the Secretary of Health, Education, and Wel-
particular specialized disciplines within the broader field of biomedi-
fare as confidential material. Thus, research information was not
cine and are comprised primarily of members of the public. One mem-
released to the public and the portions of committee meetings in which
ber of each IRG, the Executive Secretary, is a Federal employee.
such information was reviewed were closed to the public.
Applications for research support are referred by the Executive
In 1973, a public interest group, the Washington Research Project,
Secretary to one member of the IRG as the "primary assignee", and to
Inc., requested that the National Institute of Mental Health release
one or more other members who assume secondary responsibility. This
records relating to eleven research grant awards studying the effects of
subgroup undertakes a preliminary evaluation of the application and
drug therapy on children with learning difficulties or behavioral dis-
gathers such additional information as it feels is necessary. This may
orders. The NIMH released certain factual information with respect
involve a "site visit" to the facility at which the applicant proposes to
to the grant applications but refused to release most of the informa-
conduct his research in order to better evaluate the application by, for
tion contained in the associated summary sheets, site visit reports, and
example, observing an experimental technique intended to be used in
renewal applications. The Washington Research Project challenged
the proposed research, or determining the appropriateness of the
this refusal in the United States District Court for the District of
facilities available to the applicant.
Columbia, invoking the Freedom of Information Act. HEW based
An evaluation of each application, and a site visit report, where ap-
its claim for confidential treatment of the documents on the three ex-
propriate, are written by the assignee group and circulated to the
emptions cited above. The District Court held that these exemptions
whole IRG, together with the application. The application is then
were inapplicable and ordered that the requested documents be made
discussed at length at a subsequent meeting of the full IRG. and a
available for inspection and copying, with provision for deletion of
recommendation voted. If approval is recommended, the application
certain names and identifying marks. (Washington Research Project
is also given a priority rating since the cost of all proposals deemed
worthy of funding usually exceeds available funding.
Inc. V. Department of Health, Education, and Welfare, 366 F. Supp.
929 (U.S.D.C. 1973).) On appeal, the United States Court of Appeals
Following the IRG meeting, the Executive Secretary prepares a
for the District of Columbia Circuit reversed the lower court on two
Summary Statement, called a "pink sheet", for each application con-
counts, holding that site visit reports and summary opinions were not
sidered by the group which describes the proposal and recounts the
substantive considerations that led the IRG to recommend approval
subject to disclosure, but upheld the lower court's findings concerning
or disapproval. It contains an opinion of the professional qualifica-
release of grant applications (504 F2d 238 (D.C. Cir. 1974)).
tions of the sponsor and an evaluation of his competence and facilities.
The resultant requirement that research designs, hypotheses and
The IRG's evaluation of the risk to human subjects, if appropriate, is
protocols contained in grant applications be released to the public gen-
erated concern within the research community, which believes that a
included, as well as the site visit report, if any. If there is a minority
opinion of two or more, the minority's view is also summarized,
scientist's ideas are his or her "stock-in-trade" and deserve protection
from disclosure in order to avoid plagiarism. While many members of
without attribution.
Each application and the corresponding pink sheet is then sub-
the research community have urged that legislation exempting re-
mitted to an advisory council established within HEW for the purpose
search information from disclosure be enacted, most public interest
groups oppose legislation designed to withhold research data from
of making recommendations to the Secretary respecting approval or
disclosure, and are especially concerned that research protocols
disapproval of the application.
The Freedom of Information Act requires disclosure, upon request,
involving human subjects be disclosed upon request.
of the final decisions and records of each agency of the government
Proposed Legislation
unless they come within one of nine specific exemptions of the Act.
The legislation on which hearings were conducted contained a pro-
Upon enactment of the Freedom of Information Act, the Department
vision which would provide the Secretary of HEW with a limited au-
of Health, Education, and Welfare took-the position that research
thority to withhold from public disclosure information contained in
grant applications, site visit reports and pink sheets fell under one or
research protocols, hypotheses and designs submitted in connection
more of the following statutory exemptions from disclosure:
with an application for a grant, fellowship or contract under the Public
Section (b) (4), Trade secrets and commercial or financial
Health Service Act until twelve months after the application was ap-
information obtained from a person and privileged or confidential.
proved, except in cases in which the information involves research on
Section (b) (5), Inter-agency or intra-agency memorandums
human subjects.
or letters which would not be available by law to a party other
During hearings, representatives of the research community were
than an agency in litigation with the agency.
unable to demonstrate that the court decision had resulted in plagerism
Section 552 (b) (6), Personnel and medical files and similar
of scientists' ideas. Thus, in executive session the Subcommittee on
files, the disclosure of which would constitute a clearly unwar-
Health and the Environment deleted the provisions in title III author-
ranted invasion of privacy.
izing limited disclosure of research information and substituted a pro-
18
19
vision requiring the President's Biomedical Research Panel (which
true genetic diseases; 36 percent of all spontaneous abortions are
was established in 1974 by P.L. 93-352, and was charged with the
caused by chromosomal defects; 40 percent of all infant mortality
responsibility of assessing policy issues concerning biomedical and
results from genetic factors; 80 percent of the incidence of mental
behavioral research conducted and supported under programs of the
retardation in this country is genetically related. These estimates do
National Institutes of Health and the National Institute of Mental
not take into account many of the conditions that have either recently
Health) to conduct an investigation of the implications of public dis-
been demonstrated to have genetic involvements or are strongly sus-
closure of information contained in research protocols, hypotheses and
pected to have such involvements. These conditions include heart dis-
designs obtained by the Secretary of HEW in connection with applica-
eases, certain forms of arthritis, diabetes, and cancer, and the most
tions for grants, fellowships and contracts submitted during the period
devastating and prevalent mental illnesses-schizophrenia. and de-
January 1, 1975 through December 31, 1975. This provision requires
pressive illness.
that in making the study the panel is to determine the number of
The costs-both economic and social-of genetic disease are enor-
requests for disclosure of such information, the purposes for which
mous. The cost to society of caring for those suffering from Down's
the disclosed information was used, and the effect of disclosure on
Syndrome, for example, which results in mental retardation and has
patent rights, on the protection of human subjects of such research,
an estimated frequency of one in 600 births, is approximately $1.7 bil-
and on the adequacy of informed consent procedures.
lion annually. The estimated medical bill in the case of a child with
The Committee does not intend that the Panel restrict itself to the
Tay-Sachs disease ranges from $20,000 to $40,000 per year for the
determinations listed in the bill and would welcome consideration
three to five year average life span of an affected child. Treatment for
by the Panel of other matters relevant to disclosure of research
hemophilia can cost as much as $12,000 per year. Regardless of the
information.
financial costs of treating genetic disease, the emotional pressure on the
The findings of the Panel are to be reported to the Committee by
family of an affected individual is staggering.
April 30, 1976.
Genetic Technology
TITLE IV-GENETIC DISEASES
Background
Studies of the inheritance of metabolic diseases and physical defects
The hereditary character of many of the most serious chronic and
are beginning to produce beneficial returns at a rapidly accelerating
acute diseases has been known, if imperfectly understood, for many
rate. Screening procedures have been developed which can identify and
years. As more knowledge is made available each year, it is becoming
potentially reduce the incidence or severity of certain genetic diseases;
increasingly obvious that the extent of genetic disease is far greater
new treatment modes have the capability of preventing or controlling
than has been estimated previously. The number of recognized genetic
many hereditary disorders which were considered incurable only a
few years ago.
disorders approaches 2,000 and the list is growing at a rate of from
Recent advances in scientific and biomedical knowledge have re-
75 to 100 newly identified disorders each year.
There are four types of genetic disease. The first includes single-
sulted in the development of several large-scale screening programs
gene disorders that may be either transmitted from one parent or
for the detection of certain recessive disorders. Screening techniques
both or might result from a new mutation. These diseases can be dom-
have been developed to detect carriers of more than sixty recessive
inant, in which one of the parents is affected and each child has a 50
genetic diseases including sickle cell anemia, Cooley's anemia, and Tay-
Sachs disease, thus enabling "at risk" potential parents to assess
percent chance of being affected (e.g. Huntington's chorea) ; recessive,
the possibility of having affected children and thus to choose to
in which both parents are normal and each child has a 25 percent
chance of being affected (e.g. Cooley's anemia) ; or sex-linked, in
abstain from having children or assume the risks involved in preg-
which a gene that produces a certain trait is located on the X-chromo-
nancy. Screening programs which permit prompt identification of
some therefore affects only males (e.g. hemophilia). The second
an affected newborn can, in some cases, permit treatment which
many prevent the serious consequences of genetic defects. The most
type of genetic disease is exemplified by aberrations in the number and
structure of chromosomes (e.g. Down's sydrome). It has been calcu-
frequently cited example is phenylketonuria (PKU), a disease of
lated that each year in the United States approximately 20,000 in-
newborns caused by the absence of an enzyme which usually causes
fants are born with a chromosome abnormality. Another category of
mental retardation. Identification of PKU through relatively simple
testing procedures may result in the prevention of such retardation
genetic disease includes those caused by the interaction of multiple
through use of a special diet.
genes (e.g. diabetes). In these disorders, knowledge about the number
The capacity to treat other genetic disorders is somewhat more
of genes involved and how they interact is very limited. Finally, the
fourth type of genetic disorder is caused by incompatibility between
limited. Common modes of treatment include surgery, diet, drug
fetus and mother, such as Rh hemolytic disease of the newborn.
therapy, transplantation, blood transfusion, physical therapy, and
enzyme induction. While there has been substantial progress in de-
Extent of the Problem
veloping different modes of therapy, most genetic diseases do not
When considered as a group, genetic disorders constitute a highly
respond to such treatment to the extent that affected individuals can
visible and growing problem, resulting in significant individual and
lead "normal" lives. For instance, diabetics treated with insulin ex-
social burdens. It has been estimated that 12 million Americans carry
perience an increased incidence of vascular disorders compared to
the normal population; transfusion therapy for Cooley's anemia can
20
21
lead to a life-threatening accumulation of iron in various organs
legitimate claim to a share of the Nation's health resources. H.R. 7988
of the body: the use of urea as a prophylactic remedy in sickle cell
as reported by the Committee seeks to maintain and enhance the Fed-
crises is accompanied by severe diuresis which can lead to dehydration
eral effort in genetic diseases and to provide a more appropriate setting
and death.
for that effort.
Research efforts into identifying genetic defects, developing new
The Committee is aware that the term "genetic diseases" defies pre-
screening techniques for at-risk populations, and better prophylactic
cise definition. A number of diseases are clearly inherited the causes
therapy without attendant side effects, as well as into positive cures
of others are unknown; still others appear to be the result of a complex
for genetic diseases continue to promise advances in the technology of
interaction between heredity and environment. Although some wit-
genetic medicine. The rapid growth of various genetic technologies
nesses urged that an operational definition of genetic disease be in-
is providing an improved capability to diagnose, treat and eliminate
cluded in the bill, no specific recommendations were offered and the
numerous individual genetic defects. While this growing capability
Committee concluded that broad, general language would permit the
promises significant improvements in genetically-based health, it also
greatest flexibility in exploiting opportunities for progress.
raises complex questions regarding its application. The protection
Proposed Legislation
of human subjects of genetic research, the informed consent and vol-
untary participation of patients in genetic screening programs as
Title IV of H.R. 7988 is designed to accomplish three major pur-
well as the confidentiality of information gathered in connection with
poses. First, the categorical authorities for testing, counseling, infor-
screening programs must be guaranteed by professionals in the genetic
mation, and education programs for sickle cell anemia and Cooley's
technology field.
anemia are replaced by a broader authority which authorizes the Sec-
retary to support projects for voluntary testing and counseling pro-
Legislative Background
grams for all genetic diseases with the authorizations of $20 million
In 1972, Congress enacted two categorical disease programs-the
for fiscal year 1976, and $25 million for fiscal year 1977 for such pur-
National Sickle Cell Anemia Control Act (P.L. 92-294) and the Na-
poses. The Committee is persuaded that a flexible approach is most
tional Cooley's Anemia Control Act (P.L. 92-414). Both laws au-
appropriate for the broad spectrum of disorders known as genetic di-
thorized programs for research, screening and counseling, and infor-
seases although it does not intend that this approach in any way vitiate
mation and education programs, and directed that treatment be made
the existing research or service programs respecting sickle cell anemia
available through Public Health Service facilities. In both instances
or Cooley's anemia. In addition, the Committee supports the principle
the National Institutes of Health was designated as the agency princi-
of providing services relating to genetic diseases as part of an inte-
pally responsible for implementation of these programs. The NIH
grated health care setting wherever possible, and has therefore directed
assumed responsibility for research; service programs were carried
that these efforts primarily utilize existing programs supported under
out by the Health Services Administration under a reimbursable
Title X of the Public Health Service Act (Family Planning Services)
agreement with the National Institutes of Health.
and Title V of the Social Security Act (Maternal and Child Health
The sickle cell and Cooley's anemia legislation provided a valuable
Services).
and needed spur to Federal efforts in those areas. Significant findings.
While recognizing the desirability of a noncategorical approach, the
have been produced by research and service programs. For example,
Committee has also directed that the service components of these pro-
as noted in the report's discussion of the implementation of the 1972
grams be administered through an identifiable administrative unit
heart, lung and blood legislation, it has been determined that trials
within the Department of Health, Education, and Welfare, in order to
have demonstrated that the use of urea as an anti-sickling agent is not
assure efficient coordination and monitoring of programs. The Com-
effective in the treatment of the sickle cell crisis, and new approaches
mittee hopes that establishment of such a unit will provide sufficient
are being evaluated. The experience with twenty-six sickle cell anemia
visibility and impetus for the coordinated genetic disease programs
screening and education clinics has resulted in demonstrations of new
envisaged by the legislation and that appropriate funding of the new
types of screening procedures, an evaluation of counseling methods,
program will be achieved. In this connection, it should be noted that
and attempts to integrate these services into more comprehensive
the Committee expects the Department of Health, Education, and Wel-
health centers.
fare to utilize the new authorities provided for these purposes, and
On balance, the categorical approach embodied in the 1972 legisla-
was pleased to hear from Department witnesses that in the future such
tion appears to fall short of meeting the national need in the complex
specific directives would not be ignored without prior consultation
area of genetic diseases. Targeted research efforts in the area of sickle
with the Committee.
cell anemia and Cooley's anemia, while productive, can and should be
A second major component of title IV directs the Secretary to use
expanded to include research on other genetic disorders. Experience
the broad research authorities of section 301 of the Public Health Serv-
with the service programs suggest that much remains to be learned
ice Act for projects for research in diagnosis, treatment, and control
about identifying populations at risk and providing information and
(including prevention) of genetic diseases, training programs for ge-
services in a useful way. Finally, it has become increasingly obvious
netic counseling and related professions, education programs for
that the victims of many other inherited disorders have an equally
health care practitioners and the public, and development of counsel-
22
23
ing and testing programs and other programs for the diagnosis, pre-
cialized facilities, and diverse scientific and engineering talent, and
vention, control, and treatment of genetic diseases. The Committee rec-
are ideally suited and highly qualified to attack many problems in the
ognizes that the best hope for long-term progress in this area rests in
biomedical, behavioral, and environmental areas. Examples of such
vigorous pursuit of research opportunities by the several NIH Insti-
Federal institutions and facilities are the NASA Jet Propulsion
tutes whose purview includes diseases of genetic origin. At the same
Laboratory and the Armed Forces Institute of Pathology, both of
time, the Committee expects the NIH and other components of the
which conduct cardiovascular research. In addition, the Energy Re-
Department of Health, Education and Welfare to lend their full sup-
search and Development Administration conducts research in a va-
port to the educational and program development efforts essential to
riety of areas including the study of radioisotopes, an area of major
success of the service programs.
interest to the National Heart, Lung and Blood Institute. But for
Finally, new sectión 1103 directs the Secretary to establish a pro-
the limitations of section 507, the National Heart, Lung and Blood
gram within the Public Health Service of voluntary genetic testing,
Institute and other NIH Institutes could be more directly engaged in
diagnosis, counseling, and treatment, to be made available through
facilities of the Public Health Service.
the support of these important research activities and in improved
collaborative efforts with other Federal research facilities.
The reported bill further provides that participation in any pro-
gram authorized by title IV shall be wholly voluntary; that informa-
Committee Proposal
tion obtained about individuals shall be kept confidential; and that
Title V adopts the request of the Department of Health, Education,
community representation in program development and operation
and Welfare. It would amend section 507 of the Public Health Serv-
shall be provided for, where appropriate. Data generated from such
ice Act to expand the authority of the Secretary of Health, Educa-
programs should be made available as appropriate to researchers in
tion, and Welfare to award grants for research, training and demon-
order to support further progress, consistent with the protection of
stration projects and other programs to Federal institutions. As noted
individual privacy. The bill further stipulates that programs be based
above, existing provisions of section 507 limit this authority to awards
on the prevalence of diseases and presence of high-risk populations,
to hospitals of the Public Health Service, of the Veterans' Admini-
and that testing and counseling be directed primarily to persons enter-
stration and of the Bureau of Prisons, and to Saint Elizabeths Hos-
ing their child-producing years. While not set forth specifically in the
pital. Title V would expand this authority to authorize the Secretary
legislation, the Committee would assume that programs directed at
to utilize appropriations for grants for research, training and demon-
newborn screening and treatment would also receive a high priority in
stration projects under the Public Health Service Act and certain
the administration of the Act. The Committee is also particularly con-
other grants under that Act and the Community Mental Health Cen-
cerned that screening programs include adequate counseling and fol-
ters Act to make grants for the same purpose to any Federal Insti-
low-up of persons who have or who are likely to transmit a genetic
tution.
disease, and that information programs include efforts to clarify any
AGENCY REPORT
public misunderstandings in this area.
The following letter from the Department of Health, Education, and.
TITLE V-MISCELLANEOUS
Welfare, dated July 21, 1975, setting forth that agency's views on the
bill, H.R. 7988, was received by the Committee.
Legislative Background
In 1967, at the request of the Administration, Congress enacted sec-
SECRETARY OF HEALTH, EDUCATION, AND WELFARE,
tion 507 of the Public Health Service Act which authorized that ap-
Washington, D.C., July 21, 1975.
propriations for research, training or demonstration project grants
Hon. HARLEY O. STAGGERS,
be made available, for grants for the same purpose, to hospitals of
Chairman, Commmittee on Interstate and Foreign Commerce, House
the Public Health Service, of the Veterans' Administration, of the
of Representatives, Washington, D.C.
Bureau of Prisons and to Saint Elizabeths Hospital on the same terms
DEAR MR. CHAIRMAN: This is a report on H.R. 7988, a bill "To
and conditions that apply to non-Federal institutions. This authority
amend the Public Health Service Act to revise and extend the program
had previously been permitted under provisions of annual appro-
under the National Heart and Lung Institute, to revise and extend the
priations acts. Section 507 was further amended in 1970 to expand
program of National Research Service Awards, and to establish a na-
the scope of grants which could be made to these institutions and to
tional program with respect to genetic diseases; and to require a study
provide that grants to such institutions could be funded at up to 100
and report on the release of research information."
percent of the costs.
Title I of the bill would provide several amendments to Title IV,
The Department of Health, Education, and Welfare has requested
part B, of the Public Health Service Act. It would change the yearly
that this authority be expanded further to encompass all Federal
reporting requirement for the Director of the National Heart and
institutions and facilities. The basis for this request is that other
Lung Institute from a calendar to a fiscal year basis, and require
Federal institutions in addition to the hospitals now eligible to
that such report set forth recommendations concerning staff and
receive HEW support also provide unique research capabilities, spe-
appropriations.
H. Rept. 94-498-4
24
25
The bill would authorize extension of the Heart, Blood Vessel, Lung,
Title II of the bill would amend the provisions of the Public Health
and Blood Disease Control Program for two years at the level of $20
Service Act relating to research training programs of the National
million for fiscal year 1976 and $30 million for fiscal year 1977. Other
Institutes of Health and the Alcohol, Drug Abuse, and Mental Health
programs of the National Heart and Lung Institute would be extended
Administration. It would make eligible for National Research Service
for two years at authorization levels of $340 million for fiscal year 1976
Awards persons at all Federal institutions, rather than only those at
and $375 million for fiscal year 1977. The bill would also amend the
the National Institutes of Health or the Alcohol, Drug Abuse, and
provision concerned with national research and demonstration centers
Mental Health Administration. The title would also eliminate interest
SO that prevention programs, as well as research programs, would deal
charges for the period after an award was made but before the United
with all heart, lung, and related diseases, not solely cardiovascular
States became entitled to recover the monetary payback required of
diseases; and would authorize the $5 million maximum limit for single
individuals who failed to fulfill the service requirement. Title II would
grants to research centers to be exceeded for cost of living increases.
further amend present law to require the National Academy of Sci-
The bill would substitute the Director, National Science Foundation,
ences to conduct its study of research personnel needs in consultation
for the abolished position of Director, Office of Science and Technol-
with the Director of the National Institutes of Health. It would extend
ogy, as an ex officio member of the National Heart and Lung Advisory
appropriation authorizations for National Research Service Awards
Council.
for two years at $175 million for fiscal year 1976 and $200 million for
Provisions in the existing law would also be amended to clarify the
fiscal year 1977.
fact that the authority of the National Heart and Lung Institute in-
With regard to the proposed amendments to the National Research
cludes blood resources activities. The Director of the Institute would
Service Awards authorities, we recommend Committee adoption of the
be authorized to obtain the services of not more than 100 experts or
Administration proposal, introduced as H.R. 7049. We particularly
consultants, rather than not more than 50, as in present law. Finally,
oppose the provision on extension of the authorizations. The appro-
title I would modify the National Heart and Lung Advisory Council's
priation authorizations are not consistent with the President's 1976
functions to (1) require that the program progress report be sub-
Budget, and we believe that a three-year rather than two-year exten-
mitted to the Secretary for transmittal to the President and the Con-
sion is necessary to provide the stability necessary for the success of
gress by November 30 of each year; and (2) include making rec-
our research training efforts. We would therefore recommend that
ommendations to the Secretary concerning areas of research to be
$136 million be authorized for the fiscal year ending June 30, 1976, and
supported by contracts and the percentage of the Institute's budget
for each of the two succeeding fiscal years.
which should be expended for such contracts.
In addition, the Administration's proposal includes a provision to
With respect to title I of H.R. 7988, the Department wishes to re-
ameliorate the harshness of the payback formula by allowing three-
affirm its commitment to maintain the momentum of the heart, blood
fourths credit for time served instead of one-half credit in the present
vessel, lung, blood research, and blood resources programs. In our view,
law. Although H.R. 7988 does change the computation of interest of
these programs have a high health priority. We believe that extension
the present formula, the Administration's proposal in certain cases
of these authorities is unnecessary for the continuation of our efforts in
would ameliorate the payback burden to an even greater extent. and
this area. We do not object to the enactment of the title I provisions
we urge that the Department's amendment be incorporated in H.R.
of H.R. 7988, as long as the authorization levels are consistent with
7988.
the President's 1976 budget and no new programs are mandated.
Similarly, while Title II of H.R. 7988 includes an amendment di-
We would also make the following technical suggestions:
recting the National Academy of Sciences to conduct its manpower
1. Section 105 of the bill be modified to refer to the President's
study in consultation with the Director of the National Institutes of
science advisor, rather than specifically to the Director of the National
Health, the Department's proposal would make several more substan-
Science Foundation. This will ensure that whatever official in any
tive changes with regard to the National Academy of Sciences' study
particular period is acting as the President's science advisor will be
which, we feel, would provide additional clarification of the fact that
the person who also sits on the National Heart and Lung Advisory
the study is advisorv in nature. Here, too. we strongly urge that the
Council.
Department's amendments be incorporated in H.R. 7988. We would
2. Section 102 (d) be deleted as unnecessary "alter" and "renovate"
also note that for consistency and appropriateness the National Acad-
connote the same idea as the present wording "improve" and "repair."
emv of Sciences manpower study should be conducted in consultation
3. Sections 102(b) (1) and 106(3) be modified, as indicated in the
with the Administrator of the Alcohol. Drug Abuse, and Mental
enclosed technical attachment, to allow for the change-over to the new
Health Administration as well as the Director of the National In-
fiscal vear period.
stitutes of Health.
4. The provisions concerned with blood resources be modified and
Finallv. sections (b) and (c) should be deleted as unnecessary;
extended, as indicated in the enclosed technical attachment. SO as to
"or" in this context in the Public Health Service Act is inclusive
insure uniform interpretation throughout title IV, part B, of the
(and/or), not exclusive.
Public Health Service Act.
The Department looks forward to working with the Committee re-
5. The redundancy in lines 4 and 5, page 1, of the bill be corrected.
garding modifications of the existing research training authority. We
26
27
would not oppose title II of H.R. 7988 if it is amended as we suggest,
Our understanding of all diseases, including those which are currently
and if no new program activities are mandated.
called "genetic diseases," is constantly evolving. We are now inclined
Title III of H.R. 7988 is concerned with disclosure of research in-
to believe that there is a genetic component in nearly every kind of
formation. It would require the President's Biomedical Research
disease. However, in some cases diseases which we have thought to be
Panel [which was established by Section 201 (a) of P.L. 93-352, the
primarily genetic in origin, such as childhood diabetes, may in fact be
National Cancer Act Amendments of 1974] to conduct an investiga-
caused by a virus. In short, the severe definitional problems posed by
tion and study of the implication of disclosure to the public of in-
this title would not enhance and could potentially confound present
formation contained in research protocols, research hypothese, and
research activities on genetic diseases.
research designs obtained by the Secretary of Health, Education, and
Another issue is that title IV is unnecessary. Advances in genetics re-
Welfare in connection with a grant application or contract proposal
search to date suggest that the potential benefits of, for example, pre-
submitted to the Secretary under the Public Health Service Act in the
natal diagnosis, enzyme therapy, and therapeutic modification of
period beginning January 1, 1975, and ending December 31, 1975.
genetic material, have been and will continue to be the result of im-
[Note: The bill reads "December 31, 1976" which is clearly in error,
proved understanding of the most basic hereditary processes. We have,
as the bill also requires the entire study to be completed by March 15,
under existing provisions of the Public Health Service Act, ample au-
1976.]
thority to continue such research whether it is called genetic research
The Panel would be required to complete its investigation and study
or not.
not later than March 15, 1976, and submit a report on this study to
Moreover, past and current research efforts in the field of genetics
the House Committee on Interstate and Foreign Commerce and the
are not insignificant. We estimate that at the present time some $138
Senate Committee on Labor and Public Welfare not later than April
million is being expended by the National Institutes of Health in
30, 1976. The report would contain whatever legislative recommenda-
genetic disease research (though the definitions used to obtain these
tions the Panel deemed appropriate.
figures are somewhat arbitrary), and we estimate that an additional
While it is important that the issues associated with disclosure of
$70 million is expended in research related to genetic diseases.
research information be clarified, the Freedom of Information Act, en-
We believe that it would be unwise at this time to enact a law requir-
acted in 1966 and revised in 1967 and 1974, the Federal Advisory Com-
ing establishment of an identifiable administrative unit for genetic
mittee Act of 1972, and the Privacy Act of 1976 contain general provi-
testing and counseling programs and an identifiable unit for dissemi-
sions pertaining to public access to information. We believe that the
nation of information concerning genetic diseases. We see no need for a
issue raised by this proposal (which would modify the impact of the
law to require what can and is being done by administrative action.
Freedom of Information Act on the release of research information)
Therefore, because title IV(1) is plagued by definitional problems
requires additional study to determine its implications for other pro-
which would make it difficult to administer and (2) would duplicate
grams of the Executive Branch. Therefore we are unable to endorse
authorities already contained in the Public Health Service Act for
enactment of this title.
genetic disease counseling and education programs which already exist
Title IV of H.R. 7988 would establish a national program to provide
in the Department, we are opposed to enactment of this Title at this
research, training, testing, counseling, and information dissemination
time.
with respect to genetic diseases. Specifically, it would authorize the
There is one additional legislative change which the Department
Secretary. through an identifiable administrative unit in the Depart-
proposes to submit and which we believe could be appropriately in-
ment of Health, Education, and Welfare, to make grants and contracts
cluded in H.R. 7988 under title V-Miscellaneous. This would be a
for the operation of voluntary genetic testing and counseling programs
modification of Section 507 of the Public Health Service Act to make
and for the development and dissemination of information and ma-
all Federal institutions eligible under the same conditions (except for
terials on genetic diseases. It would also authorize the Secretary, in
100 percent funding) under which non-Federal institutions are eligi-
carrying out Section 301 of the Public Health Service Act, to make
ble to receive research, training, and demonstration project grants
grants and contracts for research, training, education programs, and
under the Public Health Service Act, and certain other grants under
counseling and testing programs on the nature, diagnosis, treatment,
that Act and the Community Mental Health Centers Act. Currently
and control of genetic diseases. Title IV of the bill would also direct
only hospitals of the Public Health Service, Veterans Administration,
the Secretary to establish within the Public Health Service a voluntary
and Federal Bureau of Prisons, and St. Elizabeths Hospital are au-
testing, diagnosis, counseling, and treatment program respecting ge-
thorized to receive such support. Since other Federal institutions also
netic diseases. Title IV specifically includes, but is not limited to, sickle
provide unique research capabilities, specialized facilities and diverse
cell anemia, Cooley's anemia, and Tay-Sachs disease.
scientific and engineering talent, they are ideally suited and highly
We are opposed to the categorical genetic diseases authority pro-
qualified to attack many problems in the biomedical, behavioral, and
posed in title IV. Such authority is duplicative, unnecessary, and would
environmental areas. Examples of such Federal institutions and facili-
not enhance the administration of programs concerned with genetic
ties are the NASA Jet Propulsion Laboratory and the Armed Forces
diseases.
Institute of Pathology, both of which conduct cardiovascular research.
A major problem inherent in title IV is that it is difficult to identifv
In addition, the Energy Research and Development Administration
which diseases should be included under the rubric "genetic diseases."
conducts research in a variety of areas including the study of radio-
28
29
isotopes, a subject very relevant to the National Heart and Lung In-
hearings on the National Institutes of Health in April of 1975 at which
stitute. But for the limitations of Section 507, the National Heart and
time many of these programs were discussed.
Lung Institute and other NIH Institutes could be more directly en-
The Committee has not received oversight reports from either its
gaged in the support of these important research activities and in im-
own Subcommittee on Investigations and Oversight or the Commit-
proved collaborative efforts with other Federal research facilities.
tee on Government Operations.
We therefore suggest that Section 507 be amended to delete mention
of the specifically named institutions and to insert instead language
SECTION-BY-SECTION ANALYSIS
which would encompass Federal research institutions and facilities
generally. We urge the Committee to consider this amendment to the
TITLE I-REVISION OF NATIONAL HEART AND LUNG INSTITUTE
Public Health Service Act and would be happy to work with the Com-
PROGRAMS
mittee further on this matter.
Subject to the exceptions noted above, we do not oppose enactment
Section 101 amends section 411 of the Public Health Service Act
of H.R. 7988.
(hereinafter, "the Act") to change the name of the National Heart and
We are advised by the Office of Management and Budget that there
Lung Institute to the National Heart, Lung and Blood Institute.
is no objection to the presentation of this report from the standpoint
Section 102 amends section 412 of the Act to (1) make a technical
of the Administration's program.
and conforming amendment to reflect the change in the name of the
Sincerely,
Institute's Advisory Council accomplished by amendments to section
STEPHEN KURZMAN,
417 of the Act; and (2) make it explicit that the responsibilities of the
Acting Secretary.
Director of the National Heart, Lung and Blood Institute include ac-
tivities with respect to the use of blood and blood products and the
INFLATION IMPACT STATEMENT
management of blood resources.
Section 103 amends section 413 of the Act to (1) change the name of
The Committee is unaware of any inflationary impact on the econ-
the National Heart, Blood Vessel, Lung and Blood Disease Program
omy that would result from passage of the proposed legislation. The
to the National Heart, Blood Vessel, Lung and Blood Diseases and
proposed authorization for fiscal year 1976 of $555 million represents
Blood Resources Program and make it explicit that the program en-
only .15 percent of the total estimated Federal outlay for fiscal year
compasses blood resources; (2) change the existing requirement for
1976, and less than 2 percent of the estimated Federal outlay for health
submission of an annual report respecting the Program SO that future
programs for fiscal year 1976. Furthermore, the proposed authoriza-
reports will be concerned with the accomplishments of the Program on
tion represents only a slight increase over the fiscal year 1975 appro-
a fiscal, rather than calendar, year basis and to provide that future five-
priation of $526.2 million for these programs, despite the expansion
year plans submitted with such reports will include estimates of neces-
of the genetic diseases program to encompass all genetic disorders.
sary personnel and recommendations for appropriations; (3) increase
The programs supported by the provisions of this bill are of critical
from 50 to 100 the number of experts and consultants authorized to be
importance to the health and welfare of the more than 40 million
utilized by the National Heart, Lung and Blood Institute; (4) broaden
Americans who are directly affected by genetic disorders and diseases
the authority of the Institute with respect to construction to include
of the heart, lung, and blood. The economic costs associated with dis-
authority to alter and renovate facilities and to make it explicit that
eases of the heart, lung, and blood and those which are genetically-
the construction authority extends to blood resource facilities; (5)
related have been estimated at more than $50 billion annually. The
change the title of the Assistant Director for Health Information Pro-
authorization levels in H.R. 7988, in the Committee's view, offer a
grams to the Assistant Director for Prevention, Education and Con-
significant opportunity to lower the economic and social costs as well
trol to more clearly reflect his responsibilities and expand the scope
as the incidence of these diseases, and, by supporting biomedical and
of the health information programs for which the Assistant Director
behavioral research training programs, insure the future quality of
is responsible to include programs with regard to blood diseases and
this Nation's research effort.
blood resources; and (6) make a conforming amendment to the title
of section 413.
PROGRAM OVERSIGHT
Section 104 amends section 4(b) of the Act to extend the Heart,
Blood Vessel, Lung and Blood Disease Prevention and Control Pro-
The Committee's principal oversight activities with respect to this
gram for two years with authorizations of appropriations of $20
program have been conducted by the Subcommittee on Health and the
million for fiscal year 1976 and $30 million for fiscal year 1977 for the
Environment in connection with its consideration of the legislative au-
Program.
thorities for these programs. Legislative hearings on the programs
Section 105 amends section 415 of the Act to (1) make it explicit
were conducted on May 20, 21, and 22, 1975, and the findings are dis-
that the authority for the development of research and demonstra-
cussed in the report under Committee Propoal as the proposed legis-
tion centers with respect to heart, blood vessel and blood diseases
lation is designed to respond to the Subcommittee's findings. The Sub-
includes authority with respect to the management of blood resources;
committee on Health and the Environment also conducted oversight
30
31
(2) remove the stipulation that the authority for the development of
Section 110 amends section 301 of the Act to (1) make a technical
research centers with respect to lung disease be limited to chronic
and conforming amendment to reflect the change of the name of the
diseases; (3) expand the scope of the prevention programs to be con-
Advisory Council accomplished by amendments to section 417 of the
ducted by the research and demonstration centers to include programs
Act; and (2) make it explicit that the functions of the council au-
for pulmonary and blood diseases; (4) expand the existing authority
thorized by section 301 apply to heart, blood vessel, lung and blood
to support centers which provide research, training and demonstra-
diseases and blood resources and not only to heart disease, as existing
tion methods with respect to heart, blood vessel, lung and blood dis-
statutory language implies.
eases to include the authority to support centers which provide re-
search, training and demonstrations with respect to the management
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
of blood resources; (5) authorize that support of such centers may
exceed the annual statutory maximum of $5,000,000 by an amount
Section 201 (a) amends section 472(a) (1) (A) (iii) of the Act to
attributable to increases reflected in the Consumer Price Index; and
authorize the award of National Research Service Awards to indi-
(6) make a conforming amendment to the title of section 415.
viduals engaged in biomedical and behavioral research at Federal
Section 106 amends section 417 of the Act to (1) substitute the Di-
rector of the National Science Foundation as an ex-officio member of
institutions. institutions as well as nonfederal public and nonprofit private
the National Heart, Lung and Blood Advisory Council in place of
Sections 201 (b) and (c) amend sections 472(c) (1) (A) (i) and 472
the Director of the Office of Science and Technology since that office
(c) (2) (A) of the Act to make it explicit that service requirements
has been abolished; (2) change the name of the National Heart and
applicable to persons who receive National Research Service Awards
Lung Advisory Council to the National Heart, Lung and Blood Ad-
may include a combination of health research or teaching and not
visory Council; and (3) make a conforming change in the title of
either health research or teaching.
section 417.
Section 201 (d) amends section 472 (d) of the Act to extend the Na-
Section 107 amends section 418 of the Act to (1) expand the func-
tional Research Service Award Act for two years with authorizations
tions of the National Heart, Lung and Blood Advisory Council to
of appropriations of $175 million for fiscal year 1976 and $200 million
include review and approval of research and training programs in the
for fiscal year 1977.
use of blood and blood products and the management of blood re-
Section 202 amends sections 472 (a) (i) (A) (i) and 472 (2) of the
sources, and the collection of information with respect to the use of
Act to authorize the award of National Research Service Awards for
blood and blood products and the management of blood resources;
research within any of the divisions of the Department of Health, Ed-
(2) expand the Council's functions to include making recommenda-
ucation, and Welfare. Existing law limits such awards to research at
tions to the Secretary on areas of research which should be supported
the National Institutes of Health and the Alcohol, Drug Abuse and
by contracts and on the percentage of the Institute's budget which
Mental Health Administration.
should be expended for such contracts; (3) change the timing and
Section 203 amends section (4) of the Act, which provides for
manner of submission of the report required to be submitted by the
the recovery by the Federal government of the monetary value, in-
Council to the President to require that the report be transmitted
cluding interest, of a National Research Service Award in those
by the Secretary to the President and the Congress simultaneously
instances in which a recipient fails to fulfill the applicable service re-
not later than November 30 of each year; and (4) to clarify that the
quirement. Interest on the award would be computed from the time the
focus of the report is to be on the progress of the National Heart,
United States becomes entitled to recover all or part of the award,
Blood Vessel, Lung and Blood Diseases and Resources Program dur-
rather than from the time the award is made, as is the case under
ing the preceding fiscal year.
present law. The new method of computing interest is made applicable
Section 108 amends section 419A of the Act to (1) make its various
to National Research Service Awards made from appropriations be-
administrative provisions apply to the use of blood and blood products
ginning in the fiscal year ending June 30, 1975.
and the management of blood resources and (2) change the authority
Section 204 amends section 473 (b) of the Act to direct that the Na-
of the Director of the Institute to approve research and training
tional Academy of Sciences or other group or association conducting
grants not exceeding $35,000 without Council review to provide that
the continuing study of biomedical and behavioral research personnel
the $35,000 limitation apply only to the direct costs of research and
required by section 473 (a) to conduct such study in consultation with
training.
the Director of the National Institutes of Health.
Section 109 amends section 419B of the Act to (1) extend the pro-
grams authorized by Part B of Title IV of the Act (except the Pre-
TITLE II-DISCLOSURE OF RESEARCH INFORMATION
vention and Control Programs authorized by section 414) for two
years and authorize appropriations of $340 million for fiscal year
Section directs the President's Biomedical Research Panel
1976 and $375 million for fiscal year 1977 for such programs; and
(established by Section 201 (a) of the National Cancer Act Amend-
(2) specify that the requirement that not less than 15 percent of sums
ments of 1974) to conduct a study of the implication of public disclos-
appropriated under section 419B be reserved for programs respecting
ure of information contained in research protocols, hypotheses, and
blood diseases applies to programs in blood resources as well.
designs submitted during the period from January 1, 1975 to Decem-
H. Rept. 94-498-5
32
33
ber 31, 1975 to the Secretary of Health, Education, and Welfare in
New Section 1102 of the Act authorizes the Secretary, in imple-
connection with an application or proposal for a grant, fellowship, or
menting his general authority to foster research under section 301 of
contract under the Act. The study is to include a determination of the
the Act, to make grants and enter into contracts for (1) basic or ap-
number of requests for disclosure of such information, the interests
plied research leading to the understanding, diagnosis, treatment and
represented by persons for whom the requests were made, and the pur-
control of genetic diseases; (2) special programs for the training of
poses for which information disclosed was used. The study is also to
genetic counselors, social and behavioral scientists and other health
address the effect of disclosure of such information on proprietary in-
professionals; (3) educational programs regarding the nature of
terests, patent rights, the ability of peer review systems to insure high-
genetic processes, inheritance patterns of genetic diseases and the avail-
quality Federally funded research, the adequacy of protection of the
able means, methods and facilities to diagnose, control and treat genetic
public against research which presents an unreasonable risk to human
diseases; and (4) the development of counseling, testing and other
subjects, and informed consent procedures. The Panel is directed to
programs for the diagnosis, control and treatment of genetic diseases.
complete its study no later than March 15, 1976, and report thereon to
New Section 1103 of the Act requires that participation in genetic
the Committee on Interstate and Foreign Commerce of the House of
disease programs authorized by title IV of the bill be wholly volun-
Representatives and the Committee on Labor and Public Welfare of
tary and not a prerequisite to participation in any other program.
the Senate no later than April 30, 1976. The report is to contain such
New Section 1104(a) of the Act requires that applications for
recommendations for legislation as the Panel deems appropriate.
grants and contracts shall contain such information as the Secretary
Section 301 (b) changes from July 1, 1976 to January 1, 1977 the
may require and that each applicant for a grant or contract shall (1)
effective date on which the National Advisory Council for the Pro-
administer or supervise the programs and activities for which assist-
tection of Human Subjects of Biomedical and Behavioral Research is
ance is sought; (2) provide for strict confidentiality of test results,
to be established.
medical records and other information regarding persons treated ex-
TITLE IV-GENETIC DISEASES
cept for information which the patient or his guardian gives informal
Section 401 provides that title IV of the bill may be cited as the
consent to be released and for statistical data compiled without ref-
"National Genetic Diseases Act."
erence to the identity of the patient; (3) provide for community rep-
Section 402 states that purposes of title IV are to establish programs
resentation in the development or operation of genetic counseling pro-
of basic research, applied research, research training, testing, counsel-
grams; (4) in cases of applications for programs involving delivery of
ing, information, and education with respect to genetic diseases includ-
services, provide assurances that genetic testing and counseling serv-
ing, but not limited to, sickle cell anemia, Cooley's anemia, and Tay-
ices will involve widely prevalent diseases and high risk population
Sachs disease.
groups and be directed especially to persons entering child producing
Section 403 provides that, effective July 1, 1975, Title XI of the
years, and that arrangements will be made to provide counseling to per-
Act is amended by striking out Parts A and B (relating to programs
sons found to have a genetic disease and to persons found to carry a
for sickle cell anemia and Cooley's anemia) and substituting for such
gene or chromosome which may cause a deleterious effect in their off-
programs a new Part A, entitled "Genetic Diseases" which adds the
spring; and (5) establish appropriate fiscal control and accounting
following new sections to the Act:
procedures.
New section 1101 of the Act authorizes the Secretary, through an
New Section of the Act provides that in making grants or
identifiable administrative unit within the Department of Health,
entering into contracts for testing and counseling programs under sec-
Education, and Welfare, to make grants and enter into contracts for
tion 1101 of the Act, the Secretary shall take into account the number
the establishment and operation of voluntary genetic counseling and
of persons to be served and the extent to which rapid and effective use
testing programs. Such programs are to be conducted primarily in
will be made of funds awarded, and give priority to programs in areas
conjunction with existing health programs, including Federally sup-
having the greatest number of persons who will benefit from and are in
ported family planning programs under title X of the Act and mater-
need of services.
nal and child health programs under title V of the Social Security Act.
Section 403 (b) makes a technical change in Section 1121 (b) (5) of
In addition, under new section 1101, the Secretary is directed to carry
the Act (relating to authorizations of appropriations for grants and
out, through an identifiable administrative unit within HEW, a pro-
contracts for sudden infant death syndrome programs) to reflect the
gram to develop and disseminate information and educational ma-
change in the date on which fiscal years will terminate pursuant to the
terials relating to genetic diseases in order to make available the latest
Congressional Budget and Impoundment Control Act of 1974; redesig-
advances in the testing, diagnosis, counseling and treatment respecting
nates part C of title XI of the Act as Part B and makes a technical
genetic diseases. The Secretary is authorized to make grants and enter
and conforming change in the heading of title XI.
into contracts as above for the development and dissemination of such
TITLE V-MISCELLANEOUS
materials. Appropriations of $20 million for fiscal year 1975 and $25
million for fiscal year 1977 are authorized for payments under grants
Section 501 (a) redesignates the second paragraph (4) of section
and contracts under new section 1101.
472(c) of the Act as paragraph (5).
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35
Section 501 (b) amends section 507 of the Act (which authorizes the
Secretary of Health, Education, and Welfare to utilize appropriations
laboratories, and other institutions for the general support of their
available for grants for research, training, and demonstration projects
research: Provided, That such uniform percentage, not to exceed 15
and other programs under this Act or the Community Mental Health
per centum, as the Surgeon General may determine, of the amounts
Centers Act to make grants for the same purpose to hospitals of the
provided for grants for research projects for any fiscal year through
Public Health Service, the Veterans' Administration, the Bureau of
the appropriations for the National Institutes of Health may be trans-
Prisons and to Saint Elizabeths Hospital at up to 100 percentum of
ferred from such appropriations to a separate account to be available
costs) to authorize the Secretary to award grants authorized under
for such research grants-in-aid for such fiscal year;
such section to any Federal institution.
(h) Adopt, upon recommendation of the National Advisory Health
Council, or, with respect to cancer, upon recommendation of the Na-
CHANGES IN EXISTING LAW MADE BY THE BILL, As REPORTED
tional Cancer Advisory Board or with respect to mental health, upon
recommendation of the National Advisory Mental Health Council, or,
In compliance with clause 3 of rule XIII of the Rules of the House
with respect to [heart diseases] heart, blood vessel, lung, and blood
of Representatives, changes in existing law made by the bill, as re-
diseases and blood resources, upon recommendation of the National
ported, are shown as follows (existing law proposed to be omitted is
Heart and Lung Advisory Council, or, with respect to dental diseases
enclosed in black brackets, new matter is printed in italic, existing law
and conditions, upon recommendation of the National Advisory Dental
in which no change is proposed is shown in roman) :
Research Council, such additional means as he deems necessary or ap-
propriate to carry out the purposes of this section.
PUBLIC HEALTH SERVICE ACT
TITLE IV-NATIONAL RESEARCH
*
*
*
*
INSTITUTES
TITLE III-GENERAL POWERS AND DUTIES
*
*
*
*
PART A-RESEARCH AND INVESTIGATION
PART B-NATIONAL HEART AND LUNG INSTITUTE
IN GENERAL
ESTABLISHMENT OF INSTITUTE
SEC. 301. The Surgeon General shall conduct in the Service, and
SEC. 411. There is hereby established in the Public Health Service a
encourage, cooperate with, and render assistance to other appropriate
National [Heart and Lung] Heart, Lung, and Blood Institute (here-
public authorities, scientific institutions, and scientists in the conduct
after in this part referred to as the "Institute").
of, and promote the coordination of, research, investigations, experi-
ments, demonstrations, and studies relating to the causes, diagnosis,
RESEARCH AND TRAINING IN DISEASES OF THE HEART, BLOOD VESSELS, LUNG,
treatment, control, and prevention of physical and mental diseases and
AND BLOOD AND IN THE MANAGEMENT OF BLOOD RESOURCES
impairments of man, including water purification, sewage treatment,
and pollution of lakes and streams. In carrying out the foregoing the
SEC. 412. In carrying out the purposes of section 301 with respect
Surgeon General is authorized to-
to heart, blood vessel, lung, and blood diseases and with respect to the
(a)
*
*
*
use of blood and blood products and the management of blood re-
*
*
*
*
*
sources the Secretary through the Institute and in cooperation with
(c) Make grants-in-aid to universities, hospitals, laboratories, and
the National Heart and Lung Advisory Council (hereinafter in this
other public or private institutions, and to individuals for such re-
part referred to as the "Council"), shall-
search projects as are recommended by the National Advisory Health
(1) conduct, assist, and foster researches, investigations, experi-
Council, or, with respect to cancer, recommended by the National
ments, and demonstrations relating to the cause, prevention, and
Cancer Advisory Board, or, with respect to mental health, recom-
methods of diagnosis and treatment of heart, blood vessel, lung,
mended by the National Advisory Mental Health Council, or with
and blood diseases and to the use of blood and blood products and
respect to [heart diseases] heart, blood vessel, lung, and blood diseases
the management of blood resources;
and blood resources, recommended by the National Heart [and Lung],
(2) promote the coordination of research and control programs
Lung, and Blood Advisory Council, or, with respect to dental diseases
conducted by the Institute, and similar programs conducted by
and conditions, recommended by the National Advisory Dental Re-
other agencies, organizations, and individuals;
search Council, and include in the grants for any such project grants
(3) make available research facilities of the Service to approp-
of penicillin and other antibiotic compounds for use in such project;
riate public authorities, and to health officials and scientists en-
and make, upon recommendation of the National Advisory Health
gaged in special studies related to the purposes of this part;
Council, grants-in-aid to public or nonprofit universities, hospitals,
(4) make grants-in-aid to universities, hospitals, laboratories,
and other public or private agencies and institutions, and to in-
36
37
dividuals for such research projects relating to heart, blood vessel,
(2) studies and research into the basic biological processes and
lung, and blood diseases and to the use of blood and blood products
mechanisms involved in the underlying normal and abnormal
and the management of blood resources as are recommended by
heart, blood vessel, lung, and blood phenomena;
the Council, including grants to such agencies and institutions
(3) research into the development, trial, and evaluation of
for the construction, acquisition, leasing, equipment, and mainte-
techniques, drugs, and devices (including computers) used in, and
nance of such hospital, clinic, laboratory, and related facilities,
approaches to, the diagnosis, treatment (including emergency
and for the care of such patients therein, as are necessary for such
medical service), and prevention of heart, blood vessel, lung, and
research:
blood diseases and the rehabilitation of patients suffering from
(5) establish an information center on research, prevention,
such diseases;
diagnosis, and treatment of heart, blood vessel, lung, and blood
(4) establishment of programs that will focus and apply
diseases and on the use of blood and blood products and the man-
scientific and technological efforts involving biological, physical,
agement of blood resources, and collect and make available,
and engineering sciences to all facets of heart, blood vessel, lung,
through publications and other appropriate means, information
and blood diseases with emphasis on refinement, development, and
as to, and the practical application of, research and other activ-
evaluation of technological devices that will assist, replace, or
ities carried on pursuant to this part;
monitor vital organs and improve instrumentation for detection,
(6) secure from time to time, and for such periods as he deems
diagnosis, and treatment of those diseases;
advisable, the assistance and advice of persons from the United
(5) establishment of programs for the conduct and direction of
States or abroad who are experts in the field of heart diseases;
field studies, large-scale testing and evaluation, and demonstra-
(7) in accordance with regulations and from funds appropri-
tion of preventive, diagnostic, therapeutic, and rehabilitative
ated or donated for the purpose, provide clinical training and in-
approaches to, and emergency medical services for, such diseases;
struction and establish and maintain clinical traineeships, in the
(6) studies and research into blood diseases and blood, and into
Institute and elsewhere in matters relating to the diagnosis, pre-
the use of blood for clinical purposes and all aspects of the man-
vention, and treatment of heart, blood vessel, lung, and blood
agement of its resources in this country, including the collection,
diseases and to the use of blood and blood products and the man-
preservation, fractionalization, and distribution of it and its
agement of blood resources with such stipends and allowances (in-
products;
cluding travel and subsistence expenses) for trainees as he may
(7) the education and training of scientists, clinicians, and edu-
deem necessary, the number of persons receiving such training
cators, in fields and specialties (including computer sciences)
and instruction, and the number of persons holding such trainee-
requisite to the conduct of clinical programs respecting heart,
ships, to be fixed by the Council, and, in addition, provide for
blood vessel, lung, and blood diseases and blood resources;
such training, instruction, and traineeships through grants, upon
(8) public and professional education relating to all aspects of
recommendation of the Council, to public and other nonprofit
such diseases and the use of blood and blood products and the
institutions.
management of blood resources;
(9) establishment of programs for study and research into
NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE DISEASES
AND
heart, blood vessel, lung, and blood diseases of children (includ-
BLOOD RESOURCES PROGRAM
ing cystic fibrosis, hyaline membrane, and hemolytic and hemo-
philic diseases) and for the development and demonstration of
SEC. 413. (a) The Director of the Institute, with the advice of the
diagnostic, treatment, and preventive approaches to these diseases;
Council, shall develop a plan for a National Heart, Blood Vessel,
and
Lung, and Blood Disease Diseases and Blood Resources Program
(10) establishment of programs for study, research, develop-
(hereafter in this part referred to as the "Program") to expand,
ment, demonstrations and evaluation of emergency medical serv-
intensify, and coordinate the activities of the Institute respecting
ices for people who become critically ill in connection with heart,
heart, blood vessel, lung, and blood diseases and blood resources
blood vessel, lung, or blood diseases, which programs shall include
(including its activities under section 412) and shall carry out the
programs for (A) the training of paraprofessionals in (i) emer-
Program in accordance with such plan. The Program shall be coordi-
gency treatment procedures, and (ii) utilization and operation of
nated with the other research institutes of the National Institutes of
emergency medical equipment, (B) the development and opera-
Health to the extent that they have responsibilities respecting such
tion of (i) mobile critical care units (including helicopters and
diseases and shall provide for-
other airborne units where appropriate), (ii) radio, telecommuni-
(1) investigation into the epidemiology, etiology, and preven-
cations, and other means of communications, and (iii) electronic
tion of all forms and aspects of heart, blood vessel, lung, and blood
monitoring systems, and (C) the coordination with other commu-
diseases, including investigations into the social, environmental,
nity services and agencies in the joint use of all forms of emer-
behavioral, nutritional, biological, and genetic determinants and
gency vehicles, communications systems, and other appropriate
influences involved in the epidemiology, etiology, and prevention
services.
of such diseases;
38
39
The Program shall give special emphasis to the continued development
tion Programs] Prevention Education, and Control, shall conduct a
in the Institute of programs relating to atherosclerosis, hypertension,
program to provide the public and the health professions with health
thrombosis, and congenital abnormalities of the blood vessels as causes
information with regard to cardiovascular, blood, and pulmonary di-
of stroke, and to effective coordination of such programs with related
seases and blood resources. In the conduct of such program, special em-
stroke programs in the National Institute of Neurological Diseases
phasis shall be placed upon dissemination of information regarding
and Stroke.
diet, exercise, stress, hypertension, cigarette smoking, weight control,
(b) (1) The plan required by subsection (a) of this section shall (A)
and other factors affecting the prevention of arteriosclerosis and other
be developed within one hundred and eighty days after the effective
cardiovascular diseases and of pulmonary and blood diseases.
date of this section, (B) be transmitted to the Congress, and (C) set
out the Institute's staff requirements to carry out the Program and
HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE PREVENTION AND CONTROL
recommendations for appropriations for the Program.
PROGRAMS
(2) The Director of the Institute shall, as soon as practicable after
the end of each [calendar] fiscal year, prepare in consultation with the
SEC. 414. (a) The Director of the Institute, under policies estab-
Council and submit to the President for transmittal to the Congress a
lished by the Director of the National Institutes of Health and after
report on the activities, progress, and accomplishments under the Pro-
consultation with the Council, shall establish programs as necessary
for cooperation with other Federal Health agencies, State, local, and
gram during the preceding [calendar] fiscal year and a plan for the
regional public health agencies, and nonprofit private health agencies
Program during the next five years. Each such plan shall contain (A)
in the diagnosis, prevention, and treatment (including the provision
an estimate of the number and type of personnel which will be required
of emergency medical services) of heart, blood vessel, lung, and blood
by the Institute to carry out the Program during the five years with
diseases, appropriately emphasizing the prevention, diagnosis, and
respect to which the plan is submitted, and (B) recommendations for
treatment of such diseases of children.
appropriations to carry out the Program during such five years.
(b) There is authorized to be appropriated to carry out this section
(c) In carrying out the Program, the Director of the Institute,
$25,000,000 for the fiscal year ending June 30, 1973, $35,000,000 for the
under policies established by the Director of the National Institutes
fiscal year ending June 30, 1974, [and] $45,000,000 for the fiscal year
of Health and after consultation with the Council and without regard
ending June 30, 1975, $20,000,000 for fiscal year 1976, and $30,000,000
to any other provision of this Act may-
for fiscal year 1977.
(1) if authorized by the Council, obtain (in accordance with
section 3109 of title 5, United States Code, but without regard
NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD
to the limitation in such section on the number of days or the
VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD RESOURCES
period of such service) the services of not more than [fifty] one
hundred qualifications; experts or consultants who have scientific or professional
SEC. 415. (a) (1) The Director of the Institute may provide for the
development of-
(2) acquire, construct, improve, repair, operate, alter, renovate
(A) fifteen new centers for basic and clinical research into,
and maintain heart, blood vessel, lung, and blood disease and
training in, and demonstration of, advanced diagnostic, preven-
blood resource laboratory, research, training, and other necessary
tion, and treatment methods (including methods of providing
facilities and equipment, and related accommodations as may be
emergency medical services) for heart, blood vessel, and blood di-
necessary, and such other real or personal property (including
seases and for research in the use of blood and blood products and
patents) as the Director deems necessary; and acquire, without
in the management of blood resources; and
regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or
(B) fifteen new centers for basic and clinical research into,
otherwise, through the Administrator of General Services, build-
training in, and demonstration of, advanced diagnostic, preven-
ings or parts of buildings in the District of Columbia or commu-
tion, and treatment methods (including methods of providing
nities located adjacent to the District of Columbia for the use of
emergency medical services) for [chronic] lung diseases (includ-
the Institute for a period not to exceed ten years; and
ing bronchitis, emphysema, asthma, cystic fibrosis, and other lung
(3) enter into such contracts, leases, cooperative agreements, or
diseases of children).
other transactions, without regard to sections 3648 and 3709 of
(2) The centers developed under [paragraph (1) (A)] subpara-
the Revised Statutes of the United States (31 U.S.C. 529, 41
graphs (A) and (B) of paragraph (1) shall, in addition to being
U.S.C. 5), as may be necessary in the conduct of his functions,
utilized for research, training, and demonstrations, be utilized for the
with any public agency, or with any person, firm, association,
following prevention programs for cardiovascular, pulmonary, and
corporation, or educational institution.
blood diseases:
(d) There shall be in the Institute an Assistant Director for [Health
(A) Programs to develop improved methods of detecting indi-
Information Programs] Prevention Education, and Control who shall
viduals with a high risk of developing [cardiovascular disease]
be appointed by the Director of the Institute. The Director of the In-
cardiovascular, pulmonary, and blood diseases.
stitute, acting through the Assistant Director for [Health Informa-
40
41
(B) Programs to develop improved methods of intervention
aspects of all Federal health programs and activities relating to heart,
against those factors which cause individuals to have a high risk
blood vessel, lung, and blood diseases and to blood resources to assure
of developing [such disease] such diseases.
the adequacy and technical soundness of such programs and activ-
(C) Programs to develop health professions and allied health
ities and to provide for the full communication and exchange of infor-
professions personnel highly skilled in the prevention of [such
mation necessary to maintain adequate coordination of such programs
disease such diseases.
and activities.
(D) Programs to develop improved methods of providing emer-
gency medical services for persons with such disease such
Committee and the Committee shall include representation from all
(b) The Director of the Institute shall serve as Chairman of the
diseases.
Federal department and agencies whose programs involve health func-
(3) Centers developed under this subsection may be supported under
tions or responsibilities as determined by the Secretary.
subsection (b) or under any other applicable provision of law. The
research, training, and demonstration activities carried out through
NATIONAL HEART [AND LUNG] LUNG, AND BLOOD ADVISORY COUNCIL
any such center may relate to any one or more of the diseases referred
to in paragraph (1) of this subsection.
SEC. 417. (a) There is established in the Institute a National
Heart
(b) The Director of the Institute, under policies established by the
and Lung Advisory Council] National Heart, Lung, and Blood Ad-
Director of the National Institutes of Health and after consultation
visory Council to be composed of twenty-three members as follows:
with the Council, may enter into cooperative agreements with public
(1) The Secretary, the Director of the National Institutes of
or nonprofit private agencies or institutions to pay all or part of the
Health, the [Director of the Office of Science and Technology]
cost of planning, establishing, or strengthening, and providing basic
Director of the National Science Foundation and the chief medi-
operating support for, existing or new centers (including centers es-
cal officer of the Veterans' Administration (or their designees),
tablished under subsection (a)) for basic or clinical research into,
and a medical officer designated by the Secretary of Defense, shall
training in, and demonstration of, the management of blood resources
be ex officio members of the Council.
and advanced diagnostic, prevention, and treatment methods for heart,
(2) Eighteen members appointed by the Secretary.
blood vessel, lung, or blood diseases. Funds paid to centers under co-
Eleven of the appointed members shall be selected from among the
operative agreements under this subsection may be used for-
leading medical or scientific authorities who are skilled in the sciences
(1) construction, notwithstanding section 405,
relating to diseases of the heart, blood vessels, lungs, and blood; two
(2) staffing and other basic operating costs, including such
of the appointed members shall be selected from persons enrolled in
patient care costs as are required for research,
residency programs providing training in heart, blood vessel, lung, or
(3) training, including training for allied health professions
blood diseases; and five of the appointed members shall be selected
personnel, and
from members of the general public who are leaders in the fields of
(4) demonstration purposes.
fundamental or medical sciences or in public affairs.
The aggregate of payments (other than payments for construction)
(b) (1) Each appointed member of the Council shall be appointed
made to any center under such an agreement [may not exceed $5,000,-
for a term of four years, except that-
000 in any year. for its costs (other than indirect costs) described
(A) any member appointed to fill a vacancy occurring prior
in the first sentence may not exceed $5,000,000 in any year, except that
to the expiration of the term for which his predecessor was ap-
the aggregate of such payments in any year may exceed such amount
pointed shall be appointed for the remainder of such term; and
to the extent that the excess amount is attributable to increases in such
(B) of the members first appointed after the effective date of
year in appropriate costs as reflected in the Consumer Price Index
this section, five shall be appointed for a term of four years, five
published by the Bureau of Labor Statistics. Support of a center
shall be appointed for a term of three years, five shall be ap-
under this subsection may be for a period of not to exceed five years
pointed for a term of two years, and three shall be appointed for a
and may be extended by the Director of the Institute for additional
term of one year, as designated by the Secretary at the time of
periods of not more than five years each, after review of the operations
of such center by an appropriate scientific review group established
Appointed appointment. members may serve after the expiration of their terms
by the Director. As used in this section, the term "construction" does
until their successors have taken office.
not include the acquisition of land; and the term "training" does not
(2) A vacancy in the Council shall not affect its activities, and
include research training for which fellowship support may be pro-
twelve members of the Council shall constitute a quorum.
vided under section 472.
(3) The Council shall supersede the existing National Advisory
Heart Council appointed under section 217, and the appointed mem-
INTERAGENCY TECHNICAL COMMITTEE
bers of the National Advisory Heart Council serving on the effective
date of this section shall serve as additional members of the National
SEC. 416. (a) The Secretary shall establish an Interagency Techni-
Heart and Lung Advisory Council National Heart, Lung, and Blood
cal Committee on Heart, Blood Vessel, Lung and Blood Diseases and
Advisory Council for the duration of their terms then existing, or
Blood Resources which shall be responsible for coordinating those
for such shorter time as the Secretary may prescribe.
42
43
(4) Members of the Council who are not officers or employees of
(4) recommend to the Secretary (A) areas of research in heart,
the United States shall receive for each day they are engaged in
blood vessels, lung, and blood diseases and in the use of blood and
the performance of the functions of the Council compensation at rates
blood products and the management of blood resources which it
not to exceed the daily equivalent of the annual rate in effect for
determines should be supported by the awarding of contracts in
grade GS-13 of the General Schedule, including traveltime; and all
order to best carry out the purposes of this part, and (B) the
members, while SO serving away from their homes or regular places of
percentage of the budget of the Institute which should be ex-
business, may be allowed travel expenses, including per diem in
pended for such contracts;
lieu of subsistence, in the same manner as such expenses are authorized
[(4)] (5) collect information as to studies which are being
by section 5703 of title 5, United States Code, for persons in the Gov-
carried on in the United States or any other country as to the
ernment service employed intermittently.
cause, prevention, or methods of diagnosis or treatment of heart,
(c) The Secertary (or his designee) shall be the Chairman of the
blood vessel, lung, and blood diseases and to the use of blood and
Council.
blood products and the management of blood resources, by cor-
(d) The Director of the Institute shall (1) designate a member of
respondence or by personal investigation of such studies, and
the staff of the Institute to act as Executive Secretary of the Council,
with the approval of the Secretary make available such informa-
and (2) make available to the Council such staff, information, and
tion through appropriate publications for the benefit of health
other assistance as it may require to carry out its functions.
and welfare agencies and organizations (public or private), phy-
(e) The Council shall meet at the call of the Chairman, but not less
sicians, or any other scientists, and for the information of the
often than four times a year.
general public;
[(5)] (6) recommend to the Secretary for acceptance condi-
FUNCTIONS OF THE COUNCIL
tional gifts pursuant to section 501 for carrying out the purposes
of this part; and
SEC. 418. (a) The Council is authorized to—
[(6)] (7) advice, consult with, and make recommendations to
(1) review research projects or programs submitted to or ini-
the Secretary, the Director of the National Institutes of Health,
tiated by it relating to the study of the cause, prevention, or meth-
and the Director of the National Heart and Lung Institute with
ods of diagnosis or treatment of heart, blood vessel, lung, and
respect to carrying out the provisions of this part.
blood diseases and to the use of blood and blood products and the
(b) (1) The Council shall advise and assist the Director of the Insti-
management of blood resources, and certify approval to the Secre-
tute with respect to the Program established under section 413. The
tary, for prosecution under section 412, any such projects which
Council may hold such hearings, take such testimony, and sit and act
it believes show promise of making valuable contributions to hu-
at such times and places, as the Council deems advisable to investigate
man knowledge with respect to the cause, prevention, or methods
programs and activities of the Program.
of diagnosis or treatment of heart, blood vessel, lung, and blood
(2) The Council shall submit a report to the Secretary for simul-
diseases and to the use of blood and blood products in the manage-
taneous transmittal, not later than November 30 of each year, to the
ment of blood resources;
President and to the Congress on the progress of the Program toward
(2) review applications from any university, hospital, labora-
the accomplishment of its objectives during the preceding fiscal year.
tory, or other institution or agency, whether public or private, or
from individuals, for grants-in-aid for research projects relating
ADMINISTRATION
to heart, blood vessel, lung, and blood diseases and to the use of
blood and blood products and the management of blood resources,
SEC. 419A. (a) In carrying out the provisions of section 412 all
and certify to the Secretary its approval of grants-in-aid in the
appropriate provisions of section 301 shall be applicable to the author-
cases of such projects which show promise of making valuable
ity of the Secretary, and except as provided in subsection (c), grants-
contributions to human knowledge with respect to the cause, pre-
in-aid for heart, blood vessel, lung, and blood disease research and
vention, or methods of diagnosis or treatment of heart, blood ves-
training projects and projects with respect to the use of blood and
sel, lung, and blood disease;
blood products and the management of blood resources shall be made
(3) review applications from any public or other nonprofit
only after review and recommendation of the Council made pursuant
institution for grants-in-aid for training, instruction, and trainee-
to section 414.
ships in matters relating to the diagnosis, prevention, and treat-
(b) The Secretary may, in accordance with section 501, accept con-
ment of heart, blood vessel, lung, and blood diseases and to the
ditional gifts for study, investigation, or research into the cause,
use of blood and blood products and the management of blood
prevention, or methods of diagnosis or treatment of heart, blood vessel,
resources, and certify to the Secretary its approval of such appli-
lung, and blood diseases and into the use of blood and blood products
cations for grants-in-aid as it determines will best carry out the
and the management of blood resources, or for the acquisition of
purposes of this act;
grounds or for the erection, equipment, or maintenance of premises,
44
45
buildings, or equipment of the Institute. Donations of $50,000 or over
or other health problems to which the activities of the Insti-
for carrying out the purposes of this part may be acknowledged by
tutes and Administration are directed diseases or other
the establishment within the Institute of suitable memorials to the
health problems.
donors.
(ii) training at the Institutes and Administration of indi-
(c) Under procedures approved by the Director of the National In-
viduals to undertake such research,
stitutes of Health, the Director of the National Heart and Lung Insti-
(iii) biomedical and behavioral research at [non-Federal]
tute may approve grants under this Act for research and training in
public institutions and at nonprofit private institutions, and
heart, blood vessel, lung, and blood diseases and for research and train-
(iv) pre- and post-doctoral training at such public and
ing in the use of blood and blood products and the management of
private institutions of individuals to undertake such research;
blood resources-
and
(1) [in amounts not to exceed $35,000] if the direct costs of such
(B) make grants to non-Federal public institutions and to non-
research and training do not exceed $35,000, but only after appro-
profit private institutions to enable such institutions to make to
priate review for scientific merit but without review and recom-
individuals selected by them National Research Service Awards
mendation by the Council, and
for research (and training to undertake such research) in the
(2) [in amounts exceeding $35,000] if the direct costs of such
matters described in subparagraph (A) (i).
research and training exceed $35,000, but only after appropriate
A reference in this subsection to the National Institutes of Health or
review for scientific merit and recommendation for approval by
the Alcohol, Drug Abuse, and Mental Health Administration shall be
the Council.
considered to include the institutes, divisions, and bureaus included in
the Institutes or under the Administration, as the case may be.
AUTHORIZATION OF APPROPRIATIONS
(2) National Research Service Awards may not be used to support
SEC. 419B. For the purpose of carrying out this part (other than
residencies.
section 414), there is authorized to be appropriated $375,000,000 for
(3) Effective July 1, 1975, National Research Service Awards may
the fiscal year ending June 30, 1973, $425,000,000 for the fiscal year
be made for research or research training in only those subject areas
ending June 30, 1974, [and] $475,000,000 for the fiscal year ending
for which, as determined under section 473, there is a need for
June 30, 1975. $340,000,000 for fiscal year 1976, and $375,000,000 for
personnel.
fiscal year 1977. Of the sums appropriated under this section for any
(b) (1) No National Research Service Award may be made by the
fiscal year, not less than 15 per centum of such sums shall be reserved
Secretary to any individual unless-
for programs under this part respecting diseases of the lung and not
(A) the individual has submitted to the Secretary an applica-
less than 15 per centum of such sums shall be reserved for programs
tion therefor and the Secretary has approved the application;
under this part for programs respecting diseases of the blood blood
(B) the individual provides, in such form and manner as the
diseases and blood resources.
Secretary shall by regulation prescribe, assurances satisfactory to
*
*
*
*
*
*
the Secretary that the individual will meet the service requirement
of subsection (c) (1) ; and
PART I-GENERAL PROVISIONS
(C) in the case of a National Research Service Award for a pur-
pose described in subsection (a) (1) (A) (iii) or (a) (1) (A) (iv),
DIRECTORS OF INSTITUTES
the individual has been sponsored (in such manner as the Secre-
tary may by regulation require) by the institution at which the
SEC. 471. The Director of the National Institutes of Health shall be
research or training under the Award will be conducted.
appointed by the President by and with the advice and consent of the
An application for an Award shall be in such form, submitted in such
Senate; and the Director of the National Cancer Institute shall be
manner, and contain such information, as the Secretary may by regu-
appointed by the President. Except as provided in section 407 (b) (9),
lation prescribe.
the Director of the National Cancer Institute shall report directly to
(2) The award of National Research Service Awards by the Secre-
the Director of the National Institutes of Health.
tary under subsection (a) and the making of grants for such Awards
shall be subject to review and approval by the appropriate advisory
NATIONAL RESEARCH SERVICE AWARDS
councils [to the entities of the National Institutes of Health and the
Alcohol, Drug Abuse, and Mental Health Administration] within the
SEC. 472. (a) (1) The Secretary shall-
Department of Health, Education, and Welfare (A) whose activities
(A) provide National Research Service Awards for-
(i) biomedical and behavioral research at the National
relate to the research or training under the Awards, or (B) at which
such research or training will be conducted.
Institutes of Health and the Alcohol, Drug Abuse, and Mental
Health Administration in matters relating to the cause, diag-
(3) No grant may be made under subsection (a) (1) (B) unless an
application therefor has been submitted to and approved by the Secre-
nosis, prevention, and treatment of [the disease (or diseases)
tary. Such application shall be in such form, submitted in such man-
46
47
ner, and contain such information, as the Secretary may by regulation
prescribe. Subject to the provisions of this section other than para-
or teaching if the Secretary determines that there are no suitable
graph (1) of this subjection, National Research Service Awards made
health research or teaching positions available to such individual.
under a grant under subsection (a) (1) (B) shall be made in accord-
(2) For each year for which an individual receives a National Re-
search Service Award he shall-
ance with such regulations as the Secretary shall prescribe.
(4) The period of any National Research Service Award made to
(A) for twelve months engage in health research or teaching or
any individual under subsection (a) may not exceed three years in the
any combination thereof which is in accordance with the usual
patterns of academic employment or, if SO authorized, serve as a
aggregate unless the Secretary for good cause shown waives the appli-
cation of the three-year limit to such individual.
member of the National Health Services Corps, or
(5) National Research Service Awards shall provide for such stip-
(B) if authorized under paragraph (1) (B) or (1) (C), for
ends and allowances (including travel and subsistence expenses and
twenty months serve in his specialty or engage in a health-related
dependency allowances) for the recipients of the Awards as the Secre-
activity.
tary may deem necessary. A National Research Service Award made
(3) The requirement of paragraph (1) shall be complied with by
to an individual for research or research training at a non-Federal
any individual to whom it applies within such reasonable period of
public or nonprofit private institution shall also provide for payments
time, after the completion of such individual's award, as the Secre-
to be made to the institution for the cost of support services (including
tary shall (A) by regulation prescribe (i) the type of research and
the cost of faculty salaries, supplies, equipment, general research sup-
teaching which an individual may engage in to comply with such re-
port, and related items) provided such individual by such institution.
quirement, and (ii) such other requirements respecting such research
The amount of any such payments to any institution shall be deter-
and teaching and alternative service authorized under paragraphs (1)
mined by the Secretary and shall bear a direct relationship to the rea-
(B) and (1) (C) as he deems necessary; and (B) to the extent feasible,
sonable costs of the institution for establishing and maintaining the
provide that the members of the National Health Service Corps who
quality of its biomedical and behavioral research and training
are serving in the Corps to meet the requirement of paragraph (1)
shall be assigned to patient care and to positions which utilize the clini-
programs.
(c) (1) (A) Each individual who receives a National Research Serv-
cal training and experience of the members.
ice Award shall, in accordance with paragraph (3), engage in-
(4) (A) If any individual to whom the requirement of paragraph
(i) health research or teaching or any combination thereof
(1) is applicable fails, within the period prescribed by paragraph (3),
which is in accordance with usual patterns of academic employ-
to comply with such requirement, the United States shall be entitled
to recover from such individual an amount determined in accordance
ment,
with the formula-
(ii) if authorized under subparagraph (B), serve as a member of
the National Health Service Corps or serve in his specialty, or
(iii) if authorized under subparagraph (C), serve in a health
related activity approved under that subparagraph.
for a period computed in accordance with paragraph (2).
(B) Any individual who received a National Research Service
in which "A" is the amount the United States is entitled to recover;
Award and who is a physician, dentist, nurse, or other individual
"d" is the sum of the total amount paid under one or more National
trained to provide health care directly to individual patients may,
Research Service Awards to such individual [and the interest on such
upon application to the Secretary, be authorized by the Secretary to-
amount which would be payable if at the time it was paid it was a loan
(i) serve as a member of the National Health Service Corps,
bearing interest at a rate fixed by the Secretary of the Treasury after
(ii) serve in his specialty in private practice in a geographic
taking into consideration private consumer rates of interest prevailing
area designed by the Secretary as requiring that specialty, or
at the time each Award to such individual was made] "t" is the total
(iii) provides services in his specialty for a health maintenance
number of months in such individual's service obligation; and "S" is
organization to which payments may be made under section 1876
the number of months of such obligation served by him in accordance
of title XVIII of the Social Security Act and which serves a
with paragraphs (1) and (2) of this subsection.
medically underserved population (as defined in section 1302(7)
(B) Any amount which the United States is entitled to recover
of this Act),
under subparagraph (A) shall, within the three-year period beginning
in lieu of engaging in health research or teaching if the Secretary de-
on the date the United States becomes entitled to recover such amount,
termines that there are no suitable health research or teaching posi-
be paid to the United States. Until any amount due the United States
tions available to such individual.
under subparagraph (A) on account of any National Research Service
(C) Where appropirate the Secretary may, upon application, au-
Award is paid, there shall accrue to the United States interest on such
thorize a recipient of a National Research Service Award, who is not
amount [at the same rate as that fixed by the Secretary of the Treasury
trained to provide health care directly to individual patients, to en-
under subparagraph (A) to determine the amount due the United
gage in a health-related activity in lieu of engaging in health research
States] 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.
48
49
[(4)] (5) (A) Any obligation of any individual under paragraph
conduct such study and prepare and submit the reports thereon as
(3) shall be canceled upon the death of such individual.
provided in subsection (c).
(B) The Secretary shall by regulation provide for the waiver or
(3) The National Academy of Sciences or other group or associa-
suspension of any such obligation applicable to any individual when-
tion conducting the study required by subsection (a) shall conduct
ever compliance by such individual is impossible or would involve
such study in consultation with the Director of the National Institutes
extreme hardship to such individual and if enforcement of such obliga-
of Health.
tion with respect to any individual would be against equity and good
.conscience.
(d) There are authorized to be appropriated to make payments
under National Research Service Awards and under grants for such
TITLE V-MISCELLANEOUS
Awards $207,947,000 for the fiscal year ending June 30, 1975, $175,000,-
,000 for fiscal year 1976, and $200,000,000 for fiscal year 1977. Of the
sums appropriated under this subsection, not less than 25 per centum
shall be made available for payments under National Research Service
GRANTS TO FEDERAL INSTITUTIONS
Awards provided by the Secretary under subsection (a) (1) (A).
SEC. 507. Appropriations to the Public Health Service available
STUDIES RESPECTING BIOMEDICAL AND BEHAVIORAL RESEARCH
under this Act for research, training, or demonstration project grants
PERSONNEL
or for grants to expand existing treatment and research programs and
facilities for alcoholism, narcotic addiction, drug abuse, and drug
SEC. 473. (a) The Secretary shall, in accordance with subsection (b),
dependence, and appropriations available under the Community
arrange for the conduct of a continuing study to-
Mental Health Centers Act for construction and staffing of community
(1) establish (A) the Nation's overall need for biomedical and
behavioral research personnel, (B) the subject areas in which
mental health centers and alcoholism and narcotic addiction, drug
abuse, and drug dependence facilities shall also be available, on the
such personnel are needed and the number of such personnel
same terms and conditions as apply to non-Federal institutions, for
needed in each such area, and (C) the kinds and extent of training
grants for the same purpose to [hospitals of the Service, of the Veter-
which should be provided such personnel;
ans' Administration, or of the Bureau of Prisons of the Department of
(2) assess (A) current training programs available for the
Justice, and to Saint Elizabeths Hospital, except that grants to such]
training of biomedical and behavioral research personnel which
are conducted under this Act at or through institutes under the
Federal institutions, except that grants to Federal institutions may be
funded at 100 per centum of the costs.
National Institutes of Health and the Alcohol, Drug Abuse, and
Mental Health Administration, and (B) other current training
TITLE XI-GENETIC [BLOOD DISORDERS] DISEASES
programs available for the training of such personnel;
(3) identify the kinds of research positions available to and
AND SUDDEN INFANT DEATH SYNDROME
held by individuals completing such programs;
[PART A-SICKLE CELL ANEMIA PROGRAMS
(4) determine, to the extent feasible, whether the programs re-
ferred to in clause (B) of paragraph (2) would be adequate to
[SICKLE CELL ANEMIA SCREENING AND COUNSELING PROGRAMS AND
meet the needs established under paragraph (1) if the programs
INFORMATION AND EDUCATION PROGRAMS
referred to in clause (A) of paragraph (2) were terminated; and
(5) determine what modifications in the programs referred to
[Sec. 1101. (a) (1) The Secretary may make grants to public and
in paragraph (2) are required to meet the needs established under
nonprofit private entities, and may enter into contracts with public and
paragraph (1).
private entities, for projects for the establishment and operation of
(b) (1) The Secretary shall request the National Academy of
voluntary sickle cell anemia screening and counseling programs, pri-
Sciences to conduct the study required by subsection (a) under an
marily through other existing health programs.
arrangement under which the actual expenses incurred by such
[(2) The Secretary shall carry out a program to develop informa-
Academy in conducting such study will be paid by the Secretary. If
tion and educational materials relating to sickle cell anemia and to
the National Academy of Sciences is willing to do so, the Secretary
disseminate such information and materials to persons providing
shall enter into such an arrangement with such Academy for the con-
health care and to the public generally. The Secretary may carry out
duct of such study.
such program through grants to public and nonprofit private entities
(2) If the National Academy of Sciences is unwilling to conduct
or contracts with public and private entities and individuals.
such study under such an arrangement, then the Secretary shall enter
[(b) For the purpose of making payments pursuant to grants and
into a similar arrangement with other appropriate nonprofit private
contracts under this section, there are authorized to be appropriated
groups or associations under which such groups or associations will
$20,000,000 for the fiscal year ending June 30, 1973, $30,000,000 for
50
51
the fiscal year ending June 30, 1974, and $35,000,000 for the fiscal year
ending June 30, 1975.
[(5) set forth such fiscal control and fund accounting pro-
cedures as may be necessary to assure proper disbursement of and
accounting for Federal funds paid to the applicant under this
[PROJECT GRANTS AND CONTRACTS
part; and
SEC. 1102. (a) The Secretary may make grants to public and non-
[(6) provide for making such reports in such form and con-
profit private entities, and may enter into contracts with public and
taining such information as the Secretary may reasonably require.
private entities and individuals, for projects for (1) research and re-
[(b) In making any grant or contract under this part, the Secretary
search training in the diagnosis, treatment, and control of sickle cell
shall (1) take into account the number of persons to be served by the
anemia, (2) the development of programs to educate the public re-
program supported by such grant or contract and the extent to which
garding the nature and inheritance of the sickle cell trait and sickle
rapid and effective use will be made of funds under the grant or con-
cell anemia, and (3) the development of sickle cell anemia counseling
tract; and (2) give priority to programs operating in areas which the
and testing programs and other programs for diagnosis, control, and
Secretary determines have the greatest number of persons in need of
treatment of sickle cell anemia.
the services provided under such programs.
[(b) For the purpose of making payments pursuant to grants and
contracts under this section, there are authorized to be appropriated
[PUBLIC HEALTH SERVICE FACILITIES
$5,000,000 for the fiscal year ending June 30, 1973, $10,000,000 for the
[SEC. 1105. The Secretary shall establish a program within the
fiscal year ending June 30, 1974, and $15,000,000 for the fiscal year
Public Health Service to provide for voluntary sickle cell anemia
ending June 30, 1975.
screening, counseling, and treatment. Such program shall be made
available through facilities of the Public Health Service to any person
[VOLUNTARY PARTICIPATION
requesting screening, counseling, or treatment, and shall include ap-
[SEC. 1103. The participation by any individual in any program or
propriate publicity of the availability and voluntary nature of such
portion thereof under this part shall be wholly voluntary and shall
programs.
not be a prerequisite to eligibility for or receipt of any other service or
[REPORTS
assistance from, or to participation in, any other program.
[SEC. 1106. (a) The Secretary shall prepare and submit to the
[APPLICATIONS; ADMINISTRATION OF GRANT AND CONTRACT PROGRAMS
President for transmittal to the Congress on or before April 1 of each
year a comprehensive report on the administration of this part.
[Sec. 1104. (a) A grant under this part may be made upon applica-
[(b) The report required by this section shall contain such recom-
tion to the Secretary at such time, in such manner, containing and
mendations for additional legislation as the Secretary deems neces-
accompanied by such information, as the Secretary deems necessary.
sary.
Each applicant shall-
[PART B-Cooley's ANEMIA PROGRAMS
[(1) provide that the programs and activities for which assist-
ance under this part is sought will be administered by or under the
[COOLEY'S ANEMIA SCREENING, TREATMENT, AND COUNSELING, RESEARCH,
supervision of the applicant;
AND INFORMATION AND EDUCATION PROGRAMS
[(2) provide for strict confidentiality of all test results, medi-
cal records, and other information regarding screening, counsel-
[SEC. 1111. (a) (1) The Secretary may make grants to public and
ing, or treatment of any person treated, except for (A) such in-
nonprofit private entities, and may enter into contracts with public
formation as the patient (or his guardian) consents to be released;
and private entities, for projects for the establishment and operation,
or (B) statistical data compiled without reference to the identity
primarily through other existing health programs, of Cooley's anemia
of any such patient;
screening, treatment, and counseling programs.
[(3) provide for appropriate community representation in the
[(2) The Secretary may make grants to public and nonprofit pri-
development and operation of any program funded by a grant
vate entities, and may enter into contracts with public and private en-
under this part;
tities and individuals, for projects for research in the diagnosis, treat-
[(4) in the case of an application for a grant under section
ment, and prevention of Cooley's anemia, including projects for the
1101 (a) (1), provide assurances satisfactory to the Secretary that
development of effective and inexpensive tests which will identify
(A) the screening and counseling services to be provided under
those who have the disease or carry the trait.
the program for which the application is made will be directed
[(3) The Secretary shall carry out a program to develop informa-
first to those persons who are entering their child-producing years,
tion and educational materials relating to Cooley's anemia and to dis-
and secondly to children under the age of 7, and (B) appropriate
seminate such information and materials to persons providing health
arrangements have been made to provide counseling to persons
care and to the public generally. The Secretary may carry out such
found to have sickle cell anemia or the sickle cell trait;
program through grants to public and nonprofit private entities or
contracts with public and private entities and individuals.
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53
[(b) (1) For the purpose of making payments pursuant to grants
[(2) The Secretary may make a grant under section 1111 (a) (1)
and contracts under subsection (a) (1), there are authorized to be ap-
for a screening, treatment, and counseling program when he deter-
propriated $1,000,000 for the fiscal year ending June 30, 1973, and for
mines that the screening provided by such program will be done
each of the next two fiscal years.
through an effective and inexpensive Cooley's anemia screening test.
[(2) For the purpose of making payments pursuant to grants and
contracts under subsection (a) (2), there are authorized to be approp-
[PUBLIC HEALTH SERVICE FACILITIES
riated $1,700,000 for the fiscal year ending June 30, 1973, and for each
of the next two fiscal years.
[SEC. 1114. The Secretary shall establish a program within the
(3) For the purpose of carrying out subsection (a) (3), there are
Public Health Service to provide for voluntary Cooley's anemia screen-
authorized to be appropriated $1,000,000 for the fiscal year ending
ing, counseling, and treatment. Such program shall utilize effective
June 30, 1973, and for each of the next two fiscal years.
and inexpensive Cooley's anemia screening tests, shall be made avail-
able through facilities of the Public Health Service to any person
[VOLUNTARY PARTICIPATION
requesting screening, counseling, or treatment, and shall include appro-
propriate publicity of the availablity and voluntary nature of such
[SEC. 1112. The participation by any individual in any program or
programs.
portion thereof under this part shall be wholly voluntary and shall not
[REPORTS
be a prerequisite to eligibility for or receipt of any other service or
assistance from, or to participation in, any other program.
[SEC. 1115. (a) The Secretary shall prepare and submit to the Presi-
dent for transmittal to the Congress on or before April 1 of each year
[APPLICATIONS; ADMINISTRATION OF GRANT AND CONTRACT PROGRAMS
a comprehensive report on the administration of this part.
[(b) The report required by this section shall contain such recom-
[SEC. 1113. (a) A grant under this part may be made upon applica-
mendations for additional legislation as the Secretary deems
tion to the Secretary at such time, in such manner, containing and ac-
necessary.]
companied by such information, as the Secretary deems necessary.
PART A-GENETIC DISEASES
Each application shall-
[(1) provide that the programs and activities for which as-
TESTING AND COUNSELING PROGRAMS AND INFORMATION
sistance under this part is sought will be administered by or under
AND EDUCATION PROGRAMS
the supervision of the applicant;
[(2) provide for strict confidentiality of all test results, med-
SEC. 1101. (a) (1) The Secretary through an identifiable administra-
ical records, and other information regarding screening, counsel-
tive unit within the Department of Health, Education, and Welfare
ing, or treatment of any person treated, except for (A) such in-
may make grants to public and nonprofit private entities, and may
formation as the patient (or his guardian) consents to be released,
enter into contracts with public and private entities, for projects to
or (B) statistical data compiled without reference to the identity
establish and operate voluntary genetic testing and counseling pro-
of any such patient;
grams primarily in conjunction with other existing health programs,
((3) provide for appropriate community representation in the
including programs assisted under title X of this Act and title V of
the Social Security Act.
development and operation of any program funded by a grant
under this part;
(2) The Security shall carry out, through an identifiable adminis-
[(4) set forth such fiscal control and fund accounting proced-
trative unit within the Department of Health, Education, and Wel-
fare, a program to develop ormation and educational materials re-
ures as may be necessary to assure proper disbursement of and
lating to genetic diseases and to disseminate such information and ma-
accounting for Federal funds paid to the applicant under this
terials to persons providing health care, to teachers and studends, and
part; and
to the public generally in order to most rapidly make available the lat-
(5) provide for making such reports in such form and con-
est advances in the testing, diagnosis, counseling, and treatment of in-
taining such information as the Secretary may reasonably require.
dividuals respecting genetic diseases. The Secretary may, under such
[(b) (1) In making any grant or contract under this title, the Secre-
program, make grants to public and nonprofit private entities and en-
tary shall (A) take into account the number of persons to be served
by the program supported by such grant or contract and the extent to
ter into contracts with public and private entities and individuals for
the development and dissemination of such materials.
which rapid and effective use will be made of funds under the grant
(b) For the purpose of making payments pursuant to grants and
or contract; and (B) give priority to programs operating in areas
contracts under this section, there are authorized to be appropriated
which the Secretary determines have the greatest number of persons
$20,000,000 for the fiscal year 1976, and $25,000,000 for the fiscal
in need of the services provided under such programs.
year 1977.
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55
RESEARCH PROJECT GRANTS AND CONTRACTS
years, and (B) appropriate arrangements will be made to provide
SEC. 1102. In carrying out section 301, the Secretary may make
counseling to persons found to have a genetic disease and to per-
grants to public and nonprofit entities, and may enter into contracts
sons found to carry a gene or chromosome which may cause a
with public and private entities and individuals, for projects for (1)
deleterious effect in their offspring; and
basic or applied research leading to the understanding, diagnosis, treat-
(5) establish fiscal control and fund accounting procedures as
ment, and control of genetic diseases, (2) planning, establishing, dem-
may be necessary to assure proper disbursement of and accounting
onstrating, and developing special programs for the training of genetic
of Federal funds paid to the applicant under this part.
counselors, social and behavioral scientists, and other health profes-
(b) In making any grant or entering into any testing and counseling
sionals, (3) the development of programs to educate practicing physi-
programs under section 1101, contract for the Secretary shall (1) take
cians, other health professionals, and the public regarding the nature
into account the number of persons to be served by the program sup-
of genetic processes, the inheritance patterns of genetic diseases, and
ported by such grant or contract and the extent to which rapid and
the means, methods, and facilities available to diagnose, control, coun-
effective use will be made of funds under the grant or contract; and
sel, and treat genetic diseases, and (4) the development of counseling
(2) give priority to programs operating in areas which the Secretary
and testing programs and other programs for the diagnosis, control,
determines have the greatest number of persons who will benefit from
and treatment of genetic diseases.
and are in need of the services provided under such programs.
PUBLIC HEALTH SERVICE FACILITIES
VOLUNTARY PARTICIPATION
SEC. 1103. The participation by any individual in any program or
SEC. 1105. The Secretary shall establish a program within the Serv-
portion thereof under this part shall be wholly voluntary and shall not
ice to provide voluntary testing, diagnosis, counseling, and treatment
be a prerequisite to eligibility for or receipt of any other service or as-
of individuals respecting genetic diseases. Services under such pro-
sistance from, or to participation in, in any other program.
gram shall be made available through facilities of the Service to per-
sons requesting such services, and the program shall provide appropri-
APPLICATIONS; ADMINISTRATION OF GRANTS AND CONTRACT PROGRAMS
ate publicity of the availability and voluntary nature of such services.
SEC. 1104. (a) A grant or contract under this part may be made
REPORTS
upon application submitted to the Secretary at such time, in such
manner, and containing and accompanied by such information, as
SEC. 1106. (a) The Secretary shall prepare and submit to the Presi-
the Secretary may require necessary. Each applicant shall-
dent for transmittal to the Congress on or before April 1 of each year
(1) provide that the programs and activities for which assist-
a comprehensive report on the administration of this part.
ance under this part is sought will be administered by or under
(b) The report required by this section shall contain such recom-
the supervision of the applicant;
mendations for additional legislation as the Secretary deems necessary.
(2) provide for strict confidentiality of all test results, medi-
cal records, and other information regarding testing, diagnosis,
PART [C] B-SUDDEN INFANT DEATH SYNDROME
counseling, or treatment of any person treated, except for (A)
such information as the patient (or his guardian) gives informed
SUDDEN INFANT DEATH SYNDROME COUNSELING, INFORMATION,
consent to be released, or (B) satisfied data compiled without ref-
EDUCATIONAL, AND STATISTICAL PROGRAMS
erence to the identity of any such patient;
SEC. 1121. (a) The Secretary, through the Assistant Secretary for
(3) provide for community representation where appropriate
Health, shall carry out a program to develop public information and
in the development and operation of voluntary genetic testing or
professional educational materials relating to sudden infant death
counseling programs funded by a grant under this part;
syndrome and to disseminate such information and materials to per-
(4) in the case of an applicant for a grant or contract for the
sons providing health care, to public safety officials, and to the public
delivery of services under section 1101 (a) (1), provide assurances
generally.
satisfactory to the Secretary that (A) the services for community-
(b) (1) The Secretary may make grants to public and nonprofit
wide testing and counseling to be provided under the program
private entities, and enter into contracts with public and private en-
for which the application is made (i) will take into consideration
tities, for projects which include both-
widely prevalent diseases with a genetic component and high-
(A) the collection, analysis, and furnishing of information
risk population groups in which certain genetic diseases occur,
(derived from post mortem examinations and other means) re-
and (ii) where appropriate will be directed especially but not
lating to the causes of sudden infant death syndrome; and
exclusively to persons who are entering their child-producing
(B) the provision of information and counseling to families
affected by sudden infant death syndrome.
56
57
(2) No grant may be made or contract entered into under this sub-
SECTION 211 OF THE NATIONAL RESEARCH ACT
section unless an application therefor has been submitted to and ap-
proved by the Secretary. Such application shall be in such form, sub-
*
mitted in such manner, and contain such information as the Secretary
shall by regulation prescribe. Each application shall-
TITLE I-PROTECTION OF HUMAN SUBJECTS OF
(A) provide that the project for which assistance under this
BIOMEDICAL AND BEHAVIORAL RESEARCH
subsection is sought will be administered by or under supervision
of the applicant;
*
*
(B) provide for appropriate community representation in the
development and operation of such project;
PART B-MISCELLANEOUS
(C) set forth such fiscal controls and fund accounting pro-
cedures as may be necessary to assure proper disbursement of and
NATIONAL ADVISORY COUNCIL FOR THE PROTECTION OF SUBJECTS OF
accounting for Federal funds paid to the applicant under this
BIOMEDICAL AND BEHAVIORAL RESEARCH
subsection; and
(D) provide for making such reports in such form and con-
SEC. 211. (a) Section 217 of the Public Health Service Act is
taining such information as the Secretary may reasonably require.
amended by adding at the end the following new subsection:
(3) Payments under grants under this subsection may be made in
(f) (1) There shall be established a National Advisory Council for
advance or by way of reimbursement, and at such intervals and on
the Protection of Subjects of Biomedical and Behavior Research (here-
such conditions, as the Secretary finds necessary.
inafter in this subsection referred to as the 'Council') which shall con-
(4) Contracts under this subsection may be entered into without
sist of the Secretary who shall be Chairman and not less than seven
regard to sections 3648 through 3709 of the Revised Statutes (31
nor more than fifteen other members who shall be appointed by the
U.S.C. 529; 44 U.S.C. 5).
Secretary without regard to the provisions of title 5, United States
(5) For the purpose of making payments pursuant to grants and
Code, governing appointments in the competitive service. The Secre-
contracts under this subsection, there are authorized to be appropri-
tary shall select members of the Council from individuals distinguished
ated $2,000,000 for the fiscal year [ending June 30,] 1975, $3,000,000
in the fields of medicine, law, ethics, theology, the biological, physical,
for the fiscal year [ending June 30,1 1976, and $4,000,000 for the fiscal
behavioral and social sciences, philosophy, humanities, health adminis-
year [ending June 30,] 1977.
tration, government, and public affairs; but three (and not more than
(c) The Secretary shall submit, not later than January 1, 1976, a
three) of the members of the Council shall be individuals who are or
comprehensive report to the Committee on Labor and Public Welfare
who have been engaged in biomedical or behavioral research involving
of the Senate and the Committee on Interstate and Foreign Com-
human subjects. No individual who was appointed to be a member of
merce of the House of Representatives respecting the administration
the National Commission for the Protection of Human Subjects of
of this section and the results obtained from the programs authorized
Biomedical and Behavioral Research (established under title II of the
by it.
National Research Act) may be appointed to be a member of the Coun-
cil. The appointed members of the Council shall have terms of office of
four years, except that for the purpose of staggering the expiration of
the terms of office of the Council members, the Secretary shall, at the
TITLE XVI-HEALTH RESOURCES DEVELOPMENT
time of appointment, designate a term of office of less than four years
for members first appointed to the Council.
*
*
(2) The Council shall-
(A) advise, consult with, and make recommendations to, the
PART B-ALLOTMENTS
Secretary concerning all matters pertaining to the protection of
human subjects of biomedical and behavioral research;
" (B) review policies, regulations, and other requirements of the
Secretary governing such research to determine the extent to
AUTHORIZATION OF APPROPRIATION
which such policies, regulations, and requirements require and are
SEC. 1613. Except as provided in section 1625(d), there are au-
effective in requiring observance in such research of the basic
thorized to be appropriated for allotments under section [1510] 1610
ethical principles which should underlie the conduct of such
$125,000,000 for the fiscal year ending June 30, 1975, $130,000,000 for
research and, to the extent such policies, regulations, or require-
ments do not require or are not effective in requiring observance
the fiscal year ending June 30, 1976, and $135,000,000 for the fiscal year
ending June 30, 1977.
of such principles, make recommendations to the Secretary re-
specting appropriate revision of such policies, regulations, or
*
requirements; and
58
"(C) review periodically changes in the scope, purpose, and
types of biomedical and behavioral research being conducted and
the impact such changes have on the policies, regulations, and
other requirements of the Secretary for the protection of human
subjects of such research.
"(3) The Council may disseminate to the public such information,
recommendations, and other matters relating to its functions as it
deems appropriate.
"(4) Section 14 of the Federal Advisory Committee Act shall not
apply with respect to the Council."
(b) The amendment made by subsection (a) shall take effect
[July 1, 1976] January 1, 1977.
94TH CONGRESS
HOUSE OF REPRESENTATIVES
REPORT
1st Session
No. 94-523
CONSIDERATION OF H.R. 7988
SEPTEMBER 30, 1975.-Referred to the House Calendar and ordered to be printed
Mr. PEPPER, from the Committee on Rules,
submitted the following
REPORT
[To accompany H. Res. 757]
The Committee on Rules, having had under consideration House
Resolution 757, by a nonrecord vote, report the same to the House with
the recommendation that the resolution do pass.
57-008
Calendar No. 493
94TH CONGRESS
SENATE
REPORT
1st Session
No. 94-509
NATIONAL BIOMEDICAL HEART, BLOOD VESSEL, LUNG,
BLOOD, AND RESEARCH TRAINING ACT OF 1975
DECEMBER 5 (legisative day, DECEMBER 2), 1975.-Ordered to be printed
Mr. KENNEDY, from the Committee on Labor and Public Welfare,
submitted the following
REPORT
[To accompany S. 988]
The Committee on Labor and Public Welfare, to which was referred
the bill (S. 988) to amend the Public Health Service Act to revise
and extend programs of the National Heart and Lung Institute and
National Research Service Awards, having considered the same, re-
ports favorably thereon with an amendment and recommends that the
bill as amended do pass.
CONTENTS
Page
I. Introduction
1
II. Summary of the bill
2
III. Need for the legislation
3
IV. Public hearings
17
V. Program accomplishments
17
VI. Administration position
21
VII. Committee amendments and views
25
VIII. Cost of the bill
44
IX. Votes in committee
45
X. Section-by-section analysis
45
XI. Changes in existing law
55
I. INTRODUCTION
The National Heart, Lung, Blood, and Blood Vessel Act, P.L. 92-
243 was initially enacted September 19, 1972. The Act expired June 30,
1975.
Title I of the National Research Act, P.L. 93-348, Biomedical and
Behavioral Research Training was initially enacted July 12, 1974. It
also expired June 30, 1975.
S. 988, the National Biomedical, Heart, Blood Vessel, Lung, Blood,
and Research Training Act of 1975, is the Committee's bill to improve
57-010
2
3
and extend these authorities for two additional fiscal years through
June 30, 1977 and for other purposes.
conditions; and provide FDA authority to regulate vitamin and min-
eral products marketed for pregnant and lactating women and chil-
II. SUMMARY OF THE BILL
dren to age 12.
Title V of the bill are technical and conforming amendments to the
Title I of the bill extends for 2 fiscal years the authority of HEW
National Arthritis Act.
to conduct research, experiments and demonstration programs with re-
spect to heart, lung, blood and blood vessel diseases. The major sub-
III. NEED FOR THE LEGISLATION
stantive revisions are provisions that change the title of the National
Heart and Lung Institute to the National Heart, Lung and Blood
A. HEART AND LUNG¹
Institute and provide explicit authority for the Institute to conduct
Cardiovascular diseases (heart and blood vessel diseases) continue
programs with respect to the use of blood products and the manage-
ment of blood resources.
to be the primary health problem in the United States. It is estimated
There are authorized $10 million for fiscal year 1976 and $25 million
that 28,000,000 Americans are afflicted with some form of heart or
for fiscal year 1977 for prevention and control programs, and there are
blood vessel disease: 23,000,000 of them have hypertension, 3,900,000
authorized $338 million for fiscal year 1976 and $372 million for fiscal
suffer from coronary heart disease and 1,700,000 from rheumatic heart
year 1977 for the national heart, blood vessel, lung and blood diseases
disease, while 1,650,000 have had one or more strokes. In 1972, an esti-
and blood resources program.
mated 1,060,000 Americans died from heart and blood vessel diseases;
Title II would extend, with only technical modifications, for fiscal
this represented more than 54 percent of deaths from all causes.
years 1976 and 1977, the explicit authority of the Secretary of Health,
Arteriosclerosis
Education, and Welfare to provide awards to individuals and institu-
Arteriosclerosis, or "hardening of the arteries," is by far the most
tions for biomedical and behavioral research training. It would au-
common of the serious diseases affecting man in Western society. It
thorize $160 million for fiscal year 1976 and $176 million for fiscal
represents a chronic progressive pathologic change in which the inner
year 1977.
lining of the arteries becomes rough, thick, hard, and covered with
The total authorization for such programs is $59 million below the
lipid-rich plaques. Eventually, the inner diameter of the vessels de-
comparable House passed provisions.
creases and blood flow in the diseased arteries diminishes or stops
Title III of the bill includes miscellaneous provisions respecting
completely. Arteriosclerosis begins early in life and generally becomes
1. Deletion of the prohibition of the Secretary of HEW's au-
manifest in middle age or later. Until it does become manifest as heart
thority to waive a right of recovery under section 1631 (b) of the
attacks, stroke, or other illness, it is often without symptoms and is
PHS Act.
therefore undetected. Its first clinical manifestation may be an abrupt
2. Rights and benefits equality for PHS officers of the com-
catastrophic illness.
missioned corps to the Armed Forces under the Soldiers and Sail-
Virtually all adult American males and post-menopausal women are
ors Civil Relief Act.
afflicted to some degree. The economic impact of arteriosclerotic disease
3. Broadens the scope of Federal institutions eligible for fund-
in the United States has been estimated at $26 billion per year in lost
ing as requested by the Department, respecting its authority under
productivity and expenses for medical care. If arteriosclerosis could be
section 507 of the PHS Act.
prevented, hundred of thousands of lives might be prolonged. Inter-
4. A one year extension, at a reduced level of authorizations of
national statistics reveal a great variation in death rates for athero-
scholarships. $2 million for fiscal year 1976, for physician area shortage
sclerotic coronary heart disease. For instance, in Denmark and Swe-
den, the death rate for men under the age 55 is less than half that for
5. A one year extension of health profession student loan pro-
the same age group in the United States; in many countries it is
grams for fiscal year 1976, at their current authorization level,
far lower and in some, for example Japan, atherosclerotic coronary
$60 million and $35 million.
disease is a rare condition. This difference indicates that the high
6. Authorizes a stipend up to $25,000 to be paid visiting scien-
death rates due to arteriosclerosis in the United States are neither nec-
tists who agree to teach at minority schools and authorizes the
essary nor inevitable. Although attempts to learn why the United
Minority Access to Research Careers (MARC) Program in Hew,
States fares SO poorly in these comparisons have not been conclusive,
to initiate programs at the undergraduate level.
studies have suggested that differences in diet, lifestyle, and personal
Title IV of the bill amends the Federal Food, Drug and Cosmetic
habits may be important. Risk factors associated with an increased
Act to prohibit regulation of vitamin and mineral supplements solely
rate of development and progression of arteriosclerosis are age, sex,
on the basis of potency; permit sale of any combination of vitamins
high levels of cholesterol in the blood, high blood pressure, and smok-
and minerals and other foods; define foods "for special dietary use"
ing. Of these, the latter three can potentially be controlled, and con-
using the current definition provide FDA authority to seize a manu-
siderable effort is currently being expended in the National Program
facturer's product if his advertising is false and misleading in a ma-
terial respect; permit seizure in retail outlets under certain, limited
1 Excerpted from the "Second Annual Report of the Director of the National Heart and
Lung Act," March 10, 1975 as required by section 413(b) of the Public Health Service
Act.
4
5
to learn more about these as well as other factors which may play a
mally nourished by the artery. This produces death of the heart
role in the development of atherosclerosis.
muscle, technically called myocardial infarction. Depending upon the
site of the coronary blockage, a small or a large fraction of the total
Hypertension
heart may be involved.
Hypertension, or high blood pressure, is a common and often serious
Heart disease associated with arteriosclerosis of the coronary ar-
condition. An estimated 23 million adult Americans, or about 15 per-
teries remains the predominant form of heart disease in the adult
cent of the adult population, have some degree of hypertension. It is
American population. It is responsible for chronic illness in 4 million
more common in the black population than in the white population.
Americans, 2.5 million below the age of 65. In 1972, coronary heart
It predisposes to arteriosclerosis and is a risk factor for heart attack
disease accounted for about 685,000 deaths in this country. It is the
and heart failure, and it is the major predisposing factor for stroke.
largest single cause of death from cardiovascular disease and is the
Hypertension can be treated, and treatment reduces the incidence
leading cause of death in men after age 40 and in women after age 60.
of stroke, kidney failure, and heart failure. However, it is uncertain
Each year, approximately 170,000 persons below age 65 die of coronary
at present whether treatment will also reduce the incidence of heart
heart disease.
attacks. It is also uncertain whether slight or mild degrees of hyper-
Coronary heart disease may also result in angina pectoris (a tempo-
tension require treatment. Current treatment, while effective, is un-
rary pain usually located in the center and left arm that is brought on
satisfactory in that it requires lifelong adherence to medication, is
by exercise, exposure to cold, and other factors and relieved by rest),
expensive, has some side effects, and must be individualized. In more
heart failure (impaired pumping performance of the heart leading
than nine out of ten cases of hypertension, the cause of the disorder
to accumulation of fluid in the body and congestion in the lungs),
is unknown and hence we still lack the means to prevent or cure it
disturbances of heart rhythm, and sudden death.
even though treatment and control are possible.
The coronary artery bypass operation has been perfected surgically
High blood pressure is easily detected, but may exist for many years
and can bring increased blood supply to endangered heart muscle.
without symptoms. While it can be controlled with available therapy,
This technique uses a blood vessel graft to bypass narrowed or
of the millions of Americans with this disease, half are probably
occluded segments of coronary arteries. Over 25,000 such operations
unaware that they have it, and of those who are aware, less than half
are being done annually in the United States, with hospitalization
are receiving adequate therapy. The National Program is expending
costs in excess of $5,000 for each operation. Although such surgery
efforts both on research to discover the causes of hypertension and on
generally provides substantial decrease of symptoms in patients with
programs to educate the public about the dangers of hypertension and
severe angina pectoris, the long-term effects upon mortality and the
the benefits of treatment.
clinical circumstances in which it is preferable to medical therapy
Cerebrovascular Disease
are not adequately defined.
Cerebrovascular disease occurs when an artery supplying blood to
Peripheral Vascular Diseases
the brain is blocked, ruptured, or injured. Cerebrovascular disease due
Peripheral vascular diseases are the cause of considerable suffering
primarily to arteriosclerosis and hypertension is the basis for the great
and disability. They are abnormalities that occur within arteries or
majority of strokes. The individual and public health burden of death,
veins. Atherosclerotic narrowing may result in inadequate blood flow
paralysis, and brain damage from cerebrovascular disease is large. Of
through the arteries. The veins may become dilated (varicosities) or
the 1.7 million adults who have this disease, 800,000 are partially or
inflamed and obstructed by blood clots (thrombophlebitis). These
completely disabled and 200,000 reside in nursing homes. Stroke kills
diseases may be painful and result in organ damage, skin ulcerations,
about 200,000 persons a year particularly at older ages. The death rate
and gangrene. Peripheral vascular disease in the legs may affect the
is greater among men than women, and greater among blacks than
ability to walk or run. Thrombosis in the veins may produce plumo-
whites. Each year, nearly 600,000 patients are discharged from our
nary embolism, i.e., clot fragments may be carried in the blood from
hospitals with a diagnosis of stroke, and each year about 250,000 in-
their site of origin to the lungs. This in turn may result in shock and
dividuals between the ages of 25 and 64 are crippled mentally or phys-
death. About 265,000 patients are discharged from hospitals each
ically by a stroke. Many more lives could be saved and disabilities pre-
year with a primary diagnosis of peripheral vascular disease.
vented if we had effective methods for prevention and treatment of
arteriosclerosis and hypertension, and if available treatment were
Arrhythmias
more widely applied. There has been an appreciable decrease in deaths
Arrhythmias, or abnormal heart rhythms, are one of the most com-
from stroke, and some of this decrease may be attributable to recent
mon manifestations of various types of heart disease and they are
advances in therapy for high blood pressure.
frequently the immediate cause of heart failure and death. Arrhyth-
mias result from an alteration in the normal generation and transmis-
Coronary Heart Disease
sion of electrical impulses within the heart.
Coronary heart disease refers to the consequences of atherosclerosis
They may also occur without recognizable disease. Many rhythm
in the arteries that supply the heart muscle. A heart attack is a mani-
disturbances have minor influence upon life expectancy and cause
festation of coronary heart disease and occurs when a coronary artery
little disability, while others cause serious symptoms, and some are
is blocked, preventing the blood from reaching the heart muscle nor-
almost instantaneously fatal. For example, arrhythmias kill more
6
7
than half of the patients with coronary heart disease and are a major
Rheumatic fever and rheumatic heart disease were once considered
problem in patients with rheumatic heart disease. The National Pro-
leading causes of serious childhood illnesses. They can now be pre-
gram is concerned with the development of improved methods for
vented. Rheumatic fever is almost always preceded by a streptococcal
prevention, diagnosis, and management of arrhythmias.
infection and may be preventd by prompt treatment of such infections.
Heart Failure and Shock
Rheumatic heart disease is an immunological disturbance that fre-
Heart failure and shock represent major causes of death and may
quently occurs years after initial rheumatic fever and prior strepto-
be the consequence of various disorders ranging from inadequate
coccal infection. This type of heart disease may lead to serious dam-
pumping by a severely damaged heart (cardiogenic shock), loss of
age of the heart valves. This, in turn, may not only shorten life, but
blood (hemorrhagic shock), and impairment in the control of arterial
also seriously impair the quality of the patient's life. Improved under-
tone. Heart failure occurs when the heart has been damaged SO exten-
standing and control of immunological problems is thus important
sively that its ability to pump blood is impaired and it can no longer
in the identification of susceptibility and the preventon of rheumatic
meet the needs of the body. In its chronic form, it is often associated
heart disease, as well as in the sucess of cardiac transplants and in the
with shortness of breath, accumulation of fluid, and swelling of the
prevention of cariomyopathies and possibly other forms of heart
legs. Shock is also a secondary phenomenon characterized by an in-
disease.
ability of the heart and peripheral arterial tone to maintain adequate
Cardiomyopathies and Infections of the Heart
blood pressure and blood perfusion. Left untreated, it rapidly leads
Cardiomyopathies and infections of the heart are diseases of the
to irreversable damage to such critical organs as the brain and the
heart muscle and its lining. These diseases cause enlargement of the
kidney, and ultimately to death.
heart, heart failure, irregularities of the heart rhythm, and occasion-
Heart failure and shock are the most common causes of in-hospital
ally sudden death. The prevalence of these diseases, caused by a variety
deaths from heart attack and most other types of heart disease, thus
of factors, is unknown. Known factors producing cardiomyopathies
accounting for about a quarter of a million deaths annually. In addi-
include toxic substances, viral infections, alcohol, immunological
tion, chronic heart failure may follow a heart attack or result from
phenomena, nutritional deficiencies, muscular dystrophy, and a num-
high blood pressure or other cardiovascular diseases. About two mil-
ber of rare diseases. The condition may be acute or chronic and pro-
lion Americans have chronic heart failure. In the majority of chronic
gressive. Rapidly fatal disease may be associated with heart failure,
heart failure patients, symptoms can be relieved by drugs.
disturbances of rhythm, and sudden death. Infections may affect the
In the absence of valvular lesions or intracardiac defects, insufficient
heart muscle (myocarditis), its interior wall (endocarditis), or its
surviving or poorly functioning heart muscle is the immediate cause of
exterior surface (pericarditis). They may be caused by certain viruses,
heart failure and shock in most instances. An improved understand-
bacteria, or fungi. Cardiomyopathies and myocarditis are being recog-
ing of energy utilization in heart muscle is essential for adequate con-
trol or prevention of heart failure and shock in these cases.
nized with increasing frequency.
Congenital and Rheumatic Heart Diseases
Circulatory Assistance
Circulatory assistance to the failing heart may be provided by many
Congenital heart disease occurs when the heart or major blood ves-
sels near the heart fail to mature normally before birth. About half
types of devices currently under development. Some are applied ex-
of the children born with this disease do not survive until their first
ternally to the lower extremities in synchrony with the heart beat. In
others, the pumping action of the heart is enhanced by synchronously
birthday. The causes of congenital heart disease are generally un-
known. Less than three percent are known to be related to a particu-
expanding and collapsing a "balloon" positioned in the aorta, the
lar event or disorder occurring during pregnancy, such as rubella (Ger-
artery leading from the heart. On a very limited scale, a few devices
have been employed which require substantial surgery and the actual
man thalidomide. measles), infection, or the use of certain drugs, such as
positioning of a pumping device within the chest. While circulatory
At present there are 35 recognizable types of congenital or inborn
assist devices are designed to improve the mechanical function of the
heart defects and about 25,000 babies are born each year with heart
heart, the apparatus also generally involves important electronic,
defects. The postnatal mortality from heart defects is about 7,500
pneumatic, hydraulic, and mechanical systems.
per year. In addition, there are 100,000 children and 1,600,000 adults
Diseases of the lung constitute a major national health problem of
with known rheumatic heart disease with an annual mortality rate of
increasing dimensions. In the United States, lung diseases covered by
about 15,000.
the Program account for an estimated 150,000 deaths each year, cause
The earliest surgical successes in the treatment of heart diseases were
45 million days lost from work, 40 million days of bed-restricted ac-
in the correction or palliation of congenital heart disease. These suc-
tivity, and cost the economy approximately $6 billion a year in lost
cesses are being exploited in the development of diagnostic and surgi-
productivity and wages and medical care costs.
cal techniques applicable to the newborn. Important insights have also
Respiratory diseases that represent national health problems in-
been gained into the development of the cardiovascular system. How-
clude chronic obstructive pulmonary diseases (COPD), acute respira-
ever, in most cases, it is still not known what makes the heart develop
tory distress syndromes (RDS), and fibrotic and immunologic lung
abnormally before a baby is born.
diseases. The economic cost of these diseases has been estimated at $6.3
billion per year.
&
9
Lung diseases afflict both the young and the old. In the newborn, the
tion) and immunologic responses are characteristic of a variety of lung
most common cause of death is the neonatal respiratory distress syn-
diseases. Among the factors that may induce these responses are ex-
drome. Neonatal RDS is implicated in the development of adult respi-
posure to substances such as coal dust, silica, and asbestos in the envi-
ratory diseases as well. Fibrotic and immunologic lung diseases are a
ronment; viral and bacterial infections; diseases of the connective tis-
major cause of lung problems in the young adult, and may cause
sue such as rheumatoid arthritis, lupus, and scleroderma; radiation
COPD. Of the adult respiratory diseases, emphysema and chronic
damage; and exposure to substances like molds and dust that initiate
bronchitis are the major causes of death. An estimated 10 million
hypersensitivity reactions. Diseases characterized by pulmonary fibro-
Americans are currently affected by these diseases. Together with
sis and/or immunologic reactions include pneumoconiosis, sarcoidosis,
asthma, emphysema and chronic bronchitis represent a particularly
diffuse hypersensitivity pneumonitis, farmer's lung, and bronchial
pressing health problem since the death rate and prevalence of these
asthma. This group of lung diseases is a major national health problem,
conditions have been increasing at an alarming rate over the past 15
second in magnitude among lung diseases only to emphysema and
years. As a disabling disease, emphysema is the third leading cause of
chronic bronchitis.
worker retirement on social security disability payments. Seven major
Statistical data on fibrotic lung diseases are inadequate because these
problem areas are defined below:
diseases are difficult to diagnose and poorly reported. However, their
Pediatric Pulmonary Diseases
national health impact is far greater than is generally appreciated. For
Pediatric pulmonary diseases present health problems of national
example, sarcoidosis is about 12 to 15 times more common among blacks
dimensions. Hyaline membrane disease (neonatal respiratory distress
than among whites in this country, and now outranks tuberculosis as a
syndrome), cystic fibrosis (an inherited disease of abnormal mucus
cause of disability from pulmonary insufficiency in black populations.
It is also more common in women.
secretion), and bronchiolitis (acute airway obstruction in young chil-
dren) are among the most important disorders of childhood that in-
Among immunologic lung diseases, asthma is the most common,
affecting about 6 million persons in this country (approximately 3 per-
volve the lung and the airways. About 40,000 babies are born each year
cent of the population). It is responsible for 5 percent of all chronic
with hyaline membrane disease. Many of these will die unless given
disabilities and causes an annual loss of about 4 million workdays.
prompt facilities. treatment, presently unavailable except in a few specialized
Other immunologic lung diseases are associated with specific occupa-
tions where exposure to organic dusts or molds is high; for example,
Cystic fibrosis occurs in about one of every 2,000 live births and ap-
proximately 5 percent of the general population in the United States
farmer's lung in the north central states, bagassosis among sugar cane
workers in the south, and hypersensitivity pneumonitis from organisms
carries the gene for this disorder. Cystic fibrosis is one of the main
causes of chronic illness in children and young adults and accounts for
growing in humidifiers and air conditioners. While none of these dis-
eases is very common in the general population, their importance stems
most of the deaths from pulmonary disease in the pediatric age group.
Bronchiolitis is a common pediatric disorder, but data are not avail-
from their high incidence in particular environments.
able on its incidence.
Respiratory Failure
Emphysema and Chronic Bronchitis
Respiratory failure is a complication of many nonpulmonary dis-
eases. Acute respiratory distress syndromes have been recognized as
Emphysema and chronic bronchitis are among the major causes of
mortality and illness from pulmonary diseases. Emphysema is a disease
such only recently. For these two reason, data on incidence are not
available. A conservative estimate is that 150,000 adult cases of acute
in whice the thin walls in the alveoli (air sacs) lose their elasticity and
tear. Chronic bronchitis refers to a persistent inflamation of the lungs
respiratory distress syndrome occur each year in the United States
characterized by recurrent coughing and excess mucus in the airways.
with a mortality rate of 40 percent. These figures do not include failure
These diseases may be associated with certain risk factors, such as
due to chronic pulmonary disease (see italics section on Emphysema
and Chronic Bronchitis), nor do they adequately reflect the true in-
cigarette smoking, and in some cases with genetic determinants (e.g.,
deficiency of alpha,-antitrypsin enzyme). Emphysema is a leading
cidence because SO many cases are unreported.
cause of death in this country and an even greater cause of disability.
Pulmonary Vascular Diseases
Data from 1967 indicate that chronic bronchitis and emphysema ac-
Pulmonary vascular diseases include cor pulmonale, pulmonary
count for half of the total 181,000 man-years lost due to lung diseases.
hypertension, and pulmonary edema. Cor pulmonale refers to enlarge-
The crude death rate for chronic bronchitis doubled between 1950 and
ment of the heart due to an increased workload of the right ventricle
1967. The death rate for emphysema increased thirteen-fold in the
resulting from conditions which affect the pulmonary circulation. Pul-
same period to a level of 10.6 per 100,000 population. Since 1968, the
monary hypertension is characterized by elevation of pulmonary
emphysema. rate decreased 10 percent for chronic bronchitis and 12 percent for
arterial pressure above normal levels. The condition is considered pri-
mary when found in the absence of cardiac or pulmonary diseases and
Fibrotic and Immunologic Lung Disease
secondary when associated with these diseases. Primary hypertension
Fibrotic and immunologic lung diseases are induced by many factors.
may be caused by factors such as high altitude and low oxygen, or
Fibrotic responses (proliferation of connective tissue or scar forma-
ingestion or certain drugs and chemicals; secondary hypertension may
result from destruction of the pulmonary vascular bed, congenital
S. Rept. 509-75-2
10
11
heart disease, pulmonary vasoconstriction, or congestive heart failure.
circulation is an important part of the circulatory system. It carries
Pulmonary edema, difficult to detect early, is a pathologic state in
to the cells of the body the materials needed for their metabolism
which there is abnormal extravascular storage of fluid in the lung.
and function and removes their waste products SO that the internal
Reliable data on the incidence and prevalence of these diseases are not
environment is maintained in a manner which allows the cells to sur-
available. However, it has been estimated that cor pulmonale alone
vive and perform their interrelated tasks. Bleeding and clotting in
occurs in 40 percent of cases of emphysema and chronic bronchitis,
the microcirculation contribute to the adverse effects of many diseases
both of which are chronic respiratory diseases of national impact.
and disorders such as hypertension, stroke, diabetes, infectious and
Inhalation Diseases
inflammatory disease, autoimmune disease, host-graft rejection, can-
Inhalation diseases are becoming more prevalent in the United
cer, sickle cell anemia, drug toxicity, mismatched blood transfusion,
States as industrialization and the technological age progress. Of all
liver disease, nephritis and hemophilia. The impact of the bleeding
occupational illnesses, dust inhalation diseases, or pneumoconioses,
and clotting diseases is vast even if it cannot be expressed statistically.
are the most serious health problem. The dusts inhaled are SO fine that
Biomaterials
they escape the natural cleaning mechanism of the upper respiratory
Biomaterials are synthetic materials which can be implanted in the
tract and lodge permanently in the lungs. If exposure is sufficiently
body and used in a variety of medical devices. To be "blood compati-
high and prolonged, the accumulated particles may cause fibrosis
ble", such materials must not cause damage to the various components
or scarring of the lung tissue and in many cases lead to serious disa-
of blood and must not induce blood to clot. In addition, biomaterials
bility and even death. One of the most serious problems in our country
must possess specific properties suitable for specialized functions (for
today comes from the direct handling of asbestos by some 200,000
example, gas permeability for oxygenation devices) and have minimal
workers and by another 3 to 5 million persons who are secondarily
risk of causing chemical toxicity, allergic reactions, and tumors. Sev-
exposed to the dust. Asbestos is believed to be a leading factor in the
eral approaches are being pursued in the development of suitable bio-
deaths of over 2,000 persons each year in the U.S. The breathing of
materials. Properties of the vessel wall have been imitated by "hy-
quartz dust, or silica, is another hazard which gradually causes ir-
drogels," a network structure of long polymer chains and water. Blood
reversible damage to the lungs. Of the more than 125,000 workers now
compatible surfaces can be grafted or bonded to a variety of materials
engaged in coal mining in the United States, an estimated 10 to 20
which have otherwise promising physical properties. Another ap-
percent have coal worker's pneumoconiosis, or "black lung." Beryllium,
proach involves the use of human cells which can be grown in culture
iron, tin, and barium dusts are also hazardous to the lung tissue.
and attached to certain man-made materials to make them compatible
Pneumoconioses are also caused by organic dusts from plants such as
with blood. Materials can be synthesized which contain anticoagulants,
lung). cotton (byssinosis), sugar cane (bagassosis), and moldy hay (farmer's
clot-dissolving enzymes, and surface-active agents. Composite ma-
terials can be produced which are based on a variety of components
Respiratory Assistance
mentioned above.
Respiratory assistance can be provided by mechanical devices (venti-
Sickle Cell Disease and Other Disorders of the Red Blood Cell
lators or membrane oxygenators) that support the gas transfer func-
The three groups of disorders considered here include sickle cell
tions of the lung when, as a consequence of the disease, the lungs are
anemia and sickle cell trait, conditions closely related to sickle cell
unable to maintain proper levels of oxygen and carbon dioxide. Ven-
disease such as Cooley's anemia, and defects affecting the red blood
tilators are devices that mechanically inflate the lungs and can deliver
cell membrane and its metabolic machinery.
increased amounts of oxygen. Membrane oxygenators are externally
Sickle Sell Anemia and Sickle Cell Trait.-Sickle cell trait, the most
placed "artificial lungs" which are connected with the patient's cir-
common inherited blood abnormality in the United States, is believed
culatory system. Blood from the patient enters the oxygenator, carbon
to be carried by more than 2 million U.S. citizens, primarily blacks.
dioxide is removed, the blood is oxygenated, and then returned to the
However, most of these "carriers" are healthy. If two carriers marry,
patient's circulatory system. At present, oxygenators can only be used
each of their children has a one in four chance of having sickle cell
safey for several days. Recent experience suggests that this method of
anemia, a painful and debilitating disorder affecting nearly 50,000 in-
respiratory assistance holds promise for treatment of some patients
dividuals (see Figure 11). About one in 500 black babies in this coun-
in acute respiratory failure.
try is born with sickle cell anemia.
The following summarizes the four major problem areas in blood
Sickle cell anemia is a disorder characterized by the presence of
diseases and blood resources.
painful "crises" which may last for hours or days, a chronic anemia
Bleeding and Clotting Disorders
related to accelerated destruction of red blood cells and acute aid chro-
Before describing the major bleeding and clotting disorders ad-
nic damage to various body organs. These clinical manifestations are
dressed in the National Program, the general principles involved in
caused by the presence of an abnormal hemoglobin (Hb S) leading to
the arrest of bleeding (hemostasis) are outlined below. The hemostatic
crescent shaped "sickled" red cells. Sickled red cells have difficulty
mechanism is designed to repair breaks in the wall of small blood
traversing the small blood vessels and tend to occlude them. This in
vessels, namely the components of the microcirculation. The micro-
turn results in impaired circulation, tissue damage, and painful crises.
Sickle cell anemia, the homozygous state for the gene for Hb S
12
13
(S/S disease), often causes severe and disabling symptoms and may
markedly shorten life. Milder symptoms and greater longevity are en-
Membrane and Enzyme Defects.-Defects in red cell membranes and
countered in certain genetic variants of sickle cell disease (Hb S-C
red cell enzymes also produce anemia by causing premature destruc-
disease, Hb S-thalassemia).
tion of the red blood cells. Such defects are relatively rare, except one,
called glucose-6-phosphate dehydrogenase (G6PD) deficiency, which
occurs in about 10 percent of black males and less frequently in males
When Both Parents are Carriers:
of Mediterranean ancestry and other populations. Most of these indi-
viduals are healthy, but may develop anemia with certain illnesses or if
they take a variety of commonly used drugs.
Blood Resources
Safe and adequate supplies of blood must be available for the nation.
Most whole blood is collected by an assemblage of organizations which
might be referred to as the blood service complex. As stated earlier,
whole blood contains red blood cells, white blood cells, and platelets
suspended in plasma. About 9 million units of whole blood and another
Sickle
Sickle
8.5 million unit equivalents of blood plasma are collected and used for
Cell
Cell
therapy in the United States each year. The optimal management and
Trait
Trait
utilization of this national resource is vital to the improved health
care of the nation.
Transfusion of red blood cells is important in restoring the normal
oxygen-carrying capacity of the blood in patients acutely anemic as a
****
result of hemorrhage or chronically anemic because of diseases inter-
fering with normal red cell production. Of all the blood components
used in transfusion therapy, red cells are needed in the greatest quan-
tity. White blood cells are vital to the body's defense against infestion.
In cancer, leukemia, and certain allergic states, circulating leukocytes
Sickle
Sickle
Sickle
(a type of white blood cell) are frequently diminished in quantity or
Cell
Cell
Cell
Normal
impaired in functional quality. As a result, the patient is susceptible
Anemia
Trait
Trait
to serious infections that may not respond to antibiotic treatment.
Transfusions of white blood cells may be beneficial in such cases.
FIGURE 1. Hereditary Impact of Sickle Cell Trait.
Platelets play a prominent role in the initiation of coagulation and in
If sickling of the red cells could be altered or prevented, perhaps by
the maintenance of the blood vessel integrity. Leukemia patients often
a suitably designed pharmacologic agent. both the quality and dura-
have low circulating platelet levels, either as a result of the disease it-
tion of life for patients with sickle cell disease would be greatly im-
self or as a toxic reaction to the drugs used in treating their disease.
proved. While we know the primary defect in sickle cell disease (a
Drug treatment of solid tumors also frequently reduces platelet levels.
mutation which leads to the substitution of a single amino acid in one
Such platelet deficiencies can result in serious, often fatal hemorrhage.
of the two kinds of polypeptide chains in hemoglobin), much remains
Platelet transfusions are vital for these patients.
to be learned about the formation and structure of the aggregates of
Approximately 1.7 million liters of plasma are collected each year,
deoxygenated Hb S and the interactions of these polymers of Hb S
mainly for the preparation of plasma protein fractions such as serum
with other red cell components. In a sense, the molecular and cellular
albumin used to treat shock; blood grouping protein needed for blood
manifestations can be considered "causes" of sickle cell disease, since
typing; gamma globulin for antibodies to fight disease; and anti-
the clinical manifestations are based upon the molecular and cellular
hemophilic globulin to allay bleeding in hemophiliacs.
phenomena.
B. NATIONAL RESEARCH SERVICE AWARDS 2
The cost of caring for a patient with sickle cell disease may approach
$2,500 to $5,000 a year. The loss of time from school and jobs, and the
NATIONAL ACADEMY OF SCIENCES.
resultant psychological and educational problems, make this disorder
Washington, D.C., June 16, 1975.
one of high social and economic impact.
Hon. CASPAR W. WEINBERGER,
Cooley's Anemia.-Cooley's anemia (thalassemia) results from de-
Secretary of Health, Education, and Welfare,
fective production of one of the sub-units of the hemoglobin molecule,
Washington, D.C.
leading to rapid destruction of the red cells. It occurs in perhaps 5,000
My DEAR MR. SECRETARY I am pleased to present to the Department
Americans, largely of Mediterranean ancestry. Its victims suffer pro-
of Health, Education, and Welfare the 1975 report of the Committee
found anemia and require repeated blood transfusions for survival.
As with the sickle cell trait, most carriers do not have symptoms, but
2 Excerpted from "Personnel Needs and Training for Biomedical and Behavioral Re-
one in four offspring may be affected if two carriers marry.
search," Commission on Human Resources-National Research Council.
14
15
on a Study of National Needs for Biomedical and Behavioral Research
John E. Jacobs, Ph.D., Walter P. Murphy Professor of Electrical En-
Personnel. This continuing study has been undertaken by the National
gineering and Engineering Sciences, Director, Biomedical Engi-
Research Council pursuant to Title I of the National Research Act of
neering Center, Northwestern University.
1974 (Public Law 93-348). It responds to your request of September 16,
David Mechanic, Ph.D., Professor of Sociology, University of Wis-
1974 that the National Academy of Sciences make such a study and
follows my letter of March 6, 1975 indicating that the Academy would
Lincoln consin. E. Moses, Ph.D., Dean of Graduate Studies, Stanford Uni-
accept this task. The work has been supported under Contract NO1
OD 5 2109 with the National Institutes of Health.
Carl versity. Pfaffmann, Ph.D., Vice President, Rockefeller University.
The Act states (Section 473 (a) ) that the purposes of the study are
Mitchell W. Spellman, M.D., Executive Dean, Charles R. Drew Post-
to: "(1) establish (A) the Nation's overall need for biomedical and
behavioral research personnel, (B) the subject areas in which such
P. Roy Vagelos, M.D., Professor and Chairman, Department of Bio-
graduate Medical School, Los Angeles, California.
personnel are needed and the number of such personnel needed in each
logical Chemistry, Director, Division of Biology and Biomedical
such area, and (C) the kinds of and extent of training which should
Sciences, Washington University.
be provided such personnel; (2) assess (A) current training programs
James B. Wyngaarden, M.D., Chairman, Department of Medicine,
available for the training of biomedical and behavioral research per-
Duke University Medical Center.
sonnel which are conducted under this Act at or through institutes
under the National Institutes of Health and the Alcohol, Drug Abuse,
SUMMARY
and Mental Health Administration, and (B) other current training
programs available for the training of such personnel; (3) identify
We recapitulate some points of the earlier discussion:
the kinds of research positions available to and held by individuals
1. Federal support of research training contributes to the continu-
completing such programs; (4) determine, to the extent feasible,
ing vitality of biomedical and behavioral research, and, thus, con-
whether the programs referred to in clause (b) of paragraph (2)
tributes a vital buttress to health care in the United States. The fed-
would be adequate to meet the needs established under paragraph (1)
eral presence brings with it national standards. The peer-review sys-
if the programs referred to in clause (A) of paragraph (2) were
tem ensures that the standards will be uniformly applied to recognize
terminated; and (5) determine what modifications in the programs
excellence. Biomedical research training itself (a) aids in selecting
referred to in paragraph (2) are required to meet the needs estab-
the next generation of research leaders, (b) accelerates their gradu-
lished under paragraph (1).
ate education, (c) gives M.D.'s essential research tools and Ph.D.'s
The present document, submitted in order to meet the requirement
essential contact with medical problems, (d) makes it possible for
for a report in fiscal year 1975, was prepared little more than three
postdoctoral scientists to move into undersupplied fields of specializa-
months after commencement of the study, hence, it cannot respond
tion, (e) stimulates the development of new fields of research, and (f)
fully to the broad and difficult requirements set by the Act. But a
beginning has been made. I trust that our reports in 1976 and there-
medical and behavioral graduate education, independent of their pri-
provides opportunity for the most able students to have access to bio-
after will deal in a more detailed and meaningful way with the sig-
vate resources.
nificant problem you have brought to us.
2. The competitively awarded research training grant is a unique
staff. We shall be glad to discuss this report for 1975 with you and your
and versatile mechanism that offers advantages beyond those of sup-
plying trained personnel. Among them are: (a) maintenance of a com-
Sincerely yours,
plete training environment, (b) encouragement of existing interdisci-
PHILIP HANDLER, President.
plinary linkages and of new interaction of disciplines, and (c) recog-
nition of excellence of training environments in the same way that
COMMITTEE ON A STUDY OF NATIONAL NEEDS FOR BIOMEDICAL AND
fellowships recognize excellence of individual performance.
BEHAVIORAL RESEARCH PERSONNEL
3. Largely due to training efforts of the last decade, a cadre of about
47,000 biomedical and behavioral researchers exists in the United
Chairman: Robert J. Glaser, M.D., President, The Henry J. Kaiser
States. About 70 percent of them conduct research in the basic. bio-
Family Foundation.
medical sciences, 14 percent in the behavioral sciences, 14 percent in the
Vice Chairman: Henry W. Riecken, Ph.D., Professor of Behavioral
clinical sciences, and 2 percent in health services studies. Seventeen
Sciences, University of Pennsylvania.
percent hold M.D. degrees, and 83 percent hold Ph.D.'s.
John J. Burns, Ph.D., Vice President of Research, Hoffmann-La
4. Essentially full employment currently exists for doctoral scien-
Roche. Inc., Nutley, New Jersey.
tists in these fields of research. Unemployment in 1973 was at the
Allan M. Cartter, Ph.D., Professor of Higher Education, Director,
"frictional". level of about 1.2 percent for all fields and age groups
Laboratory of Research in Higher Education, University of Cali-
combined, but may be higher now-perhaps 2 percent overall with
fornia, Los Angeles.
somewhat higher rates for some fields and for the most recent recipi-
Julius H. Comroe, Jr., M.D., Professor of Physiology, University of
ents of the Ph.D. In a few fields-health services research is an ex-
California, San Francisco.
ample-personnel shortages exist. The commonly used market indi-
16
17
cators, such as trends in relative salaries, stiggest that, overall, no seri-
9. We have found existing data and field taxonomies insufficient for
ous disequilibrium exists at the moment.
our task of forecasting personnel needs and the adequacy of the sup-
5. There is reason, however, to be concerned about future oversupply
ply. The recommendations in this report are limited by that con-
in some of the fields and about the costs thereof. Graduate enrollments
sideration to statements about immediate training requirements in
have been growing strongly, indicating a plentiful supply of graduat-
broad fields. In the course of the year ahead, we expect to acquire
ing Ph.D.'s over the next five years. The cadre of established research
more satisfactory data about the training pipeline, the research-
workers is relatively young, and attrition will be relatively low. Re-
personnel pool and the mobility of persons in it, and the components
search and development funds are stabilizing, and demand for per-
of demand. We also expect to develop a more adequate list of the
sonnel will stabilize accordingly. Although M.D. researchers can turn
training and research specialties in these areas.
to private practice for alternative careers, similar opportunities will
be more limited for Ph.D.'s. The demographic facts suggest there will
IV. PUBLIC HEARINGS-S. 988
be relatively few new appointments to faculties in the 1980's. Some
caution is needed, and the Committee is not prepared on the basis of
The Subcommittee on Health conducted hearings on S. 988 on
its limited studies to urge significant further growth of research
March 17, 1975. At that time testimony was received from
training.
A. The Administration:
6. The training "pipeline" is long-seven years on the average from
Theodore Cooper, M.D., Acting Assistant Secretary for Health.
baccalaureate to Ph.D., 10 years from the baccalaureate to the M.D.
Ronald Lamont-Havers, M.D., Acting Director, National Insti-
researcher. The flow cannot be rapidly turned on or off. Time is re-
tutes of Health.
quired to set up high-quality training programs, and stability is neces-
Robert Ringler, M.D., Acting Director, National Heart and
sary for an efficient and high-quality system. In this regard, the fed-
Lung Institute.
eral-budget decision not to include any funds for new starts in train-
B. The American Lung Institute: Gareth M. Green, President,
ing at the predoctoral level in FY 1976 causes the Committee great
American Thoracic Society.
concern.
C. The American Heart Association Elliott Rapaport, President.
7. Certain structural and administrative problems connected with
D. The National Kidney Association James C. Hunt, M.D., Presi-
research training have emerged. In the past, some two thirds of post-
dent.
doctoral M.D. trainees and fellows in these programs entered medical
E. The Association of American Medical Colleges:
practice soon after completion of training. This result was expected
John F. Sherman, Ph.D., Vice President.
in an earlier period of the training programs when program goals in-
Thomas E. Morgan, M.D., Director, Division of Biomedical
cluded the training of clinical specialists in shortage fields. Now, how-
ever, this goal has essentially been met, and there seems to be little
F. Research. The American College of Cardiology: Charles Fisch, M.D.,
reason to maintain training for clinical practice in the future. A second
President.
issue, almost as old as the training programs themselves, concerns the
G. The American College of Chest Physicians:
percentage of training-grant funds allotted to various forms of insti-
Arthur C. Beall, Jr., M.D., President.
tutional support-faculty salaries, salaries of supporting staffs, equip-
Joseph C. Ross, M.D., Chairman, Committee on Government
ment purchases, library and computer costs, purchase of supplies,
and SO on, The Committee believes there should be a limit on the per-
All Liaison. of the witnesses testified to the need to reauthorize and improve
centage of training funds used for these purposes, but notes that
the expired authorities contained in S. 988, as introduced.
the matter is complex. The strength of the training-grant mechanism
resides in large part in its ability to create a strong and vital total
V. PROGRAM ACCOMPLISHMENTS
environment for training. Stipends for trainees are an essential re-
quirement for training, but SO are a strong faculty, adequate equip-
The Act.-Section 413(a). The Director, NHLI, with the advice
ment and supplies, and other training elements.
of the Council. shall develop a plan for a National Heart, Blood Ves-
8. The difficult problem of proliferation of programs that results
sel, Lung and Blood Program.
in excess training capacity cannot easily be disposed of. The decade
Response.-In 1972, NHLI undertook a review of programs at NIH
of the 1960's witnessed a rapid growth of training programs in response
and at other Federal Agencies, and also, with the aid of approxi-
to perceptions of national needs. Now that some of those needs have
mately 300 consultants, reviewed the state of knowledge in the four
been met, the situation is changing. The Committee urges upon agen-
areas specified in the 1972 Act. namely, Heart and Blood Vessel Dis-
cies of government and training institutions a readiness for change
cases, Lung Diseases, Blood Diseases and Blood Resources. The re-
in both the character and the magnitudes of the training. programs.
view resulted in an assessment of the ongoing programs, and the op-
Legitimate aspirations of institutions and departments can best be
accommodated within an adaptive mechanism that recognizes new
Heart and Lung Advisory Council, the Interagency Technical Com-
portunities for additional efforts. With the advice of the National
needs, establishes excellence as the governing criterion, and sets a
mittee (IATC) and representatives of nonfederal and voluntary or-
high priority on flexible response.
ganizations with related programs, NHLI organized the results of
S. Rept. 509-75-3
18
19
this review into a National Program Plan (DHEW Publication No.
NHLI
shall conduct a program to provide public and health pro-
(NIH) 73-515) supported by extensive resource material from the
fessionals with health information.
Council, Panels and IATC.
Response.-The Institute has established and filled the position of
The National Program Plan was forwarded by the Director of the
Assistant Director for Health Information Programs. An analysis
Institute in May 1972 for transmittal to the Congress and was trans-
of public and professional inquiries has resulted in several workshops,
mitted to the Congress on July 24, 1973.
and new publications for broad distribution are being developed. New
As forwarded, the total report is contained in the following publi-
approaches to communication involving multi-media approaches are
cations:
being developed. The distribution of health related information is
Volume I: National Heart and Lung Institute Summary. (This in-
steadily increasing; last year in the area of hypertension alone, ap-
cluded the actual 5 year plan as required by the Act and the Institute's
proximately 30,000 articles appeared in magazines and newspapers
projections on the appropriation necessary to carry it out.)
(or the print media).
Volume II: Report of the National Heart and Lung Advisory Coun-
The Act.-Section 414(a) (1). Director of NHLI shall establish
cil. (This contains the Council's recommendations, after having re-
control programs as necessary for cooperation with other federal
viewed the scientific inputs of the Panel Reports (Volume IV) and
health agencies, state, local, and regional
and non-profit private
the analysis of current program activities (Volume V).)
health agencies.
Volume III: Report of the Panel Chairmen.
Response.-The National High Blood Pressure Education Pro-
Volume IV Panel Reports:
gram is the major effort currently involving active cooperation and
Part I-Report of the Heart and Blood Vessel Diseases Panel.
participation of other federal, state, local and regional public health
Part II-Report of the Lung Diseases Panel.
agencies. There are currently about 100 such agencies actively involved
Part III-Report of the Blood Diseases Panel.
in this program. This activity is of high priority to the Institute and
Part IV-Report of the Blood Resources Panel.
will continue. The Sickle Cell Disease Program is another major
Volume V : Program Analysis:
program involving the coordination by NHLI of the National Insti-
Part I-National Heart and Lung Institute.
tutes of Health, Health Services Administration, Center for Disease
Part II-National Institutes of Health (Exclusive of NHLI).
Control, Veterans' Administration, Department of Defense and the
Part III-Other Federal Agencies.
Labor Department. Major emphasis is on decreasing morbidity and
The
Act.-Section
413(a)
and (The Director, NHLI)
mortality in sickle cell disease through a program of research and
shall carry out the Program in accordance with the plan.
development and demonstration activities in public education, testing,
Response.-Within the constraints of available resources the pro-
rehabilitation and follow-up. Other cooperative efforts are in the plan-
gram is carried out as detailed in the report, described above.
ning stages to deal with cardiac rehabilitation, hemophilia and diet
The Act.-Section 413(b) (2). The Director of the NHLI shall
modification.
prepare annually a report on activities, progress and accomplishments
The Act.-Section 415 (1). Director, NHLI may provide for
during the preceding calendar year and a plan for the Program for
development of (A) 15 new centers for research and demonstration
the next five years.
in heart and blood diseases, (B) 15 new centers for research and
Response.-During the latter part of 1973 and the early part of
demonstration in lung diseases.
1974, an update of the National Program Plan was prepared, which
Response.-(A) During FY 1975 one National Research and Dem-
presented the Institute's revised plan for FY 1976-1980. This updated
onstration Center was established for heart diseases (Baylor College
plan (The First Annual Report of the Director of the NHLI, DHEW
of Medicine, Houston, Texas) and one for blood resources (King
Publication No. (NIH) 75-514), was forwarded to the President who
County Central Blood Bank, Inc., Seattle, Washington). Each of
transmitted it to the Congress on September 24, 1974. The updated
these deals with a broad spectrum of issues including basic and
plan for FY 1977-1981 (The Second Annual Report of the Director
clinical investigation, community demonstrations of diagnostic and
of the NHLI, DHEW Publication No. (NIH) 75-748) was forwarded
preventive techniques and public and health professional education
to the President who transmitted it to the Congress on June 27, 1975.
dealing with current knowledge and new approaches to disease control.
The Act.-Section 413 (c) (1). If authorized by Council, obtain serv-
(B) One National Research and Demonstration Center for lung
ices of not more than 50 experts or consultants.
diseases (University of Vermont, Burlington, Vermont) has been
Response.-The Institute currently has on board 3 full-time and 1
established. It focuses primarily on occupational safety and health
part-time experts/consultants under these provisions. The Institute
as related to lung diseases. The program of this center covers the spec-
did not make fuller use of these provisions because these special NHLI
trum as in (A) above.
experts/consultants were not exempted from the Institute's regular
The Act.-Section 416(a). The Secretary shall establish an Inter-
personnel ceiling. During FY 1975, this ruling was changed, and the
agency Technical Committee responsible for coordinating all related
Institute is actively recruiting experts/consultants with the expecta-
Federal programs and providing for full communication and exchange
tion that the number will increase substantially during the next year.
of information.
The Act.-Section 413(d). There shall be in NHLI an Assistant
Response.-The Interagency Technical Committee on Heart, Blood
Director for Health Information Programs appointed by Director,
Vessel, Lung and Blood Diseases and Blood Resources was established
21
20
The Act.-Section 5, Section 419A(2) (c). The Director, NHLI,
by the Secretary, DHEW, on November 3, 1972. Departments and
agencies represented on this committee are:
may approve grants not to exceed $35,000 without review and recom-
Constituent Agencies of HEW:
mendation by Council.
Alcohol, Drug Abuse and Mental Health Administration.
Response.-The Institute has not taken advantage of this provision
because of administrative difficulties and the necessity for clarification
Center for Disease Control.
whether the stipulated sum refers to direct cost or total cost. The In-
Food and Drug Administration.
stitute has submitted a legislative recommendation that the $35,000 be
Health Resources Administration.
identified as direct costs in a similar manner to the provision in the Na-
Health Services Administration.
tional Cancer Act Amendment of 1974 (P.L. 93-352, July 23, 1974).
National Institutes of Health.
The Act.-Section 419B. Appropriations for any fiscal year shall be
Social and Rehabilitation Services.
Social Security Administration.
not less than 15% lung and 15% blood.
Other Departments and Agencies:
Response.-This requirement has been met. For FY 1974 this alloca-
Department of Agriculture.
tion for Lung Diseases was 15%; for Blood Diseases and Resources,
Department of Defense.
17%. The Act.-Section 8. The Secretary, HEW, shall carry out a review
Department of Transportation.
of all administrative processes and submit a report to Congress within
Atomic Energy Commission.
Environmental Protection Agency.
one year of the findings.
National Science Foundation.
Response.-The Secretary, HEW, forwarded the required report on
National Aeronautics and Space Administration.
administrative processes to the Congress on September 27, 1973. The
Veterans Administration.
report concluded that the authorities made available by the 1972 Act
This Committee has assisted in the preparation of an annual report
generally have provided the administrative tools necessary to imple-
ment the National Heart, Blood Vessel, Lung and Blood Act
which summarizes the Federally-supported research programs in
Heart, Blood Vessel, Lung and Blood Diseases and Resources. It has
efficiently.
VI. ADMINISTRATION Position-S. 988
also provided a vehicle for exchange of information on current oper-
ating programs and the development of new programs.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
The Act.-Section 417(a). There is established a Heart and Lung
JUNE 6, 1975.
Advisory Council of 23 members.
Hon. HARRISON A. WILLIAMS, Jr.,
Response.-The Council was revised to 23 members following enact-
Chairman, Committee on Labor and Public Welfare,
ment of the legislation.
U.S. Senate, Washington, D.C.
The Act.-Section 417(d). The Director, NHLI, shall designate a
DEAR MR. CHAIRMAN: This is in response to your request of March
member of the staff to act as Executive Secretary to the Council.
Response.-Following the enactment of P.L. 92-423, the Director
13, 1975, for a report on S. 988, a bill "To amend the Public Health
Service Act to revise and extend programs of the National Heart and
appointed a senior member of the Institute staff to serve as Executive
Secretary to the Council. One of the major duties of the Executive
Lung Institute and National Research Service Awards."
Title I of the bill would provide several amendments to title IV,
Secretary is to assist the Council in preparation of the annual Coun-
cil report required by P.L. 92-423.
part B, of the Public Health Service Act. It would change the yearly
The Act.-Section 417(e). The Council shall meet not less often
reporting requirement for the Director of the National Heart and
than 4 times per year.
Lung Institute from a calendar to a fiscal-year basis and require the
Director to submit his annual report to the Secretary for transmittal
Response.-The Council as a whole meets regularly four times per
to the President and the Congress simultaneously; and require that
year; in addition, subcommittees or working groups meet between
such report set forth staff and appropriations recommendations. It
Council meetings as necessary.
The Act.-Section 418(b) (2). The Council shall submit a report to
would also change the title of the Assistant Director for Health In-
formation to Assistant Director for Prevention and Education.
the President for transmittal to the Congress not later than January
The bill would extend the Heart, Blood Vessel, Lung, and Blood
31 of each year.
Response.-The First Annual Report of the National Heart and
Control Program for two years at $45 million, the current level of
authorizations, and extend the other programs of the National Heart
Lung Advisory Council, DHEW Publication No. (NIH) 74-508, was
forwarded to the President who transmitted it to the Congress on
and Lung Institute for two years at the current authorization levels
July 29, 1974. The Second Annual Report of the National Heart and
of $475 million annually. The bill would also amend the provision con-
cerned with national research and demonstration centers SO that pre-
Lung Advisory Council, DHEW Publication No. (NIH) 75-747, was
forwarded to the President who transmitted it to the Congress on
vention programs, as well as research programs, would deal with all
May 15, 1975.
heart, lung, and related diseases, not solely cardiovascluar diseases;
23
22
authorize the $5 million maximum limit for single grants to research
regarding broad principles of program balance in extramural activi-
centers to be exceeded for "cost of living" increases; and substitute the
ties and by performing periodic overviews of the objectives and
Director, National Science Foundation, for the abolished position of
accomplishments of Institute programs. The Council, composed of
Director, Office of Science and Technology, as a member of the
public representatives and scientists with diverse areas of expertise,
National Heart and Lung Advisory Council.
is better qualified to serve in a general advisory function than to
Finally, title I would amend the National Heart and Lung Advisory
make specific decisions concerning the percentage of Institute funds
Council's functions to include the submission of a program progress
to be utilized in the contract program. Institute scientific program
report to the Secretary for transmittal to the President and Congress
advisory groups now provide the kinds of detailed advice needed to
by November 30 of each year; amend Council functions to include
identify more specific priorities in technical areas and more definitive
the approval of areas of research supported by contracts and approval
guidelines are being developed at Department and NIH levels to
of the percentage of the National Heart and Lung Institute's budget
standardize appropriate uses of the grant and contract award
expended for such contracts; and allow the Director of the National
Heart and Lung Institute to approve grants not exceeding $35,000 in
instruments. The choice of funding mechanism should remain the Institute's
direct costs without Council review.
within broad agency and departmental guidelines.
Title II of the bill would amend the section of the PHS Act con-
Finally, we would make the following technical suggestions:
cerned with the National Research Service Awards. It would make
(1) The order of words in the bill's short title be changed to
eligible for National Research Service Awards persons at all Federal
read, "National Biomedical Heart, Blood Vessel, Lung, Blood,
institutions, rather than those only at the National Institutes of Health
and Research Training Act of 1975," to coincide with the title
or the Alcohol, Drug Abuse, and Mental Health Administration. The
of the 1972 Act.
bill would also change the date by which the Secretary must submit a
(2) We recommend against changing current law to require the
report to Congress on the results of the research manpower study from
Director of the National Heart and Lung Institute to recommend
March 31 to September 30 of each year. Finally, this title would
staffing and appropriation levels in his annual report. Such recom-
extend appropriation authorization levels for two years at the present
mendations would not reflect the needs for that one institute in
level of $207.9 million annually.
the context of the needs in NIH elsewhere in light of the overall
Addressing first the provisions of title I of S. 988, the Department
availability of resources. We also oppose the title change in
wishes to reaffirm its commitment to maintain the momentum of the
the bill for the Assistant Director for Health Information as
heart, blood vessel, lung, and blood research programs. In our view,
these efforts have a high health priority. Although we believe that
unnecessary. (3) Sections 101 and 108 of the bill be modified, as indicated
extension of the authorities is unnecessary for the continuation of these
in the enclosed technical attachment, to allow for the change-over
efforts, we do not object to extension of the heart and lung appropria-
to the new fiscal year period.
tion authorities, provided that the authorization levels are consistent
(4) " 'such disease' in section 105 (c) be changed to " 'such
with the President's 1976 Budget and that no new activities are
diseases'
mandated.
(5) Section 102 be deleted as unnecessary: "alter" and "reno-
We disagree with the authorization level for heart and lung activi-
vate" connote the same idea as the present wording "improve"
ties proposed by S. 988 because of our need to consider these programs
and "repair".
against the background of the total resources available for other
Turning to the amendments concerned with the National Research
health research efforts and for other Federal programs as well.
Service Awards, we recommend Committee adoption of the Adminis-
We are opposed to the amendment specified in section 109 of the
tration proposal which has been introduced as H.R. 7049. We particu-
bill, which would modify the Advisory Council's duties to include
larly oppose the provision on extension of the authorizations. The ap-
approval of research areas to be supported by contracts and approval
propriation authorizations are not consistent with the President's 1976
of the percentage of the Institute budget which may be expended for
Budget and we believe that a three-year rather than two-year extension
such contracts. These provisions would change the role of the Council
is necessary to provide the stability necessary for the success of our
from its advisory role as established in the 1972 Act to administra-
research training efforts. We would therefore recommend that $136
tive role, which is properly reserved to Department officials who can
million be authorized for the fiscal year ending June 30, 1976, and for
be held accountable for their decisions. This accountability is charac-
each of the two succeeding fiscal years.
teristic not olny of the Department of Health, Education, and Welfare
The Department has submitted legislation to the Congress which
officials but also of officials in all other Government agencies.
embodies our proposed changes concerning the National Research
In addition, the Institute's planned expenditures for contracts and
Service Awards. Two specific changes included in this bill are propos-
grants are approved by Congress in the appropriation process, and
als to ameliorate the harshness of the pay-back formula by allowing
the Institute must obtain approval from Congress for any major
three-fourths credit for time served instead of one-half credit in the
shifts in planned expenditures. Given time and other constraints, the
present law and to clarify that the NAS study is advisory in nature.
Council would be unable to function effectively in the appropriation
We strongly urge that these amendments be incorporated in S. 988.
process. Therefore, the Department feels that the Council's efforts
The Department looks forward to working with the Committee re-
regarding contracts can best be directed towards providing advice
garding modifications of the existing research training authority. We
25
24
period beginning January 1, 1975, and ending December 31, 1975, and
would not oppose S. 988 if it is amended to incorporate our comments
the period beginning January 1, 1976, and ending September 30, 1976,
and proposals.
shall each be considered a fiscal year."
We would also suggest the following technical changes for title II:
(1) References to section 472 of the PHS Act refer also to the
II. SUGGESTED CHANGES IN SECTION 108 OF THE BILL
specific section heading "National Research Service Awards", as
there is presently another section 472 dealing with peer review.
A. Add a subsection designation "(a)" after "Sec. 108."
(2) Section 202 of the bill be deleted as unnecessary "or" in this
B. Add new subsections (b) and (c), as follows:
context in the PHS Act is inclusive (and/or), not exclusive.
(b) For purposes of paragraph (2) of subsection (b) of section 418
Although not addressed in S. 988, several additional legislative is-
of the Public Health Service Act, the period beginning July 1, 1975,
sues were raised at the hearings on S. 988 before the Subcommittee on
and ending September 30, 1976, shall be considered a fiscal year.
Health on March 17. We would like to comment on two of them at this
"(c) This section shall take effect on January 1, 1976."
time.
The Department urges that amendments be made to the current law
III. SUGGESTED NEW SECTION 112
to clarify the fact that the authority of the National Heart and Lung
"References to Blood Resources
Institute includes blood resources activities. Although the 1972 amend-
ments included blood resources in its provision relating to studies of
blood diseases, it omits reference to blood resources in several relevant
"Sec. 112. (a) Section 414 of such Act is amended by-
"(1) In subsection (a), inserting ', and in blood resources
sections. We recommend that section 414 and 415 be amended by in-
activities' after 'children', and
serting references to blood resources where appropriate. Suggested
"(2) in the heading, inserting 'and blood resources' after
wording may be found in the enclosed technical attachment.
'control'.
There is a provision in the Department's proposed legislation which
we believe could be appropriately included in S. 988. This would
"(b) Section 415 is amended by-
"(1) In paragraph (a) (1) (A), (A) striking out 'demonstra-
modify section 507 of the PHS Act to make all Federal institutions
tion of,' and inserting instead 'demonstration concerning, (i)',
eligible, under the same conditions under which non-Federal insti-
and (B) inserting ', and (ii) blood resources' after 'blood
tutions are eligible (except that 100 percent funding may be pro-
,vided), for research, training, and demonstration project grants
diseases', "(2) In paragraph (a) (3)., inserting 'and to blood resources'
under the PHS Act, and certain other grants under that Act and the
immediately before the last period,
Community Mental Health Centers Act. Currently only Public Health
"(3) In paragraph (b), (A) striking out 'demonstration of,'
Service Veterans Administration, and Federal Bureau of Prisons
and inserting instead 'demonstration concerning, (1)', and (B)
hospitals and St. Elizabeths Hospital are authorized to receive such
inserting or (2) blood resources' after 'or blood diseases', and
support. Since other Federal institutions also provide unique research
"(4) Adding at the end of the heading and blood resources"."
capabilities such as specialized facilities and diverse scientific and
engineering talent, they are ideally suited and highly qualified to
VII. COMMITTEE AMENDMENTS AND VIEWS
attack many problems in the biomedical, behavioral, and environ-
mental areas. Examples of such Federal institutions and facilities are
A. TITLE I-HEART, LUNG, AND BLOOD RESEARCH
the NASA Jet Propulsion Laboratory and the Armed Forces Insti-
tute of Pathology, both of which conduct cardiovascular research.
1. The principal change made respecting the authority of Public
Subject to the exceptions noted above, we do not oppose enactment
Law 92-423, the 1972 Act, by the reported bill involves a series of
of S. 988.
amendments designed to provide increased emphasis on the need for
We are advised by the Office of Management and Budget that there
a coordinated effort between programs in blood research and the use
is no objection to the presentation of this report from the standpoint
of blood resources. Thus, the reported bill contains provisions which
of the Administration's program.
would change the name of the National Heart and Lung Institute to
Sincerely,
the National Heart Lung and Blood Institute, make a comparable
CASPAR W. WEINBERGER,
change in the name of the Institute's advisory council, and make it
Secretary.
clear that the authority of the Institute extends to the use of blood
Enclosure.
products and the management of blood resources.
TECHNICAL ATTACHMENT
The Committee, however, wishes to emphasize strongly that these
amendments respecting blood, blood products and blood resources in
I. SUGGESTED CHANGES IN SECTION 101 OF THE BILL
no way are intended set in motion a series of actions by HEW with
regard to an overall national blood policy centered in the National
A. Add a subsection designation "(a)" after "Sec. 101."
Heart, Lung and Blood Institute. The committee has, as yet, held no
B. Add a new subsection (b), as follows:
hearings and made no legislative record with regard to the creation
"(b) For purposes of paragraph (2) of subsection (b) of section 413
of the Public Health Service Act (as amended by this Act), the
S. Rept. 509-75-4
27
26
of a coherent national blood policy in general, including the role of
Nonhuman primates have proven to be excellent experimental
the Federal Government in the implementation of that policy.
models for investigations in a variety of biomedical research areas,
The committee intends to turn its attention to this vital public pol-
including cardiovascular, cancer, infectious diseases, drug develop-
icy issue in the context of its overall review of the Nation's biomedical
ment, vaccine testing, and behavioral studies. Because of their close
research policy over the period of the next two years.
phylogenetic relationship to the human, primates are widely con-
2. The Committee's bill authorizes $10 million for the fiscal year
sidered to be the model of choice for investigations in several areas of
ending June 30, 1976, and $25 million for fiscal year ending June 30,
cardiovascular (CV) research, including atherosclerosis. The effects
1977, for the continuation of the programs to prevent and control
of dietary constituents and modifying drugs on, for example, chole-
heart, blood vessel, lung, and blood diseases. These programs are, in
sterol levels is currently being studied in a number of laboratories.
the Committee's judgment, of vital importance to the nation. The
Extensive use has also been made of the nonhuman primate model
Administration's lack of performance in implementing this authority
to further the understanding of physiological mechanisms involved
concerns the Committee. The Committee wishes to point out that it
in the CV system.
considers authority like this to be one of the crucial aspects of a well-
The Committee believes an adequate supply of such animals is vitally
functioning NIH. It is the Committee's belief that the NIH, its sister
important. Because the normal overseas supply is diminishing, the
research institutions throughout the nation, and research scientists
Committee would recommend that NIH establish the necessary ar-
and clinicians are in the best position to assure that research advances
rangements to provide for domestic sources.
are rapidly translated into improved patient care. The Committee
6. In the course of hearings on S. 988 the Association of American
urges HEW, NIH, and the National Heart, Lung, and Blood Insti-
Medical Colleges raised the concern it has respecting the confidenti-
tute to effectively implement this authority.
ality of research grant data. The Association proposed an amendment
3. With the Committee's amendments to increase emphasis on blood,
to remedy the problem it perceived.
blood products, and blood resources, the Committee has amended Sec-
The Association testified: Under a recent court ruling, data in re-
tion 415 of the Act SO as to permit the creation of ten new centers for
search grant applications is subject to public disclosure. Under the
basic and clinical research respecting heart disease, ten new centers
court's interpretation, Exemption 4 of the Freedom of Information
for basic and clinical research in lung disease, and ten new centers for
Act (which protects commercial trade secrets) does not apply to the
basic and clinical research for blood and blood vessel diseases.
research protocols for funded research grants awarded by the Na-
tional Institutes of Health and the National Institute of Mental
The Committee urges the Administration to implement this au-
Health. The Association believes that confidentiality of these docu-
thority effectively and expeditiously.
4. The Committee also is concerned about the implementation of
ments is essential, and that public disclosure will produce deleterious
Section 416 of the Act respecting the Interagency Technical Commit-
consequences. The information provided in grant applications submitted to the
tee. The Committee wishes to reaffirm its support for such a Com-
mittee. The Committee is concerned that there has not been effective
NIH is treated as confidential. Because research scientists and aca-
demic clinicians owe their advancement and standing in the scientific
coordination of the federal effort respecting heart, lung, and blood re-
search, which spans many federal departments. In addition, the
community to their original research contributions, their creative
Committee is concerned that there has not been effective coordination
ideas are of critical importance, and research scientists carefully pro-
tect their ideas. Thus, to the scientist and to the research clinician, re-
of these functions within HEW. Therefore, given the breadth of the
authority regarding these diseases and the scope of federal depart-
search designs and protocols are regarded and treated as proprietary
information, just as trade secrets are protected by the commercial and
ments involved, the Committee urges the Interagency Committee to
industrial sector. If vigorous competition in health research is to be
seriously consider the creation of working sub-groups for each of
the major disease areas with special emphasis upon intra-HEW
encouraged, the NIH must respect applicant's ideas and protect them.
coordination.
If they cannot be assured of this confidentiality, the NIH peer review
5. The Committee feels the duties of the National Heart, Lung, and
system and its encouragement of scientific competition could not be
sustained. Scientists would not supply the explicit details of their
Blood Advisory Council should include the making of recommenda-
tions concerning those portions of the National Program that are
proposed research approach and methodology essential for competent
conducted under contract awards. Since the membership includes
review, and the NIH ability to obtain effective evaluation of scientific
public representatives as well as scientists with diverse areas of ex-
merit for further programmatic judgments would be markedly
pertise, the council has a wide perspective from which to provide
hampered. The Association recognizes that the Congress and the public have a
advice regarding broad principles of program balance in extramural
activities. Thus, the reported bill specifically includes as mandated
fundamental right to know how Federal revenues are being spent. It
functions of the advisory council the development of recommendations
suggests that, when awards are made, the names of recipients of awards
regarding general areas of research and development suitable for
and a brief description of research design should be published, and
that details of research applications should be public information one
award under contracts, and suggestions as to portions of the Institute
budget to be devoted to such research and development areas.
year after an award is made. This procedure would allow the applicant
28
29
a reasonable opportunity to begin to develop and test the research de-
sign, while safeguarding the public's right to know.
ideas are the primary determinant in establishing the investigator's
The Association therefore recommends that the Public Health Serv-
scientific reputation and career opportunities. Therefore, these ideas
ice Act be amended by adding the following new subsection
are of a proprietary nature and should be afforded some measure of
protection.
301 (j) : Disclose to the public information of a proprietary
Second, the one-year period acknowledges the importance of the
or confidential nature (including any detailed research proto-
integrity and the internationally acclaimed success of the current sys-
col, research hypothesis, or research design) in the records
tem of scientific peer review sponsored by the National Institutes of
or possession of the Public Health Service obtained in con-
Health. Under this system researchers' ideas are protected, but at the
nection with an application or proposal for a grant, fellow-
same time are subjected to intense scrutiny for scientific merit by ex-
ship, or contract either with the consent of the applicant or
perts in the investigator's field. These experts on the peer review panels
proposer or on condition that at least one year has elapsed
represent the public interest by helping to assure that only the highest
following acceptance by the applicant or proposer of a grant,
caliber of scientific research will be supported by Federal funds. In
fellowship, or contract award based upon said application or
addition, current and proposed Federal regulations will ensure
proposal.
that research protocols will also be closely examined for ethical
This amendment would be an important and significant step in pre-
considerations.
serving the high quality of health research in this country.
The Association would like to point out that a researcher's findings
Subsequent to its testimony the Association modified its proposed
are subjected to a second, unofficial, form of peer review, through pub-
amendment in a letter to the Committee dated April 1, 1975, as follows
lication in journals which use the referee system. This dual system of
review is, the Association believes, in the best public interest.
ASSOCIATION OF AMERICAN MEDICAL COLLEGES,
Unlike investigators participating in the NIH peer review and the
Washington, D.C., April 1975.
academic referee systems, many competing scientists (for example,
Hon. EDWARD M. KENNEDY,
those in the private sector,) are not subject to intense scrutiny for sci-
Chairman, Health Subcommittee, Committee on Labor and Public
entific merit. If the traditional confidentiality of Federally funded
Welfare, U.S. Senate, Washington, D.C.
basic science research projects is removed, these scientists may gain
DEAR MR. CHAIRMAN : During the course of hearings on S. 988, the
immediate access to the new ideas of young investigators. While they
extension of heart and research training legislation, you expressed
might be able to develop or expand these ideas, the public will not be
your concerns about the relationship between the protection of human
able to scrutinize the methods, the ethics, or the financial interest in
research subjects and the confidentiality of information contained in
marketing a given product. The Association believes that such a situ-
research grant protocols.
ation would not be in the best interests of the public.
In response to your concerns, the Association would like to propose
Third, and of crucial importance, the one-year interval will help
language which it believes will provide both protection and confi-
prevent premature-and potentially hazardous-disclosure of scien-
dentiality until the National Commission for the Protection of Human
tific discoveries and hypotheses before they can be tested and proved.
Subjects of Biomedical and Behavioral Research sets forth its recom-
Premature publication of such hypotheses may create intense public
mendations. A copy of this language is attached for your consideration.
pressure upon practicing physicians to apply research advances before
The major feature of this proposal is the authority given to the
they have undergone sufficient investigation by research scientists. In
Secretary to disclose upon request all research protocols, research
the long run, the public interest will be served best by thorough scien-
hypotheses, and research designs of investigations which involve
tific investigation. Therefore, the public's understandable desire to
human subjects but which have not been exempted by the Congress
hasten the application of research findings must not be allowed to out-
from the Freedom of Information Act. This provision acknowledges
weigh the need for responsible and adequate scientific evaluation and
that, where human rights are at issue, public disclosure may con-
control.
tribute to the assurance of adequate protection for human subjects
In summary, Mr. Chairman, the Association believes that the pro-
and promote confidence in the nation's biomedical research efforts.
posed language provides for protection of human subjects and the
In those cases where human subjects are not involved and where
protection of nascent scientific ideas. This combination will not only
Freedom of Information Act exemptions are not applicable, the Sec-
fulfill the best public interest, but will help ensure that the system of
retary may disclose these documents one year after the award of the
scientific peer review developed by the National Institutes of Health
grant, contract, or fellowship. This one-year period will give the
will not be compromised.
researcher an opportunity to begin to test his or her hypothesis, and
The Association of American Medical Colleges appreciates this op-
it is absolutely essential for three important reasons:
portunity to express its views on this subject. If I or other members of
First, it prevents the possibility that the investigator's ideas will
the Association staff may be of assistance to you in this or other
be appropriated by another scientist before the investigator has an
matters, please do not hesitate to call upon us.
opportunity to implement the research design. The research scientist's
Sincerely yours,
principal stock-in-trade is the ability to generate creative ideas. These
JOHN F. SHERMAN, Ph. D.,
Vice President.
Attachment.
31
30
complex, particularly with regard to those biomedical and behavioral
AAMC PROPOSED LANGUAGE TO AMEND THE PUBLIC HEALTH SERVICE ACT
research projects that deal with human subjects.
TO PROVIDE FOR THE PROTECTION OF HUMAN SUBJECTS AND CONFIDEN-
As you know, the Panel is addressing a number of critical issues
TIALITY OF RESEARCH PROTOCOLS
among which is that of peer review. We do not feel that we have ade-
Section 301 of the Public Health Service Act is amended by adding
quate information at the present time to deal with all the nuances
embodied in the proposed legislation. While we are in support of pro-
the following:
viding the relief it seeks, we feel unable to endorse any specific legis-
(j) Disclose to members of the public, upon request, re-
lation at this time.
search protocols, research hypotheses, and research designs
Therefore, the Panel would prefer to develop this issue in the con-
in the records or possessions of the Public Health Service
text of its own investigation and to maintain close contact with you
obtained in connection with any application or proposal for
and your colleagues as this progresses.
a grant, fellowship, or contract only on condition that: (1)
Sincerely yours,
the protocol, hypothesis, or design is not exempt from dis-
FRANKLIN D. MURPHY, M.D.,
closure under 5 U.S.C. 552 (b) ; and (2) at least 12 months
Chairman, President's Biomedical Research Panel.
have elapsed following award of a grant, fellowship, or con-
tract based upon said application or proposal, provided that
the Secretary, upon request of any member of the public,
may waive the 12 month time period before disclosure in the
HARVARD MEDICAL SCHOOL,
case of research protocols, hypotheses or designs which pro-
BOSTON HOSPITAL FOR WOMEN,
pose to involve human subjects. The Secretary may deny re-
Boston, Mass., May 27, 1975.
quests for waiver of the time period only after consultation
Senator EDWARD M. KENNEDY,
with the National Advisory Council for the Protection of
Chairman, Senate Health Subcommittee, Committee on Labor and
Subjects of Biomedical and Behavioral Research established
Public Welfare, Washington, D.C.
by Section 217 (f) of this Act. Until such time as such Ad-
DEAR SENATOR KENNEDY: I should like to acknowledge receipt on
visory Council is established, the Secretary may deny such
May 21, 1975 of the letter from Senators Javits, Schweiker and your-
requests only after consultation with the National Commis-
self relating to the AAMC amendment to the National Heart and
sion for the Protection of Human Subjects of Biomedical
Lung Act. This will be distributed to all Commission members and be
and Behavioral Research established by P.L. 93-348.
on the agenda of our next meeting on June 20, 21. As soon as possible
a reply will be forthcoming. Should an earlier response be required,
Because of its concern about the justification of the need for such
it would be possible to poll the Commission members, and I will await
an amendment, in early May, 1975, Senators Kennedy, Javits, and
Schweiker solicited the views of the National Commission for the
your advice on this matter.
Protection of Human Subjects of Biomedical and Behavioral Re-
Sincerely,
KENNETH J. RYAN, M.D.
search, the President's Cancer Panel, and the President's Biomedical
Research Panel.
The responses follow:
J. H. WHITNEY & Co.,
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE,
New York, N.Y., June 3, 1975.
OFFICE OF THE SECRETARY,
Senator EDWARD M. KENNEDY,
Washington, D. C., May 26 1975.
Senator JACOB K. JAVITS,
Hon. EDWARD M. KENNEDY,
Senator RICHARD S. SCHWEIKER,
U.S. Senate, Committee on Labor and Public Welfare,
Senate Health Subcommittee,
Washington, D.C.
Washington, D.C.
DEAR SENATOR KENNEDY: On behalf of the President's Biomedical
GENTLEMEN I am pleased to respond to your letter of May 14, 1975,
Research Panel, I am responding to the letter from you and Senators
requesting the opinion of the President's Cancer Panel regarding
Javits and Schweiker of May 14 concerning the material contained in
the necessity and appropriateness of an amendment proposed by the
Title III of HR 7039.
Association of American Medical Colleges which proposes to restrict
The Panel discussed this matter at its meeting on May 26 and is
public access to biomedical research protocols.
deeply aware of the sensitive issues involved. Clearly, there is a need
In general, the Panel favors openness and full disclosure wherever
to provide relief from the decision of Judge Gesell, as well as that of
possible. However, peer review as it has operated up to this time is
the Appellate Court, interpreting the Freedom of Information Act
fundamental to the excellence that has characterized the research pro-
in such a way as to permit immediate public scrutiny of all research
grams of the N.I.H. We would be seriously concerned about any change
protocols funded at the National Institutes of Health and the Alcohol,
in peer review procedures that would be likely to lessen their effective-
Drug Abuse, and Mental Health Administration. This area is most
33
32
opinion regarding the necessity and appropriateness of the amend-
ness. We have grave doubts that peer review would work with any-
ment would not be possible at the present time. Although the Com-
thing approaching today's effectiveness in a climate of nonconfiden-
mission will be conducting comprehensive studies and investigations
tiality.
regarding the protection of human subjects, it does not now have ma-
Our concern has two aspects. First, we believe it is desirable that
terials at hand on which to base conclusions regarding the specific
grant applications remain confidential. Originality and creativity of
issues raised by the AAMC amendment.
ideas are the scientist's life blood and he will be reluctant to make the
Sincerely yours,
detailed disclosures which now characterize grant applications unless
KENNETH J. RYAN, M.D.,
he can rely on their confidentiality. Hence, we believe that nonconfi-
Chairman.
dentiality will lead to a new pattern of grant applications which will
make them far less descriptive. This could be particularly damaging
On May 19, 1975, the Association of American Medical Colleges
to the chances of the young scientist whose reputation is not yet estab-
wrote to the Subcommittee on Health and urged prompt action on S.
lished. The second aspect of the problem relates to the deliberations
988, as follows:
and the processes of evaluation. Scientists will be far less likely to
state their opinions candidly if what they say and write is on the
ASSOCIATION OF AMERICAN MEDICAL COLLEGES,
record. Frankness is assessing the scientific merit of applications and
Washington, D.C., May 19, 1975.
the quality of work of individual scientists has been the essence of the
Hon. EDWARD M. KENNEDY,
effectiveness of peer review. Nothing should be done that will impinge
Chairman, Subcommittee on Health, Committee on Labor and Public
even slightly on this frankness.
Welfare, U.S. Senate, Washington, D.C.
We have not been aware of legitimate complaints in this area of
DEAR SENATOR KENNEDY: As you will recall in the testimony pre-
sufficient magnitude or importance to justify a change in procedures
sented on behalf of our Association during your hearings on S. 988,
that have served the public interest SO well. Therefore, we would favor
we suggested consideration of an amendment to the Public Health
legislation that would protect the confidentiality of peer review as it
Service Act to protect the confidentiality of biomedical scientists' ideas
has heretofore existed notwithstanding the provisions of the Freedom
as included in research grant applications. The substance of our pro-
of Information Act. However, if some change is needed, we believe
posal was to permit a scientist, particularly the younger investigator
that a review procedure can be created for the purpose of reviewing
attempting to establish his scientific reputation, sufficient lead time
specific complaints which would preserve the essential confidentiality
to initiate his research before his ideas are subject to public disclosure.
and at the same time provide even further assurance against the pos-
An equally important component of the proposal would provide for
sibility of inequity.
disclosure upon funding of applications in which human subjects were
We have checked with a large number of scientists who have been
involved. We did not explicitly recommend the inclusion of such an
personally involved in the peer review system and, without exception,
amendment in S. 988; nonetheless, the simultaneous consideration of
they are of the view that the confidentiality of applications and study
renewal of the heart/lung and research training authorities seemed
section proceedings is a critical aspect of peer review as it now oper-
to offer a reasonable vehicle for such an amendment.
ates. Therefore, while we feel that the proposed AAMC amendment
It has come to our attention that our introduction of this subject
would be preferable to permitting interpretations of the Freedom of
for consideration at that time may have served inadvertently to delay
Information Act to eliminate confidentiality entirely, we prefer legis-
the mark-up of S. 988 by your Subcommittee. While we feel very
lation as above suggested.
Sincerely yours,
strongly about the principle involved in our proposition as a matter
of deep concern for the public interest and desire that its purpose be
BENNO C. SCHMIDT.
satisfied with appropriate legislation, we have no desire to impede
prompt passage by the Senate of S. 988.
NATIONAL COMMISSION FOR PROTECTION
We note that the recently introduced House Bill renewing the
OF HUMAN SUBJECTS OF BIOMEDICAL
heart/lung and research training authorities, H.R. 7039, does contain
AND BEHAVIORAL RESEARCH,
a provision similar to that which we have suggested. This will permit
Bethesda, Md., July 26, 1975.
consideration during the forthcoming hearings scheduled by the House
Hon. EDWARD M. KENNEDY,
and subsequent action as deemed suitable by the Congress. Because
Chairman, Senate Health Subcommittee, U.S. Senate,
of this circumstance and as no amendment has been introduced in the
Washington, D.C.
Senate, there would seem to be no basis for delay on this account.
DEAR MR. CHAIRMAN: The letter from Senators Javits, Schweiker
Thank you for your continued interest in and concern for the Na-
and yourself relating to the AAMC amendment to the National Heart
tion's biomedical research program.
and Lung Act was extensively discussed by the members of the Na-
Sincerely yours,
tional Commission for the Protection of Human Subjects of Bio-
JOHN F. SHERMAN, Ph. D.,
medical and Behavioral Research at their meeting on June 28, 1975.
Vice President.
The members determined that preparation and adoption of a formal
S. Rept. 509-75-5
34
35
The Committee continues in its committment to the spirit and let-
appropriated for the construction or modernization of health facili-
ter of the Freedom of Information Act, as well as to support of a
ties. The Committee's amendment permits the Secretary of HEW
quality peer review system and excellence in biomedical research. The
to waive the right of recovery, which heretofore has been partially
Committee is not yet convinced that there is at this point in time suffi-
limited.
cient justification for an amendment to the Freedom of Information
2. The Committee's bill amends section 212 of the PHS Act by
Act or the Public Health Service Act which would in effect exempt
adding a new section respecting the Soldiers and Sailors Civil Relief
research grant data from public scrutiny.
Act of 1940.
Accordingly, no such amendment is included in the Committee's
The PHS Commissioned Corps is governed by a personnel system—
bill.
including appointment, promotion, pay, leave, and retirement-which
The Committee will hold whatever hearings are necessary, and
is similar or identical to the personnel system of the Army, Navy
stands ready to take whatever action it believes appropriate, including
and Air Force. Like officers of the other services, PHS commissioned
joint hearings with the Senate Judiciary Committee, which has juris-
officers are subject to assignment to any location in the world to which
diction respecting the Freedom of Information Act, in the event the
the Public Health Service orders them. To this extent, the Congress
Committee is presented with substantial and persuasive evidence that,
has recognized the similarity between service in the Public Health
in fact, material damage is being done to continued excellence in bio-
Service and service in the Armed Forces, and PHS officers enjoy
medical research as a consequence of the provisions in the Freedom of
many of the rights, benefits, and privileges provided members of the
Information Act.
Armed Forces under Federal law. In addition, a male officer serving
The Committee solicits further views from the President's Biomedi-
in the PHS Commissioned Corps could fulfill his selective service
cal Research Panel concerning this important matter, as the Panel's
obligation when the draft was operative.
letter of May 26, 1975 indicates will be forthcoming. In addition, the
Unfortunately, the Commissioned Corps of the U.S. Public Health
Committee urges all of the interested parties in this complicated pub-
Service does not have available to it the provisions of the Soldiers
lic policy issue to present to the Committee whatever data they may
and Sailors Civil Relief Act. As a matter of fact, on December 31,
have and whatever recommendations they may wish to make. In par-
1970, President Nixon signed into law a bill-Public Law 91-621-
ticular, the Committee urges the Administration, the scientific com-
which extended to commissioned officers of the National Oceanic and
munity, the Commission for the Protection of Human Subjects, the
Atmospheric Administration-NOAA-the provisions of the act,
President's Cancer and Biomedical Research Panels, and public inter-
est law firms to continue to monitor and assess the extent to which
leaving the PHS Commissioned Corps as the only uniformed service
not covered under this act.
there are, in fact, real problems in this area requiring legislative
A provision of the Soldiers and Sailors Civil Act of 1940-title 50,
remedy.
United States Code-war, appendix, section 574-provides, in effect,
B. TITLE II-RESEARCH TRAINING
that for the purposes of State income tax liability a member of the
1. The Committee is concerned that the National Research Service
military service shall not be regarded as having lost his residence or
Awards authority has been and continues to be misconstrued by the
domicile in his "home" State solely because he is absent under military
Administration and, further, that the Administration appears to be
or naval orders; nor shall he be regarded as having acquired a resi-
unwilling to commit the resources necessary to support the vigorous
dence or domicile in any other State solely because of such absence.
biomedical and behavioral research training programs mandated in
It also provides that a State-other than "home" State-cannot tax
the law. Indeed, many of the actions of the Administration during the
the income of a member of a military service merely because he resides
first year of the authority appear to be consistent with its previous
and/or performs his duties there. The act further provides that a
attempts to abandon the program.
member of a military service may continue to register and license his
The Administration's reluctance to support predoctoral-level re-
solely owned automobile in his State of legal residence provided that
search training has also caused the Committee great concern. It is from
the license, fee or exercise required by that State has been duly paid.
the predoctoral ranks that postdoctoral-level research scientists
One of the basic elements of the Public Health Service Commissioned
emerge. The Committee believes it is vitally important to support
Corps is mobility. Commissioned officers spend many years of their
graduate students seeking the Ph. D. or a combined degree with a view
careers at stations which are located in a State other than the home
to engaging in careers in biomedical or behavioral research. Not only
State. In many instances, this results in the officer's having to pay a
should the supply of highly qualified Ph. D. candidates be maintained,
State income tax in two or more jurisdictions. To this extent the officers
but vigorous steps should be taken to attract bright young persons to
involved receive a reduction in pay as compared to their fellow officers
careers as research scientists through programs of support for pre-
in the other uniformed services who are only required to pay an in-
doctoral training.
come tax in the State of their domicile, and then only if such State
imposes an income tax.
C. TITLE III.-MISCELLANEOUS
In view of these circumstances, PHS officers should be provided this
long overdue benefit and that is what this bill achieves. It would not
1. The Committee's bill amends Section 1631 of the Public Health
entail the expenditure of any Federal funds and correct an inequity in
Service Act respecting the rights of the United States to cover funds
existing law.
36
37
3. The Committee's bill, as proposed by the Administration in their
The committee understands that the methods alluded to are the
views on the legislation, set forth in section VI of the report, amends
following:
section 507 of the Public Health Service Act to expand the authority
1. Schools participating in the federal student loan program
of the Secretary of Health, Education, and Welfare to award grants
can use any balance in the schools' federal capital contribution
for research, training and demonstration projects to Federal institu-
account as of June 30, 1975, to support new student loans.
tions. Existing provisions of section 507 limit this authority to awards
2. Amounts repaid by former students to the schools during
to hospitals of the Public Health Service, of the Veterans Administra-
the period July 1, 1975-June 30, 1976, can be loaned to new stu-
tion and of the Bureau of Prisons, and to Saint Elizabeths Hospital.
dents. However, a school cannot award loans in anticipation of
The bill expands this authority to authorize the Secretary to make
such repayments. Also, any school that participates in the Health
grants for research, training and demonstration projects under the
Professions Training Fund (revolving fund) would not have
Public Health Service Act and certain other grants under that Act
those repayments available because they go to the federal
and the Community Mental Health Centers Act to any Federal
government.
institution.
The committee views the first of the two methods as unrealistic be-
4. In order to provide continuity for funding the Committee's bill
cause most schools award all possible loan funds, retaining only ex-
amends Section 786 of the Public Health Service Act to provide $2
tremely small balances in their capital contribution accounts. The sec-
million for the fiscal year ending June 30, 1976, for the physician area
ond is almost equally unrealistic because the loan program has been in
shortage scholarship program.
operation for such a limited time that only negligible amounts are like-
5. The Committee added Section 305 respecting health professors
ly to be repaid during fiscal year 1976. In short, neither method pro-
student assistance to ensure that the student loan program for health
vides a realistic means to meet in any way the financial needs of new
professions is not interrupted. The Committee is aware that action has
students.
not been taken on the extension of most programs under Title VII of
Thus, while this may have been technically correct-since the funds
the Public Health Service Act, including the authorization contained
for loans financing students beginning in the Fall of 1976 would not
in part C, section 742 (a) (3), for student loans. Without extension of
normally be committed until the Spring of 1976-in fact, the result
that section, the student loan program goes into statutory phase out,
would have been vastly different.
meaning that any funds distributed to the health professions schools
Moreover, the Committee notes with concern that a number of insti-
through the continuing appropriations resolution authority for FY
tutions were being told informally by DHEW that no first-year stu-
1976 cannot be used by the school to ward loans to new students. Only
dent loans could be granted for the coming academic year, because no
students who have been previous recipients of federal health profes-
authority existed in the summer of 1975.
sions loans can be supported.
The Committee is distressed by the conduct displayed by DHEW in
The loan program legislative authority for first year students lapsed
trying to abolish this program contrary to the wishes of Congress-
with the Health Manpower Act in 1974. Congress intended for the pro-
particularly with its relating information, which while within the
gram to continue, however, as is evidenced by clearly stated authority
letter of the law, violates the spirit of the law.
for nurse training loans in the Health Services and Nurse Training
6. These new sections have been included because of the Committee's
Act. Moreover, loan authority for other health profession will be a
concern that the National Research Service Awards program was in-
critical factor in health manpower legislation soon to be considered by
terpreted in such a way as to deny authority for the NIH and
the Committee.
ADAMHA programs designed to assist colleges, universities, and
In the interim, the Committee believes that a simple one year exten-
health professional schools with large enrollments of minority group
sion of the student loan authority will place the Department of Health,
students. The Committee is firmly convinced that minority group per-
Education and Welfare on notice-as was achieved under P.L. 93-
sons are under-represented in the biomedical and behavioral research
385-that Congress intends for the program to continue and to let in-
community and that they are, as a group, a largely untapped resource
stitutions and needy potential students make their plans sufficiently in
with great potential to contribute to the health programs of the Na-
advance to take advantage of the loan program.
tion. A 1974 study conducted by the National Academy of Sciences
When the Senate considered the resolution continuing appropria-
indicates that, of the 208,000 science and engineering Ph.D.'s in the
tions for certain departments and agencies for Fiscal Year 1976, au-
United States, only 0.8 percent are blacks, 0.6 percent are Latins, and
thority was allowed to lapse for beginning students. Such action oc-
less than 0.1 percent are American Indians.
curred because members of the Appropriations Committee provided
The Committee realizes that, to help improve these dismal statistics,
assurances from the DHEW that certain programs, including the loan
sound undergraduate programs in science and other related disciplines
program for new students, would not need funding during the first
are necessary to provide the foundation for the successful training of
two quarters of the fiscal year.
minority group students for later careers in biomedical and behavior
In the Senate debate on the continuing appropriations resolution
research. Completely adequate backgrounds are not now being pro-
for fiscal year 1976, Senators were assured that the Department of
Health, Education, and Welfare had a way to support new students.
1 Minority Groups among United States Doctoral-Level Scientists, Engineers, and
Scholars, 1973, National Academy of Sciences, Washington, D.C., 1974.
38
39
vided at institutions with large enrollments of minority group stu-
dents in many instances, and the Committee believes it is vital that
D. TITLE IV.-FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS
there be unambiguous authority providing support at teh undergradu-
The Committee's amendment respecting vitamins is designed to
ate level for such institutions.
clarify Congress' position on the vitamin controversy which has existed
Furthermore, the Committee has added Section 475 as a separate
for the past decade. On August 2, 1973, the Food and Drug Adminis-
authority because it believes that, given the special situation and the
tration (FDA), after lengthy deliberations, promulgated regulations
special needs of such institutions and their undergraduate students,
which would have placed most vitamins and minerals exceeding 150
applying the service obligations of the National Research Service
percent of the U.S. RDA (United States Recommended Daily Allow-
Award would tend to discourage their participation in the very pro-
ance) under the jurisdiction of Chapter V of the Federal Food, Drug,
grams designed to assist them. The Committee feels it is not practical
and Cosmetic Act. Where the potency of vitamin or mineral products
or reasonable to require such undergraduate students, who are working
exceeded 150 percent of the RDA, those products would generally have
toward careers in biomedical research through the Minority Access to
become over-the-counter drugs. The regulations would have restricted
Research Careers of the National Institutes of Health and similar
combinations of vitamins and minerals that did not contain all FDA
training programs, to incur an added service obligation beyond that
approved vitamins and minerals.
currently required for the graduate and postgraduate-level training
In a concurrent action, the FDA limited high dosages of vitamins
under the National Research Service Awards authority. New Section
A and D (dosages exceeding 100 percent of the U.S. RDA of vita-
475 therefore is to relieve this category of student from the payback
min D or 200 percent of the U.S. RDA of Vitamin A) to sale by
requirement and to enable the institution with large enrollments of
prescription because of evidence that high levels of these fat soluble
minority group students to receive grants to improve the quality of
vitamins could cause serious harm.
its undergraduate-level programs without requiring payback agree-
On August 15, 1974, the U.S. Court of Appeals for the Second
ments from its students.
Circuit issued a decision upholding most of FDA's requirements
Awards to visiting scientists authorized in new Section 474 are
but ordering reconsideration of others (National Nutritional Foods
designed to draw on the special talents of scientists-teachers from other
Association V. FDA, 504 F.2d 761 (2nd Cir., 1974), cert. denied, 95
institutions by bringing them to colleges, universities, and health pro-
S. Ct. 1326 (1975). The Court decided that FDA could properly
fessional schools with large enrollments of minority group students,
restrict the variety of combinations of vitamins and minerals offered
and by supporting their participation in research, teaching, and cur-
to consumers, but should consider permitting the marketing of certain
riculum development. These individuals are mature, established, bio-
additional combination products. The Court also held that FDA
medical and behavioral scientists and academicians. New Section 474
could not deem vitamin or mineral products to be drugs solely on
provides that such scientists of high accomplishment in the field of
the basis of their potency, but had to consider as well the use for
biomedical science who are willing to assist minority schools in devel-
which they are marketed.
oping programs in biomedical sciences are given stipends more in
Title IV of S. 988 reaffirms and positively states the position of
keeping with salaries which they would be earning at their home
the Senate in this matter. This section prohibits the FDA from
institutions. Moreover, Section 474 is intended to insure that the visit-
regulating the composition of oral preparations of vitamins and
ing scientists not be subject to the payback provision of the National
minerals and combinations thereof, unless they are toxic, habit form-
Research Service Act authority. These persons are not receiving train-
ing, or must be administered by the direction of a physician or where
ing in any sense but rather are giving service through assisting in-
they are marketed for drug use. Last year, the Senate accepted an
stitutions with large enrollments of minority group students.
amendment, of similar purpose, offered by Senator Proxmire, by
By the term "enter into agreements" with the Secretary is meant
the vote 81-10 to the Health Manpower Bill. Subsequently, this
the submission of a competitive application detailing the activities such
bill died with the adjournment of the 93rd Congress.
a "visiting scientist" will undertake in providing assistance for a
Title IV does contain one major, new provision, not contained in
specified period of time to a minority institution to develop a program
last year's bill. It gives, for the first time, the FDA authority to
of biomedical sciences. Such applications shall be reviewed by the
regulate advertising for vitamin and mineral products. When adver-
appropriate review groups. If a scientist who receives a visiting scien-
tising is found to be deceptive or misleading in a material respect,
tist award is unable to serve the entire term of his award according
the FDA can seize the offending advertiser's product, at the manu-
to his agreement, Section 474 would require that he forfeit no more
than that portion of the stipend which he has not as yet earned by
facturing, distributional, or retail levels. In exercising his authority
with respect to seizures, the Committee calls to the attention of the
serving in this capacity.
National Research Service Awards may, of course, be available to
Secretary section 306 of the Federal Food, Drug, and Cosmetic Act,
21 U.S.C. 336. The Committee believes that seizure need not be insti-
minority group students, faculty, and institutions with high enroll-
ments of minority group students in the same manner and under the
tuted for minor violations of the Act whenever the Secretary believes
same conditions as they are available to all others with respect to
that the public interest will be adequately served by a suitable written
graduate and postgraduate training. The National Research Service
notice or warning.
Award authorities are, however, separate from those contained in new
On May 8, 1975, Senators Proxmire and Schweiker introduced
Sections 474 and 475,
S. 1692, which is identical in many respects to Title IV. The original
40
41
version of the bill (S. 1692) included several specific references to the
Secretary's obligation or authority to act by regulation. It is not in-
and combinations which this amendment endorses, however, would be
tended that the omission of these repetitive references should be under-
inappropriate.
stood as in any way restricting the Food and Drug Administration's
Section 411 (b) (2) (A) of the bill requires the listing of in-
present authority to adopt regulations refining and enforcing the pro-
gredients which are not vitamins or minerals in the labeling of the
visions of the Federal Food, Drug and Cosmetic Act, as amended. The
food product in a list of all ingredients of the product and in ac-
FDA in recent years has relied increasingly on administrative rule-
cordance with applicable regulations promulgated under section 403
making to enforce the requirements of the law. Rulemaking affords
(j). This provision should not be construed as allowing the Secre-
opportunity for broader participation in the formulation of agency
tary, by action or inaction, to prevent or render impracticable the
policy, promotes clarity of legal requirements, and assures equitable
Committee's intent to permit the listing of all ingredients which are
application of the law, while at the same time reduces the cost to the
not vitamins or minerals. When applicable regulations under section
taxpayer of case-by-case enforcement. The FDA's legal authority,
403 (j) of the Food, Drug, and Cosmetics Act are in effect, ingredients
under section (a) of the Act, 21 U.S.C. (a), to adopt binding
which are not vitamins or minerals must be listed in accordance with
regulations has been recognized by the Supreme Court, see Veinberger
these regulations.
V. Hynson, Westcott & Dunning, 412 U.S. (1973) Abbott Labora-
Considerable and continuing concern has been expressed by con-
tories, Inc. V. Gardner, 387 U.S. 136 (1967), and has recently been up-
sumers and by various members of the food supplement industry
held by the United States Court of Appeals for the Second Circuit.
and related publishers about the impact of the advertising provisions
National Nutritional Foods Ass'n V. Weinberger, 512 F.2d 688 (2d
in this bill upon freedom of the press under the First Amendment.
Cir. 1975.).
Obviously, nothing in this bill is intended to contravene such rights
Furthermore, as originally introduced, S. 1692 stated specifically
in any way.
that the restrictions imposed by section 411 (a) (1) did not limit the
It is intended that the term "advertising", whenever used in this
authority of the Food and Drug Administration to regulate vitamins
bill, should be SO interpreted as to be confined to overt advertising, as
and minerals, or other food ingredients, under section 402 (the food
that term is generally understood in the advertising industry.
adulteration provision), 406 (the emergency permit provision), and
Furthermore, the Committee wishes to make clear that the confer-
409 (the food additives provision) of the present Act. The deletion of
ring of regulatory authority over vitamin and mineral supplement
these references to specific provisions of the statute does not imply any
advertising, being in the nature of a quid pro quo to counterbalance
limitation on the FDA's present authority to assure that such food
the limitations placed upon FDA's authority over these products, is in
constitutents are safe for consumption. It is recognized that consumers
no sense a precedent for extending the agency's regulatory power over
must be protected against potentially toxic food ingredients, as well as
other types of advertising.
constitutents that are acknowledged to be hazardous. It is intended
In any action initiated or prosecuted under these advertising pro-
that the FDA should retain its present authority to deal with these
visions, with respect to, or against, any food supplement because of,
matters of public health.
or based upon, the allegedly deceptive advertising thereof, the editorial
Because of suggestions that the Food and Drug Administration,
content or policy of any independently owned and circulated publica-
having failed to regulate safe vitamins as dangerous drugs, might
tion or periodical (or of any particular or single issue thereof) in
attempt to regulate them as food additives, the authors of the vitamin
which such advertising appears, should not be considered as part of,
amendment considered language to prohibit the Food and Drug Ad-
or contributing or auxiliary to, the content, substance, meaning or
ministration from regulating safe vitamins, minerals, and associated
interpretation of the advertising which is the basis of such action.
ingredients of foods as food additives.
However, it is recognized that at some point a publication supported
This was not done for two reasons. First of all, it is unnecessary.
by advertising can become a cloak for deceptive advertisements of a
It would be inappropriate and contrary to the intention of this Title
product if its editorial content is prepared, controlled, or financed by
for the FDA to treat vitamins, minerals, and their associated ingredi-
the advertiser of such product or if there is a commercial scheme to
ents about whose safety there currently is no doubt, as food additives.
sell and position advertising in exchange for editorial comment on
There are those who considered vitamins and minerals essentially
the product of the advertiser. The publication, sale, and distribution
foods with a long history of safe use. The authors rejected that course
of false or misleading matter concerning an article of trade by a person
of action on grounds that there was insufficient evidence to support
engaged or financially interested in commerce in that trade could
such a course of action at this time.
be treated as false or misleading advertising under certain circum-
Second, there are some nutrients and ingredients or natural chemi-
stances, see Scientific Mfg. Co. V. FTC, 124 F. 2d 640, 644 (3d Cir.
cals which are tangentially a part of vitamins or minerals which cur-
1941) and Perma-Maid Co. V. FTC, 121 2d 282 (6th Cir. 1941). In
rently may be considered food additives because of their potential
such cases the editorial content or policy of the publication might be
toxicity. We did not wish to prevent the FDA from acting in these
considered as a basis for an action by the FDA. Certainly, for example,
circumstances. For the agency to do SO based on the policies on potency
the dressing up of an advertisement in the format and style of a news
42
43
article or editorial in the publication (commonly referred to as a
"reader ad") could be, in certain circumstances, a deceptive advertise-
gress on December 19, 1974, as modifications to the House Amend-
ment rather than speech protected by the First Amendment. In cases
ments to the Senate-passed National Arthritis Act (now P.L. 93-640).
of this category, only the courts can ultimately articulate the difficult
The House was unable to take action on the amendments due to the
distinction between commercial advertising masquerading as protected
press of other legislative matters under consideration that day and the
speech and protected speech bearing a superficial resemblance to com-
next. The 93rd Congress adjourned on December 20, 1974.
mercial advertising.
The amendments are primarily of a technical, clarifying, and per-
We recognize that it is a well-accepted marketplace fact that manu-
fecting nature. Two are of a more substantive nature.
facturers of particular types of products will normally place their
1. (a) The first substantive amendment would add the phrase (here-
advertising in publications or periodicals, the editorial content of
inafter in this Act collectively referred to as 'arthritis') in the Find-
which normally deals with the categories of products being advertised,
ings and Declaration of Purpose section of the Act. Inclusion of this
and which are addressed to a readership which is interested in such
phrase is necessary to make it clear that the mandate by the Public
subjects and products. Thus, a manufacturer of motorboats or marine
Law given the National Commission on Arthritis covers arthritis and
related musculoskeletal diseases.
accessories or products could be expected to place advertising in maga-
zines or other publications which deal with motorboating and related
(b) A conforming change has been made in amendments to Part D
of title IV of the Public Health Service Act SO that it is clear that
subjects.
the term "arthritis" includes "arthritis and related musculoskeletal
This bill does not contemplate that any nexus should be implied
diseases" wherever it is referred to in that Part of the Public Health
from the fact that an otherwise acceptable advertisement for a par-
Service Act.
ticular food supplement appears in a magazine, the editorial content
2. The second substantive amendment would reallocate the total
of which may deal with that specific type of product and which con-
amounts of appropriations authorized SO that the authorizations for
tains matter which, if contained in the paid advertising in question,
fiscal year 1975 would be slightly reduced and the authorization for
might be deemed to make such paid advertising unacceptable under
this bill.
fiscal years 1976 and 1977 would be commensurately increased. The
Senate bill had authorized a total of $75.5 million over a three-year
The simple existence of any publication which has not been singled
out by the owner or operator of a retail establishment to advertise a
period. The House reduced this to $50 million, and, in doing so, did
not retain the proportionate relationship among the funding authori-
particular product within the establishment does not constitute ad-
zations and among the years in the Senate bill. The Senate bill had a
vertising for that product. What does constitute advertising of a prod-
comparatively low amount authorized for fiscal year 1975 in the belief
uct is the specific use of prominent display of the publication to en-
that by the time of enactment, there would be insufficient time remain-
courage or convince consumers that they should purchase the product.
ing in fiscal year 1975 to obligate funds effectively. This, of course,
The owner or operator of the establishment must affirmatively link
has been borne out.
the publication to the product.
One modification from the original amendments has been made in
This bill does not take away the regulatory authority of FDA with
the allocation of the funds. In S. Con. Res. 127 in the 93rd Congress,
regard to vitamin and mineral preparations intended for use by preg-
it was proposed to reallocate the appropriations authorizations under
nant or lactating women and children under 12. However, the Com-
section 439(h) which authorizes funding for the development, mod-
mittee is concerned that attention must also be given to those vitamin
ernization, and operation of Comprehensive Arthritis Centers, by de-
and mineral products not intended for use by this special group but
ducting $6 million from fiscal year 1975 and dividing that amount
inadvertently taken by or administered to them. Just as the fetus
equally between fiscal years 1976 and 1977, authorizing $16 and $18
may be affected by excessive doses of some food supplements, excessive
million, respectively.
doses of vitamins and minerals taken by children during the period
Public Law 93-640 states that these centers are to be supported con-
of growth and hormonal development (up to 18 years of age) can
sistent with the Arthritis Plan developed by the National Commis-
interfere with their normal development. Because of the possibility
sion on Arthritis, established by that Public Law. It now appears
of unrecognized or unanticipated harm which might come from the
that the Commission will not complete its studies until December and
administration of large doses of vitamins and minerals, the Committee
that firm recommendations on the development and allocation of re-
recommends that FDA consider promulgating regulations with re-
source support will not be completed until January. That time sched-
spect to vitamin and mineral products designed to assure that such
ule will permit the inclusion in a supplemental appropriation bill for
preparations are not inadvertently administered to children.
fiscal year 1976 of an appropriation for support of the Centers, but
will not permit the effective obligation of the $16 million originally
E. TITLE V. NATIONAL ARTHRITIS ACT AMENDMENTS
suggested. The amendment included in S. 988 reflects the practicalities
of the appropriations time schedule and provides for the addition of
The amendments to the National Arthritis Act (with slight modi-
the full $6 million to the fiscal year 1977 authorization of appropria-
fications as noted below) were originally introduced as S. Con. Res.
tions, for a total authorization of $21 million for Center support for
127 and adopted by the Senate during the last days of the 93rd Con-
that year and makes no change in the amount authorized to be appro-
priated for fiscal year 1976 ($13 million).
45
44
[In millions of dollars]
The reallocation of authorizations are explained on the following
chart:
Fiscal year-
1976
1977
Total
AUTHORIZATIONS OF APPROPRIATIONS UNDER THE NATIONAL ARTHRITIS ACT OF 1974
[In millions of dollars]
Heart, lung, and blood prevention and control
10
25
35
Heart, lung, and blood research
338
372
710
Research training
160
176
336
Fiscal year-
Physician area shortage scholarships
2
2
Health manpower, loans
60
60
Authorization
1975
1976
1977
Nursing loans
35
35
Total
605
573
1. Commission on Arthritis and Musculoskeletal Diseases (sec. 3(k)):
1,178
Existing law
2.0
(1)
(1)
Original Senate bill
.5
0.5
Proposed amendment
1.5
(1)
(1)
IX. VOTES IN COMMITTEE
2. Screening projects and data bank (see 438(d) of PHS Act):
Existing law
2.0
3.0
4
Original Senate bill
5.0
10.0
15
Proposed amendment
1.5
4.0
4
Pursuant to section 133 (b) of the Legislative Reorganization Act
3. Comprehensive Arthritis Centers (sec. 439(h) of PHS Act):
of 1949, as amended, the following is a tabulation of votes in
Existing law
11.0
13.0
15
15.0
Committee:
Original Senate bill
10.0
20
Preposed amendment
5.0
13.0
21
Motion by Senator Schweiker to amend the Federal Food, Drug,
and Cosmetic Act respecting vitamins adopted 7 to 4 as follows:
Note: 3-yr grant total:
Existing law
$50.0
Original Senate bill
75.5
AYE
Proposed amendment
50.0
NAY
Javits
Beall
1 To remain until expended.
Loxalt
Hathaway
Pell
Kennedy
3. A third substantive amendment included in the original Concur-
Randolph
Mondale
rent Resolution has been dropped in the amendments offered to S. 988.
Schweiker
That amendment would have provided that the Commission must
Stafford
submit the Arthritis Plan within two hundred and ten days after the
Williams
date on which the Commission holds its first meeting, rather than 210
days after funds were first appropriated for the Commission. This
Motion to favorably report S. 988, as amended, to the Senate carried
amendment was offered originally to avoid any undue delay in the
unanimously by voice vote.
submission of the plan which might result from appropriations acts
X. SECTION-BY-SECTION ANALYSIS
being out of sequence with the Commission's calendar or work pace.
However, initial funds were appropriated for the Commission in the
PREAMBLE
Second Supplemental Appropriations Act for FY 1975. This appro-
priation makes the original amendment unnecessary.
The preamble to S. 988, as reported by the Senate Committee on
4. The technical amendments:
Labor and Public Welfare remains "A bill to amend the Public Health
(a) Specify in the Findings and Declaration of Purpose section
Service Act to revise and extend programs of the National Heart and
that the annual cost of arthritis includes $2,500,000,000 in medical
Lung Institute and the National Research Service Awards."
expenses.
(b) Insert a purpose clause, dropped by the House, in the Find-
SHORT TITLE
ings and Declarations of Purpose section.
(c) Make a number of purely technical and perfecting
S. 988, as reported, provides that the Act may be cited as the "Na-
amendments.
tional Biomedical Heart, Blood Vessel, Lung, Blood, and Research
Training Act of 1975."
VIII. COST ESTIMATES PURSUANT TO SECTION 252 OF THE LEGISLATIVE
REORGANIZATION ACT OF 1970 *
TITLE I-NATIONAL HEART AND LUNG INSTITUTE
In accordance with Section 252 (a) of the Legislative Reorganization
FINDINGS AND DECLARATION OF PURPOSE
Act of 1970 (Public Law 91-510, 91st Congress) the Committee esti-
mates that the cost which would be incurred in carrying out this bill
Section 101. (a) Repeats the eight major findings originally declared
is as follows:
in The National Heart, Blood Vessel, Lung, and Blood Act of 1972
[subsections (1)-(7), (9)]. Inserts an additional major finding [sub-
*The reallocation of costs representing the committee's amendment to Public Law 93-640,
section (8) relating to the devastating impact of blood diseases, espe-
the National Arthritis Act are contained in the chart included in sec. VII of this report.
46
47
cially nutritional anemias, sickle cell anemia, Cooley's anemia, hemor-
rhagic defects, and malignancies of the lymph nodes and bone mar-
acquiring, constructing, improving, repairing, and maintaining, fa-
row; notes that these diseases require major attention.
cilities and equipment necessary to administer the National Program
Section 101. (b) Declares that it is the purpose of this Act to enlarge
respecting blood diseases and blood resources as well as heart, blood
vessel, and lung diseases.
the authority of the National Heart, Lung, and Blood Institute in order
Section 105. (d) Amends the title of the Assistant Director for
to advance the attack upon heart, blood vessel, lung, and blood diseases
and resources.
Health Information Programs every time it appears in Section 413 (d)
of the same Act to read 96 Assistant Director for Prevention and Edu-
cation". Requires that this Assistant Director provide information on
REPORT AND PLAN OF THE DIRECTOR OF THE INSTITUTE
blood diseases and blood resources, as well as on cardiovascular and
Section 102. (a) Amends Chapter IV, Part B, Section 413 (b) (2)
pulmonary diseases, to the public and health professions as part of the
of the Public Health Service Act (relating to the National Heart and
Institute's health information program.
Lung Institute) to require that the Director of the National Heart,
Section 105. (e) Amends the heading of Section 413 to read "Na-
Lung, and Blood Institute prepare in consultation with the Institute's
tional Heart, Blood Vessel, Lung, and Blood Diseases and Blood
Advisory Council and submit to the Secretary of the Department of
Resources Program".
Health, Education, and Welfare as soon as possible after the end of
each fiscal year, an annual report on the activities, progress, and ac-
AUTHORIZATION OF APPROPRIATIONS
complishments under the program during the preceding fiscal year
Section 106. Amends Section 414(b) of the same Act to authorize
and a plan for the program during the next five years. Reiterates that
appropriations for heart, blood vessel, lung, and blood disease pre-
the plan should also project the staff and recommend appropriations
vention and control programs in the following amounts: $10,000,000
for the program. Requires that the annual report be transmitted
for fiscal year 1976, and $25,000,000 for fiscal year 1977.
by the Secretary DHEW to the President and the Congress
simultaneously.
Section 102. (b) Redefines the fiscal year for the purposes of submit-
NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART,
BLOOD VESSEL, LUNG, AND BLOOD DISEASES
ting annual reports. The fiscal years are defined as the period begin-
ning January 1, 1975 and ending December 31, 1975, and the period
Section 107. (a) Amends Section 415 (a) (1) (A) of the same Act by
beginning January 1, 1976 and ending September 30, 1976.
specifying the number of Research and Demonstration Centers for
heart diseases as ten.
CONFORMING AMENDMENTS
Section 107. (b) Amends Section 415 (1) (B) to limit the number
Section 103. Amends the heading of Title IV, Part B, National
of Research and Demonstration Centers for lung diseases to ten, in-
stead of the present fifteen.
Heart and Lung Institute, of the Public Health Service Act to read
Section 107. (c) Inserts into Section 415 (a) (1) a new subsection
"National Heart, Lung, And Blood Institute."
(C) to provide for the development of ten new Research and Demon-
Section 104. Amends Section 411, Establishment of Institute, of
the same Act to read "There is hereby established in the Public Health
stration Centers for basic and clinical research, training, and demon-
stration of advanced diagnostic, prevention, and treatment methods
Service a National Heart, Lung, and Blood Institute."
(including emergency medical services) for blood, blood vessel
diseases, research in the use of blood products, and research in the
NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASES AND BLOOD
management of blood resources.
RESOURCES PROGRAM
Section 107. (d) Amends Section 415 (a) (2) to include prevention
Section 105. (a) Amends Section 413 (a) of the same Act to require
programs for lung and blood diseases, in addition to those prevention
that the Director of the Institute specifically include blood diseases
programs for cardiovascular diseases, in the research, demonstration,
and blood resources as part of the plan for the National Heart, Blood
and training programs of the Research and Demonstration Centers.
Vessel, Lung and Blood Diseases and Blood Resources Program.
Section 107. (e) Amends Section 415 (a) (2) (A) to include pre-
Amends Section 413 (a) generally to include blood diseases and re-
ventive programs for the development of improved detection methods
sources in the National Program administered by the Institute and co-
regarding lung and blood diseases, as well as cardiovascular diseases,
ordinated with other research institutes of the National Institutes of
in high risk individuals.
Health.
Section 107. (f) Amends Section (a) (2) (B) to include preven-
Section 105. (b) Amends Section (a) (7) to explicitly include the
tive programs for the development of improved intervention methods
education and training of scientists, clinicians, and educators in the
against those factors which cause individuals to have a high risk of
fields and specialties requisite to the conduct of programs in blood re-
developing lung, blood, and/or cardiovascular diseases.
sources, as well as in blood, heart, blood vessel, and lung diseases.
Section 107. (g) Amends Section 415 (a) (2) (C) to include programs
Section 105. (c) Amends Section 413 (c) (2) to require that the Di-
for the development of health professions and allied health professions
rector of the Institute operate, alter, and rennovate, in addition to
personnel highly skilled in the prevention of lung, blood, and/or car-
diovascular diseases.
48
49
Section 107. (h) Amends Section 415 (a) (2) (D) to include preven-
tive programs to develop improved methods of providing emergency
Section 111. (b) Amends Section 419A (c) to authorize the Direc-
medical services for persons with lung, blood, and/or cardiovascular
tor of the Institute to approve grants for research and training in the
diseases.
use of blood and blood products and in the management of blood re-
Section 107. (i) Amends Section 415 (b) to provide that the purposes
sources as well as in heart, blood vessel, lung, and blood diseases.
for which Federal support of new or existing Research and Demon-
stration Centers include research in the management of blood re-
AUTHORIZATION OF APPROPRIATIONS
sources. Provides that Federal payments for the operation of these
Centers may only exceed $5,000,000 per year if the annual excess can
Section 112. (a) Amends Section 419B to authorize appropriations
be attributed to increased costs as reflected in the cost of living index
for programs and activities (other than those authorized in Section
published by the Department of Labor for that year.
414) of the National Heart Lung and Blood Institute in the following
amounts: $338,000,000 for fiscal year 1976, and $372,000,000 for fiscal
NATIONAL HEART AND LUNG ADVISORY COUNCIL
year 1977.
Section 112. (b) Amends Section 419B to provide that not less than
Section 108. Amends Section 417 (a) (1) of the same Act to remove
15% of the Institute's appropriations be reserved for programs re-
the Director of the Office of Science and Technology, and to include the
specting blood diseases.
Director of the National Science Foundation among the ex officio mem-
Section 112. (c) Amends Section 419B to provide that blood re-
bers of the National Heart and Lung Advisory Council.
sources be considered with blood diseases in the minimum allocation of
15% of the Institute's total appropriation.
FUNCTIONS OF THE COUNCIL
RESEARCH AND INVESTIGATION IN GENERAL
Section 109. (a) Amends Section 418(b) (2) to require that the Ad-
visory Council submit to the Secretary DHEW an annual report on the
Section 113. Amends Section 301 (d) and 301 (i) of the same Act to
progress of the national program toward accomplishment of its objec-
authorize grants-in-aid, and any other necessary actions, for research
tives during the preceding fiscal year. Requires that the Secretary
and investigations in heart, blood vessel, lung, and blood diseases and
DHEW must transmit this report simultaneously to the President and
resources.
to the Congress not later than November 30 of each year.
Section 109. (b) Provides that the period beginning July 1, 1975 and
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
ending September 30, 1976 be considered a fiscal year for the purpose
of submitting Advisory Council reports.
NATIONAL RESEARCH SERVICE AWARDS PUBLIC LAW 93-348-NATIONAL
Section 109. (c) Provides that the effective date of Section 109 is
RESEARCH ACT
January 1, 1976.
Section 110. (a) Amends Section (a) of the same Act by redes-
Section 201. Amends Section 472 (a) (1) (A) (iii) of the Public
ignating paragraphs (4), (5), and (6) as paragraphs (5), (6), and
Health Service Act to permit the Secretary DHEW to provide Na-
tional Research Service Awards for biomedical and behavioral re-
(7) respectively.
Section 110. (b) Amends Section 418(a) by inserting a new para-
search at Federal as well as non-Federal public institutions.
graph (4) which authorizes the National Heart and Lung Advisory
Section 202. (a) Amends Section 412(a) (1) (B) of the same Act to
Council to approve contract-supported areas or research in heart, blood
permit the Secretary DHEW to make grants to Federal as well as
vessel, lung, blood diseases, and the use of blood and blood products
non-Federal public institutions to enable these institutions to admin-
and research in the management of blood resources. Authorizes the
ister National Research Service Awards.
Council to approve the percentage of the Institute's budget to be ex-
Section 202. (b) Amends Section 412(a) (1) (B) to include the re-
lated programs administered by the National Advisory Council on
pended for these contracts.
Section 110. (c) Amends Section 418 (a) to insert the phrase "heart
Nurse Training among those institutes, divisions, and bureaus in the
diseases" instead of "heart" each time it appears.
National Institutes of Health, and the Alcohol, Drug Abuse, and Men-
Section 110. (d) Amends Section 418 (a) to insert "the use of blood
tal Health Administration for reference purposes in Section (a).
and blood products and research in the management of blood resources"
Section 203. Amends Section 472(b) (2) to require that awards and
after "blood diseases" each time it appears.
grants under National Research Service Awards be subject to review
and approval by the National Advisory Council on Nurse Training,
as well as by other appropriate advisory councils of the National In-
ADMINISTRATION
stitutes of Health and the Alcohol, Drug Abuse, and Mental Health
Section 111. (a) Amends Section 419A of the same Act to au-
Administration.
thorize the Director of the Institute to approve grants for research
Section 204. (a) Amends Section 472 (1) (A) (i) of the same Act
and training in amounts not to exceed $35,000 (excluding indirect
to permit any combination of health research or teaching which is in
costs).
accordance with usual patterns of academic employment as legitimate
50
51
activities required to be performed by the individual recipient of a
AUTHORIZATION OF APPROPRIATIONS
National Research Service Award.
Section 204. (b) Amends Section 472 (c) (2) (A) of the same Act
Section 304. Amends Section 786 of the Public Health Service Act
to require that the individual recipient of a National Research Service
to authorize appropriations for the Physician Shortage Area Scholar-
Award engage in any combination of health research or teaching
ship Program as follows: $3,500,000 for fiscal year 1975, and $2,000,000
which reflects the usual patterns of academic employment for a period
for fiscal year 1976.
of twelve months.
Section 305. (a) Amends Section 742 (a) of the same Act to authorize
appropriations for Federal loans to certain schools as follows: $60,-
AUTHORIZATION OF APPROPRIATIONS
000,000 for fiscal year 1976.
Section 205. Amends Section 472(d) of the same Act to authorize
Section 305. (b) Amends Section 740(b) (4) of the same Act to
provide that no student who has attended certain schools before
payments and grants under National Research Service Awards in
July 1, 1975 may receive a loan from a fund established by Section
the following amounts $160,000,000 for fiscal year 1976, and $176,000,-
204 of the National Defense Education Act of 1958.
000 for fiscal year 1977.
Section 305. (c) Amends Section 824 of the same Act to authorize
appropriations for loans as follows: $35,000,000 for fiscal year 1976.
STUDIES RESPECTING BIOMEDIC AND BEHAVIORAL RESEARCH PERSONNEL
Section 305. (d) Amends Section 822 (b) (4) of the same Act
Section 206. Amends Section 473 (c) of the same Act to require
to provide that no student who has attended nursing schools before
that studies on biomedical and behavioral research personnel be sub-
July 1, 1975 may receive a loan from a fund established by Section
mitted by the Secretary DHEW to the House Committee on Inter-
204 of the National Defense Education Act of 1958.
state and Foreign Commerce and the Senate Committee on Labor and
Public Welfare not later than September 30 of each year.
STIPENDS
Section 306. Amends Title IV, National Research Institutes, of
REFERENCES
the Public Health Service Act by adding two new sections, Section
Section 207. Provides that all references to Section 472, National
474, Stipends, and Section 475, Undergraduate Training In Bio-
Research Service Awards, of the National Research Act shall be fol-
medical Sciences in Minority Schools:
lowed by "Public Law 93-348-National Research Act".
STIPENDS
TITLE III-MISCELLANEOUS PROVISIONS
(a) Permits the Secretary DHEW to grant a maximum stipend of
$25,000 per year to visiting scientists who agree formally with the
HEALTH RESOURCES DEVELOPMENT-GENERAL PROVISIONS
Secretary to assist minority schools in developing programs in bio-
Section 301. Amends Section 1631 (b), Recovery, of the Public
medical sciences. Permits the United States to recover an amount,
Health Service Act to permit the Secretary DHEW to waive a right
set forth by the recovery formula in Section 472 (c) (4) of the
of recovery which arose one year before January 4, 1975.
National Research Act-Public Law 93-348, if the recipient of a
stipend does not complete the requirements of his agreement with
the Secretary DHEW.
MILITARY BENEFITS
(b) Definitions.-Defines "visiting scientist" to mean an accom-
Section 302. Amends Section 212 of the Public Health Service Act
plished, reputable scientist in the fields of biomedical sciences who
to include a new subsection (e) which provides that active service of
has entered into an agreement with the Secretary DHEW. Defines
commissioned officers of the Public Health Service shall be deemed
"minority school" to mean an institution of postsecondary education
to be active military service in the Nation's armed forces for the
which has enrolled a substantial number of minority students as
purposes of all rights, privileges, immunities, and benefits now or
determined in regulations established by the Secretary DHEW.
hereafter provided under the Soldiers' and Sailors' Civil Relief Act
Defines "biomedical sciences to mean all health related sciences and
of 1940, as amended.
requisite related courses.
(c) Authorization of Appropriations.-Authorizes such sums as
GRANTS TO FEDERAL INSTITUTIONS
may be necessary to carry out this program of stipends for visiting
scientists.
Section 303. Amends Section 507 of the Public Health Service Act
to provide that grants may be made to any Federal institution, on the
UNDERGRADUATE TRAINING IN BIOMEDICAL SCIENCES IN MINORITY SCHOOLS
same terms and conditions that apply to non-Federal institutions,
except that grants to Federal institutions may be funded at 100%
(a) Permits the Secretary DHEW to make grants to minority
of the costs.
schools to initiate the development of undergraduate programs in bio-
medical sciences.
52
53
(b) Stipulates that each minority school which establishes grant-
DEFINITIONS
supported programs in biomedical sciences must do SO in accord-
ance with regulations promulgated by the Secretary DHEW.
Section 402. (a) Amends Section 201 (f) of the Food, Drug, and
(c) Definitions.-Defines "minority school to be an institution of
Cosmetic Act by redesignating Section 201 to redefine the term "spe-
post secondary education which has enrolled a substantial number of
cial dietary use" as applied to food. "Special dietary use" is defined to
minority students as determined in regulations established by the
mean a particular use for which a food is represented to be used, in-
Secretary DHEW. Defines "biomedical sciences to mean all health
cluded but not limited to: supplying a special dietary need that exists
related sciences and requisite related courses.
by reason of any health condition; supplementing the diet to increase
(d) Authorization of Appropriations.-Authorizes such sums as may
the total intake of vitamins, minerals, or other food ingredients; sup-
be necessary to carry out this Federally supported grant program for
plying a special dietary need because a food is the sole item in the diet.
undergraduate training in biomedical sciences in minority schools.
REGULATIONS
TITLE IV-FOOD, DRUG, AND COSMETIC ACT
AMENDMENTS
Section 402. (b) Directs the Secretary DHEW to amend existing
regulations and promulgate these amendments to make all regulations
Section 401. Amends Chapter IV, Food, of the Food, Drug, and
consistent with the new Section 411.
Cosmetic Act, after Section 410, Bottled Drinking Water, by inserting
a new Section 411:
ADVERTISING
VITAMINS AND MINERALS
Section 403. (a) Amends Section 403 (a), Misbranded Food, of the
(a) Prohibits the Secretary DHEW from: limiting the potency
Food, Drug, and Cosmetic Act, by redesignating this subsection to
of any vitamin or mineral within a food; classifying any single or
include a new paragraph (2) which provides that a food as defined
combination vitamin/mineral product as a drug on the basis of high
by new Section 411 is defined to be misbranded if its advertising is
potency which the Secretary determines to be in excess of nutritional
false or misleading in a material respect or if its labeling is in viola-
usefulness; limiting the combination or number of vitamins or min-
tion of the new Section 411. Amends Section 201 (n), Definitions, of
erals or other ingredients in foods to which Section 411 applies. Per-
the same Act, SO that the specifications employed to determine mis-
mits the Secretary DHEW to exercise his authority regarding Chapter
leading labeling would be employed to determine misleading adver-
IV, Food, Chapter V, Drugs and Devices, or any other provision of
tising. Amends Section 303, Penalties, of the same Act by adding a
the Food, Drug, and Cosmetic Act except as is prohibited above re-
new subsection (d) which exempts a person from prison penalties and
garding vitamins, minerals, or other food ingredients. Permits the
fines when a food has been deemed to be misbranded due to its ad-
Secretary DHEW to regulate vitamins, minerals, or other food in-
vertising, unless the violation is committed with the intent to defraud
gredients which the Secretary determines by regulation to be repre-
or mislead. Amends Section 304 (a), Seizure, of the same Act, by
sented for use by pregnant or lactating women or children under the
adding a new subparagraph (3) which prohibits the institution of a
age of twelve years.
libel for condemnation against any food misbranded because of its
MISBRANDED FOODS
advertising and being held for sale to the consumer in an establish-
ment not owned or operated by the manufacturer, packer, or distribu-
(b) Clarifies Section 403, Misbranded Food, of the same Act SO that
tor of the food; and which permits such a condemnation if the food's
foods labeled to include all ingredients or advertised to refer to all
advertising was disseminated in the selling establishment, was dis-
ingredients beside vitamins and/or minerals cannot be deemed mis-
seminated by the owner or operator of such establishment, was paid
branded. Permits the labeling of non-vitamin/non-mineral constitu-
for by the owner or operator, or was used to promote the sale of the
ents of foods only in the list of ingredients and only in accordance
food.
with, and by exemptions to, regulations promulgated by the Secretary
GENERAL ADMINISTRATIVE PROVISIONS
DHEW. Prohibits the labeling or advertising of any food from em-
phasizing ingredients which are not vitamins, minerals, or sources of
Section 403. (b) Amends Chapter VII, General Administrative
vitamins/minerals.
Provisions, of the Food, Drug, and Cosmetic Act by adding a new
DEFINITIONS
Section 707, "Advertising of Certain Foods", which requires that the
Secretary DHEW must consult and coordinate with the Federal
(c) Defines "food to which this section applies" as food for humans
Trade Commission any action to be taken against food deemed to be
which is a food for special dietary use; which is or contains any vita-
misbranded because of its advertising.
min or mineral; which is intended for ingestion in tablet, capsule, or
liquid form: and which does not simulate or is not represented to be
EFFECTIVE DATE
conventional food if it is not in the specified form. Defines a food in
liquid form to be formulated in a fluid carrier and be intended for in-
Section 403. (c) Provides that the amendments made by Section
gestion in daily, small units of measure.
403 (a), Misbranded Food, of this Act take effect 180 days after en-
actment of this Act.
54
55
TITLE V-ARTHRITIS ACT AMENDMENTS
diseases" to make this subsection consistent with the language as clari-
fied in Section 502 (a) of this Act.
SHORT TITLE
Section 503. (c) Amends Section 434 of the Public Health Serv-
Section 501. Provides that this title may be cited as the "National
ice Act to make this subsection consistent with the language as clarified
Arthritis Act Technical Amendments of 1975".
in Section 502 (a) of this Act.
Section 503. (d) Amends Section 438 (a) of the Same Act to correct
FINDINGS AND DECLARATIONS OF PURPOSE
existing grammatical errors. Amends Section 438 (d) to change author-
ized appropriations for arthritis screening, detection, prevention, and
Section 502. (a) Amends Public Law 93-640 by inserting "(a)"
referral demonstration projects, and data bank to the following
after "Sec. 2.", and by inserting a clause to permit references to the
amounts: $1,500,000 for fiscal year 1975, and $4,000,000 for fiscal year
term "arthritis" in the National Arthritis Act of 1974 to collectively
1976.
mean arthritis and related musculoskeletal diseases. Inserts a phrase to
Section 503. (e) Amends Section 439 (a) of the same Act to permit
designate that the annual cost to the Nation's economy due to arthritis,
the Secretary DHEW to provide for the development, modernization,
$9,200,000,000, includes $2,500,000,000 in medical expenses. Adds
and operation of new and existing comprehensive arthritis centers.
a new subsection (b) which states that the purpose of the National
Amends Section 439 (c) of the same Act to correct existing grammat-
Arthritis Act of 1974 is to provide for a long-range plan to expand
ical errors. Amends Section 439 (h) to change authorized appropria-
and coordinate the national research, treatment and control effort
tions for comprehensive arthritis centers to the following amounts:
against arthritis; to advance educational activities to alert the Na-
$5,000,000 for fiscal year 1975, and $21,000,000 for fiscal year 1977.
tion's citizens to the early indications of arthritis; to emphasize early
detection, proper control, and possible complications of these diseases;
XI. CHANGES IN EXISTING LAW
to establish and support the development of improved methods for
arthritis screening, prevention and referral; to establish a central
In compliance with subsection (4) of rule XXIX of the Standing
arthritis screening and detection data bank; to develop, modernize
Rules of the Senate, changes in existing law made by titles I through
and operate centers for arthritis screening, detection, diagnosis, pre-
V of the bill, as reported, are shown as follows (existing law proposed
to be omitted is enclosed in black brackets; new matter printed in
vention, control, treatment, education, rehabilitation, research and
training programs.
italic) :
PUBLIC HEALTH SERVICE AcT, AS AMENDED
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NATIONAL COMMISSION ON ARTHRITIS; ARTHRITIS PLAN
TITLE II-ADMINISTRATION
Section 502. (b) Amends Section 3 (b) (4) of Public Law 93-640 to
correct the reference to the Chief Medical Director of the Veterans
*
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*
*
*
Administration as a member of the National Commission on Arthritis
and Related Musculoskeletal Diseases. That section currently incor-
MILITARY BENEFITS
rectly identifies the "Chief Medical Director" as the "chief medical
SEC. 212.
*
*
*
officer" of the Veterans Administration.
Amends Section 3(k) of the same Public Law to authorize, without
(e) Active service of commissioned officers of the Service shall be
fiscal year limitation, an appropriation of $1,500,000 to support the
deemed to be active military service in the Armed Forces of the United
Commission's specified activities.
States for the purposes of all rights, privileges, immunities, and bene-
fits now or hereafter provided under the Soldiers' and Sailors' Civil
CHANGE OF HEADING
Relief Act of 1940, as amended (50 App. U.S.C.50 et seq.).
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*
*
Section 502. (c) Amends the heading above Section 4 of Public Law
93-640 to read 'Arthritis Coordinating Committee, Projects, and Com-
TITLE III-GENERAL POWERS AND DUTIES OF
prehensive Arthritis Centers".
PUBLIC HEALTH SERVICE
CONFORMING AMENDMENTS
PART A-RESEARCH AND INVESTIGATION IN GENERAL
Section 503. (a) Amends Section 431 (c), Research Funding, of the
SEC. 301. The Surgeon General shall conduct in the Service, and
Public Health Service Act to remove "and related musculoskeletal dis-
encourage, cooperate with, and render assistance to other appropriate
eases" to make this subsection consistent with the language as clarified
public authorities, scientific institutions, and scientists in the conduct
in Section 502 (a) of this Act.
of, and promote the coordination of, research, investigations, experi-
Section 503. (b) Amends Section 434(b), Advisory Council, of the
ments, demonstrations, and studies relating to the causes, diagnosis,
Public Health Service Act to remove "and related musculoskeletal
treatment, control, and prevention of physical and mental diseases
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57
and impairments of man, including water purification, sewage treat-
NATIONAL HEART, BLOOD VESSEL, LUNG, AND BLOOD [DISEASE] DISEASES
ment, and pollution of lakes and streams. In carrying out the forego-
AND BLOOD RESOURCES PROGRAM
ing the Surgeon General is authorized to-
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*
SEC. 413. (a) The Director of the Institute, with the advice of the
(d) Make grants-in-aid to universities, hospitals, laboratories, and
Council, shall develop a plan for a National Heart, Blood Vessel, Lung,
other public or private institutions, and to individuals for such re-
and Blood Disease Diseases and Blood Resources Program (here-
search or research training projects as are recommended by the Na-
after in this part referred to as the "Program") to expand, intensify,
tional Advisory Health Council, or, with respect to cancer, recom-
and coordinate the activities of the Institute respecting heart, blood
mended by the National Cancer Advisory Board, or, with respect to
vessel, lung, and blood diseases and blood resources (including its.
mental health, recommended by the National Advisory Mental Health
activities under section 412) and shall carry out the Program in ac-
Council, or with respect to heart diseases heart, blood vessel, lung,
cordance with such plan. The Program shall be coordinated with the
and blood diseases and blood resources, recommended by the National
other research institutes of the National Institutes of Health to the
Heart and Lung Advisory Council, or, with respect to dental diseases
extent that they have responsibilities respecting such diseases and
and conditions, recommended by the National Advisory Dental Re-
resources and shall provide for-
search Council, and include in the grants for any such project grants
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*
*
*
*
of penicillin and other antibiotic compounds for use in such project;
(7) The education and training of scientists, clinicians, and educa-
and make, upon recommendation of the National Advisory Health
tors, in fields and specialties (including computer sciences) requisite to
Council, grants-in-aid to public or nonprofit universities, hospitals,
the conduct of programs respecting heart, blood vessel, lung; and
laboratories, and other institutions for the general support of their
blood diseases and resources;
research and research training programs: Provided, That such uni-
*
*
form percentage, not to exceed 15 per centum, as the Surgeon General
(b)
*
*
*
may determine, of the amounts provided for grants for research or
[(2) The Director of the Institute shall, as soon as practicable after
research training projects for any fiscal year through the appropria-
the end of each calendar year, prepare in consultation with the Coun-
tions for the National Institutes of Health may be transferred from
cil and submit to the President for transmittal to the Congress a re-
such appropriations to a separate account to be available for such
port on the activities, progress, and accomplishments under the Pro-
research and research training program grants-in-aid for such fiscal
gram during the preceding calendar year and a plan for the program
year;
during the next five years.
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*
(2) The Director of the Institute shall, as soon as possible after the
(i) Adopt, upon recommendation of the National Advisory Health
end of each fiscal year, prepare in consultation with the Council and
Council, or, with respect to cancer, upon recommendation of the Na-
submit to the Secretary of Health, Education, and Welfare for trans-
tional Cancer Advisory Board or with respect to mental health, upon
mittal to the President and the Congress simultaneously a report on
recommendation of the National Advisory Mental Health Council,
the activities, progress, and accomplishments under the program dur-
or, with respect to Theart diseases' heart, blood vessel, lung, and blood
ing the next five years. The plan shall also project the staff required
diseases and blood resources, upon recommendation of the National
by the Institute to carry out the program and recommendations for.
Heart and Lung Advisory Council, or, with respect to dental diseases
appropriations for the program.
and conditions, upon recommendation of the National Advisory
(c) In carrying out the Program, the Director of the Institute, under-
Dental Research Council, such additional means as he deems necessary
policies established by the Director of the National Institutes of Health
or appropriate to carry out the purposes of this section.
and after consultation with the Council and without regard to any
*
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other provision of this Act, may ***
(2) acquire, construct, improve, repair, [operate] operate, alter,
TITLE IV-NATIONAL RESEARCH INSTITUTES
renovate, and maintain heart, blood vessel, lung, and blood [disease]
diseases and blood resources laboratory, research, training, and other
necessary facilities and equipment, and related accommodations as may
PART B-NATIONAL HEART [AND] LUNG AND BLOOD INSTITUTE
be necessary, and such other real or personal property (including pat-
ents) as the Director deems necessary; and acquire, without regard
ESTABLISHMENT OF INSTITUTE
to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise,
through the Administrator of General Services, buildings or parts of
Sec. 411. There is hereby established in the Public Health Service a
buildings in the District of Columbia or communities located adjacent
National Heart [and] Lung and Blood Institute (hereinafter in this
to the District of Columbia for the use of the Institute for a period
part referred to as the "Institute").
not to exceed ten years; and
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59
(d) There shall be in the Institute an [Assistant Director for Health
(B) Programs to develop improved methods of intervention against
Information Programs Assistant Director for Prevention and Educa-
those factors which cause individuals to have a high risk of developing
tion who shall be appointed by the Director of the Institute. The
[such disease these diseases.
Director of the Institute, acting through the Assistant Director for
(C) Programs to develop health professions and allied health pro-
Health Information Programs Assistant Director for Prevention and
fessions personnel highly skilled in the prevention of such [disease]
Education, shall conduct a program to provide the public and the
diseases.
health professions with health information with regard to cardio-
(D) Programs to develop improved methods of providing emer-
vascular and pulmonary and blood diseases and blood resources. In the
gency medical services for persons with such "disease diseases.
conduct of such program, special emphasis shall be placed upon
*
dissemination of information regarding diet, exercise, stress, hyper-
(b) The Director of the Institute, under policies established by the
tension, cigarette smoking, weight control, and other factors affecting
Director of the National Institutes of Health and after consultation
the prevention of arteriosclerosis and other cardiovascular diseases and
with the Council, may enter into cooperative agreements with public
of pulmonary diseases.
or nonprofit private agencies or institutions to pay all or part of the
cost of planning, establishing, or strengthening, and providing basic
HEART, BLOOD VESSEL, LUNG, AND BLOOD DISEASE PREVENTION AND CONTROL
operating support for, existing or new centers (including centers es-
PROGRAMS
tablished under subsection (a)) for basic or clinical research into,
SEC. 414.
*
training in, and demonstration of, advanced diagnostic, prevention,
(b) There is authorized to be appropriated to carry out this section
and treatment methods for heart, blood vessel, lung, or blood diseases
$25,000,000 for the fiscal year ending June 30, 1973, $35,000,000 for the
or research in the management of blood resources. Funds paid to cen-
fiscal year ending June 30, 1974, [and $45,000,000 for the fiscal year
ters under cooperative agreements under this subsection may be used
for-
ending June 30, 1975] and $10,000,000 for the fiscal year ending
June 30, 1976, and $25,000,000 for the fiscal year ending June 30, 1977.
(1) construction, notwithstanding section 405,
(2) staffing and other basic operating costs, including such pa-
tient care costs as are required for research,
NATIONAL RESEARCH AND DEMONSTRATION CENTERS FOR HEART, BLOOD
VESSEL, LUNG, AND BLOOD DISEASES
(3) training, including training for allied health profession
personnel, and
Sec. 415. (a) (1) The Director of the Institute may provide for the
(4) demonstration purposes.
development of-
The aggregate of payments (other than payments for construction)
(a) [fifteen] ten new centers for basic and clinical research into,
made to any center under such an agreement may not exceed $5,000,000
training in, and demonstration of, advanced diagnostic, prevention,
in any year. The aggregate of payments (other than payments for con-
and treatment methods (including methods of providing emergency
struction) made to any center under such an agreement may not exceed
medical services) for heart [, blood vessel, and blood diseases diseases;
$5,000,000 (excluding indirect costs) in any year, except that such
and
aggregate may exceed such sum in any year to the extent that any
(B) [fifteen] ten new centers for basic and clinical research into,
excess amount is attributable to increases in appropriate costs as re-
training in, and demonstration of, advanced diagnostic, prevention,
flected in the cost of living index published by the Department of
and treatment methods (including methods of providing emergency
Labor for such year. Support of a center under this subsection may be
medical services) for chronic lung diseases (including bronchitis,
for a period of not to exceed five years and may be extended by the
emphysema, asthma, cystic fibrosis, and other lung diseases of
Director of the Institute for additional periods of not more than five
children).
years each, after review of the operations of such center by an appro-
(C) Ten new centers for basic and clinical research into, training
priate scientific review group established by the Director. As used in
in, and demonstration of, advanced diagnostic, prevention, and treat-
this section, the term "construction" does not include the acquisition of
ment methods (including methods of providing emergency medical
land.
services) for blood, blood vessel diseases, research in the use of blood
products, and research in the management of blood resources.
NATIONAL HEART AND LUNG ADVISORY COUNCIL
(2) The centers deevloped under paragraph (1) (A) (B) and (C)
shall, in addition to being utilized for research, training, and demon-
SEC. 417. (a) There is established in the Institute a National Heart
strations, be utilized for the following prevention programs for cardio-
and Lung Advisory Council to be composed of twenty-three members
vascular, lung and blood diseases:
as follows:
(A) Programs to develop improved methods of detecting individu-
(1) The Secretary, the Director of the National Institutes of Health,
als with a high risk of developing [cardiovascular disease these
the Director of the Office of Science and Technology Director of the
diseases.
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61
National Science Foundation, and the chief medical officer of the
(6) recommend to the Secretary for acceptance conditional gifts
Veterans' Administration (or their designees), and a medical officer
pursuant to section 501 for carrrying out the purposes of this part;
designated by the Secretary of Defense, shall be ex officio members of
and
the Council.
(7) advise, consult with, and make recommendations to the Sec-
retary, the Director of the National Institutes of Health, and the Di-
rector of the National Heart Diseases and Lung Institute with respect
FUNCTIONS OF THE COUNCIL
to carrying out the provisions of this part.
(b)
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SEC. 418. (a) The Council is authorized to-
[(2) The Council shall submit a report to the President for trans-
(1) review research projects or programs submitted to or initiated
mittal to the Congress not later than January 31 of each year on the
by it relating to the study of the cause, prevention, or methods of diag-
progress of the Program toward the accomplishment of its
nosis or treatment of heart diseases, blood vessel, lung, and blood dis-
objectives.]
eases , the use of blood and blood products and research in the manage-
(2) The Council shall submit a report to the Secretary of Health,
ment of blood resources, and certify approval to the Secretary, for
Education, and Welfare for transmittal to the President and to the
prosecution under section 412, any such projects which it believes show
Congress simultaneously not later than November 30 of each year on
promise of making valuable contributions to human knowledge with
the progress of the program toward the accomplishment of its objec-
respect to the cause, prevention, or methods of diagnosis or treatment
tives during the preceding fiscal year.
of heart diseases, blood vessel, lung, and blood diseases, the use of blood
and blood products and research in the management of blood resources;
(2) review applications from any university, hospital, laboratory,
SEC. 419A.
*
or other institution or agency, whether public or private, or from in-
(c) Under procedures approved by the Director of the National In-
dividuals, for grants-in-aid for research projects relating to heart
stitutes of Health, the Director of the National Heart and Lung Insti-
diseases, blood vessel, lung, and blood diseases, the use of blood and
tute may approve grants under this Act for research and training in
blood products and research in the management of blood resources,
heart, blood vessel, lung, and blood diseases, the use of blood and blood
and certify to the Secretary its approval of grants-in-aid in the cases
products and research in the management of blood resources-
of such projects which show promise of making valuable contributions
(1) in amounts not to exceed [$35,000] $35,000 (excluding indirect
to human knowledge with respect to the cause, prevention, or methods
costs) after appropriate review for scientific merit but without review
of diagnosis or treatment of heart diseases, blood vessels, lung, and
and recommendation by the Council, and
blood disease;
(2) in amounts exceeding [$35,000] $35,000 (excluding indirect
(3) review applications from any public or other nonprofit institu-
costs) after appropriate review for scientific merit and recommenda-
tion for grants-in-aid for training, instruction, and traineeships in
tion for approval by the Council.
matters relating to the diagnosis, prevention, and treatment of heart
diseases, blood vessel, lung, and blood diseases, the use of blood and
AUTHORIZATION OF APPROPRIATIONS
blood products and research in the management of blood resources,
and certify to the Secretary its approval of such applications for
SEC. 419B. For the purpose of carrying out this part (other than
grants-in-aid as it determines will best carry out the purpose of this
section 414), there is authorized to be appropriated $375,000,000 for
act;
the fiscal year ending June 30, 1973, $425,000,000 for the fiscal year
(4) approve areas of research in heart, blood vessel, lung, blood
ending June 30, 1974, [and $475,000,000 for the fiscal year ending
diseases, and the use of blood and blood products and research in the
June 30, 1975] and $475,000,000 for the fiscal year ending June 30,
management of blood resources to be supported by the awarding of
1976 and $372,000,000 for the fiscal year ending June 30, 1977; of the
contracts and approve the percentage of the budget of the Institute
sums appropriated under this section for any fiscal year, not less than
which may be expended for such contracts;
15 per centum of such sums shall be reserved for programs under this
(5) collect information as to studies which are being carried on
part repecting diseases of the lung and not less than 15 per centum of
in the United States or any other country as to the cause, prevention,
such sums shall be reserved for programs under this part for programs
or methods of diagnosis or treatment of heart diseases, blood vessel,
respecting blood diseases [of the blood] and blood resources.
lung, and blood diseases, the use of blood and blood products and re-
*
search in the management of blood resources, by correspondence or by
personal investigation of such studies, and with the approval of the
PART D-NATIONAL INSTITUTE ON ARTHRITIS, RHEUMATISM, AND META-
BOLIC DISEASES, NATIONAL INSTITUTE OF NEUROLOGICAL DISEASES AND
Secretary make available such information through appropriate pub-
lications for the benefit of health and welfare agencies and organiza-
STROKE, AND OTHER INSTITUTES-ESTABLISHMENT OF INSTITUTES
tions (public or private), physicians, or any other scientists, and for
SEC. 431.
the information of the general public;
(c) Of the sums appropriated for any fiscal year under this Act for
the National Institutes of Health, not less than $500,000 shall be
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63
obligated for basic and clinical orthopedic research conducted within
(d) There are authorized to be appropriated to carry out this sec-
the National Institute of Arthritis, Metabolism, and Digestive Diseases
tion [$2,000,000] $1,500,000 for fiscal year ending June 30, 1975,
which relates to the methods of preventing, controlling, and treating
[$3,000,000] $4,000,000 for fiscal year ending June 30, 1976, and $4,-
arthritis [and related muscoloskeletal diseases], including research in
000,000 for fiscal year ending June 30, 1977.
implantable biomaterials and biomechanical and other orthopedic pro-
cedures and research in the development of new and improved ortho-
COMPREHENSIVE ARTHRITIS CENTERS
pedic treatment methods.
SEC. 439. (a) The Secretary, acting through the Assistant Secretary
*
*
for Health may, after consultation with the National Advisory Council
NATIONAL INSTITUTE OF ARTHRITIS, METABOLISM, AND DIGESTIVE
established under section 434(a) and consistent with the Arthritis
DISEASES
Plan developed pursuant to the National Arthritis Act of 1974, pro-
SEC. 434.
*
vide for the development, modernization, and operation (including
(b) There is established in the National Arthritis, Metabolism, and
staffing and other operating costs such as the costs of patient care re-
Digestive Diseases Advisory Council a committee to advise the Di-
quired for research) of new and existing centers for arthritis research,
rector of the Institute respecting the activities of the Institute con-
screening, detection, diagnosis, prevention, control, and treatment, for
cerning digestive diseases. The committee shall be composed of those
education related to arthritis, and for rehabilitation of individuals who
members of the Advisory Council who are outstanding in the diagnosis,
suffer from arthritis. For purposes of this section, the term "modern-
prevention, and treatment of digestive diseases. The committee shall
ization" means the alteration, remodeling, improvement, expansion,
review applications made to the Director for grants for research
and repair of existing buildings and the provision of equipment for
projects relating to the diagnosis, prevention, and treatment of di-
such buildings to the extent necessary to make them suitable for use
gestive diseases and shall recommend to the Director for approval
as centers describing in the preceding sentence.
those applications and contracts which the committee determines will
*
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*
*
best carry out the purposes of this part. The Advisory Council shall re-
(c) Each center assisted under this section may conduct programs
view applications made to the Director for grants for research projects
to-
related to arthritis [and related musculoskeletal diseases] and shall
(1) develop new and improved methods of screening and
recommend to the Director for approval those applications and con-
early detection, referral, and diagnosis of individuals with a risk
tracts which the Council determines will best carry out the purposes of
of developing arthritis, asymptomatic arthritis, or symptomatic
this part. The Advisory Council shall also review and evaluate the
arthritis
;
arthritis programs under this part and shall recommend to the Director
(2) disseminate the results of research, screening, and other
such changes in the administration of such programs as it determines
activities, and develop means of standardizing patient data and
are necessary.
recordkeeping[,
;
*
(3) develop community consultative services to facilitate the
*
(e) There is established within the Institute the position of As-
referral of patients to centers for treatment.
sociate Director for Arthritis and Related Musculoskeletal Disease
*
([hereinafter] in this part referred to as the 'Associate Director)"
(h) For purposes of this section, there are authorized to be appro-
who shall report directly to the Director of such Institute and who,
priated [$11,000,000] $5,000,000 for fiscal year ending June 30, 1975,
under the supervision of the Director of such Institute, shall be re-
$13,000,000 for fiscal year ending June 30, 1976, and [$15,000,000]
sponsible for programs regarding arthritis and related muculoskeletal
$21,000,000 for fiscal year ending June 30, 1977. Not less than 20 per
diseases ([hereinafter in] in this part collectively referred to as
centum of the funds appropriated for each fiscal year under this
"arthritis") within such Institute.
subsection shall be used for the purposes of establishing new centers.
*
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ARTHRITIS SCREENING, DETECTION, PREVENTION, AND REFERRAL
PART I-GENERAL PROVISIONS
DEMONSTRATION PROJECTS; AND DATA BANK
SEC. 438. (a) The Secretary, acting through the Assistant Secretary
for Health, may make grants to public and nonprofit entities to estab-
NATIONAL RESEARCH SERVICE AWARDS
lish and support projects for the development and demonstration of
methods for arthritis, screening, detection, prevention, and referral,
SEC. 472. (a) (1) The Secretary shall-
and for the dissemination of these methods to the health and allied
(A) provide National Research Service Awards for- *
health professions. Activities under such projects shall be coordinated
(iii) biomedical and behavioral research at [non-Federal]
with (1) Federal, State, local, and regional health agencies, (2) centers
public institutions and at nonprofit private institutions, and
assisted under section 439, and (3) the data bank established under
*
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*
subsection (c).
*
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65
(B) make grants to [non-Federal] public institutions and to non-
STIPENDS
profit private institutions to enable such institutions to make to indi-
viduals selected by them National Research Service Awards for
SEC. 474. (a) The Secretary is authorized to grant stipends, in
research (and training to undertake such research) in the matters
amounts not to exceed $25,000 per annum, to visiting scientists (as de-
described in subparagraph (A) (i).
fined in subsection (b)) who enter into agreements with the Secretary
A reference in this subsection to the National Institutes of Health
to assist minority schools in developing programs in biomedical scr-
or the Alcohol, Drug Abuse, and Mental Health Administration shall
ences. In the event a recipient of a stipend under this section does not
be considered to include the institutes, divisions, and bureaus included
complete the requirements of his agreement with the Secretary, the
in the Institutes or under the Administration, as the case may be,
United States shall be entitled to recover an amount determined under
and also to include the related programs administered by the Division
section 472 (c) (4).
of Nursing, Health Resources Administration.
(b) For the purposes of this section the term-
*
(1) "visiting scientist" means a person who by his accomplish-
(b)
ments and reputation has distinguished himself in the fields of
(2) The award of National Research Service Awards by the Secre-
biomedical science and has entered into an agreement with the
tary under subsection (a) and the making of grants for such Awards
Secretary under subsection (a);
shall be subject to review and approval by the appropriate advisory
(2) "minority school" means a school of postsecondary educa-
councils to the entities of the National Institutes of Health and the
tion which has enrolled α substantial number of minority students,
Alcohol, Drug Abuse, and Mental Health Administration and the Na-
as determined in accordance with regulations of the Secretary;
tional Advisory Council on Nurse Training (A) whose activities
and
relate to the research or training under the Awards, or (B) at which
(3) "biomedical sciences" means all the health related sciences
such research or training will be conducted.
and requisite related courses.
(c) There are authorized to be appropriated to carry out the pur-
poses of this section, such sums as may be necessary.
(c) (1) (A) Each individual who receives a National Research Serv-
ice Award shall, in accordance with paragraph (3), engage in-
UNDERGRADUATE TRAINING IN BIOMEDICAL SCIENCES IN MINORITY SCHOOLS
(i) [health research or teaching] health research or teaching
or any combination thereof which is in accordance with usual
SEC. 475. (a) The Secretary may make grants to minority schools to
patterns of academic employment,
initiate the development of undergraduate programs relating to bio-
medical sciences.
(b) Each minority school (as defined in subsection (c) (1)) may
(c) (2) For each year for which an individual receives a National
apply for a grant under subsection (a) to establish an undergraduate
Research Service Award he shall-
program in the biomedical sciences (as defined in subsection (c) (2))
(A) for twelve months engage in [health research or teaching]
in accordance with regulations established by the Secretary.
health research or teaching or any combination thereof which is in
(c) For the purposes of this section the term-
accordance with the usual patterns of academic employment, or, if SO
(1) "minority school" means α school of postsecondary educa-
authorized, * serve as a member of the National Health Service Corps,
tion which has enrolled a substantial number of minority students,
or
and as determined in accordance with regulations of the Secretary;
(2) "biomedical sciences" means all the health related sciences
(d) There are authorized to be appropriated to make payments
and requisite related courses.
under National Research Service Awards and under grants for such
(d) There are authorized to be appropriated to carry out the pur-
Awards $207,947,000 for the fiscal year ending June 30, 1975] $160,-
poses of this section, such sums as may be necessary.
000,000 for the fiscal year ending June 30, 1976, and $176,000,000 for
the fiscal year ending June 30, 1977. Of the sums appropriated under
this subsection, not less than 25 per centum shall be made available
for payments under National Research Service Awards provided by
TITLE V-MISCELLANEOUS
the Secretary under subsection (a) (1) (A).
SEC. 473. *
GRANTS TO FEDERAL INSTITUTIONS
(c) A report on the results of such study shall be submitted by the
SEC. 507. Appropriations to the Public Health Service available
Secretary to the Committee on Interstate and Foreign Commerce of
under this Act for research, training, or demonstration project grants
the House of Representatives and the Committee on Labor and Public
or for grants to expand existing treatment and research programs and
Welfare of the Senate not later than [March 31] September 30 of
facilities for alcoholism, narcotic addiction, drug abuse, and drug
each year.
dependence, and appropriations available under the Community Men-
66
67
tal Health Centers Act for construction and staffing of community
fiscal year ending June 30, 1972, $3,000,000 for the fiscal year ending
mental health centers and alcoholism and narcotic addiction, drug
June 30, 1973, and $3,500,000 for the fiscal year ending June 30, 1974,
abuse, and drug dependence facilities shall also be available, on the
and $3,500,000 for the fiscal year ending June 30, 1975 and $2,000,000
same terms and conditions as apply to non-Federal institutions, for
for the fiscal year ending June 30, 1976. For the fiscal year ending
grants for the same purpose to [hospitals of the Service, of the Vet-
June 30, 1975, and for each succeeding fiscal year, there are author-
erans' Administration, or of the Bureau of Prisons of the Department
ized to be appropriated such sums as may be necessary to continue to
of Justice, and to Saint Elizabeth's Hospital, except that grants to
be appropriated such sums as may be necessary to continue to make
such] Federal institutions, except that grants to Federal institutions
such grants to students who (prior to July 1, 1974) have received such
may be funded at 100 per centum of the costs.
a grant and who are eligible for such a grant under this part during
such succeeding fiscal year.
*
*
*
*
TITLE VII-HEALTH RESEARCH AND TEACHING FACIL-
ITIES AND TRAINING OF PROFESSIONAL HEALTH
TITLE VIII-NURSE TRAINING
PERSONNEL
*
*
*
*
*
PART B-ASSISTANCE TO NURSING STUDENTS
PART C-STUDENT LOANS
*
*
*
*
*
*
*
SUBPART I-LOANS TO STUDENTS STUDYING IN THE UNITED STATES
LOAN AGREEMENTS
SEC. 822.
*
*
LOAN AGREEMENTS
(b) Each agreement entered into under this section shall-* *
SEC. 740.
*
(4) provide that loans may be made from such fund only to students
(b) Each agreement entered into under this section shall ***
pursuing a full-time or half-time course of study at the school leading
(4) provide that loans may be made from such funds only to stu-
to a baccalaureate or associate degree in pursing or an equivalent de-
dents pursuing a full-time course of study at the school leading to a
gree or a diploma in nursing, or to a graduate degree in nursing, and
degree of doctor of medicine, doctor of dentistry, or an equivalent
that while the agreement remains in effect no such student who has at-
degree, doctor of osteopathy, bachelor of science in pharmacy or an
tended such school before July 1, [1975] 1976, shall receive a loan
equivalent degree, doctor of podiatry or an equivalent degree, doctor
from a loan fund established under section 204 of the National Defense
of optometry or an equivalent degree, or doctor of veterinary medicine
Education Act of 1958; and
*
*
or an equivalent degree, and that while the agreement remains in
*
*
*
effect no such student who has attended such school before July 1,
[1975] 1976 shall receive a loan from a loan fund established under
AUTHORIZATION OF APPROPRIATIONS FOR LOANS
section 204 of the National Defense Education Act of 1958; and ***
*
SEC. 824. There are authorized to be appropriated to the Secretary
of Health, Education, and Welfare for Federal capital contributions
AUTHORIZATION OF APPROPRIATIONS
to student loan funds pursuant to section 822 (b) (2) (A) $3,100,000
for the fiscal year ending June 30, 1965, $8,900,000 for the fiscal year
SEC. 742. (a) For the purpose of-
ending June 30, 1966, $16,800,000 for the fiscal year ending June 30,
(1) making Federal capital contributions into the loan funds of
1967, $25,300,000 for the fiscal year ending June 30, 1968, $30,900,000
schools which have established loan funds under this part,
for the fiscal year ending June 30, 1969, $20,000,000 for the fiscal year
(2) making payments into the fund established by section 744(d),
ending June 30, 1970, $21,000,000 for the fiscal year ending June 30,
and
1971, $25,000,000 for the fiscal year ending June 30, 1972, $30,000,000
(3) making transfers under section 746, there are authorized to be
for the fiscal year ending June 30, 1973, and $35,000,000 for the fiscal
appropriated $50,000,000 for the fiscal year ending June 30, 1972, $55,-
year ending June 30, 1974, [and] such sums for the fiscal year ending
000,000 for the fiscal year ending June 30, 1973, $60,000,000 for the
June 30, 1975, and $35,000,000 for the fiscal year ending June 30, 1976,
fiscal year ending June 30, 1974, [and] $60,000,000 for the fiscal year
and each of the two succeeding fiscal years as may be necessary to en-
ending June 30, 1975, and $60,000,000 for the fiscal year ending
able students who have received a loan for any academic year ending
June 30, 1976.
before July 1, 1974, to continue or complete their education. Sums ap-
*
*
*
*
*
propriated pursuant to this sèction for the fiscal year ending June 30,
1967, or any subsequent fiscal year shall be available to the Secretary
AUTHORIZATION OF APPROPRIATIONS
(1) for payments into the fund established by section 827 (d), and (2)
in accordance with agreements under this part, for Federal capital
SEC. 786. For the purpose of making scholarship grants under this
contributions to schools with which such agreements have been made,
subpart, there are authorized to be appropriated $2,500,000 for the
to be used, together with deposits in such funds pursuant to section
68
69
822 (b) (2) (B), for establishment and maintenance of student loan
(B) Supplying a vitamin, mineral, or other ingredient for use
funds, and (3) for transfers pursuant to section 829.
by man to supplement his diet by increasing the total dietary
intake.
(0) Supplying a special dietary need by reason of being a food
TITLE XVI-HEALTH RESOURCES DEVELOPMENT
for use as the sole item of the diet.
(n) If an article is alleged to be misbranded because the labeling
PART E-GENERAL PROVISIONS
or advertising is misleading, then in determining whether the labeling
or advertising is misleading there shall be taken into account (among
*
other things) not only representations made or suggested by statement,
work, design, device, or any combination thereof, but also the extent
RECOVERY
to which the labeling or advertising fails to reveal facts material in
SEC. 1631.
(b) The Secretary may waive the recovery rights of the United
the light of such representations or material with respect to conse-
States under subsection (a) with respect to a facility in any State—
quences which may result from the use of the article to which the
(1) if (as determined under regulations prescribed by the
labeling or advertising relates under the conditions of use prescribed
Secretary) the amount which could be recovered under subsection
in the labeling or advertising thereof or under such conditions of use
(a) with respect to such facility is applied to the development,
as are customary or usual.
expansion, or support of another medical facility located in such
*
State which has been approved by the Statewide Health Coordi-
CHAPTER III-PROHIBITED ACTS AND PENALTIES
nating Council for such State as consistent with the State health
plan established pursuant to section 1524 (c) ; or
(2) if the Secretary determines, in accordance with regulations,
that there is good cause for waiving such requirement with respect
PENALTIES
to such facility. If the amount which the United States is entitled
to recover under subsection (a) exceeds 90 per centum of the total
SEC. 303.
*
cost of the construction or modernization project for a facility,
(d) No person shall be subject to the penalties of subsection (a) of
a waiver under this subsection shall only apply with respect to an
this section for a violation of section 301 involving misbranded food if
amount which is not more than 90 per centum of such total cost.
the violation exists solely because the food is misbranded under sec-
[The Secretary may not waive a right of recovery which arose
tion 403(a) (2) because of its advertising, and no person shall be sub-
one year before the date of the enactment of this title.]
ject to the penalties of subsection (b) of this section for such a viola-
tion unless the violation is committed with the intent to defraud or
*
*
mislead.
SEIZURE
FEDERAL FOOD, DRUG, AND COSMETIC ACT
SEC. 304. (a)
(3) (A) Except as provided in subparagraph (B), no libel for con-
CHAPTER II-DEFINITIONS
demnation may be instituted under paragraph 1 or (2) against any
food which-
SEC. 201. For the purposes of this Act-
(i) is misbranded under section 403 (2) because of its adver-
*
*
tising, and
(f) (1) The term "food" means [(1))] (4) articles used for food
(ii) is being held for sale to the ultimate consumer in an estab-
or drink for many or other animals, [(2)] (B) chewing gum, and
lishment other than an establishment owned or operated by a
[(3)] (C) articles used for components of any such article.
manufacturer, packer, or distributor of the food.
(2) The term "special dietary use" as applied to food used by man
(B) A libel for condemnation may be instituted under paragraph
means a particular use for which a food purports or is represented to
(1) or (2) against a food described in subparagraph (4) if
be used, including but not limited to the following:
(i) (I) the food's advertising which resulted in the food being
(A) Supplying a special dietary need that exists by reason of
misbranded under section 403 (a) (2) was disseminated in the es-
a physical, physiological, pathological, or other condition, includ-
tablishment in which the food is being held for sale to the ulti-
ing but not limited to the condition of disease, convalescence, preg-
mate consumer,
nancy, lactation, infancy, allergic hypersensitivity to food, under-
(II) such advertising was disseminated by, or under the
weight, overweight, or the need to control the intake of sodium.
70
71
direction of, the owner or operator of such establishment, or
as a part of a list of all the ingredients of such food, and (ii) unless
(III) all or part of the cost of such advertising was paid
such ingredients are listed in accordance with an applicable regula-
by such owner or operator; and
tion promulgated under section 403 (j). To the extent that compliance
(ii) the owner or operator of such establishment used such ad-
with clause (i) of this subparagraph is impracticable or results in
vertising in the establishment to promote the sale of the food.
deception or unfair competition, exemptions shall be established by
regulations promulgated by the Secretary.
*
(B) Notwithstanding the provisions of subparagraph (b) (2) (A),
CHAPTER IV-FooD
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
MISBRANDED FOOD
(iii) represented as a source of vitamins or minerals.
SEC. 403. A food shall be deemed to be misbranded-
(c) (1) For purposes of subsections (a) and (b) of this section, the
(a) If (1) its labeling is false or misleading in any particular, or
term "food to which this section applies" means a food for humans
(2) in the case of a food to which section 411 applies, its advertising is
which is α food for special dietary use--
false or misleading in a material respect or its labeling is in violation
(A) which is or contains any natural or synthetic vitamin or min-
of section 411 (b) (2).
eral, and
(B) which-
(i) is intended for ingestion in tablet, capsule, or liquid form,
or
VITAMINS AND MINERALS
(ii) if not intended for ingestion in such α form, does not
SEC. 411. (a) (1) Except as provided in paragraph (2)
simulate or is not represented as conventional food.
(A) the Secretary may not establish maximum limits on the potency
(2) For purposes of paragraph (1) (B) (i), α food shall be con-
of any synthetic or natural vitamin or mineral within a food to which
sidered as intended for ingestion in liquid form only if it is formu-
this section applies;
lated in a fluid carrier and it is intended for ingestion in daily quan-
(B) the Secretary may not classify any natural or synthetic vitamin
tities measured in drops or similar small units of measure.
or mineral (or combination thereof) as a drug solely because it exceeds
the level of potency which the Secretary determines is nutritionally
rational or useful.
CHAPTER VII-GENERAL ADMINISTRATIVE PROVISIONS
(C) the Secretary may not limit the combination or number of any
synthetic or natural-
(i) vitamin,
(ii) mineral, or
ADVERTISING OF CERTAIN FOODS
(iii) other ingredient of food, within a food to which this sec-
tion applies.
SEC. 707. Before initiating any action under chapter III with respect
to any food to which section 411 applies and which is deemed to be
(2) (A) Paragraph (1) does not limit the Secretary in the exercise
of his authority under and in accordance with-
misbranded under section 403(a) (2) because of its advertising, the
(i) this chapter (other than this section) or chapter V, or
Secretary shall consult with the Federal Trade Commission and, for
the purpose of avoiding unnecessary duplication, coordinate such ac-
(ii) any other provision of this Act except to the extent that
tion with any action taken or proposed to be taken by the Commission
the authority under such other provision is to be exercised to take
under the Federal Trade Commission Act.
an action specifically prohibited by subparagraph (A), (B), or
(C) or such paragraph.
(B) Paragraph (1) shall not apply in the case of a vitamin, mineral,
PUBLIC LAW 93-640 NATIONAL ARTHRITTS Act OF 1974
or other ingredient of food which the Secretary determines by regula-
tion is represented for use by children or pregnant or lactating women.
FINDINGS AND DECLARATION OF PURPOSE
For purposes of this subparagraph, the term "children" means indi-
viduals who are under the age of twelve years.
SEC. 2. (a) The Congress makes the following findings-
(b) (1) A food to which this section applies shall not be deemed
(1) Arthritis and related musculoskeletal diseases (hereinafter in
under section 403 to be misbranded solely because its label bears, in
this Act collectively referred to as "arthritis") constitute major health
accordance with section 403 (i) (2), all the ingredients in the food or its
problems in the United States in that they afflict more than twenty
advertising contains references to ingredients in the food which are
not vitamins or minerals.
and disability.
million Americans and are the greatest single cause of chronic pain
(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
72
(3) The annual cost of arthritis to the national economy in 1970,
from medical care expenses and lost wages, was $9,200,000,000, in-
cluding $2,500,000,000 in medical expenses, and number of workdays
lost in that year totaled over 14,500,000.
*
*
*
*
*
(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, profes-
sional and allied health personnel, and the public which will
alert the citizens of the United States to the early indications
of arthritis; and
(C) to emphasize the significance of early detection and
proper control of these diseases and of the complications
which may evolve from them;
(2) the establishment and support of programs to develop new
and improved. methods of arthritis screening, detection, preven-
tion, 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.
NATIONAL COMMISSION ON ARTHRITIS; ARTHRITIS PLAN
SEC. 3.
b) The Commission shall be composed of eighteen members as
follows:
*
(4) The Director of the National Institutes of Health or his desig-
nee, the Director of the National Institute of Arthritis, Metabolism,
and Digestive Diseases or his designee, the Directors, or their desig-
nees, of the National Institute of Allegery and Infectious Diseases
and the National Institute of General Medical Science, the Associate
Director for Arthritis and Related Musculoskeletal Diseases of such
Institute, and the [chief medical officer Chief Medical Director of
the Veterans' Administration and the Secretary of Defense or their
designees, each of whom shall serve as ex officio, nonvoting members.
*
*
*
*
*
*
*
(k) There are authorized to be appropriated, without fiscal year
limitation, to carry out the purposes of this section, [$2,000,000]
$1,500,000.
ARTHRITIS COORDINATING COMMITTEE, DEMONSTRATION] PROJECTS, AND
COMPREHENSIVE ARTHRITIS CENTERS
SEC. 4. Part D. of title IV of the Public Health Service Act is
tions: amended * * by adding at the end thereof the following new sec-
*
*
*
*
94TH CONGRESS
HOUSE OF REPRESENTATIVES
REPORT
2d Session
No. 94-1005
HEALTH RESEARCH AND HEALTH SERVICES
AMENDMENTS OF 1976
APRIL 2, 1976.-Ordered to be printed
Mr. STAGGERS, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany H.R. 7988]
The committee of conference on the disagreeing votes of the two
Houses on the amendment of the Senate to the bill (H.R. 7988) 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, having met,
after full and free conference, have agreed to recommend and do
recommend to their respective Houses as follows:
That the House recede from its disagreement to the amendment of
the Senate and agree to the same with an amendment as follows:
In lieu of the matter proposed to be inserted by the Senate amend-
ment insert the following:
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.
TITLE I-REVISION 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;
57-006 0-76-1
2
3
(2) elimination of heart and blood vessel diseases as significant
causes of disability and death could increase the average American's
(3) by inserting "and to the use of blood and blood products and
life expectancy by about eleven years and could provide for annual
the (4); management of blood resources" after "diseases" in paragraph
savings to the economy in lost wages, productivity, and cost of medical
care of more than $40,000,000,000 per year;
(4) by inserting "and on the use of blood and blood products and
(3) chronic lung diseases have been gaining steadily in recent
the (5); management of blood resources" after "diseases" in paragraph
years as important causes of disability and death, with emphysema
being among the fastest rising causes of death in the United States;
(5) by striking out "heart diseases" in paragraph (6) and inserting
(4) chronic respiratory diseases affect an estimated ten million
in lieu thereof "heart, blood vessel, lung, and blood diseases and the
management of blood resources";
Americans, emphysema an estimated one million, chronic bronchitis
an estimated four million, and asthma an estimated five million;
(6) by inserting "and to the use of blood and blood products and
(5) thrombosis (the formation of blood clots in the vessels) may
the management of blood resources" after "diseases" in paragraph
(7); and
cause, directly or in combination with other problems, many deaths
and disabilities from heart disease and stroke which can now be
(7) by inserting at the end of the section heading "AND IN THE
MANAGEMENT OF BLOOD RESOURCES".
prevented;
(6) blood and blood products are essential human resources whose
(b) Section 412 is amended by striking out "National Heart and Lung
value in saving life and promoting health cannot be assessed in terms
Advisory Council" and inserting in lieu thereof "National Heart, Lung,
amd Blood Advisory Council".
of dollars;
SEC. 104. (a) Section 413(a) is amended-
(7) the provision of prompt and effective emergency medical
services utilizing to the fullest extent possible advances in transporta-
(1) by striking out "Disease" in the first sentence and inserting
tion and communications and other electronic systems and specially
in lieu thereof "Diseases and Blood Resources"; and
trained professional and paraprofessional health care personnel can
(2) by inserting "and blood resources" after "diseases" in such
reduce substantially the number of fatalities and severe disabilities
sentence and in paragraph (7).
(b) Section 413(b) is amended-
due to critical illnesses in connection with heart, blood vessel, lung,
and blood diseases;
(1) by striking out "calendar" each place it occurs in paragraph
(8) blood diseases, including nutritional anemia, anemia due to
(2) and inserting in lieu thereof "fiscal"; and
inherited abnormalities (such as sickle cell anemia and Cooley's
(2) by adding at the end of such paragraph the following: "Each
anemia (thalassemia), anemias resulting from failure of the bone
such plan shall contain (A) an estimate of the number and type of
marrow, hemorrhagic defects (a common cause of death in patients
personnel which will be required by the Institute to carry out the
with leukemia and other malignancies, and of disability from inherited
Program during the five years with respect to which the plan is sub-
diseases such as hemophilia)), and malignancies of the lymph nodes
mitted, and (B) recommendations for appropriations to carry out the
and bone marrow, such as leukemia, have a devastating impact in
program during such five years".
spite of recent advances, and constitute an important category of
in lieu thereof "one hundred".
(c) Section 413(c) (1) is amended by striking out "fifty" and inserting
illness that requires major attention; and
(d) Section 413(c) (2) is amended-
(9) the greatest potential for advancement against heart, blood
vessel, lung, and blood diseases lies in the National Heart, Lung,
(1) by striking out "operate" and inserting in lieu thereof "operate,
alter, renovate"; and
and Blood Institute, but advancement against such diseases depends
not only on the research programs of that Institute but also on the
(2) by inserting "and blood resource" after "disease".
(e) Section 413(d) is amended-
research programs of other research institutes of the National
Institutes of Health.
(1) by striking out "Assistant Director for Health Information
(b) It is the purpose of this title to enlarge the authority of the National
Programs" each place it occurs and inserting in lieu thereof "Assist-
Heart, Lung, and Blood Institute in order to advance the national attack
ant Director for Prevention Education, and Control";
upon heart, blood vessel, lung, and blood diseases and to enlarge its
(2) by striking out "and pulmonary" in the second sentence and
authority with respect to blood resources.
inserting in lieu thereof blood, and pulmonary" and by inserting
SEC. 102. Sections 411, 418(a) (6), and 419A(c) are each amended by
"and blood" after "pulmonary" in the third sentence; and
striking out "National Heart and Lung Institute" and inserting in lieu
(3) by inserting "and blood resources" after "diseases" in the
second sentence.
thereof "National Heart, Lung, and Blood Institute".
SEC. 103. (a) Section 412 is amended-
(f) The section heading of section 413 is amended by striking out
(1) by inserting "and with respect to the use of blood and blood
SOURCES". "DISEASE" and inserting in lieu thereof "DISEASES AND BLOOD RE-
products and the management of blood resources" after "diseases" in
the matter preceding paragraph (1);
SEC. 105. Section 414(b) is amended (1) by striking out "and" after
(2) by inserting "and to the use of blood and blood products and
"1974,", and (2) by inserting before the period a comma and the following:
the management of blood resources" before the semicolon at the end
"$10,000,000 for fiscal year 1976, and $30,000,000 for fiscal year 1977".
of paragraph (1);
4
5
SEC. 106. (a) (1) Subsection (a) (1) (A) of section 415 is amended by-
(c) The section heading of section 417 is amended by striking out
(A) striking out "fifteen" and inserting in lieu thereof "ten", and
"AND LUNG" and inserting in lieu thereof ", LUNG, AND BLOOD".
(B) striking out blood vessel, and blood diseases" and inserting
SEC. 108. Section 418 is amended-
in lieu thereof "diseases".
(1) by inserting "and to the use of blood and blood products and
(2) Subsection (a) (1) (B) of such section is amended by striking out
the management of blood resources" after "diseases" in paragraphs
"fifteen" and inserting in lieu thereof "ten".
(1), (2), (3), and (4) of subsection (a);
(3) Subsection (a) (1) of such section is amended-
(2) by redesignating paragraphs (4), (5), and (6) of subsection (a)
(A) by striking out "and" at the end of subparagraph (A),
as paragraphs (5), (6), and (7), respectively, and by adding after para-
(B) by striking out the period at the end of subparagraph (B)
graph (3) the following new paragraph:
and inserting in lieu thereof and", and
(4) recommend to the Secretary (A) areas of research in heart,
(C) by inserting after subparagraph (B) the following new sub-
blood vessels, lung, and blood diseases and in the use of blood and
paragraph:
blood products and the management of blood resources which it de-
"(C) ten new centers for basic and clinical research into, training
termines should be supported by the awarding of contracts in order to
in, and demonstration of, advanced diagnostic, prevention, and
best carry out the purposes of this part, and (B) the percentage of the
treatment methods (including methods of providing emergency
budget of the Institute which should be expended for such contracts;";
medical services) for blood, blood vessel diseases, research in the use
and
of blood products, and research in the management of blood re-
(3) (A) by amending paragraph (2) of subsection (b) to read as
sources.".
follows:
(b) Section 415(a) is further amended-
"(2) The Council shall submit a report to the Secretary for simultaneous
(1) by inserting "and for research in the use of blood and blood
transmittal, not later than November 30 of each year, to the President and
products and in the management of blood resources" after "diseases"
to the Congress on the progress of the Program toward the accomplishment
in paragraph (1) (A);
of its objectives during the preceding fiscal year.".
(2) by striking out "chronic" in paragraph (1) (B);
(B) For purposes of section 418(b)(2) of the Public Health
(3) by striking out "paragraph (1) (A)" in paragraph (2) and
Service Act (as amended by subparagraph (A)), the period beginning
inserting in lieu thereof "paragraph (1)";
July 1, 1975, and ending September 30, 1976, shall be considered
(4) by inserting pulmonary, and blood" before "diseases" in
a fiscal year.
paragraph (2);
(C) The amendment made by subparagraph (A) shall take effect
(5) by striking out "cardiovascular disease" in paragraph (2) (A)
as of January 1, 1976.
and inserting in lieu thereof "cardiovascular, pulmonary, and blood
SEC. 109. Section 419A is amended-
diseases"; and
(1) by inserting "and projects with respect to the use of blood and
(6) by striking out "such disease" in subparagraphs (B), (C),
blood products and the management of blood resources" after "train-
and (D) of paragraph (2) and inserting in lieu thereof "such
ing projects" in subsection (a);
diseases".
(2) by inserting "and into the use of blood and blood products and
(c) Section 415(b) is amended-
the management of blood resources" after "diseases" in subsection
(1) by inserting "the management of blood resources and" before
(b);
"advanced"; and
(3) by inserting "and for research and training in the use of blood
(2) by amending the first sentence after paragraph (4) to read as
and blood products and the management of blood resources" after
follows: "The aggregate of payments (other than payments for con-
"diseases" in subsection (c);
struction) made to any center under such an agreement for its costs
(4) by striking out "in amounts not to exceed $35,000" in para-
(other than indirect costs) described in the first sentence may not
graph (1) of subsection (c) and inserting in lieu thereof "if the
exceed $5,000,000 in any year, except that the aggregate of such
direct costs of such research and training do not exceed $35,000,
payments in any year may exceed such amount to the extent that the
but only"; and
excess amount is attributable to increases in such year in appropriate
(5) by striking out "in amounts exceeding $35,000" in paragraph
costs as reflected in the Consumer Price Index published by the
(2) of subsection (c) and inserting in lieu thereof "if the direct costs
Bureau of Labor Statistics.".
of such research and training exceed $35,000, but only".
(d) The section heading of section 415 is amended by inserting "AND
SEC. 110. Section 419B is amended-
BLOOD RESOURCES" after "DISEASES".
(1) by striking out "and" after "1974," and by inserting before
SEC. 107. (a) Section 417(a) (1) is amended by striking out "Director
the period at the end of the first sentence a comma and the following:
of the Office of Science and Technology" and inserting in lieu thereof
$$339,000,000 for fiscal year 1976, and $373,000,000 for fiscal year
"Director of the National Science Foundation".
1977"; and
(b) Section 417 is amended by striking out "National Heart and Lung
(2) by striking out "diseases of the blood" and inserting in lieu
Advisory Council" in subsection (a) and in subsection (b) (3) and insert-
thereof "blood diseases and blood resources".
ing in lieu thereof "National Heart, Lung, and Blood Advisory Council".
6
7
SEC. 111. (a) Section 301 is amended by striking out "heart diseases"
"(3) The National Academy of Sciences or other group or association
in paragraphs (c) and (h) and inserting in lieu thereof "heart, blood
vessel, lung, and blood diseases and blood resources".
conducting the study required by subsection (a) shall conduct such study
in consultation with the Director of the National Institutes of Health.'
(b) Section 301 is amended by striking out "National Heart and Lung
Advisory Council" in paragraphs (c) and (h) and inserting in lieu
SEC. 205. Subsection (c) of section 473 is amended by striking out
"March 31" and inserting in lieu thereof "September 30".
thereof "National Heart, Lung, and Blood Advisory Council".
SEC. 112. The title of Part B of title IV is amended to read as follows:
TITLE III-DISCLOSURE OF RESEARCH INFORMATION
"PART B-NATIONAL HEART, LUNG, AND BLOOD INSTITUTE".
SEC. 301. (a) (1) The President's Biomedical Research Panel (estab-
lished by section 201 of the National Cancer Act Amendments of 1974
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
(Public Law 93-352)) and the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research (established
SEC. 201. (a) (1) Subsection (a) (1) (A) of section 472 is amended
by section 201 of the National Research Act (Public Law 93-348)) shall
(A) by striking out "in matters" and inserting in lieu thereof "or under
each conduct an investigation and study of the implication of the disclosure
programs administered by the Division of Nursing of the Health Resources
Administration, in matters", and (ii) by inserting before "are directed"
to the public of information contained in research protocols, research
hypotheses, and research designs obtained by the Secretary of Health,
the following: "or Division of Nursing".
Education, and Welfare (hereinafter in the subsection referred to as the
(2) Subsections (a) (1) (A) (iii) and (a) (1) (B) of such section are each
"Secretary") in connection with an application or proposal submitted,
amended by striking out "non-Federal".
(b) Subsection (c) (1) (A) (i) of such section is amended by striking out
during the period beginning January 1, 1975, and ending December 31,
1975, to the Secretary for a grant, fellowship, or contract under the Public
"health research or teaching" and inserting in lieu thereof "health research
or teaching or any combination thereof which is in accordance with usual
Health Service Act. In making such investigation and study the Panel
and the Commission shall each determine the following:
patterns of academic employment".
(c) Subsection (c) (2) (A) of such section is amended by striking out
(A) The number of requests made to the Secretary for the disclosure
of information contained in such research protocols, hypotheses, and
"health research or teaching" and inserting in lieu thereof "health re-
designs and the interests represented by the persons for whom such
search or teaching or any combination thereof which is in accordance with
requests were made.
the usual patterns of academic employment".
(d) The first sentence of subsection (d) of such section is amended by
(B) The purposes for which information disclosed by the Secretary
pursuant to such requests was used.
inserting a comma before the period and the following: "$165,000,000 for
(C) The effect of the disclosure of such information on-
fiscal year 1976, and $185,000,000 for fiscal year 1977".
SEC. 202. (a) Subsection (a) (1)(A)(i) of section 472 is amended by
(i) proprietary interests in the research protocol, hypothesis,
or design from which such information was disclosed and on
striking out "the disease or (diseases) or other health problems to which
patent rights;
the activities of the Institutes and Administration are directed" and insert-
(ii) the ability of peer review systems to insure high quality
ing in lieu thereof "diseases or other health problems".
federally funded research; and
(b) Subsection (b) (2) of section 472 is amended by striking out "to
(iii) the (I) protection of the public against research which
the entities of the National Institutes of Health and the Alcohol, Drug
presents an unreasonable risk to human subjects of such re-
Abuse, and Mental Health Administration" and inserting in lieu thereof
search and (II) the adequacy of informed consent procedures.
"within the Department of Health, Education, and Welfare".
(2) (A) Not later than May 31, 1976, the Panel shall complete the inves-
SEC. 203. (a) (1) Subparagraph (A) of the first paragraph (4) of sub-
tigation and study required to be made by the Panel by paragraph (1), and,
section (c) of section 472 is amended by striking out "and the interest on
not later than June 30, 1976, the Panel shall submit to the Committee on
such amount" down through and including "was made".
Interstate and Foreign Commerce of the House of Representatives and the
(2) The last sentence of subparagraph (B) of such paragraph is
Committee on Labor and Public Welfare of the Senate a report on such
amended by striking out "at the same rate as that fixed by the Secretary of
investigation and study. The report shall contain such recommendations
the Treasury under subparagraph (A) to determine the amount due the
for legislation as the Panel deems appropriate.
United States" and inserting in lieu thereof "at a rate fixed by the Secre-
(B) Not later than November 30, 1976, the Commission shall complete
tary of the Treasury after taking into consideration private consumer
the investigation and study required to be made by the Commission by
rates of interest prevailing on the date the United States becomes entitled
paragraph (1), and, not later than December 31, 1976, the Commission
to such amount".
shall submit to the Committee on Interstate and Foreign Commerce of the
(b) The amendments made by subsection (a) shall apply with respect
House of Representatives and the Committee on Labor and Public Welfare
to National Research Awards under section 472 which are made from
of the Senate a report on such investigation and study. The report shall
appropriations for fiscal years ending on or after June 30, 1975.
contain such recommendations for legislation as the Commission deems
SEC. 204. Section 473(b) is amended by adding after paragraph (2)
appropriate.
the following new paragraph:
(b) Section 211 (b) of the National Research Act (Public Law 93-348)
is amended by striking out "July 1, 1976" and inserting in lieu thereof
"January 1. 1977".
8
9
TITLE IV-GENETIC DISEASES
and (4) the development of counseling and testing programs and other
programs for the diagnosis, control, and treatment of genetic diseases. In
SEC. 401. This title may be cited as the "National Sickle Cell Anemia,
making grants and entering into contracts for projects described in
Cooley's Anemia, Tay-Sachs, and Genetic Diseases Act".
clause (1) of the preceding sentence, the Secretary shall give priority to
SEC. 402. In order to preserve and protect the health and welfare of all
applications for such grants or contracts which are submitted for research
citizens, it is the purpose of this title to establish a national program to
on sickle cell anemia and for research on Cooley's anemia.
provide for basic and applied research, research training, testing, counsel-
ing, and information and education programs with respect to genetic
"VOLUNTARY PARTICIPATION
diseases, including sickle cell anemia, Cooley's anemia, Tay-Sachs disease,
cystic fibrosis, dysautonomia, hemophilia, retinitis pigmentosa, Hunt-
"SEC. 1103. The participation by any individual in any program or
ington's chorea, and muscular dystrophy.
portion thereof under this part shall be wholly voluntary and shall not
SEC. 403. (a) Title XI is amended by striking out parts A and B and
be a prerequisite to eligibility for or receipt of any other service or assist-
inserting in lieu thereof the following:
ance from, or to participation in, any other program.
"PART A-GENETIC DISEASES
"APPLICATIONS; ADMINISTRATION OF GRANTS AND CONTRACT PROGRAMS
"TESTING AND COUNSELING PROGRAMS AND INFORMATION
"SEC. 1104. (a) A grant or contract under this part may be made upon
AND EDUCATION PROGRAMS
application submitted to the Secretary at such time, in such manner,
and containing and accompanied by such information, as the Secretary
"SEC. 1101. (a) (1) The Secretary, through an identifiable admin-
may require. Each applicant shall-
istrative unit within the Department of Health, Education, and Welfare,
"(1) provide that the programs and activities for which assistance
may make grants to public and nonprofit private entities, and may enter
under this part is sought will be administered by or under the super-
into contracts with public and private entities, for projects to establish and
vision of the applicant;
operate voluntary genetic testing and counseling programs primarily in
"(2) provide for strict confidentiality of all test results, medical
conjunction with other existing health programs, including programs
records, and other information regarding testing, diagnosis, counsel-
assisted under title V of the Social Security Act.
ing, or treatment of any person treated, except for (A) such informa-
"(2) The Secretary shall carry out, through an identifiable administra-
tion as the patient (or his guardian) gives informed consent to be
tive unit within the Department of Health, Education, and Welfare, a
released, or (B) statistical data compiled without reference to the
program to develop information and educational materials relating to
identity of any such patient;
genetic diseases and to disseminate such information and materials to
"(3) provide for community representation where appropriate
persons providing health care, to teachers and students, and to the public
in the development and operation of voluntary genetic testing or
generally in order to most rapidly make available the latest advances in
counseling programs funded by a grant or contract under this part;
the testing, diagnosis, counseling, and treatment of individuals respecting
"(4) in the case of an applicant for a grant or contract under
genetic diseases. The Secretary may, under such program, make grants
section 1101 (1) for the delivery of services, provide assurances
to public and nonprofit private entities and enter into contracts with
satisfactory to the Secretary that (A) the services for community-wide
public and private entities and individuals for the development and
testing and counseling to be provided under the program for which
dissemination of such materials.
the application is made (i) will take into consideration widely
"(b) For the purpose of making payments pursuant to grants and con-
prevalent diseases with a genetic component and high-risk population
tracts under this section, there are authorized to be appropriated $30,000,-
groups in which certain genetic diseases occur, and (ii) where appro-
000 for fiscal year 1976, $30,000,000 for fiscal year 1977, and $30,000,000
priate will be directed especially but not exclusively to persons who
or fiscal year 1978.
are entering their child-producing years, and (B) appropriate
arrangements will be made to provide counseling to persons found to
"RESEARCH PROJECT GRANTS AND CONTRACTS
have a genetic disease and to persons found to carry a gene or chro-
"SEC. 1102. In carrying out section 301, the Secretary may make grants
mosome which may cause a deleterious effect in their offspring; and
to public and nonprofit private entities, and may enter into contracts with
"(5) establish fiscal control and fund accounting procedures as
public and private entities and individuals, for projects for (1) basic or
may be necessary to assure proper disbursement of and accounting of
ap plied research leading to the understanding, diagnosis, treatment, and
Federal funds paid to the applicant under this part.
control of genetic diseases, (2) planning, establishing, demonstrating, and
"(b) In making any grant or entering into any contract for testing and
developing special programs for the training of genetic counselors, social
counseling programs under section 1101, the Secretary shall (1) take into
and behavioral scientists, and other health professionals, (3) the develop-
account the number of persons to be served by the program supported by
ment of programs to educate practicing physicians, other health profes-
such grant or contract and the extent to which rapid and effective use will
sionals, and the public regarding the nature of genetic processes, the in-
be made of funds under the grant or contract; and (2) give priority to
heritance patterns of genetic diseases, and the means, methods, and
programs operating in areas which the Secretary determines have the
facilities available to diagnose, control, counsel, and treat genetic diseases,
H.R. 1005-2
10
11
greatest number of persons who will benefit from and are in need of the
"(C) the Secretary may not limit, under section 201(n), 401, or
services provided under such programs.
403, the combination or number of any synthetic or natural-
"(c) In making grants and entering into contracts for any fiscal year
"(i) vitamin,
under section 301 for projects described in section 1102 or under section
"(ii) mineral, or
1101 the Secretary shall give special consideration to applications from
"(iii) other ingredient of food,
entities that received grants from, or entered into contracts with, the
within a food to which this section applies.
Secretary for the preceding fiscal year for the conduct of comprehensive
"(2) Paragraph (1) shall not apply in the case of a vitamin, mineral,
sickle cell centers or sickle cell screening and education clinics.
other ingredient of food, or food, which is represented for use by individuals
in the treatment or management of specific diseases or disorders, by
"PUBLIC HEALTH SERVICE FACILITIES
children, or by pregnant or lactating women. For purposes of this sub-
paragraph, the term 'children' means individuals who are under the age
"SEC. 1105. The Secretary shall establish a program within the Service
of twelve years.
to provide voluntary testing, diagnosis, counseling, and treatment of indi-
"(b)(1) A food to which this section applies shall not be deemed under
viduals respecting genetic diseases. Services under such program shall be
section 403 to be misbranded solely because its label bears, in accordance
made available through facilities of the Service to persons requesting such
with section 403(i) (2), all the ingredients in the food or its advertising
services, and the program shall provide appropriate publicity of the
contains references to ingredients in the food which are not vitamins or
availability and voluntary nature of such services.
minerals.
"(2) (A) The labeling for any food to which this section applies may not
"REPORTS
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) unless such ingredients
"SEC. 1106. (a) The Secretary shall prepare and submit to the Presi-
are listed in accordance with applicable regulations under section 403.
dent for transmittal to the Congress on or before April 1 of each year a
To the extent that compliance with clause (i) of this subparagraph is
comprehensive report on the administration of this part.
"(b) The report required by this section shall contain such recommen-
impracticable or results in deception or unfair competition, exemptions
shall be established by regulations promulgated by the Secretary.
dations for additional legislation as the Secretary deems necessary.".
(b) (1) Section 1121(b)(5) is amended by striking out "ending June
"(B) Notwithstanding the provisions of subparagraph (A), the labeling
30," each place it occurs.
and advertising for any food to which this section applies may not give
prominence to or emphasize ingredients which are not-
(2) Parts C and D are redesignated as parts B and C, respectively.
"(i) vitamins,
(3) The heading of such title is amended to read as follows:
"(ii) minerals, or
"(iii) represented as a source of vitamins or minerals.
"TITLE XI-GENETIC DISEASES, HEMOPHILIA PRO-
"(c) (1) For purposes of this section, the term 'food to which this section
GRAMS, AND SUDDEN INFANT DEATH SYNDROME."
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
(c) The amendments made by subsections (a) and (b) shall take effect
mineral, and
July 1, 1976.
"(B) which-
"(i) is intended for ingestion in tablet, capsule, or liquid
TITLE V-FEDERAL FOOD, DRUG, AND COSMETIC ACT
form, or
AMENDMENTS
"(ii) if not intended for ingestion in such a form, does not
simulate and is not represented as conventional food and is not
SEC. 501 (a) Chapter IV of the Federal Food, Drug, and Cosmetic Act
represented for use as a sole item of a meal or of the diet.
is amended by adding after section 410 (21 U.S.C. 349) the following
"(2) For purposes of paragraph (1)(B)(i), a food shall be considered
new section:
as intended for ingestion in liquid form only if it is formulated in a fluid
"VITAMINS AND MINERALS
carrier and it is intended for ingestion in daily quantities measured in
drops or similar small units of measure.
"SEC. 411. (a) (1) Except as provided in paragraph (2)-
"(A) the Secretary may not establish, under section 201(n), 401,
"(3) For purposes of paragraph (1) and of section 403 (j) insofar as
or 403, maximum limits on the potency of any synthetic or natural
that section is applicable to food to which this section applies, the term
vitamin or mineral within a food to which this section applies;
'special dietary use' as applied to food used by man means a particular
"(B) the Secretary may not classify any natural or synthetic vita-
use for which a food purports or is represented to be used, including but
not limited to the following:
min or mineral (or combination thereof) as a drug solely because it
exceeds the level of potency which the Secretary determines is nu-
"(A) Supplying a special dietary need that exists by reason of
tritionally rational or useful;
a physical, physiological, pathological, or other condition, including
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.
12
"(B) Supplying a vitamin, mineral, or other ingredient for use
13
by man to supplement his diet by increasing the total dietary intake.
"(C) Supplying a special dietary need by reason of being a food
"(B) with respect to a food's advertising which the Secretary
for use as the sole item of the diet.".
determines causes the food to be so misbranded,
(b) The Secretary of Health, Education, and Welfare shall amend
the Secretary shall, in accordance with paragraph (2), notify in writing
any regulation promulgated under the Federal Food, Drug, and Cosmetic
the Federal Trade Commission of the action the Secretary proposes to
Act which is inconsistent with section 411 of such Act (as added by
take respecting such food or advertising.
subsection (a)) and such amendments shall be promulgated in accordance
"(2) The notice required by paragraph (1) shall-
with section 553 of title 5, United States Code.
"(A) contain (i) a description of the action the Secretary proposes
SEC. 502. (a) (1) Section 403(a) of the Federal Food, Drug, and
to take and of the advertising which the Secretary has determined
Cosmetic Act (21 U.S.C. 343(a)) is amended (A) by inserting "(1)"
causes a food to be misbranded, (ii) a statement of the reasons for the
after "If", and (B) by inserting before the period at the end a comma and
Secretary's determination that such advertising has caused such food
the following: "or (2) in the case of a food to which section 411 applies,
to be misbranded, and
its advertising is false or misleading in a material respect or its labeling
"(B) be accompanied by the records, documents, and other written
is in violation of section 411(b)(2)".
materials which the Secretary determines supports his determination
(2) (A) Section 201 (n) of such Act is amended by inserting "or advertis-
that such food is misbranded because of such advertising.
ing" after "labeling" each time it occurs.
"(b) (1) If the Secretary notifies the Federal Trade Commission under
(B) Section 303 of such Act is amended by adding at the end the follow-
subsection (a) of action proposed to be taken under chapter III with
ing new subsection:
respect to a food or food advertising and the Commission notifies the
"(d) No person shall be subject to the penalties of subsection (a) of this
Secretary in writing, within the 30-day period beginning on the date of
section for a violation of section 301 involving misbranded food if the
the receipt of such notice, that-
violation exists solely because the food is misbrunded under section
(A) it has initiated under the Federal Trade Commission Act an
403(a)(2) because of its advertising, and no person shall be subject to the
investigation of such advertising to determine if it is prohibited by
penalties of subsection (b) of this section for such a violation unless
such Act or any order or rule under such Act,
the violation is committed with the intent to defraud or mislead."
"(B) it has commenced (or intends to commence) a civil action
(C) Section 304(a) of such Act (21 U.S.C. 334(a)) is amended by
under section 5, 13, or 19 with respect to such advertising or the
adding after paragraph (2) the following new paragraph:
Attorney General has commenced (or intends to commence) a civil
"(3) (A) Except as provided in subparagraph (B), no libel for condemna-
action under section 5 with respect to such advertising,
tion may be instituted under paragraph (1) or (2) against any food which—
"(C) it has issued and served (or intends to issue and serve) a
"(i) is misbranded under section 403(a)(2) because of its adver-
complaint under section 5(b) of such Act respecting such advertising,
tising, and
or
"(ii) is being held for sale to the ultimate consumer in an estab-
"(D) pursuant to section 16(b) of such Act it has made a certifica-
lishment other than an establishment owned or operated by a manu-
tion to the Attorney General respecting such advertising,
facturer, packer, or distributor of the food.
the Secretary may not, except as provided by paragraph (2), initiate the
"(B) A libel for condemnation may be instituted under paragraph (1)
action described in the Secretary's notice to the Federal Trade Commission.
or (2) against a food described in subparagraph (A) if-
"(2) If, before the expiration of the 60-day period beginning on the
"(i) (I) the food's advertising which resulted in the food being
date the Secretary receives a notice described in paragraph (1) from the
misbranded under section 403(a) (2) was disseminated in the estab-
Federal Trade Commission in response to a notice of the Secretary under
lishment in which the food is being held for sale to the ultimate
subsection (a)-
consumer,
"(A) the Commission or the Attorney General does not commence
"(II) such advertising was disseminated by, or under the direction
a civil action described in subparagraph (B) of paragraph (1) of
of, the owner or operator of such establishment, or
notice, this subsection respecting the advertising described in the Secretary's
"(III) all or part of the cost of such advertising was paid by such
owner or operator; and
"(B) the Commission does not issue and serve a complaint de-
"(ii) the owner or operator of such establishment used such
scribed in subparagraph (C) of such paragraph respecting such
advertising in the establishment to promote the sale of the food.".
advertising, or
(b) Chapter VII of such Act is amended by adding after section 706
"(C) the Commission does not (as described in subparagraph (D)
(21 U.S.C. 376) the following new section:
of such paragraph) make a certification to the Attorney General re-
specting such advertising, or, if the Commission does make such a
"ADVERTISING OF CERTAIN FOODS
certification to the Attorney General respecting such advertising,
the Attorney General, before the expiration of such period, does
"SEC. 707. (a) (1) Except as provided in subsection (c), before the
not cause appropriate criminal proceedings to be brought against
Secretary may initiate any action under chapter III-
such advertising,
"(A) with respect to any food which the Secretary determines is
the Secretary may, after the expiration of such period, initiate the action
misbranded under section 403(a) (2) because of its advertising, or
described in the notice to the Commission pursuant to subsection (a). The
Commission shall promptly notify the Secretary of the commencement by
H.R. 1005-3
14
15
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
(2) The fourth sentence of section 434(b) of such Act is amended by
striking out "and related musculoskeletal diseases".
proceedings to be brought against such advertising.
"(c) The requirements of subsections (a) and (b) do not apply with
(3) Section 434(e) of such Act is amended by striking out "and related
respect to action under chapter III with respect to any food or food
musculoskeletal diseases (hereinafter in this part collectively referred to
as 'arthritis')'.
advertising if the Secretary determines that such action is required to
(b) Section 438 of such Act is amended by-
eliminate an imminent hazard to health.
"(d) For the purpose of avoiding unnecessary duplication, the Secre-
(1) inserting "the" before "health" the first time it appears in
the first sentence of subsection (a); and
tary shall coordinate any action taken under chapter III because of
(2) inserting "established" after "bank" in the second sentence
advertising which the Secretary determines causes a food to be misbranded
of subsection (a).
with any action of the Federal Trade Commission under the Federal
(c) Section 439 of such Act is amended by-
Trade Commission Act with respect to such advertising."
(c) The amendments made by subsection (a) shall take effect 180 days
(1) inserting "new and existing" before "centers" in the first
sentence of subsection (a);
after the date of the enactment of this Act.
(2) striking out "$13,000,000" and inserting in lieu thereof
TITLE VI-ARTHRITIS ACT AMENDMENTS
"$8,000,000", and striking out "$15,000,000" and inserting in
lieu thereof "$20,000,000" in subsection (h); and
SEC. 601. This title may be cited as the "National Arthritis Act
(3) redesignating subsections (e), (f), (g), and (h) as subsections
Technical Amendments of 1976".
(d), (e), (f), and (g), respectively.
SEC. 602. (a) Section 2 of the National Arthritis Act of 1974 (Public
Law 93-640) (hereinafter in this section referred to as the "Act") is
TITLE VII-DIABETES PLAN
amended by-
SEC. 701. Section 3(i) (2) of the National Diabetes Mellitus Research
(1) inserting "(a)" after "SEC. 2.";
(2) inserting a comma and "including $2,500,000,000 in medical
and Education Act (42 U.S.C. 289c-2) is amended to read as follows:
expenses," after "$9,200,000,000" in paragraph (3); and
"(2) The Commission shall cease to exist after September 30, 1976.".
(3) inserting a new subsection (b) at the end thereof as follows:
TITLE VIII-HEALTH SERVICES
"(b) It is therefore the purpose of this Act to provide for-
"(1) the formulation of a long-range plan-
AMBULATORY SURGICAL SERVICES
"(A) to expand and coordinate the national research, treat-
ment, and control effort against arthritis;
SEC. 801. (a) Section 319(a) (7) is amended by-
"(B) to advance educational activities for patients, profes-
(1) inserting after subparagraph (K) the following new sub-
sional and allied health personnel, and the public which will
paragraph:
alert the citizens of the United States to the early indications of
"(L) ambulatory surgical services;" and
arthritis; and
(2) redesignating subparagraphs (L) and (M) as subparagraph
"(C) to emphasize the significance of early detection and
(M) and (N), respectively.
proper control of these diseases and of the complications which
(b) Section 330(b) (2) is amended by-
may evolve from them;
(1) inserting after subparagraph (K) the following new sub-
"(2) the establishment and support of programs to develop new
paragraph:
and improved methods of arthritis screening, detection, prevention,
"(L) ambulatory surgical services;" and
and referral;
(2) redesignating subparagraphs (L) and (M) as subparagraphs
"(3) the establishment of a central arthritis screening and detection
(M) and (N), respectively.
data bank; and
"(4) the development, modernization, and operation of centers for
TITLE IX-INDIAN HEALTH SERVICE
arthritis screening, detection, diagnosis, prevention, control, treatment,
education, rehabilitation, and research and training programs."
SEC. 901. Section 225 is amended by adding at the end thereof the fol-
(b) Section 3 of the Act is amended by striking out "chief medical
lowing new subsection-
officer" and inserting in lieu thereof "Chief Medical Director" in sub-
"(j) Notwithstanding any other provision of law, the Secretary may,
section (b) (4).
where he deems advisable, allow the Indian Health Service to utilize non-
(c) The section heading for section 4 of the Act is amended by striking
profit recruitment agencies to assist in obtaining personnel for the Public
out "DEMONSTRATION" after "COMMITTEE,".
Health Service.".
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
TITLE X-APPOINTMENT OF ADVISORY COMMITTEES
'arthritis')'' after "musculoskeletal diseases".
SEC. 1001. All appointments to advisory committees established to assist
in implementing the Public Health Service Act, the Mental Retardation
16
17
Facilities and Community Mental Health Centers Construction Act of
(b) Section 1613 of such Act is amended by striking out "1510" and
1963, and the Comprehensive Alcohol Abuse and Alcoholism Prevention,
inserting in lieu thereof "1610".
Treatment, and Rehabilitation Act of 1970, shall be made without regard
(c) The last sentence of section 1631 of such Act is repealed.
to political affiliation.
SEC. 1107. (a) Section 132(a)(1)(A) of the Developmental Dis-
abilities Services and Facilities Construction Act (42 U.S.C. 6062)
TITLE XI-MISCELLANEOUS PROVISIONS
(hereinafter in this section referred to as the "Act") is amended by striking
out "134" and inserting in lieu thereof "133".
SEC. 1101. Section 212 of the Public Health Service Act is amended by
adding after subsection (d) the following new subsection:
(b) Section 134(b)(1) of the Act is amended by striking out "134"
and inserting in lieu thereof "133".
"(e) Active service of commissioned officers of the Service shall be
deemed to be active military service in the Armed Forces of the United
(c) Section 134(b)(1) of the Act is amended by striking out "136"
and inserting in lieu thereof "135".
States for the purposes of all rights, privileges, immunities, and benefits
now or hereafter provided under the Soldiers' and Sailors' Civil Relief
(d) Section 301(a) of the Developmentally Disabled Assistance and
Act of 1940 (50 App. U.S.C. 501 et seq.).
Bill of Rights Act is amended by striking out "101(7)" and inserting in
lieu thereof "102(7)".
SEC. 1102. (a) The second paragraph (4) of subsection (c) of section
And the Senate agree to the same.
472 of the Public Health Service Act is redesignated as paragraph (5).
(b) Section 507 of the Public Health Service Act is amended by striking
HARLEY O. STAGGERS,
out "hospitals of the Service, of the Veterans' Administration, or of the
PAUL G. ROGERS,
Bureau of Prisons of the Department of Justice, and to Saint Elizabeths
DAVID E. SATTERFIELD,
Hospital, except that grants to such" and insert in lieu thereof "Federal
JAMES W. SYMINGTON,
institutions, except that grants to".
JAMES H. SCHEUER,
SEC. 1103. Title IV of the Public Health Service Act is amended by
TIM LEE CARTER,
adding after section 475 the following new section:
JAMES T. BROYHILL,
Managers on the Part of the House.
"VISITING SCIENTIST AWARDS
HARRISON A. WILLIAMS, JR.,
CLAIBORNE PELL,
"SEC. 476. (a) The Secretary may make awards (referred to as 'Visiting
EDWARD M. KENNEDY,
Scientist Awards') to outstanding scientists who agree to serve as visiting
WALTER F. MONDALE,
scientists at institutions of post-secondary education which have significant
ALAN CRANSTON,
enrollments of disadvantaged students. Visiting Scientist Awards shall
WILLIAM D. Hathaway,
be made by the Secretary to enable the faculty and students of such insti-
JOHN A. DURKIN,
tutions to draw upon the special talents of scientists from other institutions
THOMAS F. EAGLETON,
for the purpose of receiving guidance, advice, and instruction with regard
GAYLORD NELSON,
to research, teaching, and curriculum development in the biomedical and
JACOB K. JAVITS,
behavioral sciences and such other aspects of these sciences as the Secretary
RICHARD S. SCHWEIKER,
shall deem appropriate.
ROBERT TAFT,
"(b) The amount of each Visiting Scientist Award shall include such
J. GLENN BEALL, JR.,
sum as shall be commensurate with the salary or remuneration which the
ROBERT T. STAFFORD,
individual receiving the award would have been entitled to receive from the
PAUL LAXALT,
institution with which the individual has, or had, a permanent or im-
Managers on the Part of the Senate.
mediately prior affiliation. Eligibility for and terms of Visiting Scientist
Awards shall be determined in accordance with regulations the Secretary
shall prescribe."
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".
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".
(b) Section 740(b)(4) of such Act is amended by striking out "1975"
and inserting in lieu thereof "1976".
SEC. 1106. Section 1511(b)(5) of the Public Health Service Act is
amended by striking out "1535" and inserting in lieu thereof "1536".
JOINT EXPLANATORY STATEMENT OF THE COMMITTEE
OF CONFERENCE
The managers on the part of the House and the Senate at the con-
ference on the disagreeing votes of the two Houses on the amendment
of the Senate to the bill (H.R. 7988) 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 Na-
tional Research Service Awards, and to establish a national program
with respect to genetic diseases; and to require a study on the release
of research information, submit the following joint statement to the
House and the Senate in explanation of the effect of the action agreed
upon by the managers and recommended in the accompanying con-
ference report:
The Senate amendment struck out all of the House bill after the
enacting clause and inserted a substitute text.
The House recedes from its disagreement to the amendment of the
Senate with an amendment which is a substitute for the House bill
and the Senate amendment. The differences between the House bill,
the Senate amendment, and the substitute agreed to in conference are
noted below, except for clerical corrections, conforming changes made
necessary by agreements reached by the conferees, and minor drafting
and clarifying changes.
TITLE I-REVISION OF NATIONAL HEART AND
LUNG INSTITUTE PROGRAMS
FINDINGS
The Senate amendment, in a provision not in the House bill, speci-
fied Congressional findings, with respect to the impact of diseases of
the heart, lung and blood vessels and blood disease and the need for
the proposed legislation.
The conference substitute conforms to the Senate amendment, with
technical changes.
ADVISORY COUNCIL
The House bill changed the name of the National Heart Lung Ad-
visory Council to the National Heart, Lung and Blood Advisory
Council.
The Senate amendment contained no comparable provision.
The conference substitute conforms to the House bill.
EXPERTS AND CONSULTANTS
Existing law authorizes the Director of the National Heart and
Lung Institute to obtain the services of not more than 50 experts and
consultants.
(19)
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21
The House amendment increased this number to 100.
REPORT OF THE ADVISORY COUNCIL
The Senate amendment contained no comparable provision.
The conference substitute conforms to the House bill.
Both the House bill and the Senate amendment required that the
Advisory Council submit by November 30 of each year a report to the
ASSISTANT DIRECTOR
Secretary for simultaneous transmittal to the President and to the
Congress on the progress of the National Heart, Blood Vessel, Lung,
Existing law establishes within the National Heart and Lung Insti-
and Blood Disease Program during the preceding fiscal year. However,
tute (redesignated as the National Heart, Lung and Blood Institute
the Senate amendment stipulates that for purposes of this require-
under provisions of both the House bill and the Senate amendment)
ment, the period beginning July 1, 1975 and ending September 30,
an Assistant Director for Health Information Programs.
1976 shall be considered a fiscal year and the House amendment con-
The House bill changed the name to Assistant Director for Preven-
tains no comparable provision.
tion, Education, and Control.
The conference substitute conforms to the Senate amendment.
The Senate amendment changed the name to Assistant Director for
Prevention and Information.
AUTHORIZATIONS FOR RESEARCH
The conference substitute conforms to the House bill.
The House bill authorized appropriations of $340 million for fiscal
AUTHORIZATION FOR PREVENTION AND CONTROL PROGRAMS
year 1976 and $375 million for fiscal year 1977 for carrying out the
programs of the redesignated National Heart, Lung, and Blood
The House bill authorized appropriations of $20 million for fiscal
Institute (except prevention and control programs).
year 1976 and $30 million for fiscal year 1977 for heart, blood vessel,
The Senate amendment authorized $338 million for fiscal year 1976
lung, and blood disease control programs.
and $372 million for fiscal year 1977 for such purposes.
The Senate amendment authorized appropriations of $10 million for
The conference substitute authorized $339 million for fiscal year
fiscal year 1976 and $25 million for fiscal year 1977 for such programs.
1976 and $373 million for fiscal year 1977 for such purposes.
The conference substitute authorizes $10 million for fiscal year 1976
and $30 million for fiscal year 1977 for such programs.
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
CENTERS
AUTHORIZATIONS
Existing law authorizes the development of fifteen centers for re-
The House bill authorized appropriations of $175 million for fiscal
search, training, and demonstrations respecting heart, blood vessel,
year 1976 and $200 million for fiscal year 1977 for payments for
and blood diseases, and fifteen such centers for chronic lung diseases.
National Research Services Awards.
The House bill increased the responsibilities of the heart, blood
The Senate amendment authorized $160 million for fiscal year 1976
vessel, and blood disease centers to include research in the use of
and $176 million for fiscal year 1977 for such purposes.
blood and blood products and in the management of blood resources.
The conference substitute authorizes $165 million for fiscal year 1976
Further, the House bill expanded the responsibilities of the lung
and $185 million for fiscal year 1977 for such purposes.
disease centers by deleting the word "chronic."
The Senate amendment authorized the development of ten centers
ACCRUAL OF INTEREST
for research, training, and demonstrations respecting heart diseases;
ten such centers for chronic lung diseases; and ten such centers for
Under existing law, interest accrues on National Research Service
blood, blood vessel diseases, research in the use of blood products, and
Awards from the time the award is made in instances in which recip-
research in the management of blood resources.
ients fail to fulfill applicable service requirements.
The conference substitute conforms to the Senate amendment, ex-
The House bill changed existing law to make interest on the award
cept that it authorizes the development of ten centers for lung diseases,
computed from the time the United States becomes entitled to recover
as opposed to chronic lung diseases.
all or part of the award.
The Senate bill contained no comparable provision.
FUNCTIONS OF THE ADVISORY COUNCIL
The conference substitute conforms to the House bill.
The House bill added to the existing authority of the National
STUDY RESPECTING BIOMEDICAL AND BEHAVIORAL RESEARCH
Heart, Lung, and Blood Advisory Council the prerogative to recom-
PERSONNEL
mend to the Secretary of Health, Education, and Welfare areas of
research conducted or supported by the newly designated National
Under existing law, the Secretary is to annually submit a study
Heart, Lung, and Blood Institute which the Council determines should
respecting biomedical and behavioral research personnel.
be supported by the awarding of contracts and the percentage of the
The Senate amendment changed the date for submission of the
budget of the Institute which should be expended for such contracts.
report to September 30, and the House bill contained no comparable
The Senate amendment contained no comparable provision.
The conference substitute conforms to the House bill.
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23
provision. The House bill required that the entity conducting the
TESTING AND COUNSELING PROGRAMS AND
study conduct such study in consultation with the Director of the
INFORMATION AND EDUCATION PROGRAMS
National Institutes of Health.
The conference substitute conforms to the changes made in existing
The house bill required that testing and counseling programs be
law by both the House bill and the Senate amendment.
established and operated primarily in conjunction with other existing
health programs, including programs established under title X of the
TITLE III-DISCLOSURE OF RESEARCH INFORMATION
Public Health Service Act (family planning programs) and under
title V of the Social Security Act (maternal and child health programs).
The House bill contained a provision which required the President's
The Senate amendment contained comparable requirements, except
Biomedical Research Panel to conduct an investigation and study of
that it did not specify programs under title X of the Public Health
the implication of disclosure to the public of information contained in
Service Act or under title V of the Social Security Act.
research protocols, research hypotheses, and research designs ob-
The conference substitute conforms to the House bill, except that
tained by the Secretary in conjunction with an application or proposal
only programs assisted under title V of the Social Security Act are
for a grant, fellowship, or contract under the Public Health Service
specified.
Act and to submit a report on the investigation and study to the
The Senate amendment further provided that a priority in the
House Committee on Interstate and Foreign Commerce and the
awarding of grants and contracts for genetic disease counseling and
Senate Committee on Labor and Public Welfare. The House bill also
testing programs was to be given to projects which are recipients of
included a provision which deferred, from July 1, 1976 to January 1,
awards for sickle cell anemia testing and counseling programs on the
1977, the establishment of the National Advisory Council for the
date of enactment. There was no similar provision in the House bill.
Protection of Subjects of Biomedical and Behavioral Research.
The conference substitute conforms to the Senate amendment with
The Senate amendment contained no comparable provisions.
technical amendments.
The conference substitute conforms to the House bill, except that
The House bill authorized $20 million for each of fiscal years 1976
the National Commission for the Protection of Human Subjects is also
and 1977 to support genetic disease testing and counseling programs
required to conduct the investigation and study, and technical changes
and information and education programs. The Senate amendment
are made with respect to the dates on which the Panel is to complete
authorized $20 million for fiscal year 1976, $25 million for fiscal year
its investigation and submit its report.
1977, and $30 million for fiscal year 1978 for such programs; and an
The Conferees express their concern that inadequate attention is
additional $15 million for each of fiscal years 1976, 1977, and 1978 to
being paid to the problems of transfer of research progress, technology,
support sickle cell anemia testing and counseling programs.
and information from the "bench to the bed", an area frequently re-
The conference substitute authorizes $30 million for each of fiscal
ferred to as the interface between research and the health care delivery
years 1976, 1977, and 1978 to support genetic diseases testing and
system. This includes such areas as extensive clinical trials, demon-
counseling programs and information and education programs, and
stration projects, specific disease control programs, the assessment of
provides that the Secretary shall give special consideration in the
new health technologies, health education, and the fields of preventive
awarding of grants and contracts to sickle cell anemia testing and
medicine and public health. The Conferees have received assurance
counseling project applications.
that the report of the President's Biomedical Research Panel will
address these important issues.
RESEARCH PROJECT GRANTS AND CONTRACTS
TITLE IV-GENETIC DISEASES
Both the House bill and the Senate amendment authorized the
Secretary to award grants and contracts for research projects with
SHORT TITLE AND STATEMENT OF PURPOSE
respect to genetic diseases.
Both the House bill and the Senate amendment set forth four pur-
The House bill provided for the following short title: "National
poses for which the Secretary could award research grants and con-
Genetic Diseases Act." Under the Senate amendment the short title
tracts. They are identical except that as the first purpose the House
was "National Sickle Cell Anemia, Cooley's Anemia, Tay-Sachs and
bill provided that projects for basic or applied research leading to the
Genetic Diseases Act."
understanding, diagnosis, treatment, and control of genetic diseases
The House bill stated a purpose of establishing a national program
would be eligible for funding. The Senate amendment included
for genetic diseases, including sickle cell anemia, Cooley's anemia and
projects for basic research, including lower organisms, applied research,
Tay-Sachs disease. The Senate amendment, in its statement of pur-
and research training.
pose, stipulated that genetic diseases are to include but not be limited
The conference substitute conforms to the House bill.
to sickle cell anemia, Cooley's anemia, Tay-Sachs disease, cystic fibro-
The House bill instructed the Secretary to undertake genetic disease
sis, dysautonomia, hemophilia, retinitis pigmentosa, Huntington's
research under the general authority of section 301 of the Public
chorea, and muscular dystrophy.
Health Service Act. The Senate amendment provided for a specific
The conference substitute conforms to the Senate amendment.
authority and authorized $80 million for fiscal year 1976, $100 million
for fiscal year 1977, and $120 million for fiscal year 1978; and ear-
25
24
was committed with the intent to defraud or mislead. Further, such
marked 10 percent of the sums appropriated each year under the
products which are misbranded because their advertising is false or
authority for research projects with respect to Cooley's anemia. The
misleading in a material respect and are held for sale to the ultimate
Senate amendment further provided for a separate authorization for
consumer in an establishment not owned by a manufacturer, packer or
sickle cell anemia research of $15 million for each of fiscal years 1976,
distributor, could not be seized unless (1) the advertising was dis-
1977, and 1978.
seminated in the establishment in which the product was held for
The conference substitute conforms to the House bill, except that
sale to the ultimate consumer, the advertising was disseminated by or
the Secretary is directed, in making grants and entering into contracts
under the direction of the owner or operator of such establishment, or
for research projects, to give priority to applications which are sub-
all or part of the cost of such advertising was paid for by the owner or
mitted for research on sickle cell anemia or for research on Cooley's
operator, and (2) the owner or operator used the advertising to pro-
anemia.
mote the sale of the product. Finally, the Senate amendment required
TITLE V.-VITAMINS AND MINERALS
the Secretary to consult with the Federal Trade Commission prior to
initiating action with respect to such products deemed misbranded
The Senate amendment contained provisions not included in the
because of their advertising.
House bill relating to regulation of vitamin and mineral products
The Conference substitute conforms to the Senate amendment
under the Federal Food, Drug, and Cosmetic Act (hereinafter referred
except that:
to as "the Act").
(1) It adds two technical amendments (clarifying the intention of
Under the Senate amendment, the Secretary of Health, Education
the Senate amendment) to provide specifically that foods represented
and Welfare would generally have been prohibited from establishing
for use by individuals in the treatment or management of specific
maximum limits on the potency of vitamins or minerals in dietary
diseases or disorders and foods represented for use as the sole item of
supplements or classifying vitamins or minerals as drugs solely because
a meal or of the diet are excluded from the limitations on the Secre-
they exceeded the level of potency determined by him to be nutri-
tary's authority.
tionally rational or useful. In addition, the Secretary would have been
(2) Except in instances in which immediate action is necessary to
prohibited from limiting the combination of vitamins, minerals or
eliminate an imminent hazard to health, it requires the Secretary to
other ingredients in dietary supplements. However, under the Senate
provide notification to the Federal Trade Commission of his intention
amendment, the Secretary would have retained full authority to
to initiate an action with respect to false or misleading advertising,
limit the potencies and combinations of vitamins, minerals and other
and it affords the Federal Trade Commission the opportunity to take
ingredients in foods in the exercise of his authority under chapter V
specific enforcement action against false or misleading advertising
of the Act (relating to drugs) and under provisions of the Act respect-
for a period of up to 90 days before the Secretary may take comparable
ing unsafe foods which are not generally recognized as safe.
action.
In addition, the Senate amendment contained provisions rendering
Since the House has taken no action during this Congress with
the amendment's limitations on the authority of the Secretary in-
respect to this matter, it is important to provide more legislative
applicable to vitamin and mineral products for use by children or by
history concerning these complex new provisions. Thus, presented
pregnant or lactating women.
below is a detailed description of the new provisions, as well as state-
The Senate amendment also contained provisions with respect to
ments of the intentions of the managers with respect to their
the labeling and advertising of vitamin and mineral products. It
implementation.
prohibited a product containing vitamins or minerals from being
deemed misbranded solely because its label lists all ingredients of
PRODUCTS SUBJECT TO THE CONFERENCE SUBSTITUTE
such a product. However, the amendment required that the labeling
of such products could not list ingredients which are not vitamins or
Under the conference substitute, products subject to its provisions
minerals except as a part of a list of all ingredients of the product
are defined as safe human foods for special dietary use which are or
and unless such ingredients are listed in accordance with applicable
contain any natural or snythetic vitamin or mineral and which are
regulations. Moreover, the Senate amendment prohibited the labeling
intended for ingestion in tablet or capsule form or in small units of
of or advertising for any such product to give prominence to or
liquid measure. In addition, such foods not intended for ingestion in
emphasize ingredients which are not vitamins or minerals or are not
tablet, capsule, or liquid form are subject to the provisions of the
represented as a source of vitamins or minerals.
substitute only if they do not simulate conventional foods, if they are
In addition, the Senate amendment afforded the Secretary significant
not represented to be conventional foods, and if they are not repre-
new authority with respect to the advertising of certain products
sented for use as the sole item of a meal or of the diet.
containing vitamins or minerals. (Under existing law, the Federal
The definition of "special dietary use" in the conference substitute
Trade Commission has exclusive authority with respect to the ad-
applies only to the foods to which the substitute is applicable and not
vertising of such products.) Under the Senate amendment, such
to other foods, such as foods represented for use by infants or foods
products would be deemed misbranded if their advertising were false
represented for use as the sole item of a meal or of the diet, that may
or misleading in a material respect. However, criminal penalties could
be subject to 403(j) of the Act.
not be imposed against persons who were in violation of the prohibi-
tions against false or misleading advertising unless such a violation
26
27
Thus, vitamins and minerals in tablet, capsule, or liquid form as well
as those products which are represented for special dietary use in
of the conference substitute where such product is represented for
humans and which do not simulate and are not represented as con-
use by (1) individuals in the treatment or management of specific
ventional foods or substitutes for conventional foods and which are
diseases or disorders, (2) children, or (3) pregnant or lactating women.
not represented for use as the sole item of a meal or of the diet, are
The provision with respect to foods intended for use in the treatment
products subject to the provisions of the substitutes.
or management of specific diseases or disorders was adopted in
Except with respect to products defined above, the conference
conference in order to make clear that the proposed new section 411 (a)
substitute does not alter existing provisions of the Federal Food, Drug,
of the Act does not override the Secretary's authority under sections
and Cosmetic Act with respect to foods and drugs.
401, 403, or 201 (n) of the Act to limit the potency and combination
The Secretary retains his current authority to regulate the nu-
of vitamins, minerals, other ingredients in foods, or foods, represented
tritional formulation and composition of, and potency of vitamins,
for use in the dietary treatment or management of individuals with
minerals and other ingredients in conventional foods such as milk,
specific diseases or disorders, or of post-operative or convalescing
enriched bread and enriched rice, as well as in products which simulate
medical patients. Since each of these foods must be precisely formu-
conventional foods such as soybased protein substitutes for meats and
lated to meet the needs of individuals with specific diseases and
poultry. The Secretary also retains his current authority to regulate
disorders, the conferees believe it to be important that the language
the nutritional formulation and composition of, and potency of vita-
in the conference substitute clearly preserve the authority of the
mins, minerals and other ingredients in foods represented by labeling,
Secretary to regulate as foods the nutritional formulation, composi-
advertising, or other promotional materials for use as the sole item of
tion, and potency of each product represented for such uses. Inclusion
a meal or of the diet. Because consumers purchase these foods as nu-
of this language is not, however, intended to permit the Secretary to
tritional equivalents of a well-balanced meal or diet, the conferees
limit (under sections 401, 403, or 201 (n) of the Act) the potency or
believe it is essential that the consumer of such products can be
combination of a safe vitamin, mineral, food ingredient, or food
confident that a meal or diet based upon such products is nutritionally
represented in its labeling and advertising to be solely for use by
adequate and balanced and provides for the proper maintenance of
adults, other than pregnant or lactating women, as a nutritional
the user's health for the duration of his use of these products.
supplement to general human dietary intake.
Dietary management with these products is not only of major
LIMITATIONS ON THE SECRETARY'S AUTHORITY
clinical value to the individual, but can be lifesaving in many in-
stances. In the case of a number of inborn abnormalities of metabolism,
Under the conference report, three significant restrictions would
such as phenylketonuria and maple syrup urine disease, these foods
be imposed on the Secretary with regard to the regulation of products
provide the only means for prevention of mental retardation, partic-
subject to the conference substitute. First, new section 411(a)(1)(A)
ularly in infants and young children, or for the partial restoration of
of the Act prohibits the Secretary from using his existing autho ity
mental capacity in older children. Special formula feedings are essen-
under sections 201 (n) or 403 of the Act (relating to misbranding) or
tial to long-term maintenance of severely debilitated individuals. Low
under section 401 of the Act (relating to standards of identity) to
sodium foods are useful in dietary management of individuals with
impose maximum limits on the potency of safe vitamins and minerals
severe forms of hypertension, acute heart failure, acute nephritis,
contained in products subject to the conference substitute. This
toxemias of pregnancy and similar disorders when the degree of sodium
provision would not restrict the Secretary from prescribing minimum
restriction must be greater than that achievable with conventional
potency levels for vitamins or minerals in such products in order to
foods. Chemically defined formula diets are extremely useful for nu-
prevent the addition of insignificant or useless amounts.
tritional management of patients prior to and subsequent to gastro-
Second, new section (1) (B) of the Act prohibits the Secretary
intestinal surgery.
from classifying as a drug a natural or synthetic vitamin or mineral,
The Senate amendment included, in proposed new section 411 (a) (2)
offered by itself or in combination, solely because it exceeds the level
of the Act, a specific reference to the Secretary's authority to act by
of potency that the Secretary determines is nutritionally rational or
regulation. This reference was deleted by the conferees as unnecessary.
useful.
It is not intended that the omission of this reference should be under-
Third, new section (a) (1) (C) of the Act prohibits the Secretary
stood as in any way restricting the Food and Drug Administration's
from using his authority with respect to misbranding or establishment
present authority to adopt regulations defining and enforcing the
of standards of identity to limit the combination or number of any
provisions of the Act. The Secretary in recent years has relied in-
safe vitamin, mineral or other ingredient of food in products subject
creasingly on administrative rulemaking to enforce the requirements
to the conference substitute.
of the law. Rulemaking affords opportunity for broader participation
in the formulation of agency policy, promotes clarity of legal require-
EXCEPTIONS TO LIMITATIONS ON THE SECRETARY
ments, and assures equitable application of the law, while at the same
time it reduces the cost to the taxpayer of case-by-case enforcement.
Under the conference substitute (proposed new section
The Secretary's legal authority, under section 701(a) of the Act, to
of the Act), the limitations on the Secretary, described above, do
adopt binding regulations has been recognized by the Supreme Court.
not apply with respect to a product otherwise subject to the provisions
Weinberger V. Hynson, Westcott and Dunning, Inc., 412 U.S. 609
(1973); Abbott Laboratories V. Gardner, 387 U.S. 136 (1967). This
28
29
authority has recently been upheld by the United States Court of
PROVISIONS WITH RESPECT TO LABELING AND ADVERTISING
Appeals for the Second Circuit. National Nutritional Foods Assn. V.
Weinberger, 512 F. 2d 688 (C.A. 2, 1975).
Under the conference substitute, the Secretary retains the authority
For the purposes of the conference substitute, the term "children"
to initiate enforcement actions against a product to which the con-
is defined to mean individuals under the age of 12 years. The conferees
ference substitute is applicable if its labeling is false or misleading in
are also concerned that attention should be given to those vitamin and
any particular. In addition, the conference substitute contains special
mineral preparations that are not intended for use by infants, children
provisions respecting the labeling and advertising of these products.
or pregnant or lactating women, but may be taken by or administered
The conference substitute provides that a food to which the con-
to them inadvertently. Just as the fetus may be affected by excessive
ference substitute is applicable shall not be deemed misbranded under
doses of some food supplements, excessive doses of vitamins and
section 403 of the Act solely because its label bears a listing of all of
minerals taken by children during the period of rapid growth and
the ingredients in the food, or solely because its advertising contains
maturation can interfere with their normal development. Because of
references to ingredients in the food that are not vitamins or minerals.
such possibilities of unrecognized or unanticipated harm, it is in-
Thus, for example, if a tablet or capsule of vitamin C contains rutin,
tended that the Secretary retain full authority to promulgate regu-
a substance that the Secretary has concluded has no dietary usefulness,
lations designed to assure that unsuitable or inappropriate vitamin
the list of ingredients as well as the advertising for the product may
and mineral preparations are not inadvertently administered to
refer to rutin without causing the food to be deemed misbranded.
individuals in these vulnerable groups.
However, because of the conferees' concern that consumers not be
Except as specifically provided, the conference substitute does not
misled into a belief that such substances have nutritional value, the
alter the drug or food provisions of the Federal Food, Drug, and
conference substitute provides that the labeling SO such a product may
Cosmetic Act. If a product containing vitamins, minerals or other
not list ingredients that are not vitamins or minerals except as a part
ingredients is a drug within the meaning of section 201 (g) of the Act,
of a list of all the ingredients of the food, in accordance with applicable
the Secretary may, with respect to such product, exercise his authority
regulations promulgated by the Secretary pursuant to section 403 of
under Chapter V of the Act. For example, the Secretary may bring an
the Act. The Secretary is directed that in circumstances where
action for misbranding of a product which purports to be or is repre-
compliance with this provision is impracticable or results in deception
sented as a drug (within the meaning of section 201 (g) of the Act)
or unfair competition, exceptions shall be established by regulation.
if its labeling fails to bear adequate directions for its purported use or
Further, the conference substitute provides that the labeling or
for the use for which it is represented (within the meaning of section
advertising of a food to which the conference substitute is applicable
502 (f) (1) of the Act). See V. E. Irons, Inc. v. United States, 244 F.
may not give prominence to or emphasize ingredients which are not
2d 34 (C.A. 1, 1957) Alberty Food Products v. United States, 194 F.
vitamins or minerals or are not represented as a source of vitamins
2d 463 (C.A. 9, 1952); United States v. Vitasafe Co., 345 F. 2d 864
or minerals.
(C.A. 3, 1965) United States v. Article of Drug
B-Complex Cholinos
The conference substitute also provides the Secretary new authority
Capsules, 362 F. 2d 923 (C.A. 3, 1966).
over the advertising of foods subject to the conference substitute.
The Secretary also has the authority to regulate the composition
Seizure and injunction actions are authorized in instances in which the
and potency of a product subject to the provisions of the conference
advertising of a food to which the conference substitute is applicable
substitute on the basis of safety. If a high potency preparation of a
is false or misleading in a material respect. However, in order to
vitamin or mineral is a drug as defined by section 201 (g) of the Act
protect an innocent retailer from seizures based upon deceptive
and the Secretary determines that within the meaning of section 503
advertising claims made by a manufacturer, the conference substitute
(b) of the Act, it is not safe for use except und er the supervision of a
provides that libel for condemnation may not be instituted against
physician, such a high potency preparation is subject to regulation
such products which are misbranded because of their advertising
as a prescription drug under the Act.
unless (1) the advertising was disseminated in the establishment in
Similarly, if any vitamin, mineral or other food ingredient is not
which the product was held for sale to the ultimate consumer, the
generally recognized as safe by qualified experts and meets the other
advertising was disseminated by or under the direction of the owner
criteria of the definition of a "food additive" under section 201 (s) of
or operator of such establishment, or all or part of the cost of such
the Act, it would be subject to regulation under section 409 of the
advertising was paid for by the owner or operator, and (2) the owner
Act. If such a vitamin, mineral or other ingredient is intentionally
or operator used the advertising in the establishment to promote the
added to a food, such food is adulterated (within the meaning of
sale of the food.
section 402 (a) (2) (C) of the Act) unless its use is in conformity with
The conference substitute would also add a new section 707 to the
a regulation issued by the Secretary which prescribes the conditions
Federal Food, Drug, and Cosmetic Act which would require that the
under which it may be safely used or exempts it for investigational
Federal Trade Commission be afforded the opportunity to take certain
use by qualified experts. It is on precisely this basis that the Secretary
specific enforcement actions under the Federal Trade Commission Act
has, by regulation, restricted the potency of the vitamin folic acid
for a period of up to 90 days before the Secretary could initiate an
that may be added to a food.
enforcement action under Chapter III of the Act with respect to the
advertising of a product subject to the provisions of the conference
substitute. It would prohibit the Secretary, except under limited
30
31
circumstances, from initiating such an enforcement action before,
which has caused appropriate criminal proceedings to be brought
during, or after the expiration of the 90 day period, if the Federal
against the advertising, the Secretary may act under Chapter III of
Trade Commission takes action in accordance with the conference
the Federal Food, Drug, and Cosmetic Act.
substitute.
The Commission is required to notify the Secretary promptly of the
These provisions are intended to provide the Secretary with authority
commencement of a civil action, the issuance and service of a com-
to protect the public from consumer fraud perpetrated by the false
plaint, or the causing by the Attorney General of criminal proceedings
advertising of these products. They are intended to serve as a partial
to be brought against the advertising described in the Secretary's
substitute for the authority denied to the Secretary under other pro-
notice.
visions of the conference substitute.
The conferees intend that the Commission or the Attorney General,
Proposed new section 707 of the Act would require the Secretary
where practical, take appropriate regulatory action under the Federal
to notify the Federal Trade Commission before he initiates any action,
Trade Commission Act pursuant to a notice from the Secretary. The
under Chapter III of the Federal Food, Drug, and Cosmetic Act,
conferees believe that the period of 90 days provided in the converence
with respect to any food which the Secretary determines is misbranded
substitute is sufficient time within which to take such action. However,
under proposed new section 403 (a) (2) of the Act because of its advertis-
in instances in which the Secretary determines that, although action
ing or a food's advertising which the Secretary determines causes the
has not been taken by the Commission or the Attorney General within
food to be SO misbranded. The notice by the Secretary must contain
the 90 day period, such action is imminent, he may defer taking his
(1) a description of the Secretary's proposed action, (2) a description
proposed action to permit the Commission or the Attorney General to
of the advertising which the Secretary has determined causes the food
take action.
to be misbranded under section 403(a)(2) of the Act, and (3) a state-
Under the conference substitute the notification and other pro-
ment of the reasons for the Secretary's determination that the advertis-
cedural requirements in subsections (a) and (b) of proposed new
ing has caused the food to be SO misbranded. In addition, the notice
section 707 of the Act do not apply with respect to any action under
from the Secretary must be accompanied by records, documents, and
Chapter III of the Act with respect to any food or food advertising
other written materials which the Secretary determines support his
to which the conference substitute is otherwise applicable, if the
determination that the food is SO misbranded because of its advertising.
Secretary determines that such action is required to eliminate an
If, within a 30 day period beginning on the date of receipt of the
imminent hazard to health. Under these circumstances the Secretary
notice and accompanying written materials from the Secretary, the
would neither be required to provide formal notification to the Com-
Federal Trade Commission notifies the Secretary in writing that-
mission nor delay his proposed enforcement action. However, under
(1) it has initiated an investigation of the advertising (referred
the conference substitute, if the Secretary takes any action under
to in the Secretary's notice) to determine if it is prohibited by the
Chapter III of the Act with respect to a food because of its advertising
Federal Trade Commission Act or a rule or order promulgated
or with respect to a food's advertising under proposed section 403
thereunder;
(a) (2) of the Act, proposed section 707(d) of the Act requires the
(2) it has commenced or intends to commence a civil action in
Secretary to coordinate the action with any action of the Federal Trade
the courts under section 5, 13, or 19 of such Act with respect to
Commission with respect to the advertising of such food.
such advertising or the Attorney General has commenced or
The conferees recognize that for many years the Food and Drug
intends to commence a civil action under section 5 of such Act
Administration and the Federal Trade Commission have operated in
with respect to such advertising;
overlapping areas of jurisdiction in the regulation of false claims and
(3) it has issued and served or intends to issue and serve a
that both agencies have been functioning under written memoranda of
complaint under section 5(b) of such Act with respect to such
understanding concerning jurisdiction and liaison since 1954. The
advertising; or
conferees expect both agencies to continue to coordinate their regula-
(4) it had made certification to the Attorney General under
tory actions in a manner to avoid unnecessary duplication and waste.
section 16(b) of such Act with respect to such advertising,
The conferees also emphasize that the conference substitute is not
the Secretary is prohibited from initiating his proposed action for an
intended to modify the primary role of the Federal Trade Commission
additional period of time, which is not to exceed 60 days. If the
in exercising its regulatory authority over the false or misleading
Commission notifies the Secretary that neither the Attorney General
advertising of food products.
nor the Commission intends to take any of these actions or fails to
Although the substitute gives the Secretary substantial new author-
respond to the Secretary in writing within the 30 day period, the
ity with respect to the advertising of vitamin and mineral products,
Secretary may initiate his proposed action.
the conferees intend that the Secretary use his authority under existing
If, before the expiration of the 60 day period beginning on the date
section 306 of the Federal Food, Drug, and Cosmetic Act which pro-
the Secretary receives the notice from the Commission that the
vides for written notice or warning in lieu of judicial action where the
Attorney General or the Commission intends to take one of the
Secretary believes that such notification or warning adequately pro-
actions described above, the Commission or the Attorney General has
tects the public interest.
not commenced a civil action, the Commission has not issued and
served a complaint or made certification to the Attorney General
32
33
TITLE VI-ARTHRITIS ACT AMENDMENT
Act to permit the Indian Health Service to utilize non-profit recruit-
ment agencies to assist in obtaining personnel for the Public Health
The Senate amendment contained a title, not included in the House
Service.
bill, which amended the National Arthritis Act (Public Law 93-640)
The conference substitute conforms to the Senate amendment.
The Senate amendment (1) made it clear that arthritis and related
musculoskeletal diseases are to be collectively referred to as arthritis
TITLE X-APPOINTMENT OF ADVISORY COMMITTEES
for the purposes of the Act; (2) added a statement of purposes of
the Act; (3) corrected the reference to the Chief Medical Direc-
The Senate amendment contained a title, not included in the
tor of the Veterans Administration as an ex-officio member of the
House bill, which prohibited consideration of political affiliation in
National Commission on Arthritis; (4) lowered the authorization of
making appointments to advisory committees established to assist
appropriations under that Act for the Arthritis Commission from $2
the Secretary in implementing the Public Health Service Act, the
million to $1.5 million; (5) revised the authorizations of appropriations
Mental Retardation Facilities and Community Mental Health Centers
under the Public Health Service Act for arthritis screening, de-
Construction Act of 1963, and the Alcohol Abuse and Alcoholism
tection, prevention, and referral demonstration projects and the
Prevention, Treatment, and Rehabilitation Act of 1970.
Arthritis Screening and Detection Data Bank from $2 million for
The conference substitute conforms to the Senate amendment.
fiscal year 1975, $3 million for fiscal year 1976 and $4 million for
fiscal year 1977 to $1.5 million for fiscal year 1975, $4 million for
TITLE XI-MISCELLANEOUS PROVISIONS SOLDIERS' AND
fiscal year 1976, and $4 million for fiscal year 1977; and (6) amended
section 439 of the Public Health Service Act to provide that the
SAILORS' CIVIL RELIEF ACT
Secretary may assist in the development, modernization, and opera-
tion of new and existing comprehensive arthritis centers and to revise
The Senate amendment contained a provision, not included in the
the authorizations from $11 million for fiscal year 1975, $13 million for
House bill, which equated active service of commissioned officers of
the Public Health Service with active military service in the Armed
fiscal year 1976, and $15 million for fiscal year 1977 to $5 million for
fiscal year 1975, $13 million for fiscal year 1976, and $21 million
Forces for the purposes of all rights, privileges, immunities, and
for fiscal year 1977.
benefits provided under the Soldiers' and Sailors' Civil Relief Act
of 1940.
The conference substitute conforms to the Senate amendment,
The conference substitute conforms to the Senate amendment.
except that it would authorize under the Public Health Service Act
$11 million for fiscal year 1975, $8 million for fiscal year 1976 and
VISITING SCIENTIST AWARDS
$20 million for fiscal year 1977 for the development, modernization and
operation of new and existing comprehensive arthritis centers, and
The Senate amendment contained provisions, not included in the
would not change existing law with respect to authorizations for
House bill, which (1) authorized the Secretary to grant stipends, in
demonstration projects and the Arthritis Screening and Detection
amounts not to exceed $25,000 per annum, to visiting scientists who
Data Bank.
enter into agreements with the Secretary to assist minority schools in
TITLE VII-DIABETES PLAN
developing programs in biomedical sciences, and (2) authorized the
The Senate amendment contained a title, not included in the
Secretary to make grants to minority schools to initiate the develop-
House bill, which extended the expiration date of the National
ment of undergraduate programs relating to biomedical sciences.
Diabetes Commission (established under Public Law 93-354) to
The conference substitute authorizes the Secretary to make awards
September 30, 1976.
(referred to as "Visiting Scientist Awards") to outstanding scientists
The conference substitute conforms to the Senate amdnement.
who agree to serve as visiting scientists at institutions of post-second-
ary education which have significant enrollments of disadvantaged
students. The amount of each such award shall include such sum as is
TITLE VIII-HEALTH SERVICES
commensurate with the salary or remuneration which the individual
The Senate amendment contained a title, not included in the House
had received from the institution with which he has, or had, a perma-
bill, which amended sections 319 (migrant health centers) and 330
nent or immediately prior affiliation.
(community health centers) of the Public Health Service Act to add
ambulatory surgical services as a supplemental health service which
HEALTH PROFESSIONS STUDENT ASSISTANCE
could be offered by such centers.
The conference substitute conforms to the Senate amendment.
The Senate amendment contained provisions, not included in the
House bill, which extended the authorizations of appropriations for
physician shortage area scholarships at $3.5 million for fiscal year 1975
TITLE IX-INDIAN HEALTH SERVICE
and $2 million for fiscal year 1976, and for health professions student
loans at $60 million for fiscal year 1976.
The Senate amendment contained a title, not included in the
The conference substitute conforms to the Senate amendment.
House bill, which amended section 225 of the Public Health Service
34
HARLEY O. STAGGERS,
PAUL G. ROGERS,
DAVID E. SATTERFIELD,
JAMES W. SYMINGTON,
JAMES H. SCHEUER,
TIM LEE CARTER,
JAMES T. BROYHILL,
Managers on the Part of the House.
HARRISON A. WILLIAMS, JR.,
CLAIBORNE PELL,
EDWARD M. KENNEDY,
WALTER F. MONDALE,
ALAN CRANSTON,
WILLIAM D. HATHAWAY,
JOHN A. DURKIN,
THOMAS F. EAGLETON,
GAYLORD NELSON,
JACOB K. JAVITS,
RICHARD S. SCHWEIKER,
ROBERT TAFT,
J. GLENN BEALL, JR.,
ROBERT T. STAFFORD,
PAUL LAXALT,
Managers on the Part of the Senate.
o
94TH CONGRESS
SENATE
REPORT
2d Session
No. 94-743
HEALTH RESEARCH AND HEALTH SERVICES
AMENDMENTS OF 1976
APRIL 8, 1976.-Ordered to be printed
Mr. KENNEDY, from the committee of conference,
submitted the following
CONFERENCE REPORT
[To accompany H.R. 7988]
The committee of eonference on the disagreeing votes of the two
Houses on the amendment of the Senate to the bill (H.R. 7988) 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, having met,
after full and free conference, have agreed to recommend and do
recommend to their respective Houses as follows:
That the House recede from its disagreement to the amendment of
the Senate and agree to the same with an amendment as follows:
In lieu of the matter proposed to be inserted by the Senate amend-
ment insert the following:
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.
TITLE I-REVISION 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;
57-010
0
2
3
(2) elimination of heart and blood vessel diseases as significant
(3) by inserting "and to the use of blood and blood products and
causes of disability and death could increase the average American's
the management of blood resources" after "diseases" in paragraph
life expectancy by about eleven years and could provide for annual
(4);
savings to the economy in lost wages, productivity, and cost of medical
(4) by inserting "and on the use of blood and blood products and
care of more than $40,000,000,000 per year;
the management of blood resources" after "diseases" in paragraph
(3) chronic lung diseases have been gaining steadily in recent
(5);
years as important causes of disability and death, with emphysema
(5) by striking out "heart diseases" in paragraph (6) and inserting
being among the fastest rising causes of death in the United States;
in lieu thereof "heart, blood vessel, lung, and blood diseases and the
(4) chronic respiratory diseases affect an estimated ten million
management of blood resources";
Americans, emphysema an estimated one million, chronic bronchitis
(6) by inserting "and to the use of blood and blood products and
an estimated four million, and asthma an estimated five million;
the management of blood resources" after "diseases" in paragraph
(5) thrombosis (the formation of blood clots in the vessels) may
(7); and
cause, directly or in combination with other problems, many deaths
(7) by inserting at the end of the section heading "AND IN THE
and disabilities from heart disease and stroke which can now be
MANAGEMENT OF BLOOD RESOURCES".
prevented;
(b) Section 412 is amended by striking out "National Heart and Lung
(6) blood and blood products are essential human resources whose
Advisory Council" and inserting in lieu thereof "National Heart, Lung,
value in saving life and promoting health cannot be assessed in terms
amd Blood Advisory Council".
of dollars;
SEC. 104. (a) Section 413(a) is amended-
(7) the provision of prompt and effective emergency medical
(1) by striking out "Disease" in the first sentence and inserting
services utilizing to the fullest extent possible advances in transporta-
in lieu thereof "Diseases and Blood Resources"; and
tion and communications and other electronic systems and specially
(2) by inserting "and blood resources" after "diseases" in such
trained professional and paraprofessional health care personnel can
sentence and in paragraph (7).
reduce substantially the number of fatalities and severe disabilities
(b) Section 413(b) is amended—
due to critical illnesses in connection with heart, blood vessel, lung,
(1) by striking out "calendar" each place it occurs in paragraph
and blood diseases;
(2) and inserting in lieu thereof "fiscal"; and
(8) blood diseases, including nutritional anemia, anemia due to
(2) by adding at the end of such paragraph the following: "Each
inherited abnormalities (such as sickle cell anemia and Cooley's
such plan shall contain (A) an estimate of the number and type of
anemia (thalassemia), anemias resulting from failure of the bone
personnel which will be required by the Institute to carry out the
marrow, hemorrhagic defects (a common cause of death in patients
Program during the five years with respect to which the plan is sub-
with leukemia and other malignancies, and of disability from inherited
mitted, and (B) recommendations for appropriations to carry out the
diseases such as hemophilia)), and malignancies of the lymph nodes
program during such five years".
and bone marrow, such as leukemia, have a devastating impact in
(c) Section 413(c)(1) is amended by striking out "fifty" and inserting
spite of recent advances, and constitute an important category of
in lieu thereof "one hundred".
illness that requires major attention; and
(d) Section 413(c) (2) is amended-
(9) the greatest potential for advancement against heart, blood
(1) by striking out "operate" and inserting in lieu thereof "operate,
vessel, lung, and blood diseases lies in the National Heart, Lung,
alter, renovate"; and
and Blood Institute, but advancement against such diseases depends
(2) by inserting "and blood resource" after "disease".
not only on the research programs of that Institute but also on the
(e) Section 413(d) is amended-
research programs of other research institutes of the National
(1) by striking out "Assistant Director for Health Information
Institutes of Health.
Programs" each place it occurs and inserting in lieu thereof "Assist-
(b) It is the purpose of this title to enlarge the authority of the National
ant Director for Prevention Education, and Control";
Heart, Lung, and Blood Institute in order to advance the national attack
(2) by striking out "and pulmonary" in the second sentence and
upon heart, blood vessel, lung, and blood diseases and to enlarge its
inserting in lieu thereof blood, and pulmonary" and by inserting
authority with respect to blood resources.
"and blood" after "pulmonary" in the third sentence; and
SEC. 102. Sections 411, 418(a) (6), and 419A(c) are each amended by
(3) by inserting "and blood resources" after "diseases" in the
striking out "National Heart and Lung Institute" and inserting in lieu
second sentence.
thereof "National Heart, Lung, and Blood Institute".
(f) The section heading of section 413 is amended by striking out
SEC. 103. (a) Section 412 is amended-
"DISEASE" and inserting in lieu thereof "DISEASES AND BLOOD RE-
(1) by inserting "and with respect to the use of blood and blood
SOURCES".
products and the management of blood resources" after "diseases" in
SEC. 105. Section 414(b) is amended (1) by striking out "and" after
the matter preceding paragraph (1);
"1974,", and (2) by inserting before the period a comma and the following:
(2) by inserting "and to the use of blood and blood products and
"$10,000,000 for fiscal year 1976, and $30,000,000 for fiscal year 1977".
the management of blood resources" before the semicolon at the end
of paragraph (1);
4
5
SEC. 106. (a) (1) Subsection (a) (1) (A) of section 415 is amended by-
(A) striking out "fifteen" and inserting in lieu thereof "ten", and
(c) The section heading of section 417 is amended by striking out
(B) striking out blood vessel, and blood diseases" and inserting
"AND LUNG" and inserting in lieu thereof ", LUNG, AND BLOOD".
in lieu thereof "diseases".
SEC. 108. Section 418 is amended-
(2) Subsection (a) (1) (B) of such section is amended by striking out
(1) by inserting "and to the use of blood and blood products and
"fifteen" and inserting in lieu thereof "ten".
the management of blood resources" after "diseases" in paragraphs
(3) Subsection (a) (1) of such section is amended-
(1), (2), (3), and (4) of subsection (a);
(A) by striking out "and" at the end of subparagraph (A),
(2) by redesignating paragraphs (4), (5), and (6) of subsection (a)
(B) by striking out the period at the end of subparagraph (B)
as paragraphs (5), (6), and (7), respectively, and by adding after para-
and inserting in lieu thereof "; and", and
graph (3) the following new paragraph:
(C) by inserting after subparagraph (B) the following new sub-
(4) recommend to the Secretary (A) areas of research in heart,
paragraph:
blood vessels, lung, and blood diseases and in the use of blood and
"(C) ten new centers for basic and clinical research into, training
blood products and the management of blood resources which it de-
in, and demonstration of, advanced diagnostic, prevention, and
termines should be supported by the awarding of contracts in order to
treatment methods (including methods of providing emergency
best carry out the purposes of this part, and (B) the percentage of the
medical services) for blood, blood vessel diseases, research in the use
budget of the Institute which should be expended for such contracts;";
of blood products, and research in the management of blood re-
and
sources.".
(3) (A) by amending paragraph (2) of subsection (b) to read as
(b) Section 415(a) is further amended-
follows:
(1) by inserting "and for research in the use of blood and blood
"(2) The Council shall submit a report to the Secretary for simultaneous
products and in the management of blood resources" after "diseases"
transmittal, not later than November 30 of each year, to the President and
in paragraph (1) (A);
to the Congress on the progress of the Program toward the accomplishment
(2) by striking out "chronic" in paragraph (1) (B);
of its objectives during the preceding fiscal year.".
(3) by striking out "paragraph (1) (A)" in paragraph (2) and
(B) For purposes of section 418(b) (2) of the Public Health
inserting in lieu thereof "paragraph (1)";
Service Act (as amended by subparagraph (A)), the period beginning
(4) by inserting pulmonary, and blood" before "diseases" in
July 1, 1975, and ending September 30, 1976, shall be considered
paragraph (2);
a fiscal year.
(5) by striking out "cardiovascular disease" in paragraph (2) (A)
(C) The amendment made by subparagraph (A) shall take effect
and inserting in lieu thereof "cardiovascular, pulmonary, and blood
as of January 1, 1976.
diseases"; and
SEC. 109. Section 419A is amended-
(6) by striking out "such disease" in subparagraphs (B), (C),
(1) by inserting "and projects with respect to the use of blood and
and (D) of paragraph (2) and inserting in lieu thereof "such
blood products and the management of blood resources" after "train-
diseases".
ing projects" in subsection (a);
(c) Section 415(b) is amended-
(2) by inserting "and into the use of blood and blood products and
(1) by inserting "the management of blood resources and" before
the management of blood resources" after "diseases" in subsection
"advanced"; and
(b);
(2) by amending the first sentence after paragraph (4) to read as
(3) by inserting "and for research and training in the use of blood
follows: "The aggregate of payments (other than payments for con-
and blood products and the management of blood resources" after
struction) made to any center under such an agreement for its costs
"diseases" in subsection (c);
(other than indirect costs) described in the first sentence may not
(4) by striking out "in amounts not to exceed $35,000" in para-
exceed $5,000,000 in any year, except that the aggregate of such
graph (1) of subsection (c) and inserting in lieu thereof "if the
payments in any year may exceed such amount to the extent that the
direct costs of such research and training do not exceed $35,000,
excess amount is attributable to increases in such year in appropriate
but only"; and
costs as reflected in the Consumer Price Index published by the
(5) by striking out "in amounts exceeding $35,000" in paragraph
Bureau of Labor Statistics.".
(2) of subsection (c) and inserting in lieu thereof "if the direct costs
(d) The section heading of section 415 is amended by inserting "AND
of such research and training exceed $35,000, but only".
BLOOD RESOURCES" after "DISEASES".
SEC. 110. Section 419B is amended-
SEC. 107. (a) Section (1) is amended by striking out "Director
(1) by striking out "and" after "1974," and by inserting before
of the Office of Science and Technology" and inserting in lieu thereof
the period at the end of the first sentence a comma and the following:
"Director of the National Science Foundation".
$$339,000,000 for fiscal year 1976, and $373,000,000 for fiscal year
(b) Section 417 is amended by striking out "National Heart and Lung
1977"; and
Advisory Council" in subsection (a) and in subsection (b) (3) and insert-
(2) by striking out "diseases of the blood" and inserting in lieu
ing in lieu thereof "National Heart, Lung, and Blood Advisory Council".
thereof "blood diseases and blood resources".
6
7
SEC. 111. (a) Section 301 is amended by striking out "heart diseases"
in paragraphs (c) and (h) and inserting in lieu thereof "heart, blood
"(3) The National Academy of Sciences or other group or association
vessel, lung, and blood diseases and blood resources".
conducting the study required by subsection (a) shall conduct such study
(b) Section 301 is amended by striking out "National Heart and Lung
in consultation with the Director of the National Institutes of Health."
Advisory Council" in paragraphs (c) and (h) and inserting in lieu
SEC. 205. Subsection (c) of section 473 is amended by striking out
thereof "National Heart, Lung, and Blood Advisory Council".
"March 31" and inserting in lieu thereof "September 30".
SEC. 112. The title of Part B of title IV is amended to read as follows:
TITLE III-DISCLOSURE OF RESEARCH INFORMATION
"PART B-NATIONAL HEART, LUNG, AND BLOOD INSTITUTE".
SEC. 301. (a) (1) The President's Biomedical Research Panel (estab-
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
lished by section 201 of the National Cancer Act Amendments of 1974
(Public Law 93-352)) and the National Commission for the Protection
SEC. 201. (a) (1) Subsection (a)(1)(A)(i) of section 472 is amended
of Human Subjects of Biomedical and Behavioral Research (established
(A) by striking out "in matters" and inserting in lieu thereof "or under
by section 201 of the National Research Act (Public Law 93-348)) shall
programs administered by the Division of Nursing of the Health Resources
each conduct an investigation and study of the implication of the disclosure
Administration, in matters", and (ii) by inserting before "are directed"
to the public of information contained in research protocols, research
the following: "or Division of Nursing".
hypotheses, and research designs obtained by the Secretary of Health,
(2) Subsections (a) (1) (A) (iii) and (a) (1) (B) of such section are each
Education, and Welfare (hereinafter in the subsection referred to as the
amended by striking out "non-Federal".
"Secretary") in connection with an application or proposal submitted,
(b) Subsection (c)(1)(A)(i) of such section is amended by striking out
during the period beginning January 1, 1975, and ending December 31,
"health research or teaching" and inserting in lieu thereof "health research
1975, to the Secretary for a grant, fellowship, or contract under the Public
or teaching or any combination thereof which is in accordance with usual
Health Service Act. In making such investigation and study the Panel
patterns of academic employment".
and the Commission shall each determine the following:
(c) Subsection (c) (2) (A) of such section is amended by striking out
(A) The number of requests made to the Secretary for the disclosure
"health research or teaching" and inserting in lieu thereof "health re-
of information contained in such research protocols, hypotheses, and
search or teaching or any combination thereof which is in accordance with
designs and the interests represented by the persons for whom such
the usual patterns of academic employment".
requests were made.
(d) The first sentence of subsection (d) of such section is amended by
(B) The purposes for which information disclosed by the Secretary
inserting a comma before the period and the following: "$165,000,000 for
pursuant to such requests was used.
fiscal year 1976, and $185,000,000 for fiscal year 1977".
(C) The effect of the disclosure of such information on-
SEC. 202. (a) Subsection (a) (1)(A) (i) of section 472 is amended by
(i) proprietary interests in the research protocol, hypothesis,
striking out "the disease or (diseases) or other health problems to which
or design from which such information was disclosed and on
the activities of the Institutes and Administration are directed" and insert-
patent rights;
ing in lieu thereof "diseases or other health problems".
(ii) the ability of peer review systems to insure high quality
(b) Subsection (b)(2) of section 472 is amended by striking out "to
federally funded research; and
the entities of the National Institutes of Health and the Alcohol, Drug
(iii) the (I) protection of the public against research which
Abuse, and Mental Health Administration" and inserting in lieu thereof
presents an unreasonable risk to human subjects of such re-
"within the Department of Health, Education, and Welfare".
search and (II) the adequacy of informed consent procedures.
SEC. 203. (a) (1) Subparagraph (A) of the first paragraph (4) of sub-
(2) (A) Not later than May 31, 1976, the Panel shall complete the inves-
section (c) of section 472 is amended by striking out "and the interest on
tigation and study required to be made by the Panel by paragraph (1), and,
such amount" down through and including "was made".
not later than June 30, 1976, the Panel shall submit to the Committee on
(2) The last sentence of subparagraph (B) of such paragraph is
Interstate and Foreign Commerce of the House of Representatives and the
amended by striking out "at the same rate as that fixed by the Secretary of
Committee on Labor and Public Welfare of the Senate a report on such
the Treasury under subparagraph (A) to determine the amount due the
investigation and study. The report shall contain such recommendations
United States" and inserting in lieu thereof "at a rate fixed by the Secre-
for legislation as the Panel deems appropriate.
tary of the Treasury after taking into consideration private consumer
(B) Not later than November 30, 1976, the Commission shall complete
rates of interest prevailing on the date the United States becomes entitled
the investigation and study required to be made by the Commission by
to such amount".
paragraph (1), and, not later than December 31, 1976, the Commission
(b) The amendments made by subsection (a) shall apply with respect
shall submit to the Committee on Interstate and Foreign Commerce of the
to National Research Awards under section 472 which are made from
House of Representatives and the Committee on Labor and Public Welfare
appropriations for fiscal years ending on or after June 30, 1975.
of the Senate a report on such investigation and study. The report shall
SEC. 204. Section 473(b) is amended by adding after paragraph (2)
contain such recommendations for legislation as the Commission deems
the following new paragraph:
appropriate.
(b) Section 211 of the National Research Act (Public Law 93-348)
is amended by striking out "July 1, 1976" and inserting in lieu thereof
"January 1. 1977".
8
9
TITLE IV-GENETIC DISEASES
and (4) the development of counseling and testing programs and other
SEC. 401. This title may be cited as the "National Sickle Cell Anemia,
programs for the diagnosis, control, and treatment of genetic diseases. In
Cooley's Anemia, Tay-Sachs, and Genetic Diseases Act".
making grants and entering into contracts for projects described in
SEC. 402. In order to preserve and protect the health and welfare of all
clause (1) of the preceding sentence, the Secretary shall give priority to
citizens, it is the purpose of this title to establish a national program to
applications for such grants or contracts which are submitted for research
provide for basic and applied research, research training, testing, counsel-
on sickle cell anemia and for research on Cooley's anemia.
ing, and information and education programs with respect to genetic
diseases, including sickle cell anemia, Cooley's anemia, Tay-Sachs disease,
"VOLUNTARY PARTICIPATION
cystic fibrosis, dysautonomia, hemophilia, retinitis pigmentosa, Hunt-
"SEC. 1103. The participation by any individual in any program or
ington's chorea, and muscular dystrophy.
portion thereof under this part shall be wholly voluntary and shall not
SEC. 403. (a) Title XI is amended by striking out parts A and B and
inserting in lieu thereof the following:
be a prerequisite to eligibility for or receipt of any other service or assist-
ance from, or to participation in, any other program.
"PART A-GENETIC DISEASES
"APPLICATIONS; ADMINISTRATION OF GRANTS AND CONTRACT PROGRAMS
"TESTING AND COUNSELING PROGRAMS AND INFORMATION
"SEC. 1104. (a) A grant or contract under this part may be made upon
AND EDUCATION PROGRAMS
application submitted to the Secretary at such time, in such manner,
"SEC. 1101. (a) (1) The Secretary, through an identifiable admin-
and containing and accompanied by such information, as the Secretary
istrative unit within the Department of Health, Education, and Welfare,
may require. Each applicant shall-
may make grants to public and nonprofit private entities, and may enter
"(1) provide that the programs and activities for which assistance
into contracts with public and private entities, for projects to establish and
under this part is sought will be administered by or under the super-
operate voluntary genetic testing and counseling programs primarily in
vision of the applicant;
conjunction with other existing health programs, including programs
"(2) provide for strict confidentiality of all test results, medical
assisted under title V of the Social Security Act.
records, and other information regarding testing, diagnosis, counsel-
"(2) The Secretary shall carry out, through an identifiable administra-
ing, or treatment of any person treated, except for (A) such informa-
tive unit within the Department of Health, Education, and Welfare, a
tion as the patient (or his guardian) gives informed consent to be
program to develop information and educational materials relating to
released, or (B) statistical data compiled without reference to the
genetic diseases and to disseminate such information and materials to
identity of any such patient;
persons providing health care, to teachers and students, and to the public
"(3) provide for community representation where appropriate
generally in order to most rapidly make available the latest advances in
in the development and operation of voluntary genetic testing or
the testing, diagnosis, counseling, and treatment of individuals respecting
counseling programs funded by a grant or contract under this part;
genetic diseases. The Secretary may, under such program, make grants
"(4) in the case of an applicant for a grant or contract under
to public and nonprofit private entities and enter into contracts with
section 1101 (a) (1) for the delivery of services, provide assurances
public and private entities and individuals for the development and
satisfactory to the Secretary that (A) the services for community-wide
dissemination of such materials.
testing and counseling to be provided under the program for which
"(b) For the purpose of making payments pursuant to grants and con-
the application is made (i) will take into consideration widely
tracts under this section, there are authorized to be appropriated $30,000,-
prevalent diseases with a genetic component and high-risk population
000 for fiscal year 1976, $30,000,000 for fiscal year 1977, and $30,000,000
groups in which certain genetic diseases occur, and (ii) where appro-
or fiscal year 1978.
priate will be directed especially but not exclusively to persons who
are entering their child-producing years, and (B) appropriate
"RESEARCH PROJECT GRANTS AND CONTRACTS
arrangements will be made to provide counseling to persons found to
have a genetic disease and to persons found to carry a gene or chro-
"SEC. 1102. In carrying out section 301, the Secretary may make grants
mosome which may cause a deleterious effect in their offspring; and
to public and nonprofit private entities, and may enter into contracts with
"(5) establish fiscal control and fund accounting procedures as
blic and private entities and individuals, for projects for (1) basic or
may be necessary to assure proper disbursement of and accounting of
ap plied research leading to the understanding, diagnosis, treatment, and
Federal funds paid to the applicant under this part.
control of genetic diseases, (2) planning, establishing, demonstrating, and
"(b) In making any grant or entering into any contract for testing and
developing special programs for the training of genetic counselors, social
counseling programs under section 1101, the Secretary shall (1) take into
and behavioral scientists, and other health professionals, (3) the develop-
account the number of persons to be served by the program supported by
ment of programs to educate practicing physicians, other health profes-
such grant or contract and the extent to which rapid and effective use will
sionals, and the public regarding the nature of genetic processes, the in-
be made of funds under the grant or contract; and (2) give priority to
heritance patterns of genetic diseases, and the means, methods, and
programs operating in areas which the Secretary determines have the
facilities available to diagnose, control, counsel, and treat genetic diseases,
10
11
greatest number of persons who will benefit from and are in need of the
services provided under such programs.
"(C) the Secretary may not limit, under section 201(n), 401, or
"(c) In making grants and entering into contracts for any fiscal year
403, the combination or number of any synthetic or natural-
under section 301 for projects described in section 1102 or under section
"(i) vitamin,
"(ii) mineral, or
1101 the Secretary shall give special consideration to applications from
entities that received grants from, or entered into contracts with, the
"(iii) other ingredient of food,
Secretary for the preceding fiscal year for the conduct of comprehensive
within a food to which this section applies.
sickle cell centers or sickle cell screening and education clinics.
"(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
"PUBLIC HEALTH SERVICE FACILITIES
in the treatment or management of specific diseases or disorders, by
children, or by pregnant or lactating women. For purposes of this sub-
"SEC. 1105. The Secretary shall establish a program within the Service
paragraph, the term 'children' means individuals who are under the age
to provide voluntary testing, diagnosis, counseling, and treatment of indi-
of twelve years.
viduals respecting genetic diseases. Services under such program shall be
"(b)(1) A food to which this section applies shall not be deemed under
made available through facilities of the Service to persons requesting such
section 403 to be misbranded solely because its label bears, in accordance
services, and the program shall provide appropriate publicity of the
with section 403(i) (2), all the ingredients in the food or its advertising
availability and voluntary nature of such services.
contains references to ingredients in the food which are not vitamins or
minerals.
"REPORTS
"(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
"SEC. 1106. (a) The Secretary shall prepare and submit to the Presi-
of a list of all the ingredients of such food, and (ii) unless such ingredients
dent for transmittal to the Congress on or before April 1 of each year a
are listed in accordance with applicable regulations under section 403.
comprehensive report on the administration of this part.
To the extent that compliance with clause (i) of this subparagraph is
"(b) The report required by this section shall contain such recommen-
impracticable or results in deception or unfair competition, exemptions
dations for additional legislation as the Secretary deems necessary."
shall be established by regulations promulgated by the Secretary.
(b) (1) Section 1121 is amended by striking out "ending June
"(B) Notwithstanding the provisions of subparagraph (A), the labeling
30," each place it occurs.
and advertising for any food to which this section applies may not give
(2) Parts C and D are redesignated as parts B and C, respectively.
prominence to or emphasize ingredients which are not-
(3) The heading of such title is amended to read as follows:
"(i) vitamins,
"(ii) minerals, or
"TITLE XI-GENETIC DISEASES, HEMOPHILIA PRO-
"(iii) represented as a source of vitamins or minerals.
GRAMS, AND SUDDEN INFANT DEATH SYNDROME."
"(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-
(c) The amendments made by subsections (a) and (b) shall take effect
"(A) which is or contains any natural or synthetic vitamin or
July 1, 1976.
mineral, and
"(B) which-
TITLE V-FEDERAL FOOD, DRUG, AND COSMETIC ACT
"(i) is intended for ingestion in tablet, capsule, or liquid
AMENDMENTS
form, or
"(ii) if not intended for ingestion in such a form, does not
SEC. 501 (a) Chapter IV of the Federal Food, Drug, and Cosmetic Act
simulate and is not represented as conventional food and is not
is amended by adding after section 410 (21 U.S.C. 349) the following
represented for use as a sole item of a meal or of the diet.
new section:
"(2) For purposes of paragraph (1)(B)(i), a food shall be considered
"VITAMINS AND MINERALS
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
"SEC. 411. (a) (1) Except as provided in paragraph (2)-
drops or similar small units of measure.
"(A) the Secretary may not establish, under section 201(n), 401,
(3) For purposes of paragraph (1) and of section 403 (j) insofar as
or 403, maximum limits on the potency of any synthetic or natural
that section is applicable to food to which this section applies, the term
vitamin or mineral within a food to which this section applies;
'special dietary use' as applied to food used by man means a particular
"(B) the Secretary may not classify any natural or synthetic vita-
use for which a food purports or is represented to be used, including but
min or mineral (or combination thereof) as a drug solely because it
not limited to the following:
exceeds the level of potency which the Secretary determines is nu-
"(A) Supplying a special dietary need that exists by reason of
tritionally rational or useful;
a physical, physiological, pathological, or other condition, including
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.
12
13
"(B) Supplying a vitamin, mineral, or other ingredient for use
by man to supplement his diet by increasing the total dietary intake.
"(B) with respect to a food's advertising which the Secretary
"(C) Supplying a special dietary need by reason of being a food
determines causes the food to be so misbranded,
for use as the sole item of the diet.".
the Secretary shall, in accordance with paragraph (2), notify in writing
(b) The Secretary of Health, Education, and Welfare shall amend
the Federal Trade Commission of the action the Secretary proposes to
any regulation promulgated under the Federal Food, Drug, and Cosmetic
take respecting such food or advertising.
Act which is inconsistent with section 411 of such Act (as added by
"(2) The notice required by paragraph (1) shall-
subsection (a)) and such amendments shall be promulgated in accordance
"(A) contain (i) a description of the action the Secretary proposes
with section 553 of title 5, United States Code.
to take and of the advertising which the Secretary has determined
SEC. 502. (a) (1) Section 403(a) of the Federal Food, Drug, and
causes a food to be misbranded, (ii) a statement of the reasons for the
Cosmetic Act (21 U.S.C. 343(a)) is amended (A) by inserting "(1)"
Secretary's determination that such advertising has caused such food
after "If", and (B) by inserting before the period at the end a comma and
to be misbranded, and
the following: "or (2) in the case of a food to which section 411 applies,
"(B) be accompanied by the records, documents, and other written
its advertising is false or misleading in a material respect or its labeling
materials which the Secretary determines supports his determination
is in violation of section 411(b)(2)".
that such food is misbranded because of such advertising.
(2) (A) Section 201 (n) of such Act is amended by inserting "or advertis-
"(b) (1) If the Secretary notifies the Federal Trade Commission under
ing" after "labeling" each time it occurs.
subsection (a) of action proposed to be taken under chapter III with
(B) Section 303 of such Act is amended by adding at the end the follow-
respect to a food or food advertising and the Commission notifies the
ing new subsection:
Secretary in writing, within the 30-day period beginning on the date of
"(d) No person shall be subject to the penalties of subsection (a) of this
the receipt of such notice, that-
section for a violation of section 301 involving misbranded food if the
'(A) it has initiated under the Federal Trade Commission Act an
violation exists solely because the food is misbranded under section
investigation of such advertising to determine if it is prohibited by
403(a)(2) because of its advertising, and no person shall be subject to the
such Act or any order or rule under such Act,
penalties of subsection (b) of this section for such a violation unless
"(B) it has commenced (or intends to commence) a civil action
the violation is committed with the intent to defraud or mislead."
under section 5, 13, or 19 with respect to such advertising or the
(C) Section 304(a) of such Act (21 U.S.C. 334(a)) is amended by
Attorney General has commenced (or intends to commence) a civil
adding after paragraph (2) the following new paragraph:
action under section 5 with respect to such advertising,
"(3) (A) Except as provided in subparagraph (B), no libel for condemna-
"(C) it has issued and served (or intends to issue and serve) a
tion may be instituted under paragraph (1) or (2) against any food which-
complaint under section 5(b) of such Act respecting such advertising,
"(i) is misbranded under section 403(a)(2) because of its adver-
or
tising, and
"(D) pursuant to section 16(b) of such Act it has made a certifica-
"(ii) is being held for sale to the ultimate consumer in an estab-
tion to the Attorney General respecting such advertising,
lishment other than an establishment owned or operated by a manu-
the Secretary may not, except as provided by paragraph (2), initiate the
facturer, packer, or distributor of the food.
action described in the Secretary's notice to the Federal Trade Commission.
"(B) A libel for condemnation may be instituted under paragraph (1)
"(2) If, before the expiration of the 60-day period beginning on the
or (2) against a food described in subparagraph (A) if-
date the Secretary receives a notice described in paragraph (1) from the
"(i) (I) the food's advertising which resulted in the food being
Federal Trade Commission in response to a notice of the Secretary under
misbranded under section 403(a) (2) was disseminated in the estab-
subsection (a)-
lishment in which the food is being held for sale to the ultimate
"(A) the Commission or the Attorney General does not commence
consumer,
a civil action described in subparagraph (B) of paragraph (1) of
"(II) such advertising was disseminated by, or under the direction
this subsection respecting the advertising described in the Secretary's
of, the owner or operator of such establishment, or
notice,
"(III) all or part of the cost of such advertising was paid by such
"(B) the Commission does not issue and serve a complaint de-
owner or operator; and
"(ii) the owner or operator of such establishment used such
scribed in subparagraph (C) of such paragraph respecting such
advertising, or
advertising in the establishment to promote the sale of the food.'
"(C) the Commission does not (as described in subparagraph (D)
(b) Chapter VII of such Act is amended by adding after section 706
(21 U.S.C. 376) the following new section:
of such paragraph) make a certification to the Attorney General re-
specting such advertising, or, if the Commission does make such a
"ADVERTISING OF CERTAIN FOODS
certification to the Attorney General respecting such advertising,
the Attorney General, before the expiration of such period, does
"SEC. 707. (a) (1) Except as provided in subsection (c), before the
not cause appropriate criminal proceedings to be brought against
Secretary may initiate any action under chapter III-
such advertising,
"(A) with respect to any food which the Secretary determines is
the Secretary may, after the expiration of such period, initiate the action
misbranded under section 403(a) (2) because of its advertising, or
described in the notice to the Commission pursuant to subsection (a). The
Commission shall promptly notify the Secretary of the commencement by
S.Rept. 94-743 2
14
15
the Commission of such a civil action, the issuance and service by it of
(2) The fourth sentence of section 434(b) of such Act is amended by
such a complaint, or the causing by the Attorney General of criminal
striking out "and related musculoskeletal diseases".
proceedings to be brought against such advertising.
(3) Section 434(e) of such Act is amended by striking out "and related
"(c) The requirements of subsections (a) and (b) do not apply with
musculoskeletal diseases (hereinafter in this part collectively referred to
respect to action under chapter III with respect to any food or food
as 'arthritis')'.
advertising if the Secretary determines that such action is required to
(b) Section 438 of such Act is amended by-
eliminate an imminent hazard to health.
(1) inserting "the" before "health" the first time it appears in
"(d) For the purpose of avoiding unnecessary duplication, the Secre-
the first sentence of subsection (a); and
tary shall coordinate any action taken under chapter III because of
(2) inserting "established" after "bank" in the second sentence
advertising which the Secretary determines causes a food to be misbranded
of subsection (a).
with any action of the Federal Trade Commission under the Federal
(c) Section 439 of such Act is amended by-
Trade Commission Act with respect to such advertising."
(1) inserting "new and existing" before "centers" in the first
(c) The amendments made by subsection (a) shall take effect 180 days
sentence of subsection (a);
after the date of the enactment of this Act.
(2) striking out "$13,000,000" and inserting in lieu thereof
"$8,000,000", and striking out "$15,000,000" and inserting in
TITLE VI-ARTHRITIS ACT AMENDMENTS
lieu thereof "$20,000,000" in subsection (h); and
(3) redesignating subsections (e), (f), (g), and (h) as subsections
SEC. 601. This title may be cited as the "National Arthritis Act
(d), (e), (f), and (g), respectively.
Technical Amendments of 1976".
SEC. 602. (a) Section 2 of the National Arthritis Act of 1974 (Public
TITLE VII-DIABETES PLAN
Law 93-640) (hereinafter in this section referred to as the "Act") is
amended by-
SEC. 701. Section 3(i) (2) of the National Diabetes Mellitus Research
(1) inserting "(a)" after "SEC. 2.";
and Education Act (42 U.S.C. 289c-2) is amended to read as follows:
(2) inserting a comma and "including $2,500,000,000 in medical
"(2) The Commission shall cease to exist after September 30, 1976.".
expenses," after "$9,200,000,000" in paragraph (3); and
(3) inserting a new subsection (b) at the end thereof as follows:
TITLE VIII-HEALTH SERVICES
"(b) It is therefore the purpose of this Act to provide for-
"(1) the formulation of a long-range plan-
AMBULATORY SURGICAL SERVICES
"(A) to expand and coordinate the national research, treat-
ment, and control effort against arthritis;
SEC. 801. (a) Section 319(a) (7) is amended by-
"(B) to advance educational activities for patients, profes-
(1) inserting after subparagraph (K) the following new sub-
sional and allied health personnel, and the public which will
paragraph:
alert the citizens of the United States to the early indications of
"(L) ambulatory surgical services;" and
arthritis; and
(2) redesignating subparagraphs (L) and (M) as subparagraph.
"(C) to emphasize the significance of early detection and
(M) and (N), respectively.
proper control of these diseases and of the complications which
(b) Section 330(b) (2) is amended by-
may evolve from them;
(1) inserting after subparagraph (K) the following new sub-
"(2) the establishment and support of programs to develop new
paragraph:
and improved methods of arthritis screening, detection, prevention,
"(L) ambulatory surgical services;" and
and referral;
(2) redesignating subparagraphs (L) and (M) as subparagraphs
"(3) the establishment of a central arthritis screening and detection
(M) and (N), respectively.
data bank; and
"(4) the development, modernization, and operation of centers for
TITLE IX-INDIAN HEALTH SERVICE
arthritis screening, detection, diagnosis, prevention, control, treatment,
education, rehabilitation, and research and training programs.".
SEC. 901. Section 225 is amended by adding at the end thereof the fol-
(b) Section 3 of the Act is amended by striking out "chief medical
lowing new subsection-
officer" and inserting in lieu thereof "Chief Medical Director" in sub-
"(j) Notwithstanding any other provision of law, the Secretary may,
section (b) (4).
where he deems advisable, allow the Indian Health Service to utilize non-
(c) The section heading for section 4 of the Act is amended by striking
profit recruitment agencies to assist in obtaining personnel for the Public
out "DEMONSTRATION" after "COMMITTEE,".
Health Service.".
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
TITLE X-APPOINTMENT OF ADVISORY COMMITTEES
'arthritis')' after "musculoskeletal diseases".
SEC. 1001. All appointments to advisory committees established to assist
in implementing the Public Health Service Act, the Mental Retardation
16
17
Facilities and Community Mental Health Centers Construction Act of
(b) Section 1613 of such Act is amended by striking out "1510" and
1963, and the Comprehensive Alcohol Abuse and Alcoholism Prevention,
inserting in lieu thereof "1610".
Treatment, and Rehabilitation Act of 1970, shall be made without regard
(c) The last sentence of section 1631 of such Act is repealed.
to political affiliation.
SEC. 1107. (a) Section 132(a)(1)(A) of the Developmental Dis-
abilities Services and Facilities Construction Act (42 U.S.C. 6062)
TITLE XI-MISCELLANEOUS PROVISIONS
(hereinafter in this section referred to as the "Act") is amended by striking
SEC. 1101. Section 212 of the Public Health Service Act is amended by
out "134" and inserting in lieu thereof "133".
adding after subsection (d) the following new subsection:
(b) Section 134(b)(1) of the Act is amended by striking out "134"
"(e) Active service of commissioned officers of the Service shall be
and inserting in lieu thereof "133".
deemed to be active military service in the Armed Forces of the United
(c) Section 134(b)(1) of the Act is amended by striking out "136"
States for the purposes of all rights, privileges, immunities, and benefits
and inserting in lieu thereof "135".
now or hereafter provided under the Soldiers' and Sailors' Civil Relief
(d) Section 301(a) of the Developmentally Disabled Assistance and
Act of 1940 (50 App. U.S.C. 501 et seq.)."
Bill of Rights Act is amended by striking out "101(7)" and inserting in
SEC. 1102. (a) The second paragraph (4) of subsection (c) of section
lieu thereof "102(7)".
472 of the Public Health Service Act is redesignated as paragraph (5).
And the Senate agree to the same.
(b) Section 507 of the Public Health Service Act is amended by striking
HARRISON A. WILLIAMS, JR.,
out "hospitals of the Service, of the Veterans' Administration, or of the
CLAIBORNE PELL,
Bureau of Prisons of the Department of Justice, and to Saint Elizabeths
EDWARD M. KENNEDY,
Hospital, except that grants to such" and insert in lieu thereof "Federal
WALTER F. MONDALE,
institutions, except that grants to".
ALAN CRANSTON,
SEC. 1103. Title IV of the Public Health Service Act is amended by
WILLIAM D. HATHAWAY,
adding after section 475 the following new section:
JOHN A. DURKIN,
THOMAS F. EAGLETON,
"VISITING SCIENTIST AWARDS
GAYLORD NELSON,
JACOB K. JAVITS,
"SEC. 476. (a) The Secretary may make awards (referred to as 'Visiting
RICHARD S. SCHWEIKER,
Scientist Awards') to outstanding scientists who agree to serve as visiting
ROBERT TAFT,
scientists at institutions of post-secondary education which have significant
J. GLENN BEALL, JR.,
enrollments of disadvantaged students. Visiting Scientist Awards shall
ROBERT T. STAFFORD,
be made by the Secretary to enable the faculty and students of such insti-
PAUL LAXALT,
tutions to draw upon the special talents of scientists from other institutions
Managers on the Part of the Senate.
for the purpose of receiving guidance, advice, and instruction with regard
HARLEY O. STAGGERS,
to research, teaching, and curriculum development in the biomedical and
PAUL G. ROGERS,
behavioral sciences and such other aspects of these sciences as the Secretary
DAVID E. SATTERFIELD,
shall deem appropriate.
JAMES W. SYMINGTON,
"(b) The amount of each Visiting Scientist Award shall include such
JAMES H. SCHEUER,
sum as shall be commensurate with the salary or remuneration which the
TIM LEE CARTER,
individual receiving the award would have been entitled to receive from the
JAMES T. BROYHILL,
institution with which the individual has, or had, a permanent or im-
Managers on the Part of the House.
mediately prior affiliation. Eligibility for and terms of Visiting Scientist
Awards shall be determined in accordance with regulations the Secretary
shall prescribe."
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".
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".
(b) Section 740(b)(4) of such Act is amended by striking out "1975"
and inserting in lieu thereof "1976".
SEC. 1106. Section 1511(b)(5) of the Public Health Service Act is
amended by striking out "1535" and inserting in lieu thereof "1536".
JOINT EXPLANATORY STATEMENT OF THE COMMITTEE
OF CONFERENCE
The managers on the part of the House and the Senate at the con-
ference on the disagreeing votes of the two Houses on the amendment
of the Senate to the bill (H.R. 7988) 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 Na-
tional Research Service Awards, and to establish a national program
with respect to genetic diseases; and to require a study on the release
of research information, submit the following joint statement to the
House and the Senate in explanation of the effect of the action agreed
upon by the managers and recommended in the accompanying con-
ference report:
The Senate amendment struck out all of the House bill after the
enacting clause and inserted a substitute text.
The House recedes from its disagreement to the amendment of the
Senate with an amendment which is a substitute for the House bill
and the Senate amendment. The differences between the House bill,
the Senate amendment, and the substitute agreed to in conference are
noted below, except for clerical corrections, conforming changes made
necessary by agreements reached by the conferees, and minor drafting
and clarifying changes.
TITLE I-REVISION OF NATIONAL HEART AND
LUNG INSTITUTE PROGRAMS
FINDINGS
The Senate amendment, in a provision not in the House bill, speci-
fied Congressional findings, with respect to the impact of diseases of
the heart, lung and blood vessels and blood disease and the need for
the proposed legislation.
The conference substitute conforms to the Senate amendment, with
technical changes.
ADVISORY COUNCIL
The House bill changed the name of the National Heart Lung Ad-
visory Council to the National Heart, Lung and Blood Advisory
Council.
The Senate amendment contained no comparable provision.
The conference substitute conforms to the House bill.
EXPERTS AND CONSULTANTS
Existing law authorizes the Director of the National Heart and
Lung Institute to obtain the services of not more than 50 experts and
consultants.
(19)
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21
The House amendment increased this number to 100.
REPORT OF THE ADVISORY COUNCIL
The Senate amendment contained no comparable provision.
The conference substitute conforms to the House bill.
Both the House bill and the Senate amendment required that the
Advisory Council submit by November 30 of each year a report to the
ASSISTANT DIRECTOR
Secretary for simultaneous transmittal to the President and to the
Congress on the progress of the National Heart, Blood Vessel, Lung,
Existing law establishes within the National Heart and Lung Insti-
and Blood Disease Program during the preceding fiscal year. However,
tute (redesignated as the National Heart, Lung and Blood Institute
the Senate amendment stipulates that for purposes of this require-
under provisions of both the House bill and the Senate amendment)
ment, the period beginning July 1, 1975 and ending September 30,
an Assistant Director for Health Information Programs.
1976 shall be considered a fiscal year and the House amendment con-
The House bill changed the name to Assistant Director for Preven-
tains no comparable provision.
tion, Education, and Control.
The conference substitute conforms to the Senate amendment.
The Senate amendment changed the name to Assistant Director for
Prevention and Information.
AUTHORIZATIONS FOR RESEARCH
The conference substitute conforms to the House bill.
The House bill authorized appropriations of $340 million for fiscal
AUTHORIZATION FOR PREVENTION AND CONTROL PROGRAMS
year 1976 and $375 million for fiscal year 1977 for carrying out the
programs of the redesignated National Heart, Lung, and Blood
The House bill authorized appropriations of $20 million for fiscal
Institute (except prevention and control programs).
year 1976 and $30 million for fiscal year 1977 for heart, blood vessel,
The Senate amendment authorized $338 million for fiscal year 1976
lung, and blood disease control programs.
and $372 million for fiscal year 1977 for such purposes.
The Senate amendment authorized appropriations of $10 million for
The conference substitute authorized $339 million for fiscal year
fiscal year 1976 and $25 million for fiscal year 1977 for such programs.
1976 and $373 million for fiscal year 1977 for such purposes.
The conference substitute authorizes $10 million for fiscal year 1976
and $30 million for fiscal year 1977 for such programs.
TITLE II-NATIONAL RESEARCH SERVICE AWARDS
CENTERS
AUTHORIZATIONS
Existing law authorizes the development of fifteen centers for re-
The House bill authorized appropriations of $175 million for fiscal
search, training, and demonstrations respecting heart, blood vessel,
year 1976 and $200 million for fiscal year 1977 for payments for
and blood diseases, and fifteen such centers for chronic lung diseases.
National Research Services Awards.
The House bill increased the responsibilities of the heart, blood
The Senate amendment authorized $160 million for fiscal year 1976
vessel, and blood disease centers to include research in the use of
and $176 million for fiscal year 1977 for such purposes.
blood and blood products and in the management of blood resources.
The conference substitute authorizes $165 million for fiscal year 1976
Further, the House bill expanded the responsibilities of the lung
and $185 million for fiscal year 1977 for such purposes.
disease centers by deleting the word "chronic."
The Senate amendment authorized the development of ten centers
ACCRUAL OF INTEREST
for research, training, and demonstrations respecting heart diseases;
ten such centers for chronic lung diseases; and ten such centers for
Under existing law, interest accrues on National Research Service
blood, blood vessel diseases, research in the use of blood products, and
Awards from the time the award is made in instances in which recip-
research in the management of blood resources.
ients fail to fulfill applicable service requirements.
The conference substitute conforms to the Senate amendment, ex-
The House bill changed existing law to make interest on the award
cept that it authorizes the development of ten centers for lung diseases,
computed from the time the United States becomes entitled to recover
as opposed to chronic lung diseases.
all or part of the award.
The Senate bill contained no comparable provision.
FUNCTIONS OF THE ADVISORY COUNCIL
The conference substitute conforms to the House bill.
The House bill added to the existing authority of the National
STUDY RESPECTING BIOMEDICAL AND BEHAVIORAL RESEARCH
Heart, Lung, and Blood Advisory Council the prerogative to recom-
PERSONNEL
mend to the Secretary of Health, Education, and Welfare areas of
research conducted or supported by the newly designated National
Under existing law, the Secretary is to annually submit a study
Heart, Lung, and Blood Institute which the Council determines should
respecting biomedical and behavioral research personnel.
be supported by the awarding of contracts and the percentage of the
The Senate amendment changed the date for submission of the
budget of the Institute which should be expended for such contracts.
report to September 30, and the House bill contained no comparable
The Senate amendment contained no comparable provision.
The conference substitute conforms to the House bill.
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23
provision. The House bill required that the entity conducting the
TESTING AND COUNSELING PROGRAMS AND
study conduct such study in consultation with the Director of the
INFORMATION AND EDUCATION PROGRAMS
National Institutes of Health.
The conference substitute conforms to the changes made in existing
The house bill required that testing and counseling programs be
law by both the House bill and the Senate amendment.
established and operated primarily in conjunction with other existing
health programs, including programs established under title X of the
TITLE III-DISCLOSURE OF RESEARCH INFORMATION
Public Health Service Act (family planning programs) and under
title V of the Social Security Act (maternal and child health programs).
The House bill contained a provision which required the President's
The Senate amendment contained comparable requirements, except
Biomedical Research Panel to conduct an investigation and study of
that it did not specify programs under title X of the Public Health
the implication of disclosure to the public of information contained in
Service Act or under title V of the Social Security Act.
research protocols, research hypotheses, and research designs ob-
The conference substitute conforms to the House bill, except that
tained by the Secretary in conjunction with an application or proposal
only programs assisted under title V of the Social Security Act are
for a grant, fellowship, or contract under the Public Health Service
specified.
Act and to submit a report on the investigation and study to the
The Senate amendment further provided that a priority in the
House Committee on Interstate and Foreign Commerce and the
awarding of grants and contracts for genetic disease counseling and
Senate Committee on Labor and Public Welfare. The House bill also
testing programs was to be given to projects which are recipients of
included a provision which deferred, from July 1, 1976 to January 1,
awards for sickle cell anemia testing and counseling programs on the
1977, the establishment of the National Advisory Council for the
date of enactment. There was no similar provision in the House bill.
Protection of Subjects of Biomedical and Behavioral Research.
The conference substitute conforms to the Senate amendment with
The Senate amendment contained no comparable provisions.
technical amendments.
The conference substitute conforms to the House bill, except that
The House bill authorized $20 million for each of fiscal years 1976
the National Commission for the Protection of Human Subjects is also
and 1977 to support genetic disease testing and counseling programs
required to conduct the investigation and study, and technical changes
and information and education programs. The Senate amendment
are made with respect to the dates on which the Panel is to complete
authorized $20 million for fiscal year 1976, $25 million for fiscal year
its investigation and submit its report.
1977, and $30 million for fiscal year 1978 for such programs; and an
The Conferees express their concern that inadequate attention is
additional $15 million for each of fiscal years 1976, 1977, and 1978 to
being paid to the problems of transfer of research progress, technology,
support sickle cell anemia testing and counseling programs.
and information from the "bench to the bed", an area frequently re-
The conference substitute authorizes $30 million for each of fiscal
ferred to as the interface between research and the health care delivery
years 1976, 1977, and 1978 to support genetic diseases testing and
system. This includes such areas as extensive clinical trials, demon-
counseling programs and information and education programs, and
stration projects, specific disease control programs, the assessment of
provides that the Secretary shall give special consideration in the
new health technologies, health education, and the fields of preventive
awarding of grants and contracts to sickle cell anemia testing and
medicine and public health. The Conferees have received assurance
counseling project applications.
that the report of the President's Biomedical Research Panel will
address these important issues.
RESEARCH PROJECT GRANTS AND CONTRACTS
TITLE IV-GENETIC DISEASES
Both the House bill and the Senate amendment authorized the
Secretary to award grants and contracts for research projects with
SHORT TITLE AND STATEMENT OF PURPOSE
respect to genetic diseases.
Both the House bill and the Senate amendment set forth four pur-
The House bill provided for the following short title: "National
poses for which the Secretary could award research grants and con-
Genetic Diseases Act." Under the Senate amendment the short title
tracts. They are identical except that as the first purpose the House
was "National Sickle Cell Anemia, Cooley's Anemia, Tay-Sachs and
bill provided that projects for basic or applied research leading to the
Genetic Diseases Act."
understanding, diagnosis, treatment, and control of genetic diseases
The House bill stated a purpose of establishing a national program
would be eligible for funding. The Senate amendment included
for genetic diseases, including sickle cell anemia, Cooley's anemia and
projects for basic research, including lower organisms, applied research,
Tay-Sachs disease. The Senate amendment, in its statement of pur-
and research training.
pose, stipulated that genetic diseases are to include but not be limited
The conference substitute conforms to the House bill.
to sickle cell anemia, Cooley's anemia, Tay-Sachs disease, cystic fibro-
The House bill instructed the Secretary to undertake genetic disease
sis, dysautonomia, hemophilia, retinitis pigmentosa, Huntington's
research under the general authority of section 301 of the Public
chorea, and muscular dystrophy.
Health Service Act. The Senate amendment provided for a specific
The conference substitute conforms to the Senate amendment.
authority and authorized $80 million for fiscal year 1976, $100 million
for fiscal year 1977, and $120 million for fiscal year 1978; and ear-
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was committed with the intent to defraud or mislead. Further, such
marked 10 percent of the sums appropriated each year under the
authority for research projects with respect to Cooley's anemia. The
products which are misbranded because their advertising is false or
Senate amendment further provided for a separate authorization for
misleading in a material respect and are held for sale to the ultimate
sickle cell anemia research of $15 million for each of fiscal years 1976,
consumer in an establishment not owned by à manufacturer, packer or
1977, and 1978.
distributor, could not be seized unless (1) the advertising was dis-
The conference substitute conforms to the House bill, except that
seminated in the establishment in which the product was held for
the Secretary is directed, in making grants and entering into contracts
sale to the ultimate consumer, the advertising was disseminated by or
for research projects, to give priority to applications which are sub-
under the direction of the owner or operator of such establishment, or
mitted for research on sickle cell anemia or for research on Cooley's
all or part of the cost of such advertising was paid for by the owner or
anemia.
operator, and (2) the owner or operator used the advertising to pro-
TITLE V.-VITAMINS AND MINERALS
mote the sale of the product. Finally, the Senate amendment required
the Secretary to consult with the Federal Trade Commission prior to
The Senate amendment contained provisions not included in the
initiating action with respect to such products deemed misbranded
House bill relating to regulation of vitamin and mineral products
because of their advertising.
under the Federal Food, Drug, and Cosmetic Act (hereinafter referred
The Conference substitute conforms to the Senate amendment
to as "the Act").
except that:
Under the Senate amendment, the Secretary of Health, Education
(1) It adds two technical amendments (clarifying the intention of
and Welfare would generally have been prohibited from establishing
the Senate amendment) to provide specifically that foods represented
maximum limits on the potency of vitamins or minerals in dietary
for use by individuals in the treatment or management of specific
supplements or classifying vitamins or minerals as drugs solely because
diseases or disorders and foods represented for use as the sole item of
they exceeded the level of potency determined by him to be nutri-
a meal or of the diet are excluded from the limitations on the Secre-
tionally rational or useful. In addition, the Secretary would have been
tary's authority.
prohibited from limiting the combination of vitamins, minerals or
(2) Except in instances in which immediate action is necessary to
other ingredients in dietary supplements. However, under the Senate
eliminate an imminent hazard to health, it requires the Secretary to
amendment, the Secretary would have retained full authority to
provide notification to the Federal Trade Commission of his intention
limit the potencies and combinations of vitamins, minerals and other
to initiate an action with respect to false or misleading advertising,
ingredients in foods in the exercise of his authority under chapter V
and it affords the Federal Trade Commission the opportunity to take
of the Act (relating to drugs) and under provisions of the Act respect-
specific enforcement action against false or misleading advertising
ing unsafe foods which are not generally recognized as safe.
for a period of up to 90 days before the Secretary may take comparable
In addition, the Senate amendment contained provisions rendering
action.
the amendment's limitations on the authority of the Secretary in-
Since the House has taken no action during this Congress with
applicable to vitamin and mineral products for use by children or by
respect to this matter, it is important to provide more legislative
pregnant or lactating women.
history concerning these complex new provisions. Thus, presented
The Senate amendment also contained provisions with respect to
below is a detailed description of the new provisions, as well as state-
the labeling and advertising of vitamin and mineral products. It
ments of the intentions of the managers with respect to their
prohibited a product containing vitamins or minerals from being
implementation.
deemed misbranded solely because its label lists all ingredients of
such a product. However, the amendment required that the labeling
PRODUCTS SUBJECT TO THE CONFERENCE SUBSTITUTE
of such products could not list ingredients which are not vitamins or
Under the conference substitute, products subject to its provisions
minerals except as a part of a list of all ingredients of the product
are defined as safe human foods for special dietary use which are or
and unless such ingredients are listed in accordance with applicable
contain any natural or snythetic vitamin or mineral and which are
regulations. Moreover, the Senate amendment prohibited the labeling
intended for ingestion in tablet or capsule form or in small units of
of or advertising for any such product to give prominence to or
liquid measure. In addition, such foods not intended for ingestion in
emphasize ingredients which are not vitamins or minerals or are not
tablet, capsule, or liquid form are subject to the provisions of the
represented as a source of vitamins or minerals.
substitute only if they do not simulate conventional foods, if they are
In addition, the Senate amendment afforded the Secretary significant
not represented to be conventional foods, and if they are not repre-
new authority with respect to the advertising of certain products
sented for use as the sole item of a meal or of the diet.
containing vitamins or minerals. (Under existing law, the Federal
The definition of "special dietary use" in the conference substitute
Trade Commission has exclusive authority with respect to the ad-
applies only to the foods to which the substitute is applicable and not
vertising of such products.) Under the Senate amendment, such
to other foods, such as foods represented for use by infants or foods
products would be deemed misbranded if their advertising were false
represented for use as the sole item of a meal or of the diet, that may
or misleading in a material respect. However, criminal penalties could
be subject to 403(j) of the Act.
not be imposed against persons who were in violation of the prohibi-
tions against false or misleading advertising unless such a violation
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27
Thus, vitamins and minerals in tablet, capsule, or liquid form as well
of the conference substitute where such product is represented for
as those products which are represented for special dietary use in
use by (1) individuals in the treatment or management of specific
humans and which do not simulate and are not represented as con-
diseases or disorders, (2) children, or (3) pregnant or lactating women.
ventional foods or substitutes for conventional foods and which are
The provision with respect to foods intended for use in the treatment
not represented for use as the sole item of a meal or of the diet, are
or management of specific diseases or disorders was adopted in
products subject to the provisions of the substitutes.
conference in order to make clear that the proposed new section 411 (a)
Except with respect to products defined above, the conference
of the Act does not override the Secretary's authority under sections
substitute does not alter existing provisions of the Federal Food, Drug,
401, 403, or 201 (n) of the Act to limit the potency and combination
and Cosmetic Act with respect to foods and drugs.
of vitamins, minerals, other ingredients in foods, or foods, represented
The Secretary retains his current authority to regulate the nu-
for use in the dietary treatment or management of individuals with
tritional formulation and composition of, and potency of vitamins,
specific diseases or disorders, or of post-operative or convalescing
minerals and other ingredients in conventional foods such as milk,
medical patients. Since each of these foods must be precisely formu-
enriched bread and enriched rice, as well as in products which simulate
lated to meet the needs of individuals with specific diseases and
conventional foods such as soybased protein substitutes for meats and
disorders, the conferees believe it to be important that the language
poultry. The Secretary also retains his current authority to regulate
in the conference substitute clearly preserve the authority of the
the nutritional formulation and composition of, and potency of vita-
Secretary to regulate as foods the nutritional formulation, composi-
mins, minerals and other ingredients in foods represented by labeling,
tion, and potency of each product represented for such uses. Inclusion
advertising, or other promotional materials for use as the sole item of
of this language is not, however, intended to permit the Secretary to
a meal or of the diet. Because consumers purchase these foods as nu-
limit (under sections 401, 403, or 201(n) of the Act) the potency or
tritional equivalents of a well-balanced meal or diet, the conferees
combination of a safe vitamin, mineral, food ingredient, or food
believe it is essential that the consumer of such products can be
represented in its labeling and advertising to be solely for use by
confident that a meal or diet based upon such products is nutritionally
adults, other than pregnant or lactating women, as a nutritional
adequate and balanced and provides for the proper maintenance of
supplement to general human dietary intake.
the user's health for the duration of his use of these products.
Dietary management with these products is not only of major
clinical value to the individual, but can be lifesaving in many in-
LIMITATIONS ON THE SECRETARY'S AUTHORITY
stances. In the case of a number of inborn abnormalities of metabolism,
such as phenylketonuria and maple syrup urine disease, these foods
Under the conference report, three significant restrictions would
provide the only means for prevention of mental retardation, partic-
be imposed on the Secretary with regard to the regulation of products
ularly in infants and young children, or for the partial restoration of
subject to the conference substitute. First, new section 411(a)(1) (A)
mental capacity in older children. Special formula feedings are essen-
of the Act prohibits the Secretary from using his existing authority
tial to long-term maintenance of severely debilitated individuals. Low
under sections 201 (n) or 403 of the Act (relating to misbranding) or
sodium foods are useful in dietary management of individuals with
under section 401 of the Act (relating to standards of identity) to
severe forms of hypertension, acute heart failure, acute nephritis,
impose maximum limits on the potency of safe vitamins and minerals
toxemias of pregnancy and similar disorders when the degree of sodium
contained in products subject to the conference substitute. This
restriction must be greater than that achievable with conventional
provision would not restrict the Secretary from prescribing minimum
foods. Chemically defined formula diets are extremely useful for nu-
potency levels for vitamins or minerals in such products in order to
tritional management of patients prior to and subsequent to gastro-
prevent the addition of insignificant or useless amounts.
intestinal surgery.
Second, new section 411(a)(1)(B) of the Act prohibits the Secretary
The Senate amendment included, in proposed new section (2)
from classifying as a drug a natural or synthetic vitamin or mineral,
of the Act, a specific reference to the Secretary's authority to act by
offered by itself or in combination, solely because it exceeds the level
regulation. This reference was deleted by the conferees as unnecessary.
of potency that the Secretary determines is nutritionally rational or
It is not intended that the omission of this reference should be under-
useful.
stood as in any way restricting the Food and Drug Administration's
Third, new section 411 (a) (1) (C) of the Act prohibits the Secretary
present authority to adopt regulations defining and enforcing the
from using his authority with respect to misbranding or establishment
provisions of the Act. The Secretary in recent years has relied in-
of standards of identity to limit the combination or number of any
creasingly on administrative rulemaking to enforce the requirements
safe vitamin, mineral or other ingredient of food in products subject
of the law. Rulemaking affords opportunity for broader participation
to the conference substitute.
in the formulation of agency policy, promotes clarity of legal require-
ments, and assures equitable application of the law, while at the same
EXCEPTIONS TO LIMITATIONS ON THE SECRETARY
time it reduces the cost to the taxpayer of case-by-case enforcement.
The Secretary's legal authority, under section 701(a) of the Act, to
Under the conference substitute (proposed new section 411(a)(2)
adopt binding regulations has been recognized by the Supreme Court.
of the Act), the limitations on the Secretary, described above, do
Weinberger V. Hynson, Westcott and Dunning, Inc., 412 U.S. 609
not apply with respect to a product otherwise subject to the provisions
(1973); Abbott Laboratories V. Gardner, 387 U.S. 136 (1967). This
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29
authority has recently been upheld by the United States Court of
PROVISIONS WITH RESPECT TO LABELING AND ADVERTISING
Appeals for the Second Circuit. National Nutritional Foods Assn. V.
Weinberger, 512 F. 2d 688 (C.A. 2, 1975).
Under the conference substitute, the Secretary retains the authority
For the purposes of the conference substitute, the term "children"
to initiate enforcement actions against a product to which the con-
is defined to mean individuals under the age of 12 years. The conferees
ference substitute is applicable if its labeling is false or misleading in
are also concerned that attention should be given to those vitamin and
any particular. In addition, the conference substitute contains special
mineral preparations that are not intended for use by infants, children
provisions respecting the labeling and advertising of these products.
or pregnant or lactating women, but may be taken by or administered
The conference substitute provides that a food to which the con-
to them inadvertently. Just as the fetus may be affected by excessive
ference substitute is applicable shall not be deemed misbranded under
doses of some food supplements, excessive doses of vitamins and
section 403 of the Act solely because its label bears a listing of all of
minerals taken by children during the period of rapid growth and
the ingredients in the food, or solely because its advertising contains
maturation can interfere with their normal development. Because of
references to ingredients in the food that are not vitamins or minerals.
such possibilities of unrecognized or unanticipated harm, it is in-
Thus, for example, if a tablet or capsule of vitamin C contains rutin,
tended that the Secretary retain full authority to promulgate regu-
a substance that the Secretary has concluded has no dietary usefulness,
lations designed to assure that unsuitable or inappropriate vitamin
the list of ingredients as well as the advertising for the product may
and mineral preparations are not inadvertently administered to
refer to rutin without causing the food to be deemed misbranded.
individuals in these vulnerable groups.
However, because of the conferees' concern that consumers not be
Except as specifically provided, the conference substitute does not
misled into a belief that such substances have nutritional value, the
alter the drug or food provisions of the Federal Food, Drug, and
conference substitute provides that the labeling SO such a product may
Cosmetic Act. If a product containing vitamins, minerals or other
not list ingredients that are not vitamins or minerals except as a part
ingredients is a drug within the meaning of section 201 (g) of the Act,
of a list of all the ingredients of the food, in accordance with applicable
the Secretary may, with respect to such product, exercise his authority
regulations promulgated by the Secretary pursuant to section 403 of
under Chapter V of the Act. For example, the Secretary may bring an
the Act. The Secretary is directed that in circumstances where
action for misbranding of a product which purports to be or is repre-
compliance with this provision is impracticable or results in deception
sented as a drug (within the meaning of section 201 (g) of the Act)
or unfair competition, exceptions shall be established by regulation.
if its labeling fails to bear adequate directions for its purported use or
Further, the conference substitute provides that the labeling or
for the use for which it is represented (within the meaning of section
advertising of a food to which the conference substitute is applicable
502 (f) (1) of the Act). See V. E. Irons, Inc. v. United States, 244 F.
may not give prominence to or emphasize ingredients which are not
2d 34 (C.A. 1, 1957) Alberty Food Products v. United States, 194 F.
vitamins or minerals or are not represented as a source of vitamins
2d 463 (C.A. 9, 1952); United States v. Vitasafe Co., 345 F. 2d 864
or minerals.
(C.A. 3, 1965) United States v. Article of Drug
B-Complex Cholinos
The conference substitute also provides the Secretary new authority
Capsules, 362 F. 2d 923 (C.A. 3, 1966).
over the advertising of foods subject to the conference substitute.
The Secretary also has the authority to regulate the composition
Seizure and injunction actions are authorized in instances in which the
and potency of a product subject to the provisions of the conference
advertising of a food to which the conference substitute is applicable
substitute on the basis of safety. If a high potency preparation of a
is false or misleading in a material respect. However, in order to
vitamin or mineral is a drug as defined by section 201 (g) of the Act
protect an innocent retailer from seizures based upon deceptive
and the Secretary determines that within the meaning of section 503
advertising claims made by a manufacturer, the conference substitute
(b) of the Act, it is not safe for use except und er the supervision of a
provides that libel for condemnation may not be instituted against
physician, such a high potency preparation is subject to regulation
such products which are misbranded because of their advertising
as a prescription drug under the Act.
unless (1) the advertising was disseminated in the establishment in
Similarly, if any vitamin, mineral or other food ingredient is not
which the product was held for sale to the ultimate consumer, the
generally recognized as safe by qualified experts and meets the other
advertising was disseminated by or under the direction of the owner
criteria of the definition of a "food additive" under section 201 (s) of
or operator of such establishment, or all or part of the cost of such
the Act, it would be subject to regulation under section 409 of the
advertising was paid for by the owner or operator, and (2) the owner
Act. If such a vitamin, mineral or other ingredient is intentionally
or operator used the advertising in the establishment to promote the
added to a food, such food is adulterated (within the meaning of
sale of the food.
section 402 (a) (2) (C) of the Act) unless its use is in conformity with
The conference substitute would also add a new section 707 to the
a regulation issued by the Secretary which prescribes the conditions
Federal Food, Drug, and Cosmetic Act which would require that the
under which it may be safely used or exempts it for investigational
Federal Trade Commission be afforded the opportunity to take certain
use by qualified experts. It is on precisely this basis that the Secretary
specific enforcement actions under the Federal Trade Commission Act
has, by regulation, restricted the potency of the vitamin folic acid
for a period of up to 90 days before the Secretary could initiate an
that may be added to a food.
enforcement action under Chapter III of the Act with respect to the
advertising of a product subject to the provisions of the conference
substitute. It would prohibit the Secretary, except under limited
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31
circumstances, from initiating such an enforcement action before,
which has caused appropriate criminal proceedings to be brought
during, or after the expiration of the 90 day period, if the Federal
against the advertising, the Secretary may act under Chapter III of
Trade Commission takes action in accordance with the conference
the Federal Food, Drug, and Cosmetic Act.
substitute.
The Commission is required to notify the Secretary promptly of the
These provisions are intended to provide the Secretary with authority
commencement of a civil action, the issuance and service of a com-
to protect the public from consumer fraud perpetrated by the false
plaint, or the causing by the Attorney General of criminal proceedings
advertising of these products. They are intended to serve as a partial
to be brought against the advertising described in the Secretary's
substitute for the authority denied to the Secretary under other pro-
notice.
visions of the conference substitute.
The conferees intend that the Commission or the Attorney General,
Proposed new section 707 of the Act would require the Secretary
where practical, take appropriate regulatory action under the Federal
to notify the Federal Trade Commission before he initiates any action,
Trade Commission Act pursuant to a notice from the Secretary. The
under Chapter III of the Federal Food, Drug, and Cosmetic Act,
conferees believe that the period of 90 days provided in the converence
with respect to any food which the Secretary determines is misbranded
substitute is sufficient time within which to take such action. However,
under proposed new section 403 (2) of the Act because of its advertis-
in instances in which the Secretary determines that, although action
ing or a food's advertising which the Secretary determines causes the
has not been taken by the Commission or the Attorney General within
food to be SO misbranded. The notice by the Secretary must contain
the 90 day period, such action is imminent, he may defer taking his
(1) a description of the Secretary's proposed action, (2) a description
proposed action to permit the Commission or the Attorney General to
of the advertising which the Secretary has determined causes the food
take action.
to be misbranded under section (a) (2) of the Act, and (3) a state-
Under the conference substitute the notification and other pro-
ment of the reasons for the Secretary's determination that the advertis-
cedural requirements in subsections (a) and (b) of proposed new
ing has caused the food to be SO misbranded. In addition, the notice
section 707 of the Act do not apply with respect to any action under
from the Secretary must be accompanied by records, documents, and
Chapter III of the Act with respect to any food or food advertising
other written materials which the Secretary determines support his
to which the conference substitute is otherwise applicable, if the
determination that the food is SO misbranded because of its advertising.
Secretary determines that such action is required to eliminate an
If, within a 30 day period beginning on the date of receipt of the
imminent hazard to health. Under these circumstances the Secretary
notice and accompanying written materials from the Secretary, the
would neither be required to provide formal notification to the Com-
Federal Trade Commission notifies the Secretary in writing that-
mission nor delay his proposed enforcement action. However, under
(1) it has initiated an investigation of the advertising (referred
the conference substitute, if the Secretary takes any action under
to in the Secretary's notice) to determine if it is prohibited by the
Chapter III of the Act with respect to a food because of its advertising
Federal Trade Commission Act or a rule or order promulgated
or with respect to a food's advertising under proposed section 403
thereunder;
(a) (2) of the Act, proposed section 707(d) of the Act requires the
(2) it has commenced or intends to commence a civil action in
Secretary to coordinate the action with any action of the Federal Trade
the courts under section 5, 13, or 19 of such Act with respect to
Commission with respect to the advertising of such food.
such advertising or the Attorney General has commenced or
The conferees recognize that for many years the Food and Drug
intends to commence a civil action under section 5 of such Act
Administration and the Federal Trade Commission have operated in
with respect to such advertising;
overlapping areas of jurisdiction in the regulation of false claims and
(3) it has issued and served or intends to issue and serve a
that both agencies have been functioning under written memoranda of
complaint under section 5(b) of such Act with respect to such
understanding concerning jurisdiction and liaison since 1954. The
advertising; or
conferees expect both agencies to continue to coordinate their regula-
(4) it had made certification to the Attorney General under
tory actions in a manner to avoid unnecessary duplication and waste.
section 16(b) of such Act with respect to such advertising,
The conferees also emphasize that the conference substitute is not
the Secretary is prohibited from initiating his proposed action for an
intended to modify the primary role of the Federal Trade Commission
additional period of time, which is not to exceed 60 days. If the
in exercising its regulatory authority over the false or misleading
Commission notifies the Secretary that neither the Attorney General
advertising of food products.
nor the Commission intends to take any of these actions or fails to
Although the substitute gives the Secretary substantial new author-
respond to the Secretary in writing within the 30 day period, the
ity with respect to the advertising of vitamin and mineral products,
Secretary may initiate his proposed action.
the conferees intend that the Secretary use his authority under existing
If, before the expiration of the 60 day period beginning on the date
section 306 of the Federal Food, Drug, and Cosmetic Act which pro-
the Secretary receives the notice from the Commission that the
vides for written notice or warning in lieu of judicial action where the
Attorney General or the Commission intends to take one of the
Secretary believes that such notification or warning adequately pro-
actions described above, the Commission or the Attorney General has
tects the public interest.
not commenced a civil action, the Commission has not issued and
served a complaint or made certification to the Attorney General
32
33
TITLE VI-ARTHRITIS ACT AMENDMENT
Act to permit the Indian Health Service to utilize non-profit recruit-
ment agencies to assist in obtaining personnel for the Public Health
The Senate amendment contained a title, not included in the House
Service.
bill, which amended the National Arthritis Act (Public Law 93-640)
The conference substitute conforms to the Senate amendment.
The Senate amendment (1) made it clear that arthritis and related
musculoskeletal diseases are to be collectively referred to as arthritis
TITLE X-APPOINTMENT OF ADVISORY COMMITTEES
for the purposes of the Act; (2) added a statement of purposes of
the Act; (3) corrected the reference to the Chief Medical Direc-
The Senate amendment contained a title, not included in the
tor of the Veterans Administration as an ex-officio member of the
House bill, which prohibited consideration of political affiliation in
National Commission on Arthritis; (4) lowered the authorization of
making appointments to advisory committees established to assist
appropriations under that Act for the Arthritis Commission from $2
the Secretary in implementing the Public Health Service Act, the
million to $1.5 million; (5) revised the authorizations of appropriations
Mental Retardation Facilities and Community Mental Health Centers
under the Public Health Service Act for arthritis screening, de-
Construction Act of 1963, and the Alcohol Abuse and Alcoholism
tection, prevention, and referral demonstration projects and the
Prevention, Treatment, and Rehabilitation Act of 1970.
Arthritis Screening and Detection Data Bank from $2 million for
The conference substitute conforms to the Senate amendment.
fiscal year 1975, $3 million for fiscal year 1976 and $4 million for
fiscal year 1977 to $1.5 million for fiscal year 1975, $4 million for
TITLE XI-MISCELLANEOUS PROVISIONS SOLDIERS' AND
fiscal year 1976, and $4 million for fiscal year 1977; and (6) amended
SAILORS' CIVIL RELIEF ACT
section 439 of the Public Health Service Act to provide that the
Secretary may assist in the development, modernization, and opera-
The Senate amendment contained a provision, not included in the
tion of new and existing comprehensive arthritis centers and to revise
House bill, which equated active service of commissioned officers of
the authorizations from $11 million for fiscal year 1975, $13 million for
the Public Health Service with active military service in the Armed
fiscal year 1976, and $15 million for fiscal year 1977 to $5 million for
Forces for the purposes of all rights, privileges, immunities, and
fiscal year 1975, $13 million for fiscal year 1976, and $21 million
benefits provided under the Soldiers' and Sailors' Civil Relief Act
for fiscal year 1977.
of 1940.
The conference substitute conforms to the Senate amendment,
The conference substitute conforms to the Senate amendment.
except that it would authorize under the Public Health Service Act
$11 million for fiscal year 1975, $8 million for fiscal year 1976 and
VISITING SCIENTIST AWARDS
$20 million for fiscal year 1977 for the development, modernization and
operation of new and existing comprehensive arthritis centers, and
The Senate amendment contained provisions, not included in the
would not change existing law with respect to authorizations for
House bill, which (1) authorized the Secretary to grant stipends, in
demonstration projects and the Arthritis Screening and Detection
amounts not to exceed $25,000 per annum, to visiting scientists who
Data Bank.
enter into agreements with the Secretary to assist minority schools in
TITLE VII-DIABETES PLAN
developing programs in biomedical sciences, and (2) authorized the
Secretary to make grants to minority schools to initiate the develop-
The Senate amendment contained a title, not included in the
ment of undergraduate programs relating to biomedical sciences.
House bill, which extended the expiration date of the National
The conference substitute authorizes the Secretary to make awards
Diabetes Commission (established under Public Law 93-354) to
(referred to as "Visiting Scientist Awards") to outstanding scientists
September 30, 1976.
who agree to serve as visiting scientists at institutions of post-second-
The conference substitute conforms to the Senate amdnement.
ary education which have significant enrollments of disadvantaged
students. The amount of each such award shall include such sum as is
TITLE VIII-HEALTH SERVICES
commensurate with the salary or remuneration which the individual
The Senate amendment contained a title, not included in the House
had received from the institution with which he has, or had, a perma-
bill, which amended sections 319 (migrant health centers) and 330
nent or immediately prior affiliation.
(community health centers) of the Public Health Service Act to add
HEALTH PROFESSIONS STUDENT ASSISTANCE
ambulatory surgical services as a supplemental health service which
could be offered by such centers.
The Senate amendment contained provisions, not included in the
The conference substitute conforms to the Senate amendment.
House bill, which extended the authorizations of appropriations for
physician shortage area scholarships at $3.5 million for fiscal year 1975
and $2 million for fiscal year 1976, and for health professions student
TITLE IX-INDIAN HEALTH SERVICE
loans at $60 million for fiscal year 1976.
The conference substitute conforms to the Senate amendment.
The Senate amendment contained a title, not included in the
House bill, which amended section 225 of the Public Health Service
34
HARRISON A. WILLIAMS, JR.,
CLAIBORNE PELL,
EDWARD M. KENNEDY,
WALTER F. MONDALE,
ALAN CRANSTON,
WILLIAM D. HATHAWAY,
JOHN A. DURKIN,
THOMAS F. EAGLETON,
GAYLORD NELSON,
JACOB K. JAVITS,
RICHARD S. SCHWEIKER,
ROBERT TAFT,
J. GLENN BEALL, JR.,
ROBERT T. STAFFORD,
PAUL LAXALT,
Managers on the Part of the Senate.
HARLEY O. STAGGERS,
PAUL G. ROGERS,
DAVID E. SATTERFIELD,
JAMES W. SYMINGTON,
JAMES H. SCHEUER,
TIM LEE CARTER,
JAMES T. BROYHILL,
Managers on the Part of the House.
o
H. R. 7988
Ainety-fourth Congress of the United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Monday, the nineteenth day of January,
one thousand nine hundred and seventy-six
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 by 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.
TITLE I-REVISION 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, with 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
H. R. 7988-2
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
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.
SEC. 102. Sections 411, 418(a) (6), and 419A (c) are each amended
by striking out "National Heart and Lung Institute" and inserting in
lieu thereof "National Heart, Lung, and Blood Institute".
SEC. 103. (a) Section 412 is amended-
(1) by 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".
(b) Section 412 is amended by striking out "National Heart and
Lung Advisory Council" and inserting in lieu thereof "National Heart,
Lung, and Blood Advisory Council".
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
H. R. 7988-3
(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 (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
by-
(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)";
H. R. 7988-4
(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
BLOOD RESOURCES" after "DISEASES".
SEC. 107. (a) Section 417 (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.
H. R. 7988-5
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 Advisorv 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:
"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
(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".
H. R. 7988-6
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 INI-DISCLOSURE OF RESEARCH INFORMATION
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 from which such information was disclosed
and on patent rights;
H. R. 7988-7
(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
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 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 the 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 Research Act (Public Law
93-348) is amended by striking out "July 1, 1976" and inserting in lieu
thereof "January 1, 1977".
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
"TESTING AND COUNSELING PROGRAMS AND INFORMATION
AND EDUCATION PROGRAMS
"SEC. 1101. (a) (1) The Secretary, through an identifiable admin-
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.
"(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
H. R. 7988-8
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.
"RESEARCH PROJECT GRANTS AND CONTRACTS
"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
"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.
"APPLICATIONS; ADMINISTRATION OF GRANTS AND CONTRACT PROGRAMS
"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 confidentiality 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;
H. R. 7988-9
"(3) provide for community representation where appropriate
in the development and operation of voluntary 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
satisfactory 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 account 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 centers or sickle cell screening and educa-
tion clinics.
"PUBLIC HEALTH SERVICE FACILITIES
"SEC. 1105. The Secretary shall 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 provide 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:
H. R. 7988-10
"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, under 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)
unless 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.
(B) 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
H. R. 7988-11
((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 be 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.
H. R. 7988-12
"(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
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
"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.
H. R. 7988-13
"(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 proceedings 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 III 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 III 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.
TITLE VI-ARTHRITIS ACT AMENDMENTS
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
H. R. 7988-14
"(C) to emphasize the significance of early detection and
proper control of these diseases and of the complications
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.".
(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,".
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".
(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')".
(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).
(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.
TITLE VII-DIABETES PLAN
SEC. 701. Section 3(i) (2) of the National Diabetes Mellitus Research
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.".
TITLE VIII-HEALTH SERVICES
AMBULATORY SURGICAL SERVICES
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.
H. R. 7988-15
(b) Section 330(b) (2) 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.
TITLE IX-INDIAN HEALTH SERVICE
SEC. 901. Section 225 is amended by adding at the end thereof the
following new subsection-
"(j) Notwithstanding any other provision of law, the Secretary
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.".
TITLE X-APPOINTMENT OF ADVISORY COMMITTEES
SEC. 1001. All appointments to advisory committees established to
assist in implementing the Public Health Service Act, the Mental
Retardation Facilities and Community Mental Health Centers Con-
struction Act of 1963, and the Comprehensive Alcohol Abuse and
Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970,
shall be made without regard to political affiliation.
TITLE XI-MISCELLANEOUS PROVISIONS
SEC. 1101. Section 212 of the Public Health Service Act is amended
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).
(b) Section 507 of the Public Health Service Act is amended by
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 IV 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
'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.
H. R. 7988-16
"(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
permanent or immediately prior affiliation. Eligibility for and terms
of Visiting Scientist Awards shall be determined in accordance with
regulations the Secretary shall prescribe."
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".
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".
(b) Section 740(b) (4) of such Act is amended by striking out
"1975" and inserting in lieu thereof "1976".
SEC. 1106. Section 1511 (b) (5) of the Public Health Service Act is
amended by striking out "1535" and inserting in lieu thereof "1536".
(b) Section 1613 of such Act is amended by striking out "1510" and
inserting in lieu thereof "1610".
(c) The last sentence of section 1631 of such Act is repealed.
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".
(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
Bill of Rights Act is amended by striking out "101 (7)" and inserting
in lieu thereof "102(7)".
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.
April 13, 1976
Dear Mr. Director:
The following bills were received at the White
House on April 13th:
H.J. Res. 890
H.R. 7988
Please let the President have reports and
recommendations as to the approval of these
bills as soon as possible.
Sincerely,
Robert D. Linder
Chief Executive Clerk
The Honorable James T. Lynn
Director
Office of Management and Budget
Washington, D.C.