[Senate Report 104-364]
[From the U.S. Government Publishing Office]
Calendar No. 583
104th Congress Report
SENATE
2d Session 104-364
_______________________________________________________________________
NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1996
_______
September 9, 1996.--Ordered to be printed
_______________________________________________________________________
Mrs. Kassebaum, from the Committee on Labor and Human Resources,
submitted the following
R E P O R T
together with
ADDITIONAL VIEWS
[To accompany S. 1897]
The Committee on Labor and Human Resources, to which was
referred the bill (S. 1897) to amend the Public Health Service
Act to revise and extend certain programs relating to the
National Institutes of Health, and for other purposes, having
considered the same, reports favorably thereon with amendments
and recommends that the bill (as amended) do pass.
CONTENTS
Page
I. Summary of the bill..............................................2
II. Background and need for the legislation..........................6
III. Legislative history and committee action........................10
IV. Committee views.................................................11
V. Cost estimate...................................................19
VI. Regulatory impact statement.....................................19
VII. Section-by-section analysis.....................................19
VIII.Additional views................................................34
IX. Changes in existing law.........................................35
I. Summary of the Bill
TITLE I--PROVISIONS RELATING to the NATIONAL INSTITUTES OF HEALTH
Director's discretionary fund (sec. 101)
This provision reauthorizes the discretionary fund for the
Director of the National Institutes of Health (NIH).
Children's vaccine initiative (sec. 102)
This provision reauthorizes the children's vaccine
initiative.
TITLE II--PROVISIONS relating TO THE NATIONAL RESEARCH INSTITUTES
Research on osteoporosis, Paget's disease, and related bone disorders
(sec. 201)
This provision reauthorizes research initiatives in
osteoporosis, Paget's disease, and related bone diseases.
Establishment of National Human Genome Research Institute (sec. 202)
This provision elevates the National Center for Human
Genome Research to institute status by the establishment of the
National Human Genome Research Institute (NHGRI). This will
ensure a continued focus of NIH resources on important genetic
research. It continues the commitment of the NIH to ethical,
legal, and social issues relative to genome research by
maintaining a set-aside of at least 5 percent of NHGRI
extramural research funds for research in these areas.
Increased amount of grants and other awards (sec. 203)
This provision increases from $50,000 to $100,000 the
amount that an institute can grant on the basis of technical
and peer review alone. Grants greater than $100,000 will
continue to require advisory council approval. This proposal
would eliminate duplication of the approval process beyond that
of peer review for small grants and would accelerate funding of
new, cutting-edge proposals.Meetings of advisory committees and
councils and application of Federal Advisory Committee Act (sec. 204)
This provision allows the convening of advisory councils
and committees on an as-needed basis, instead of three to four
times a year as currently required by law. This change would
permit the NIH to reduce the expense associated with bringing
advisers and committee members to Bethesda, MD, several times a
year. These groups already take advantage of telecommunications
technology for timely discussion and decision making.
The application of the provisions of the Federal Advisory
Committee Act to peer review committees is eliminated, thus
reducing this administrative burden. The provisions of this act
continue to apply to all other advisory committees and councils
of the NIH.
Elimination or modification of reports (sec. 205)
The bill increases administrative efficiency by eliminating
the requirement for reports that are duplicative or unduly
burdensome. The reports that are eliminate or modified include:
the biennial report of the Director, NIH, to Congress and the
President; the annual report of the Arthritis and
Musculoskeletal Diseases Interagency Coordinating Committee;
the annual report of the Skin Diseases Interagency Coordinating
Committee; the annual report of the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Board; the
Secretary's annual report to Congress on Health Services
Research relating to alcohol abuse and alcoholism, drug abuse,
and mental health; the Secretary's triennial report to Congress
on drug abuse; two annual reports to Congress on Sudden Infant
Death Syndrome Research; the reports of the Coordinating
Committees of Digestive Diseases, Diabetes Mellitus, and
Kidney, Urologic and Hematological Diseases; the report of the
U.S.-Japan Cooperative Medical Science Program; and the report
of the Task Force on Aging Research. It also converts the
schedule for the report on disease prevention from annual to
biennial.
title III--specific institutes and centers
National Cancer Institute (secs. 301-302)
The bill authorizes $3 billion for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999 for
general funding for the National Cancer Institute.
In addition, it specifically reauthorizes programs in
breast cancer, other gynecologic cancers, prostate cancer, and
the conditions associated with exposure to the drug
diethylstilbestrol.
National Heart, Lung, and Blood Institute (sec. 311)
The bill authorizes $1.6 billion for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999.
National Institute of Allergy and Infectious Diseases (secs. 321-322)
The bill reauthorizes the research initiative in
tuberculosis and the Terry Beirn Community-Based AIDS Research
Initiative.
National Institute of Child Health and Human Development (sec. 331)
This provisions reauthorizes the Centers for Contraception
and Infertility.
National Institute on Aging (sec. 341)
The bill authorizes $550 million for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999.
National Institute of Alcohol Abuse and Alcoholism (secs. 351-352)
The bill authorizes $330 million for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999.
Section 352 corrects an omission from earlier authorization
language regarding the definition of ``construction'' for use
with reference to the National Institute of Alcohol Abuse and
Alcoholism.
National Institute on Drug Abuse (secs. 361-363)
The bill authorizes $480 million for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999.
In addition, the medication development program is
authorized. Section 363 corrects an omission from earlier
authorization language regarding the definition of
``construction'' for use with reference to the National
Institute on Drug Abuse.
National Institute of Mental Health (sec. 371)
The bill authorizes $750 million for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999.
National Center for Research Resources (secs. 381-384)
The bill reauthorizes support for construction and
modernization of biomedical and behavior research facilities
from approved grants. It requires a larger matching component
from grantee institutions in that the amount provided by
Federal funds is reduced from 50 percent to 40 percent for
research facilities and from 40 percent to 30 percent for
multipurpose facilities.
To provide the infrastructure for clinical research and
clinical research training, the bill authorizes support for the
general clinical research centers located throughout the
country.
To address the need for expanded involvement in clinical
research, the bill establishes clinical research career
enhancement awards to support individual careers in clinical
research. In addition, it establishes innovative medical
science awards to support individual clinical research
projects.
National Library of Medicine (secs. 391-392)
The bill authorizes $160 million for fiscal year 1997 and
such sums as necessary for fiscal years 1998 and 1999. It also
increases the cap on individual extramural grants from the
National Library of Medicine to $1.25 million.
title iv--awards and training
Medical Scientist Training Program (sec. 401)
The Medical Scientist Training Program supports
professional education for students who intend to pursue
careers in academic medicine. This provision expands the fields
in which students may study in this program. It does so by
broadening the program to include the option of a doctoral
degree in certain nonbiologic science disciplines, for example,
biostatistics, epidemiology, economics, or bioethics.
General loan repayment (secs. 402-404)
The bill raises the maximum level of qualified loan
repayments from $20,000 to $35,000 for each year of service for
appropriately qualified health professionals conducting
research training as employees of the NIH. These changes relate
to established programs with respect to AIDS, contraception and
infertility, programs for research generally, and clinical
research programs for individuals for disadvantage backgrounds.
In addition, it establishes a general loan repayment program to
be under the direction of the Director of NIH. The Director
will annually designate the fields of research that will be
included in this program.
Section 404 would increase from 50 to 100 the total number
of contracts for scholarships and loan repayments that the
Secretary may provide through the Undergraduate Scholarship
Program Regarding Professions Needed By National Research
Institutes, and the Loan Repayment Program Regarding Clinical
Researchers From Disadvantaged Backgrounds. Moreover, the sites
where such training may take place are expanded beyond the NIH
campus to include clinical research training positions at
General Clinical Research Centers and other extramural sites.
At least 50 percent of these awards will go to health
professionals from disadvantaged backgrounds.
title v--research with respect to aids
Comprehensive plan for expenditure of AIDS appropriations (sec. 501)
This provision reauthorizes the research program regarding
AIDS and continues its administration through the Office of
AIDS Research.
Emergency AIDS discretionary fund (sec. 502)
The bill reauthorizes an emergency AIDS discretionary fund
that is available to the Director of the Office of AIDS
Research for projects of significant need.
title vi--general provisions
Authority of the Director of the NIH (sec. 601)
The bill gives the Director of the NIH the authority to
establish intramural training programs and gives the Director
the authority to hire and compensate health care professionals
at a level similar to the Department of Veteran Affairs.
Office of Rare Disease Research (sec. 611)
The bill codifies the Office of Rare Diseases, which
currently exists in the Office of the Director of the NIH. The
purpose of this office is to promote and coordinate the conduct
of research on rare diseases through a strategic plan and to
establish and manage a rare disease research clinical database.
Certain reauthorizations (secs. 621-622)
The bill reauthorizes the research training programs funded
as the National Research Service Awards and the nonprofit
corporation known as the National Foundation for Biomedical
Research.
Miscellaneous provisions (secs. 631-636)
Section 631 takes a first step toward establishing
additional sources of funding for biomedical research at the
NIH by creating a National Fund for Health Research in the U.S.
Department of the Treasury. This trust fund would be on budget.
A source of revenue for the fund is not provided.
A definition of clinical research is provided for reference
throughout the bill.
The bill amends the Senior Biomedical Research Service
retirement provisions to enable the Secretary of Health and
Human Services to make contributions as a nonprofit entity to
the academic retirement systems in which members participated
immediately prior to their appointment in the Service.
Section 634 authorizes a pediatric research initiative. It
authorizes $50 million over fiscal years 1997 through 1999, to
be available to the Director of the NIH to encourage increased
support across a broad spectrum of pediatric research areas.
Section 635 authorizes increased funding specifically for
research focused on diabetes.
The bill provides for an initiative for research in
Parkinson's disease. It would establish up to 10 Morris K.
Udall Research Centers for interdisciplinary study of the cause
and treatment of Parkinson's disease. In addition, it would
establish Morris K. Udall Awards for Innovation in Parkinson's
Disease Research to support innovative proposals for research
in this field.
Repeals and conforming amendments (sec. 641)
This provision makes corrections in current law regarding
references to the National Institute for Nursing Research and
the Under Secretary for Health of the Department of Veterans
Affairs.
In addition, it repeals a number of duplicative advisory
boards and committees, including the National Diabetes Advisory
Board, National Digestive Diseases Board, National Kidney and
Urologic Diseases Advisory Board, National Arthritis and
Musculoskeletal and Skin Diseases Advisory Board, National
Deafness and Other Communications Disorders Advisory Board,
National Commission on Alcoholism and Other Alcohol Related
Problems, and Advisory Council on Hazardous Substances Research
and Training.
II. Background and Need for Legislation
GENERAL
Funding for the National Institutes of Health (NIH) in the
waning 20th century cannot be considered separate from the
broader issues of health care delivery in the United states. A
recent report from the Institute of Medicine of the National
Academy of Sciences noted, ``the escalating costs of health
care and the large number of uninsured and underinsured people
in the United States have thrown health care issues into the
policy arena at all levels of government.''
Policies that shape authorizing legislation for the NIH are
influenced by two overarching issues. First is the ever-
expanding base of biomedical knowledge which creates new
promises and countless creative research opportunities.
Researchers in academic health centers (AHC's) around the
country--researchers who depend on grants from the NIH for
sustenance--generate four times as many approved proposals for
support by the NIH than can be funded by the available budgeted
dollars.
Second, the academic medical community--where the bulk of
basic biomedical research takes place--is posed with an
unprecedented challenge: how will AHC's maintain their research
mission in the context of the competitive health care
marketplace in which they now exist. The clinical practice
environment has traditionally provided an important arena for
the research and education roles of AHC's. In addition, fees
from faculty practice plans have provided cross-subsidies for
the academic mission of many AHC's. The cost of research and
education places AHC's at a disadvantage in the competition for
managed care contracts. Consequently, the very task that
distinguishes these academic health institutions places them at
a market disadvantage among their nonacademic competitors and
threatens their ability to continue their mission.
HISTORY OF THE NIH AND ITS FUNDING
After a half century of research in Public Health Service
laboratories, the NIH, as we know it today, had its birth in
1930. It moved to its present site in Bethesda, MD in 1938.
World War II gave biomedical research a substantial boost that
led to extramural funding--funding that is in the form of
grants to universities, hospitals, and other research
institutions.
Extramural research grants are funded based on a systematic
process that requires approval by expert colleagues of the
proposed research concept and plans before consideration for
funding. This peer-review process is at the heart of the NIH
research funding process. This has been enormously successful
in evaluating the scientific and technical merit of proposals,
which supports the awarding of the most meritorious projects.
This process brings together acknowledged experts who review
proposals for research funding in their respective scientific
fields. Based on their own expertise, they make decisions on
the abilities of investigators to be successful in their
proposals, as well as on the creativity of their proposals.
Subsequently, the advisory councils of the NIH Institutes and
Centers review the approved proposals for program relevance and
appropriateness of the scientific and technical review.
After World War II, debates began in Congress underscoring
the tension between research autonomy, on the one hand, and
greater public control of research spending, on the other. This
discussion continues to this day.
The NIH moved forward from the post-war era with a growth
rate that doubled research support every 5 years until 1990.
However, inflation and the effort to balance the Federal budget
have curbed this growth rate.
Regarding inflation, Dr. Harold Varmus, the Director of the
NIH, has acknowledged that Federal funding for biomedical
research has entered an era of steady-state funding. The Bureau
of Economic analysis in the U.S. Department of Commerce defines
the price index for biomedical research as the Biomedical
Research and Development Price Index (BRDPI). This index
represents the expenditure weights that are constituted by
unique costs of biomedical research--variables such as indirect
costs of administration for research and other costs of high
technology. Consistently, BRDPI has always been higher than
general inflation. Therefore, to maintain steady-state funding,
Federal funding for the NIH will have to be greater than
general inflation.
During the first session of the 104th congress, the NIH
fared well. The continuing resolution that funded the NIH for
fiscal year 1996 provided a 5.7 percent increase. It is
unlikely that such a rate of growth can be sustained in the
future given the budget pressures of other discretionary
domestic spending, as well as the pressure created by ever-
increasing entitlement spending.
POLICY ISSUES AND REAUTHORIZATION OF THE NIH
Four broad issues have been central to the discussions
leading up to reauthoriztion legislation for the NIH in the
104th Congress: first, the conflict between earmarked research
and investigator-initiated research funding; second, the
perceived diminished role for clinical research compared to
basic research funding; third, a need for administrative
simplification and efficiency to free up scarce dollars for
grant-making; and finally, concern about the educational
preparation of future biomedical researchers.
1. Earmarks versus investigator-initiated research
Earmarks for specific research programs have traditionally
driven funding for new initiatives. A recent trend in research
funding has been for preferential support for promising efforts
arising from investigator-initiated research. This was the
implication of testimony from several witnesses at hearings
conducted by the Senate Committee on Labor and Human Resources
in March 1996. This argument found its voice in the markup of
S. 1897, where members of the committee acknowledged the
difficulty inherent in a process where Congress calls for more
programs while the overall budget for the NIH has little
growth. Such a predicament creates the tension of a request for
new areas of investment by the authorizing committee but an
inability to provide resources by the appropriators.
2. Basic versus clinical research
Basic research is the pursuit of fundamental biomedical
mechanisms, proceeding from one discovery to the next, driven
by the pursuit of knowledge for its own sake. Clinical research
describes the fields of research that are patient-focused.
Clinical research applies basic research to patient care. Over
time, the line between basic research and clinical research
migrates toward basic research. As the molecular understanding
of biomedical processes expands, the research opportunities in
basic research tend to crowd out ideas for clinical research
that compete for limited research dollars.
The Director of the NIH has acknowledged a need for
attention to the issues related to clinical research by
appointing a panel on clinical research. This panel has begun
its deliberations and will provide a series of recommendations
that are based on the evolving contest in which biomedical
research is funded.
In practical terms, some feel the success of the
discoveries into the understanding of basic mechanisms of
biology and the molecular explanation of disease has fueled a
commitment by study sections--those committees made up of peers
who determine the merit ranking of submitted grants--to basic
research. Clinical investigators have been less successful in
competition with basic scientists for grant dollars. NIH is
examining the issue of whether the composition of study
sections has an influence on the success of these applications
and what actions may need to be taken in this area.
3. Administrative simplification and efficiency
Over the years, there has been a sense that increasing
administrative burdens, many created by Congress, expend
resources that could be better spent on research grants. The
requirements for formal reports to Congress, while well-
intentioned with regard to protecting the taxpayers'
investment, may have lost their value compared to newer and
faster methods of keeping Congress informed. Reports that take
months or years to produce, in traditional preparation and
publication cycles, may be less useful than more specific
response to timely questions from members of Congress. The
annual appropriations process and the triennial authorization
process provide just-in-time responses for those committees of
jurisdiction on whom the responsibility for funding falls.
In another context, reports from committees and councils of
the NIH might be replaced in some instances by the publication
of meeting minutes, or the electronic transmission of
conclusions.
Mandated meeting frequencies of advisory councils and
committees could be replaced by as-needed meetings and the use
of telecommunications technology and electronic communication
for decision making.
4. Education and training of future biomedical scientist
A growing concern is that medical graduates are shying away
from the pursuit of careers in clinical research. The
increasing cost of a medical education is said to discourage
medical graduates from the prolonged training required for such
careers. The average education loan for graduating physicians
in 1996 is over $60,000. The insecurity of funding for clinical
research and the reduced compensation associated with careers
in research, compared to careers in clinical practice, often
discourage young medical graduates from clinical research.
A recent report from the Institute of Medicine of the
National Academy of Sciences has made a series of
recommendations based on their assessment of both the state of
clinical research and the training of health care professionals
for future careers in clinical research. the report recommended
the establishment of funding mechanisms for new clinical
investigators, a recommitment to support General Clinical
Research Centers (those components of AHC's around the country
in which patient-focused research takes place), and commitment
by the Medical Scientist Training Program to a widened focus,
including population-based research along with careful tracking
of the graduates of this program.
BIOMEDICAL RESEARCH POLICY AND THE FUTURE OF FUNDING
The environment of relative shrinking growth in available
funds is likely to continue. In spite of limited resources,
there will be expanded horizons for basic research and
increased opportunities for clinical applications of basic
research findings. In addition, there will unquestionably be
new and important implications in the areas of economic,
bioethical, and health policies. Some of these new policy
implications will be based on research findings leading to the
understanding of genetic control of biologic and pathologic
processes. Many conclude that greater management flexibility
will be required for the NIH to respond to these rapid changes
in health science and technology. Biomedical research funded by
Federal dollars requires a delicate balance between the needs
and expectations of the taxpayer who funds the research and
researchers with increasingly sophisticated expertise who are
best able to establish priorities for biomedical research.
III. Legislative History and Committee Action
The National Institutes of Health Revitalization Act of
1996, S. 1897, was introduced on June 21, 1996, by Senators
Kassebaum, Kennedy, Jeffords, Pell, and Hatfield. The bill was
referred to the Senate Committee on Labor and Human Resources.
The Senate Committee on Labor and Human Resources held
hearings on the National Institutes of Health reauthorization
on March 6 and 7, 1996, and May 7, 1996.
On Wednesday, July 1996, the committee held an executive
session to consider S. 1897. Four amendments were adopted in
executive session by voice vote, and S. 1897 was ordered to be
reported favorably to the full Senate by a rollcall vote of 16
yeas.
amendments adopted by voice vote during executive session
Four amendments were adopted in executive session by voice
vote.
1. Senator Wellstone offered an amendment to establish a
program for the support of research and training with respect
to Parkinson's disease by establishing the Morris K. Udall
Awards for Innovation in Parkinson's disease research at up to
ten centers.
2. Senators DeWine and Kennedy offered an amendment to
establish within the Office of the Director of the NIH a
Pediatric Research Initiative to increase pediatric biomedical
research.
3. Senator Simon offered an amendment to increase the
authorization level of diabetes-related research by 25 percent
each year over the 3 years of the authorization. Senator
Mikulski modified the amendment to provide for a 25-percent
increase over 3 years.
4. Senator Frist offered an amendment to require the
National Institutes of Health to prepare a report to the
committee within 6 months of enactment of S.1897 explaining how
it intends to implement the findings and recommendations of an
earlier report to Congress entitled ``Support For
Bioengineering Research,'' submitted in August 1995.
amendment withdrawn during executive session
1. Senators Faircloth and Harkin offered an amendment to
establish a National Center for Pain Research within the
National Institutes of Health and 6 regional centers for pain
research. The amendment proposed to improve the integration of
pain-related research at the National Institutes of Health
through a new organizational structure. Senator Kassebaum and
others expressed concern about the administrative burden
associated with the creation of new centers. The amendment was
withdrawn by the sponsors with the understanding that work
would continue in an attempt to develop an alternative proposal
for a floor manager's amendment.
IV. Committee Views
A. General overview of S. 1897
1. General
In crafting this legislation, the committee wrestled with
the question: Should the Congress be directive and authorize
more set-asides for specific diseases, or should it authorize
institute funding that enables scientific discovery itself to
determine the direction for research funding? In general, the
committee tends toward the view that the latter is the better
course: to make resources available to scientists to pursue new
knowledge where it leads. The committee believes that this
strategy has been highly productive in the National Institutes
of Health's (NIH) assault on the diseases that afflict
Americans.
2. Renewal of expiring authorities
general
This bill renews all expiring NIH authorities through
fiscal year 1999. The committee recommends that institutes due
for reauthorization be authorized at specific dollar amounts
that have been increased to reflect biomedical research
inflation. To determine the dollar amount to be authorized for
1997, the committee has used the Biomedical Research and
Development Price Index (BRDPI) compounded over the 3 years
since the last reauthorization. This results in an increase in
the amount from 1994 to 1997 of approximately 11 percent. The
out years are reauthorized at such sums as may be necessary.
On the other hand, the committee has taken the course of
reauthorizing all other existing initiatives at such sums as
may be necessary. The successful pursuit of science can rapidly
change directions, particularly when breakthroughs point toward
successful research strategies. This approach has the benefit
of removing limits that exist over the duration of the
reauthorization legislation so that funding can be determined
annually by the appropriating process.
national cancer institute
The progress that has been made in understanding the
genetics of cancer has been gratifying. The discovery, for
example, of the BRCA-1 gene that is linked to certain forms of
breast cancer opens the door to a number of opportunities for
screening and therapy. At the same time, it is recognized by
the committee that each new discovery of this type introduces
new social and ethical issues regarding the appropriate
application of this new knowledge in a safe and reasoned way.
The committee supports NCI's efforts to expand and intensify
its activities with respect to cancer genetics and to
coordinate its activities with other institutes and agencies
with responsibilities in this area.
It is also clear to the committee that the broad
understanding of the biology of cancers of one kind is likely
to be valuable in the understanding of cancers of other organs.
While the previously created special programs in breast cancer,
cancer of the female reproductive systems, and cancer of the
prostate are all important programs, precise authorization
amounts have not been set by the committee. Rather, funding
levels will be determined through the annual appropriation
process by Congress based on the success, and potential for
success, of the science in these areas of research.
national heart, lung, and blood institute
The committee is pleased to note the progressive decline in
heart disease mortality in all segments of society. This is
certainly the result of coordinated research efforts into the
understanding of heart disease and its therapy. It is also
comment on the use of public health approaches to prevention.
Yet today cardiovascular diseases remain one of the leading
causes of death in this country. Approximately one million
deaths each year are directly related to cardiovascular
diseases. Clearly, a continued research effort in this area is
needed.
The committee is concerned about the increasing prevalence
and severity of asthma in the United States. It is gratifying
to see the application of patient education in asthma
management techniques and their critical analysis. The
demonstrated value of patient education and involvement in
their own care superbly exemplifies how worthwhile it is to
disseminate new knowledge gained from research directly to the
patient for his or her personal benefit.
While the results of clinical studies have produced
improvement in the survival of the many Americans who are born
with, and spend a lifetime with, sickle cell disease, it is
hoped that new applications of molecular medicine will yield
even more fundamental techniques for the relief of suffering
from this disease.
national institute of allergy and infectious diseases
The reemergence of tuberculosis has presented a startling
example of importance of NIH's ability to muster an agile
response in the direction of research funding. With the various
epidemiologic changes that occurred in the 1980's--such as
immune suppression associated with HIV infection and new
resistance to the usual antibiotics that treat tuberculosis--a
new epidemic of tuberculosis emerged. The National Institute of
Allergy and Infectious Diseases (NIAID) has made a substantial
commitment to research on tuberculosis. Its program of
incentives for new investigators to bring creative scientific
thinking to the problems that have developed in the field of
tuberculosis is a model for quick response to new imperatives
in the study of disease, particularly emerging infections. The
committee believes that the stabilization of the numbers of new
cases of tuberculosis over the last 2 years demonstrates the
ability of an energized infrastructure to respond to new health
problems. It looks forward to even greater success in the
reduction of this epidemic as basic research and clinical
research come together for effective management of this complex
health problem.
In past years, NIH has made very large investments in
upgrading research facilities in response to public concerns
about animal well-being and to diminish environmental factors
that adversely affect research. However, the programs in
Comparative Medicine which focus on animal-based research have
been severely curtailed. These programs address research in
genetics, infectious diseases, cancer, diabetes and many other
fields and should be strengthened.
3. Increasing administrative efficiency
general
During hearings before the committee, the Director of the
NIH described additional efforts the agency is undertaking to
streamline its research and administrative operations. The
committee urges the Director to continue these efforts and
remains committed to exploring mechanisms that will maximize
the funds available for biomedical research.
meetings of advisory committees and councils
The committee is aware that the advent of
telecommunications technology, permitting more rapid resolution
of committee and council business and other administrative
efficiencies, now makes it unnecessary to mandate meeting at
designated intervals. This provides an opportunity for resource
savings afforded by scheduling meetings only as needed.
Unneeded meetings are wasteful of resources, including time and
effort on the part of council or committee members and staff,
as well as travel expenses and compensation for members.
application of federal advisory committee act
It is the view of the committee that scientific and peer
review groups are integral components of the NIH grant-making
process. The function of these specialized peer review groups
is very different than the public advisory rule envisioned at
the inception of the Federal Advisory Committee Act (FACA). It
is appropriate, therefore, to exempt scientific and peer review
groups from the provisions of FACA and the associated
administration burden. This does not exempt from the provisions
of FACA the many other advisory committees and councils that
serve the many roles and functions of the NIH.
elimination or modification of reports
It is the view of the committee that a number of reports
required of the NIH by the Congress are sometimes duplicative
and generally do not meet the intended goal of the original law
that established their requirement. Under current law, the
Director of the NIH and the directors of institutes and centers
are required to provide administrative reports to the Secretary
of Health and Human Services and Congress. There are now more
effective mechanisms in place for communicating this
information. Such mechanisms include publications (both printed
and electronic), public testimony at the annual appropriations
process and the triennial authorization process, as well as
direct inquiry from members of the Congress.
It is the intention of the committee that elimination of
these reports will improve the efficiency of the individual
institutes and centers by allowing staff to concentrate on the
administration of research programs, rather than on producing
reports that are often untimely and no longer useful for the
Congress.
increased amount of grants that require only peer review
Grant funding by the NIH is approved by a two-tier process.
After approval by a peer review committee, grants than must be
approved by the appropriate institute or center advisory
council. It is the view of the committee that increasing from
$50,000 to $100,000 the amount for grants that can be made
after scientific and technical peer review eliminates
duplication of the approval process beyond peer review for
smaller grants and accelerates funding of new, cutting-edge
proposals.
It is the view of the committee that this modification will
streamline the workloads of the institutes, centers, and the
National Library of Medicine, resulting in shortened time from
review to award.
elimination of certain advisory boards and committees
The committee is aware that current law establishes certain
advisory committees, boards, and commissions that no longer
carry out the purposes for which they were created. In every
instance, the advisory committee, boards, and commissions
listed below no duplicate responsibilities and authorities that
are better carried out by other entities.
The functions of the National Diabetes Advisory Board, the
National Digestive Disease Board, and the National Kidney and
Urologic Diseases Advisory Board are adequately served by the
National Diabetic and Digestive and Kidney Diseases Advisory
Council. The purpose of the National Arthritis and
Musculoskeletal and Skin Diseases Advisory Board is adequately
served by the National Arthritis and Muscoloskeletal and Skin
Diseases Advisory Council, as well as two interagency
coordinating committees. The functions of the National Deafness
and Other Communications Disorders Advisory Board overlap those
served by the National Deafness and Other Communications
Disorders Advisory Council. The National Commission on
Alcoholism and Other Alcohol-Related Problems was activated
briefly in 1980. Although funds were authorized, they were
never appropriated, and it has remained inactive up to this
time. The Advisory Council on Hazardous Substances Research and
Training has completed its statutory mandate. Moreover, the
functions of this council can be adequately served by the
National Advisory Environmental Health Sciences Council.
Accordingly, the committee expects that the repeal of these
boards and committees will be associated with appropriate
savings that can be used more effectively for funding of
research grants.
the pain research consortium at nih
The Committee encourages the NIH Director to establish a
Pain Research Consortium. The creation of a Pain Research
Consortium would provide a forum for coordinating pain research
activities, sharing information about research and related
activities being conducted in the area of pain, developing
ideas for collaborative research efforts, avoiding unnecessary
duplication of research efforts, and thereby, achieving a more
efficient use of Federal dollars. All NIH Institutes, Centers
and Offices that are involved in pain research should be
included as members of the Consortium. In addition, the NIH
Pain Research Consortium should seek the opinions and advice
from private organizations interested in pain research, as well
as staff of other Federal agencies involved in studies of pain.
coordination of child abuse and neglect research
The committee recognizes that despite the magnitude and
significance of the problem of child abuse and neglect,
research in this field has not yet been organized into an
integrated organized base of knowledge. To increase the
viability of the work currently being done by NIH regarding
child maltreatment, the committee believes it is essential that
the child abuse and neglect portfolio at the NIH and its
relevant Institutes be better coordinated and focused. As an
important first step the committee strongly recommends that the
NIH convene a working group made up of representatives of its
component organizations currently supporting research on child
maltreatment. The committee further encourages this working
group to hold a conference on child abuse and neglect to assess
the state-of-the-science and make recommendations for a
research agenda in this field; including in this conference
relevant outside organizations and recognized experts in child
maltreatment.
4. National Human Genome Research Institute
The committee is aware of the importance of emerging
knowledge of the human genome for the understanding of disease
and its effective treatment. As we go into the next millennium,
knowledge of genes and gene products will radically alter the
physician's approach to disease. The committee expects that
methods advanced by the National Center for Human Genome
Research will continue to evolve and to influence many aspects
of medical science long after the human genome has been
sequenced. The committee hopes that the elevation of the
National Center for Genome Research to institute status will
ensure a continued focus of NIH resources on important genetic
research.
The attention to ethical, social, and legal issues
surrounding the genetic underpinnings of cancer and other
diseases is a valuable investment. Therefore, the current 5
percent of extramural funds set-aside for reviewing and funding
proposals to address these issues is maintained in this
institute's mission.
The additional authorities that accompany institute status
will help to increase efficiency in this new institute. The
committee expects that elevation of the center to institute
status will have no additional budgetary ramifications and will
require no additional full time employees.
5. Addressing the needs for expanded involvement in
clinical research
GENERAL
The committee is aware that there are unprecedented
pressures on academic health centers as a result of the health
care market transformations. These pressures occur particularly
in price-competitive health care markets where managed care
plans have strong incentives to direct patients away form
academic health centers to sources of care with lower costs.
Moreover, because of reduced clinical incomes, the loss of
clinical practice revenue has had the effect of reducing a
substantial source of support for clinical research. The
committee recognizes the attention that has been brought to the
need for sustained, high-quality clinical research by studies
performed by the Institute of Medicine of the National Academy
of Sciences.
The committee is pleased that the leadership of the NIH has
undertaken its own study of the ramifications of these changes
upon clinical research by appointing a group of leading experts
to a panel of clinical research. The committee believes that
the panel on clinical research should produce, as soon as
possible, specific recommendations that will increase attention
and resources for the dilemma faced by academic health centers
in their efforts to translate basic knowledge into clinical
applications for patients. There is a particular interest by
some members of the committee for the panel to evaluate what,
if any, of the financial burden for clinical research should be
assumed by managed care providers. The committee expects that
the NIH will continue to monitor the effects of the ever-
evolving market at regular intervals.
GENERAL CLINICAL RESEARCH CENTERS
The committee sees the General Clinical Research Centers as
potential sources of solutions to some of the problems faced by
academic health centers as they seek to maintain their academic
missions in this changing economic environment. General
Clinical Research Centers, widely distributed as they are
around the country, draw on a broad range of research strengths
from their parent academic institutions.
The committee expects to see increased interdisciplinary
research in these settings, as well as greater usage of diverse
settings for research such as ambulatory and even home settings
that reduce costs compared to traditional inpatient research
wards.
CLINICAL RESEARCH CAREER ENHANCEMENT AND INNOVATIVE MEDICAL SCIENCE
AWARDS
The committee recognizes the importance of sustaining
exemplary careers of expert clinical investigators and the
importance of rewarding exceptional research ideas brought
forward by clinical investigators at all stages of their
careers. The committee intends that, with specific
authorization of such awards, careers that might otherwise
become fallow without adequate support will instead continue to
develop creative solutions to the many health dilemmas that are
currently unsolved.
It is the intention of the committee that only applications
of exceptional merit will be funded. Only by maintaining such
high standards can these awards be effective in sustaining
valuable careers and leveraging creative new research concepts.
6. Education and training for clinical research
GENERAL
The committee is aware that an important resource for the
future of clinical research is the training and education for
the next generation of investigators. The increasing costs of
medical education have discouraged medical graduates for
pursuing careers in clinical research because of the prolonged
training that is required and the reduced incomes that are
associated with such career preparation.
Nevertheless, there can be no shortcut to the excellence
required for a career in patient-focused research.
Consequently, even more creative strategies must be developed
by the NIH to foster such training and careers.
RAISING LOAN REPAYMENT
To encourage qualified health professionals to pursue
training in clinical research, the committee considers it
appropriate to increase the maximum level of qualified student
loans that could be repaid for participation in clinical
research training fellowships at the NIH campus in Bethesda,
MD. In addition, the venues should be expanded to include
General Clinical Research Centers located throughout the
country in academic health centers. In view of the periodic
emergence of research fields, the committee would like to see
greater flexibility available to the NIH to determine areas of
research where loan repayment may be granted.
Medical Scientist Training Program
The Medical Scientist Training Program is a highly
successful program that has provided support for exceptionally
qualified students to pursue the M.D. as well as a Ph.D. in a
particular field that prepares the recipient for a career in
biomedical research. This program can be the source of the
future faculties of medicine and biomedical research
institutions.
However, the fields in which the Ph.D. has been pursued
have generally been the basic biologic sciences. On the other
hand, the context of medicine and clinical research is changing
dramatically. As managed care emerges as the dominant form of
support for medical care, it becomes increasingly apparent that
the sciences germane to population-focused research, as well as
the economic components of care, must be part of the research
training that is supported by Federal funds. The committee is
aware that a study performed by the Institute of Medicine of
the National Academy of Sciences has argued for broadening the
fields wherein the Ph.D. may be obtained in the Medical
Scientist Training Program. If the future faculties of medical
schools are to prepare future physicians appropriately and
soundly for their careers in medicine, those faculties must be
composed of scholars in the broader fields of the population-
based sciences, such as epidemiology, biostatistics, medical
economics, and bioethics. However, it is the opinion of the
committee that, while the NIH is best qualified to set the
targets whereby these goals can be achieved, it has not been
aggressive in encouraging grantees to pursue such a strategy.
The committee hopes that the NIH will closely track this
program and be able to provide information in the future that
may answer the following questions. What careers, in what
disciplines, are pursued by previous recipients of support from
this program? How many have pursued careers in the population-
focused fields described above? How successful is this program
in retaining its graduates in academic careers?
7. National Fund for Health Research
The committee recognizes that the pressure is never-ending
for increased funding for biomedical research created by
expanding knowledge. Only one grant can be funded for every
four applications approved by NIH peer-review groups. On the
other hand, Federal support for the NIH must complete with the
many other demands on the Federal budget.
The committee believes the importance of biomedical
research is such that additional sources of funding must be
assured. Accordingly, a National Fund for Health Research is
established in the Department of the Treasury. This trust fund
will be on budget. The committee believes that establishing
such a fund is in itself an important first step toward
assuring sustainable support for the essential mission of
biomedical research.
B. Overview of substantive changes to S. 1897 contained in legislation
adopted by the committee
1. Pediatric research initiative
The committee recognizes that developments in genetics and
gene therapy are leading toward considerable growth in
knowledge and opportunities in the prevention and treatment of
diseases that affect children. Increased support for biomedical
research at a fundamental level should lead to new treatments
and cures for a variety of childhood diseases. Moreover,
clinical effectiveness studies can potentially demonstrate how
to improve the quality of care for children while reducing
costs of care.
It is the intention of the committee that the resources
provided by the pediatric research initiative will be allocated
among NIH institutes by the Director of the NIH for extramural
research in consultation with the institutes and any external
advisers that the Director determines to be appropriate. The
Director is encouraged to consider a central role for the
National Institute of Child Health and Human Development in
advising on the development of priorities and plans for
allocation of funds. The Director should encourage trans-
institute initiatives.
2. Diabetes research
The committee is encouraged by the success of biomedical
research in recent years into causes and management of problems
associated with diabetes mellitus. However, given the striking
increase in the number of patients with diabetes, there
continues to be a compelling need for a new advances in this
field. Accordingly, the committee calls for increased funding
in this field so as to encourage new and creative research
applications.
It is anticipated that these funds would be applied
wherever creative research is found. However, a coordinating
and leadership role is recognized for both the National
Institute of Diabetes and Digestive and Kidney Diseases and to
the National Eye Institute in their initiatives directed
specifically at this disease.
3. Parkinson's disease research
The committee is pleased to honor former Congressman Morris
K. Udall, who was forced to end his 30-year service in the U.S.
House of Representatives due to the disabling effects of
Parkinson's disease. This amendment to S. 1897 is a modified
form of a bill that has had bipartisan support by over half the
Senate and a companion bill in the House that had similar
broad-based support. It is intended to provide mechanisms to
encourage expansion of the Federal Parkinson's research efforts
in a speedy and effective way.
The committee notes that the NIH has undertaken active
efforts to coordinate initiatives in this area, particularly as
reflected by the 1995 Parkinson's Disease Research Planning
Workshop. The coordination and collaboration efforts that have
grown out of this workshop should be continued. The committee
expects that new funding will be used to attract outstanding
neuroscientists with innovative ideas to the field of
Parkinson's disease research.
V. Cost Estimate
A letter form the Congressional Budget Office requested
after committee action on July 17, 1996, has not been received
to date, September 9, 1996. Due to time constraints, the CBO
letter will appear in the Congressional Record at a later date,
when it is received.
VI. Regulatory Impact Statement
The committee has determined that there will be no increase
in the regulatory burden of paperwork as the result of this
bill.
VII. Section-by-Section Analysis
Section 1. Short title
Section 1 cites the act as the ``National Institutes of
Health Revitalization Act of 1996.''
TITLE--PROVISIONS RELATING TO THE NATIONAL INSTITUTES OF HEALTH
Section 101. Director's discretionary fund
Section 101 amends section 402(i)(3) of the Public Health
Service (PHS) Act by striking the authorized dollar amount and,
instead, authorizes the Director's Discretionary Fund at such
sums as may be necessary through fiscal year 1999.
Section 102. Children's vaccine initiative
Section 102 amends section 404B(c) of the PHS Act by
striking the authorized dollar amount and, instead, authorizes
the Children's Vaccine Initiative at such sums as may be
necessary through fiscal year 1999.
TITLE II--PROVISIONS RELATING TO THE NATIONAL RESEARCH INSTITUTES
Section 201. Research on osteoporosis, Paget's disease, and related
bone disorders
Section 201 amends section 409A(d) of the PHS Act by
striking the authorized dollar amount and, instead, authorizes
the programs related to research on osteoporosis, Paget's
disease, and related bone disorders at such sums as may be
necessary through fiscal year 1999.
Section 202. National Human Genome Research Institute
Section 202 amends part C of title IV of the PHS Act,
adding a new subpart 18 which establishes the National Human
Genome Research Institute. Its purpose is to characterize the
structure and function of the human genome, including mapping
and sequencing of individual genes. This purpose includes: (1)
planning and coordinating the research goal of the genome
project; (2) reviewing and funding research proposals; (3)
conducting and supporting research training; (4) coordinating
international genome research; (5) communicating advances in
genome research to the public; (6) reviewing and funding
proposals to address the ethical, legal, and social issues
associated with the genome project (including legal issues
regarding patents); and (7) planning and administering
intramural, collaborative, and field research to study human
genetic disease. It allows the director of the institute to
conduct and support research training for which fellowship
support is not provided under section 487 (National Research
Service Awards) and is not residency training of physicians or
other health professionals. It allows the director of the
institute to make funding available at a level that is at least
5 percent of the total amount available for extramural research
grants, for research in ethical, legal, and social issues with
reference to genome research.
It transfers all functions, personnel, assets, liabilities,
contracts, property, records, unexpended balances,
authorizations, allocations, and other funds of the National
Center of Human Genome Research to the new National Human
Genome Research Institute. It transfers to the new institute
and continues in effect all legal documents of the center. It
deems that all previous references to the center in Federal
law, executive order, rule, or any document shall refer to the
new institute.
It authorizes the National Human Genome Research Institute
at such sums as may be necessary through fiscal year 1999.
Section 203. Increased amount of grant and awards
Section 203 amends section 405(b)(2)(B) of the PHS Act by
increasing from $50,000 to $100,000 the award amount that an
institute can grant on the basis of technical or peer review
alone, thereby increasing flexibility and saving the time and
administrative cost required for advisory council approval for
smaller grants.
Section 204. Meetings of advisory committees and councils
Section 204 amends section 406 of the PHS Act by
eliminating required meeting schedules for advisory committees
and councils. Specifically, it eliminates the requirements for
institute advisory councils to meet three times yearly, and for
the National Cancer Advisory Board and the advisory council of
the National Heart, Lung, and Blood Institute to meet four
times yearly. It amends section 415(a)(3) of the PHS Act by
eliminating the requirement for the President's Cancer Panel to
meet four times a year.
It amends section 429(b) of the PHS Act by eliminating the
requirement for the Institute of Diabetes and Digestive and
Kidney Interagency Coordinating Committees to meet four times a
year.
It amends section 439(b) of the PHS Act by eliminating the
requirement for the Institute of Arthritis and Musculoskeletal
and Skin Diseases Interagency Coordinating Committees to meet
four times a year.
It amends section 464E(d) of the PHS Act by eliminating the
requirement for the Institute on Deafness and Other
Communication Disorders Interagency Coordinating Committees to
meet four times a year
It amends section 464X(e) of the PHS Act by eliminating the
requirement for the Institute of Nursing Research Advisory
Council to meet three times a year.
It amends Part B of title IV of the PHS Act to create
section 409B eliminating the application of the provisions of
the Federal Advisory Committee Act (5 U.S.C. Ap. 2) to
scientific and peer-review groups of the National Institutes of
Health established under title IV.
Section 205. Elimination or modification of reports
Section 205 repeals section 403 of the PHS Act eliminating
the biennial report of the Director of the National Institutes
of Health to Congress and the President.
It repeals section 439(c) of the PHS Act eliminating the
annual report of the Arthritis and Musculoskeletal Diseases
Interagency Coordinating Committee and the annual report of the
Skin Diseases Interagency Coordinating Committee.
It repeals section 442(j) of the PHS Act eliminating the
annual report of the National Arthritis and Musculoskeletal and
Skin Diseases Advisory Board.
It repeals section 494A(b) of the PHS Act eliminating the
annual report of the Secretary of Health and Human Services on
health services research relating to alcohol abuse and
alcoholism, drug abuse, and mental health.
It repeals section 503(b) of the PHS Act eliminating the
triennial report of the Secretary of Health and Human Services
to Congress relating to alcoholism, alcohol abuse, and drug
abuse.
It amends section 402(f)(3) changing the reporting
requirement from annual to biennial for the report to the
Director of the National Institutes of Health concerning
prevention activities undertaken by the Associate Director for
Prevention.
It repeals section 429(c) of the PHS Act eliminating the
annual reports of the Coordinating Committees on Digestive
Diseases, Diabetes Mellitus, and Kidney, Urologic, and
Hematologic Diseases.
It repeals section 304 of the Home Health Care and
Alzheimer's Disease Amendments of 1990 (42 U.S.C. 242q-3)
eliminating the annual report of the Task Force on Aging.
It repeals subsections (b) and (c) of section 1122 of the
PHS Act eliminating the annual reports related to sudden infant
death syndrome.
It repeals subsection (h) of section 5 of the International
Health Research Act of 1960 eliminating the annual report of
the U.S.-Japan Cooperative Medical Science Program.
The bill instructs the Secretary of Health and Human
Services, acting through the Director of the National
Institutes of Health, to report to the Congress on plans
regarding how the findings of the report to Congress entitled
``Support for Bioengineering Research,'' submitted in August
1995, will be implemented.
Conforming amendments
The bill amends section 404C(c) of the PHS Act making
available a periodic revision of a plan regarding the use of
animals for research to the Interagency Coordinating Committee
on the Use of Animals in Research for inclusion in its minutes.
This plan previously was provided to the Director of the
National Institutes of Health for the biennial report of the
Director.
The bill amends section 404E(d)(3)(B) of the PHS Act by
eliminating the requirement for the submission of the biennial
report of the Office of Alternative Medicine for inclusion in
the biennial report of the Director of the National Institutes
of Health. The director of the office will continue to prepare
the biennial report.
The bill amends section 406(g) of the PHS Act by
eliminating the need for advisory councils of the institutes to
submit comments for inclusion in the biennial report of the
Director of the National Institutes of Health.
The bill amends section 407 of the PHS Act by changing the
section heading to ``REPORTS'' and eliminating the requirement
for the director of each national research institute to submit
a report for inclusion in the biennial report of the Director
of the National Institutes of Health.
The bill amends section 416(b) of the PHS Act by
eliminating the requirement for submission by the Associate
Director for Prevention of the National Cancer Institute of the
prevention activities of hat institute for inclusion in the
biennial report of the Director of the National Institutes of
Health. This report will be submitted directly to the Associate
Director for Prevention of the National Institutes of Health.
The bill strikes section 417(e) of the PHS Act, eliminating
the submission of a report regarding the program in breast and
gynecologic cancers for inclusion in the biennial report of the
Director of the National Institutes of Health.
Teh bill amends section 423(b) of the PHS Act by
eliminating the requirement for the report of the Associate
Director for Prevention of the National Heart, Lung, and Blood
Institute of the prevention activities of that institute for
inclusion in the biennial report of the Director of the
National Institutes of Health. This report will be submitted
directly to the Associate Director for Prevention of the
National Institutes of Health.
The bill repeals section 433 of the PHS Act by eliminating
a biennial report by the Director of the National Institute of
Diabetes and Digestive and Kidney Diseases regarding diabetes
and digestive diseases research for inclusion in the biennial
report of the Director of the National Institutes of Health.
The bill amends section 451(b) of the PHS Act by
eliminating the requirement for the report of the Associate
Director for Prevention of the National Institute of Child
Health and Human Development of the prevention activities of
that institute for inclusion in the biennial report of the
Director of the National Institutes of Health. This report will
be submitted directly to the Associate Director for Prevention
of the National Institutes of Health.
The bill amends section 452(d)(4) of the PHS Act by
eliminating the submission of a report by the Director of the
National Institute of Child Health and Human Development
regarding the research plan for the National Center for Medical
Rehabilitation Research for inclusion in the biennial report of
the Director of the National Institutes of Health. This report
will be submitted directly to the Director.
The bill amends section 464I(b) of the PHS Act by
eliminating the requirement for the report of the Associate
Director for Prevention of the National Institute on Alcohol
Abuse and Alcoholism of the prevention activities of the
institute for inclusion in the biennial report of the Director
of the National Institutes of Health. This report will be
submitted directly to the Associate Director for Prevention of
the National Institutes of Health.
The bill amends section 464M(b) of the PHS Act by
eliminating the requirement for a report of the Associate
Director for Prevention of the National Institute on Drug Abuse
of the prevention activities of that institute for inclusion in
the biennial report of the Director of the National Institutes
of Health. This report will be submitted directly to the
Associate Director for Prevention of the National Institutes of
Health.
The bill amends section 464S(b) of the PHS Act by
eliminating the requirement for a report of the Associate
Director for Prevention of the National Institute of Mental
Health of the prevention activities of that institute for
inclusion in the biennial report of the Director of the
National Institutes of Health. This report will be submitted
directly to the Associate Director for Prevention of the
National Institutes of Health.
The bill amends section 464X(g) of the PHS Act by
eliminating the submission of a report from the advisory
council of the National Institute of Mental Health regarding
research plans for inclusion in the biennial report of the
Director of the National Institutes of Health.
The bill amends section 464Y of the PHS Act by changing the
section heading to ``REPORTS'' and eliminating the requirement
for the Director of the National Institute of Mental Health to
submit a report for inclusion in the biennial report of the
Director of the National Institutes of Health.
The bill amends section 480(g) of the PHS Act by
eliminating the requirement for the submission of a report from
the advisory council of the National Center for Research
Resources for inclusion in a biennial report of the director of
the center.
The bill amends section 481 of the PHS Act by changing the
section heading to ``REPORTS'' and eliminating the requirement
for the Director of the National Center for Research Resources
to submit a report for inclusion in the biennial report of the
Director of the National Institutes of Health.
The bill amends section 486(d)(5)(B) by eliminating the
submission of a report of the advisory committee of the Office
of Women's Health for inclusion in the biennial report of the
Director of the National Institutes of Health. The report of
the committee is not, however, eliminated.
The bill amends section 486B(b) of the PHS Act by replacing
the inclusion of the biennial report of the Director of the
Office of Women's Health in the biennial report of the Director
of the National Institutes of Health with submission directly
to the Director of the National Institutes of Health.
The bill amends section 492B(f) of the PHS Act requiring
the advisory council of each research institute to submit
directly to the Director of the National Institutes of Health a
report regarding the inclusion in clinical research of women
and members of minority groups as subjects.
TITLE III--SPECIFIC INSTITUTES AND CENTERS
Subtitle A--National Cancer Institute
Section 301. Authorization of appropriations
Section 301 amends section 417B of the PHS Act in
subsection (a) authorizing the National Cancer Institute at $3
billion in fiscal year 1997 and such sums as may be necessary
for fiscal years 1998 and 1999. Subparagraph (b)(1)(A) is
amended by striking the authorized dollar amount and, instead,
authorizes programs in breast cancer basic research at such
sums as may be necessary through fiscal year 1999. Subparagraph
(b)(1)(B) is amended by striking the authorized dollar amount
and, instead, authorizes programs in breast cancer clinical
research, control programs, information and education programs,
and research demonstration centers at such sums as may be
necessary through fiscal year 1999. Paragraph (b)(2) is amended
by striking the authorized dollar amount and, instead,
authorizes research programs in ovarian cancer and other
cancers of the female reproductive system at such sums as may
be necessary through fiscal year 1999. Subsection (c) is
amended by striking the authorized dollar amount and, instead,
authorizes prostate cancer research programs at such sums as
may be necessary through fiscal year 1999.
Section 302. DES study
Section 302 amends section 403A(e) of the PHS Act by
striking the dollar amount and, instead, authorizes research
and training programs related to conditions associated with
exposure to the drug diethylstilbestrol at such sums as may be
necessary through fiscal year 1999.
Subtitle B--National Heart, Lung, and Blood Institute
Section 311. Authorization of appropriations
Section 311 amends section 425 of the PHS Act by
authorizing the National Heart, Lung, and Blood Institute at
$1.5 billion in fiscal year 1997 and such sums as may be
necessary for fiscal years 1998 and 1999.
Subtitle C--National Institute of Allergy and Infectious Diseases
Section 321. Research and research training regarding tuberculosis
Section 321 amends subpart 6 of part C of title IV in
section 447(b) by striking the dollar amount and, instead,
authorizes research and training programs related to
tuberculosis at such sums as may be necessary through fiscal
year 1999.
Section 322. Terry Beirn Community-Based AIDS Research Initiative
Section 322 amends section 2313(e) of the PHS Act by
authorizing the Terry Beirn Community-Based AIDS Research
Initiative at such sums as may be necessary through fiscal year
1999.
Subtitle D--National Institute of Child Health and Human Development
Section 331. Research centers for contraception and infertility
Section 331 amends section 452A(g) of the PHS Act by
striking the dollar amount and, instead, authorizes these
research centers at such sums as may be necessary through
fiscal year 1999.
Subtitle E--National Institute on Aging
Section 341. Authorization of appropriations
Section 341 amends section 445I of the PHS Act by
authorizing the National Institute on Aging at $550 million for
fiscal year 1997, and such sums as may be necessary for fiscal
years 1998 and 1999.
Subtitle F--National Institute on Alcohol Abuse and Alcoholism
Section 351. Authorization of appropriations
Section 351 amends section 464H(d)(1) of the PHS Act
authorizing the National Institute on Alcohol Abuse and
Alcoholism at $330 million for fiscal year 1997, and such sums
as may be necessary for fiscal years 1998 and 1999.
Section 352. National Alcohol Research Center
Section 352 amends section 464J(b) of the PHS Act by
eliminating a reference to a nonexistent section in health law
[section 701(l)], and providing a definition of
``construction'' which had been inadvertently dropped in
previous legislation. This definition is the long-used
definition of ``construction'' that appeared, prior to
elimination, in the PHS Act as amended through July 31, 1991.
Subtitle G--National Institute on Drug Abuse
Section 361. Authorization of appropriations
Section 361 amends section 464L(d)(1) of the PHS Act by
authorizing the National Institute on Drug Abuse at $480
million for fiscal year 1997, and such sums as may be necessary
for fiscal years 1998 and 1999.
Section 362. Medication development program
Section 362 amends section 464P(e) of the PHS Act by
striking the dollar amount and, instead, authorizes the
medication development program in the National Institute on
Drug Abuse at such sums as may be necessary through fiscal year
1999.
Section 363. Drug abuse research centers
Section 363 amends section 464N(b) of the PHS Act by
eliminating a reference to a nonexistent section in health law
[section 701(l)] and providing a definition of ``construction''
which had been inadvertently dropped in previous legislation.
This definition is the long-used definition of ``construction''
that appeared, prior to elimination, in the PHS Act as amended
through July 31, 1991.
Subtitle H--National Institute of Mental Health
Section 371. Authorization of appropriations
Section 371 amends section 464R(f)(1) of the PHS Act by
authorizing the National Institute of Mental Health at $750
million in fiscal year 1997 and such as may be necessary for
fiscal years 1998 and 1999.
Subtitle I--National Center for Research Resources
Section 381. Authorization of appropriations
Section 381 amends section 481A(h) and 481B(a) of the PHS
Act by striking the dollar amount and, instead, authorizes
funds that may be reserved for construction of regional primate
centers at such sums as may be necessary through 1999.
Section 382. General Clinical Research Centers
Section 382 amends part B of title IV of the PHS Act adding
a new section, 409C, General Clinical Research Centers.
Subsection (a) establishes in law General Clinical Research
Centers, entities that already exist in academic medical
centers throughout the United States. These centers are to
support clinical studies and clinical research career
development in these settings. Subsection (b) expands the
activities of clinical research centers by the use of
telecommunications and telemedicine initiatives. Subsection (c)
authorizes, for the purpose of making grants under subsection
(a), such sums as may be necessary through fiscal year 1999.
Section 383. Enhancement Awards
Section 383 amends part B of title IV of the PHS Act by
adding a new section, 409D, Enhancement Awards. Subsection (a)
establishes clinical research career enhancement awards to
support individual careers in clinical research. Applications
for these awards will be made by individual scientists. They
will not exceed $130,000 per year per grant and will be for
terms of 5 years. Up to 20 new awards will be made in each of
the first 2 fiscal years that these grants are made. It
authorizes the clinical research career enhancement awards
program at such sums as may be necessary for each of the fiscal
years 1997 through 1999.
Subsection (b) establishes innovative medical science
awards to support individual clinical research projects.
Applications for these awards will be made by individual
scientists. They will not exceed $100,000 per year per grant.
It authorizes innovative medical science awards at such sums as
may be necessary for each of the fiscal years 1997 through
1999.
Subsection (c) instructs the Director of the National
Institutes of Health, in cooperation with the Director of the
National Center for Research Resources, to establish peer
review mechanisms which include individuals who are
exceptionally qualified to appraise the merits of clinical
research to evaluate applications for clinical research
fellowships, clinical research career enhancement awards, and
innovative medical science awards.
Section 384. Waiver of limitations
Section 384 amends section 481A of the PHS Act by making
modifications in the support for modernization and construction
of biomedical and behavioral research facilities. Subsection
(b)(3)(A) enlarges the membership of the Scientific and
Technical Review Board on Biomedical and Behavioral Research
Facilities from 9 to 12 members. Subparagraph (e)(1)(A) reduces
the percentage of support provided by this funding mechanism
for the modernization and construction of such research
facilities from 50 percent to 40 percent. Subparagraph
(e)(1)(B) reduces the percentage of support provided by this
funding mechanism for the modernization and construction of
multipurpose facilities from 40 percent to 30 percent of the
necessary cost of such construction that the Director
determines to be proportionate to the contemplated use of such
a facility.
Paragraph (e)(4) allows the limitations described in
subparagraph (e)(1)(A) and (e)(1)(B) to be waived at the
discretion of the Director.
Subsection (h) is amended by striking the authorized dollar
amount and, instead, authorizes the program for modernization
and construction of research facilities at such sums as may be
necessary for each of the fiscal years 1997 through 1999.
Subtitle J--National Library of Medicine
Section 391. Authorization of appropriations
Section 391 amends section 486(a) of the PHS Act by
authorizing the National Library of Medicine at $160 million in
fiscal year 1997 and such sums as may be necessary for fiscal
years 1998 and 1999.
Section 392. Increasing the cap on grant amounts
Section 392 amends section 474(b)(2) of the PHS Act
increasing the cap on grants to medical libraries from $1
million to $1.25 million per year.
title iv--awards and training
Section 401. Medical Scientist Training Program
Section 401 instructs the Secretary of Health and Human
Services, acting through the Director of the National
Institutes of Health, to expand the Medical Scientist Training
Program to include opportunities to pursue the Ph.D. degree in
fields that will contribute to training clinical investigators
in the skills necessary for performing patient-oriented
clinical research. It instructs the Director to designate
specific percentages for such disciplines as economics,
epidemiology, public health, bioengineering, biostatistics, and
bioethics.
Section 402. Raise in maximum level of loan repayments
Section 402(a) amends subsection 487A(a) of the PHS Act by
increasing from $20,000 to $35,000 the amount of educational
loans that can be repaid by the Federal Government for each
year that a qualified health professional spends as an employee
of the National Institutes of Health performing research on
Acquired Immune Deficiency Syndrome. It amends subsection (b)
by authorizing the loan repayment program for research with
respect to AIDS at such sums as may be necessary through fiscal
year 1999.
The bill amends subsection 487B(a) of the PHS Act by
increasing from $20,000 to $35,000 the amount of educational
loans that can be repaid by the Federal Government for each
year that a qualified health professional spends conducting
research with respect to contraception and infertility.
The bill amends paragraph 487C(a)(1) of the PHS Act by
increasing from $20,000 to $35,000 the amount of educational
loans that can be repaid by the Federal Government for each
year that a qualified health professional spends as an employee
of the National Institutes of Health conducting research
without limitation as to the subject of that research.
The bill amends paragraph 487E(a)(1) of the PHS Act by
increasing from $20,000 to $35,000 the amount of educational
loans that can be repaid by the Federal Government for each
year that a qualified health professional from a disadvantaged
background spends as an employee of the National Institutes of
Health conducting clinical research. It amends paragraph
487E(a)(3) of the PHS Act to allow the National Institutes of
Health to offer participants in the clinical research loan
repayment program from disadvantaged backgrounds the same tax
reimbursement benefits provided in the National Health Service
Corps Loan Repayment Program.
Section 403. General loan repayment program
Section 403 amends part G of title IV of the PHS Act by
adding a new section, 487F, General Loan Repayment Program. It
allows the National Institutes of Health to offer participants
$35,000 in educational loan repayment by the Federal Government
for each year of participation in this program. The Director
will identify annually the areas of research for which loan
repayments can be made. Such loan repayment agreements shall be
for a minimum of 2 years.
Subsection (b) provides to participants in the General Loan
Repayment Program the same provisions that apply to the
National Health Service Corps Loan Repayment Program.
Subsection (c) authorizes the General Loan Repayment
Program at such sums as may be necessary for each of the fiscal
years 1997 through 1999.
Section 404. Clinical research assistance
Section 404 amends section 487(a)(1)(C) of the PHS Act by
increasing the number of loan repayment contracts for
individuals from disadvantaged backgrounds from 50 to 100
individuals during each fiscal year through 1999.
It amends section 487E of the PHS Act by striking from the
section heading ``FROM DISADVANTAGED BACKGROUNDS.'' It amends
subsection 487E(a)(1) of the PHS Act to eliminate reference to
health professionals who are from disadvantaged backgrounds.
Paragraph 487E(a)(2) ensures that not less than 50 percent of
the amounts used in this section are for qualified health
professionals from disadvantaged backgrounds. Subsection
487E(c) expands the positions considered as clinical research
training positions to include service in a General Clinical
Research Center or other organization and institution
determined to be appropriate by the Director of the National
Institutes of Health. Subsection 487(d) authorizes this loan
repayment program for clinical researchers at such sums as may
be necessary for each fiscal year.
title v--research with respect to aids
Section 501. Comprehensive plan for expenditure of AIDS appropriations
Section 501 amends paragraph 2353(d)(1) of the PHS Act by
authorizing the comprehensive plan for expenditure of AIDS
appropriations through fiscal year 1999.
Section 502. Emergency AIDS discretionary fund
Section 502 amends paragraph 2356(g)(1) of the PHS Act by
striking the authorized dollar amount and, instead, authorizes
the emergency AIDS discretionary fund at such sums as may be
necessary for each of the fiscal years 1997 through 1999.
title vi--general provisions
Subtitle A--Authority of the Director of the NIH
Section 601. Authority of the Director of the NIH
Section 601 amends section 402(b) of the PHS Act to expand
the authorities of the Director of the NIH. Paragraph
402(b)(13) of the PHS Act expands the authority of the Director
to conduct and support research training. Paragraph 402(b)(14)
of the PHS Act expands the authority of the Director to appoint
health care professionals subject to the provisions of title 5
of the United States Code (U.S.C.), relating to appointments
and classifications in the competitive service and their
compensation subject to provisions of chapter 74 title 38,
U.S.C.
Subtitle B--Office for Rare Disease Research
Section 611. Establishment of Office of Rare Disease Research
Section 611 amends part A of title IV of the PHS Act by
adding a new section, 404F, Office for Rare Disease Research.
Subsection (a) establishes in law the Office for Rare Disease
Research within the Office of the Director of the NIH. It is to
be headed by a Director who shall be appointed by the Director
of the NIH. Subsection (b) establishes the purpose of the
office to promote and coordinate research on rare diseases
through a strategic research plan and to establish and manage a
clinical research database. Subsection (c) establishes an
advisory council for the purpose of providing advice to the
director of the office. Subsection (d) establishes the duties
of the director of the office. These duties include: (1)
develop a comprehensive plan for the conduct and support of
research on rare diseases: (2) coordinate and disseminate
information on rare diseases among the institutes and the
public; (3) support research training and encourage the
participation of a diversity of individuals in the conduct of
rare disease research; (4) identify projects or research of
rare diseases that should be conducted or supported by the NIH;
(5) develop and maintain a central database on current
government-sponsored clinical research projects for rare
diseases; (6) determine the need for registries of research
subjects and epidemiologic studies of rare disease populations;
and (7) prepare biennial reports on the activities carried out
by the office for the Secretary and the Congress.
Subtitle C--Certain Reauthorization
Section 621. National Research Service Awards
Section 621 amends section 487(d) of the PHS Act by
striking the authorized dollar amount and, instead, authorizes
the national research service awards program at such sums as
may be necessary for each of the fiscal years 1997 through
1999.
Section 622. National Foundation for Biomedical Research
Section 622 amends section 499(m)(1) of the PHS Act by
authorizing the National Foundation for Biomedical Research at
such sums as may be necessary for each of the fiscal years 1997
through 1999.
Subtitle D--Miscellaneous Provisions
Section 631. Establishment of National Fund for Health Research
Section 631 amends part A of title IV of the PHS Act by
adding a new section, 404G, Establishment of National Fund for
Health Research. Subsection (a) establishes in the U.S.
Department of the Treasury a fund to be known as the National
Fund for Health Research to consist of amounts that may be
transferred to that fund as well as interest earned on the
investment of amounts in the fund. Subsection (b) provides that
the Secretary shall distribute all amounts in the fund to
research institutes and centers in the same proportions as the
amounts appropriated to that institute or center relative to
the total amount appropriated for the entire NIH for the fiscal
year. It further provides that no expenditure shall be made
from the fund in a fiscal year that the annual appropriated
amount for the NIH is less than the previous fiscal year. A
source of revenue for the fund is not provided.
Section 632. Definition of clinical research
Section 632 amends part A of title IV of the PHS Act by
adding a new section, 404H, Definition of Clinical Research. It
establishes that the term ``clinical research'' means patient-
oriented clinical research conducted with human subjects; or
research on the causes and consequences of disease in human
populations; or research on material of human origin (such as
tissue specimens and cognitive phenomena) for which an
investigator or colleague directly interacts with human
subjects in an outpatient or inpatient setting, to clarify a
problem in human physiology, pathophysiology or disease,
epidemiologic or behavioral studies, outcomes research, or
health services research.
Section 633. Senior Biomedical Research Service
Section 633 amends section 228 of the PHS Act by adding a
new subsection (h) which establishes that the Secretary shall
be treated as a nonprofit entity for the entity for the
purposes of making contributions to the retirement systems of
appointees under the Senior Biomedical Research Service. This
is done to permit such appointees to continue to be covered
fully under the retirement systems of which they were members
immediately prior to their appointment.
Section 634. Establishment of a Pediatric Research Initiative
Section 634 amends part A of title IV of the PHS Act by
adding a new section, 404I, Pediatric Research Initiative.
Subsection (a) establishes within the Office of Director of the
NIH a pediatric research initiative under the leadership of the
Director. Subsection (b) establishes the purpose of the
initiative. It includes: (1) increased support for pediatric
biomedical research within the NIH to ensure that the expanding
opportunities for advancement in scientific investigations and
care for children are realized; (2) enhanced collaborative
efforts among the institutes to support multidisciplinary
research in the areas that the Director deems most promising;
(3) increased support for pediatric outcomes and medical
effectiveness research; (4) the development of adequate
pediatric clinical trials and pediatric use information to
promote safer and more effective use of prescription drugs in
the pediatric population; and (5) recognition of the special
attention pediatric research deserves. Subsection (c)
establishes the duties of the Director in this capacity which
include: (1) consultation with the institutes and appropriate
advisers when considering the role of the Institute for Child
Health and Human Development; (2) allocating, with broad
discretion, initiative assistance among the institutes, among
types of grants, and between basic and clinical research as
long as the assistance is directly related to pediatric
illnesses and the assistance is extramural; and (3) oversight
of any newly appropriated initiative funds and accountability
for their expenditure to Congress and the public. Subsection
(d) authorizes the pediatric initiative at $50 million over
fiscal years 1997 through 1999.
Section 635. Diabetes research
Section 635 authorizes conduct and support of diabetes-
related research by the NIH at the amount appropriated for
fiscal year 1996 for each of the fiscal years 1997 through
1999, plus an additional 25 percent of the amount appropriated
for fiscal year 1996 over the ensuing 3 fiscal years through
fiscal year 1999.
Section 636. Parkinson's research
Section 636 amends part B of title IV of the PHS Act by
adding a new section, 409E, Parkinson's Disease. Subsection (a)
establishes a program for the conduct and support of research
and training with respect to Parkinson's disease. Subsection
(b) establishes the role of this program in interinstitute
coordination and provides for the convening of a research
planning conference every 2 years from which there will be a
report to Congress.
Subsection (c) establishes up to 10 Morris K. Udall Centers
for Research on Parkinson's Disease that will be funded by core
center grants. These centers will use the facilities of a
single institution or consortium of institutions to conduct
basic and clinical research. They may conduct training,
programs for continuing education of health professionals,
programs for dissemination of information to the public, and
develop brain banks for the collection of specimens related to
Parkinson's disease. Separately, or in collaboration with other
centers, they will establish a nationwide data system derived
from patient populations with Parkinson's disease, establish a
Parkinson's Disease Information Clearinghouse, and establish a
national education program that fosters a national focus on
Parkinson's disease. The bill establishes that Udall Centers
may use center funds to provide stipends for scientists and
health professionals enrolled in training programs. The bill
provides that Centers will be supported for periods of 5 years,
renewable for 5-year periods after peer review.
Subsection (d) establishes the Morris K. Udall Awards for
Innovation in Parkinson's Disease Research to support
outstanding neuroscientists and clinicians who bring innovative
ideas to bear on the understanding of the pathogenesis,
diagnosis, and treatment of Parkinson's disease.
Subsection (e) authorizes the Parkinson's disease research
program at $80 million for fiscal year 1997 and such sums as
may be necessary for fiscal years 1998 and 1999.
Subtitle E--Repeals and Conforming Amendments
Section 641. Repeals and conforming amendments
Section 641(a) amends section 403(5) of the PHS Act by
replacing the designation ``Division of Research Resources''
with ``National Center for Research Resources'' so as to cite
the correct designation for this center. It amends sections
403(5) and 408(a)(2) of the PHS Act by replacing the
designation ``National Center for Nursing Research'' with
``National Institute of Nursing Research'' so as to cite the
correct designation for this institute. It amends sections
406(b)(2)(A), 406(h)(2)(A)(v), 424(c)(3)(B)(v),
424(c)(3)(B)(x), 429(b), 430(b)(2)(A)(I), 439(b),
452(f)(3)(B)(xi), 466(a)(1)(B), and 480(b)(2)(A) of the PHS Act
by replacing the designation ``Chief Medical Director of the
Department of Veterans Affairs'' with ``Under Secretary for
Health of the Department of Veterans Affairs'' so as to cite
the correct designation for this position.
Section 641(b) amends section 406(h) of the PHS Act to
provide for greater flexibility in the governance of advisory
councils.
Section 641(c) repeals section 430 of the PHS Act
eliminating the National Diabetes Advisory Board, the National
Digestive Diseases Advisory Board, and the National Kidney and
Urologic Diseases Advisory Board.
Section 641(d) repeals section 442 of the PHS Act
eliminating the National Arthritis and Musculoskeletal and Skin
Diseases Advisory Board.
Section 641(e) amends subpart 6 of part C of title IV of
the PHS Act by redesignating section 447 as section 447A.
Section 641(f) repeals section 464D of the PHS Act
eliminating the National Institute on Deafness and Other
Communication Disorders Advisory Board.
Section 641(g) amends section 489 of the PHS Act by
eliminating a requirement that the National Academy of Sciences
be used to conduct continuing studies with respect to
biomedical and behavioral research personnel.
Section 641(h) repeals section 18 of the Comprehensive
Alcohol Abuse and Alcoholism Prevention, Treatment, and
Rehabilitation Amendments of 1979 (42 U.S.C. 4541 note)
eliminating the National Commission on Alcoholism and Other
Alcohol-Related Problems.
Section 641(i) amends section 311(a) of the Comprehensive
Environmental Response, Compensation and Liability Act of 1980
(42 U.S.C. 9660(a) eliminating the Advisory Council on
Hazardous Substances Research and Training.
VIII. ADDITIONAL VIEWS OF SENATORS COATS, DeWINE, FAIRCLOTH, GREGG, AND
ASHCROFT
This bill goes far toward supporting, continuing, and
revitalizing the essential work of the National Institutes of
Health and we are pleased to have supported its passage.
However, we are concerned that the bill fails to address
serious issues regarding the use of Federal funds made
available through programs authorized by this bill to
experiment on human embryos and fetuses--unborn children--some
of them living at the time of the research; others made
available by induced abortion.
Data from the National Institutes of Health confirms that
substantial Federal funds--millions of dollars--are spent on
research using human fetuses. We are alarmed by such
experimentation on these humans in these circumstances. We
suggest that the public is not well served when taxpayer funds
are used for research that is opposed by millions and millions
of Americans as fundamentally unethical. We question whether
medical science is best advanced by using scarce research funds
in this way when acceptable alternative therapies and sources
of tissue might more productively be explored.
John Ashcroft.
Dan Coats.
Lauch Faircloth.
Mike DeWine.
Judd Gregg.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
* * * * * * *
NATIONAL INSTITUTES OF HEALTH REVITALIZATION ACT OF 1996
* * * * * * *
PUBLIC HEALTH SERVICE ACT
* * * * * * *
Sec. 402(i)(3) For the purpose of carrying out this
subsection, there are authorized to be appropriated
[$25,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996.] such
sums as may be necessary for each of the fiscal years 1997
through 1999.
* * * * * * *
Sec. 404B(c) Authorization of Appropriations.--In addition
to any other amounts authorized to be appropriated for
activities of the type described in this section, there are
authorized to be appropriated to carry out this section
[$20,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996.] such
sums as may be necessary for each of the fiscal years 1997
through 1999.
* * * * * * *
Sec. 409A(d) Authorization of Appropriations.--For the
purpose of carrying out this section, there are authorized to
be appropriated [$40,000,000 for fiscal year 1994, and such
sums as may be necessary for each of the fiscal years 1995 and
1996.] such sums as may be necessary for each of the fiscal
years 1997 through 1999.
* * * * * * *
title iv, part c
* * * * * * *
Subpart 18--National Human Genome Research Institute
SEC. 464Z. PURPOSE OF THE INSTITUTE.
(a) In General.--The general purpose of the National Human
Genome Research Institute is to characterize the structure and
function of the human genome, including the mapping and
sequencing of individual genes. Such purpose includes--
(1) planning and coordinating the research goal of
the genome project;
(2) reviewing and funding research proposals;
(3) conducting and supporting research training;
(4) coordinating international genome research;
(5) communicating advances in genome science to the
public;
(6) reviewing and funding proposals to address the
ethical, legal, and social issues associated with the
genome project (including legal issues regarding
patents); and
(7) planning and administering intramural,
collaborative, and field research to study human
genetic disease.
(b) Research.--The Director of the Institute may conduct
and support research training--
(1) for which fellowship support is not provided
under section 487; and
(2) that is not residency training of physicians or
other health professionals.
(c) Ethical, Legal, and Social Issues.--
(1) In general.--Except as provided in paragraph (2),
of the amounts appropriated to carry out subsection (a)
for a fiscal year, the Director of the Institute shall
make available not less than 5 percent of amounts made
available for extramural research for carrying out
paragraph (6) of such subsection.
(2) Nonapplication.--With respect to providing funds
under subsection (a)(6) for proposals to address the
ethical issues associated with the genome project,
paragraph (1) shall not apply for a fiscal year if the
Director of the Institute certifies to the Committee on
Commerce of the House of Representatives, and to the
Committee on Labor and Human Resources of the Senate,
that the Director has determined that an insufficient
number of such proposals meet the applicable
requirements of sections 491 and 492.
(d) Transfer.--
(1) In general.--There are transferred to the
National Human Genome Research Institute all functions
which the National Center for Human Genome Research
exercised before the date of enactment of this subpart,
including all related functions of any officer or
employee of the National Center for Human Genome
Research. The personnel employed in connection with,
and the assets, liabilities, contracts, property,
records, and unexpended balances of appropriations,
authorizations, allocations, and other funds employed,
used, held, arising from, available to, or to be made
available in connection with the functions transferred
under this subsection shall be transferred to the
national Human Genome Research Institute.
(2) Legal documents.--All orders, determinations,
rules, regulations, permits, agreements, grants,
contracts, certificates, licenses, regulations,
privileges, and other administrative actions which have
been issued, made, granted, or allowed to become
effective in the performance of functions which are
transferred under this subsection shall continue in
effect according to their terms until modified,
terminated, superseded, set aside, or revoked in
accordance with law.
(3) References.--References in any other Federal law,
Executive order, rule, regulation, or delegation of
authority, or any document of or relating to the
National Center for Human Genome Research shall be
deemed to refer to the National Human Genome Research
Institute.
(e) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section, such sums as may
be necessary for each of the fiscal years 1997 through 1999.
* * * * * * *
Sec. 401(b)(1) * * *
* * * * * * *
(R) The National Human Genome Research Institute.
(2) [(D) The National Center for Human Genome Research.]
[(E)] (D) The Office of Dietary Supplements.
* * * * * * *
title iv, part e, subpart 3
[(a) The general purpose of the National Center for Human
Genome Research (in this subpart referred to as the ``Center'')
is to characterize the structure function of the human genome,
including the mapping and sequencing of individual genes. Such
purpose includes--
[(1) planning and coordinating the research goal of
the genome project;
[(2) reviewing and funding research proposals;
[(3) developing training programs;
[(4) coordinating international genome research;
[(5) communicating advances in genome science to the
public; and
[(6) reviewing and funding proposals to address the
ethical and legal issues associated with the genome
project (including legal issues regarding patents).
[(b) The Director of the Center may conduct and support
research training--
[(1) for which fellowship support is not provided
under section 487; and
[(2) that is not residency training of physicians or
other health professionals.
[(c)(1) Except as provided in paragraph (2), of the amounts
appropriated to carry out subsection (a) for a fiscal year, the
Director of the Center shall make available not less than 5
percent for carrying out paragraph (6) of such subsection.
[(2) With respect to providing funds under subsection
(a)(6) for proposals to address the ethical issues associated
with the genome project, paragraph (1) shall not apply for a
fiscal year if the Director of the Center certifies to the
Committee on Energy and Commerce of the House of
Representatives, and to the Committee on Labor and Human
Resources of the Senate, that the Director has determined that
an insufficient number of such proposals meet the applicable
requirements of sections 491 and 492.]
* * * * * * *
Sec. 405(b)(2)(B)(i) if the direct cost of the grant or
cooperative agreement to be made does not exceed [$50,000]
$100,000, such grant or cooperative agreement may be made only
if such grant or cooperative agreement has been recommended
after technical and scientific peer review required by
regulations under section 492, and
(ii) if the direct cost of the grant or cooperative
agreement to be made exceeds [$50,000] $100,000, such grant or
cooperative agreement may be made only if such grant or
cooperative agreement has been recommended after technical and
scientific peer review required by regulations under section
492 and is recommended under section 406(a)(3)(A)(ii) by the
advisory council for the national research institute involved;
and
* * * * * * *
Sec. 406(e) Meetings.--The advisory council shall meet at
the call of the chairman or upon the request of the Director of
the national research institute for which it was established [,
but at least three times each fiscal year]. The location of the
meetings of each advisory council is subject to the approval of
the Director of the national research institute for which the
advisory council was established.
* * * * * * *
(h)(2)(A)(iv) the chairman of the Board shall be selected
by the President from the appointed members and shall serve as
chairman for a term of two years; and
(v) the ex officio members of the Board shall be nonvoting
members and shall be the Secretary, the Director of the Office
of Science and Technology Policy, the Director of NIH, the
Chief Medical Director of the Department of Veterans Affairs,
the Director of the National Institute for Occupational Safety
and Health, the Director of the National Institute of
Environmental Health Sciences, the Secretary of Labor, the
Commissioner of the Food and Drug Administration, the
Administrator of the Environmental Protection Agency, the
Chairman of the Consumer Product Safety Commission, the
Assistant Secretary of Defense for Health Affairs, and the
Director of the Office of Energy Research of the Department of
Energy (or the designees of such officers) [; and].
[(vi) the Board shall meet at least four times each fiscal
year.]
* * * * * * *
(B) This section applies to the advisory council to the
National Heart, Lung, and Blood Institute[, except that the
advisory council shall meet at least four times each fiscal
year].
* * * * * * *
Sec. 415(a)(3) The Panel shall meet at the call of the
chairman[, but not less often than four times a year]. A
transcript shall be kept of the proceedings of each meeting of
the Panel, and the chairman shall make such transcript
available to the public.
* * * * * * *
Sec. 429(b) Membership; Chairman; Meetings.--Each Committee
shall be composed of the Directors of each of the national
research institutes and divisions involved in research with
respect to the diseases for which the Committee is established,
the Chief medical Director of the Veterans' Administration
(Under Secretary for Health of the Department of Veterans
Affairs), and the Assistant Secretary of Defense for Health
Affairs (or the designees of such officers) and shall include
representation from all other Federal departments and agencies
whose programs involve health functions or responsibilities
relevant to such diseases, as determined by the Secretary. Each
Committee shall be chaired by the Director of NIH (or the
designee of the Director). Each Committee shall meet at the
call of the chairman [, but not less often than four times a
year].
* * * * * * *
Sec. 439(b) Membership; Chairman; Meetings.--Each Committee
shall be composed of the Directors of each of the national
research institutes and divisions involved in research
regarding the diseases with respect to which the Committee is
established, the Chief Medical Director of the Department of
Veterans Affairs (Under Secretary for Health of the Department
of Veterans Affairs), and the Assistant Secretary of Defense
for Health affairs (or the designees of such officers), and
representatives of all other Federal departments and agencies
(as determined by the Secretary) whose programs involve health
functions or responsibilities relevant to arthritis and
musculoskeletal diseases or skin diseases, as the case may be.
Each Committee shall be chaired by the Director of NIH (or the
designee of the Director). Each Committee shall meet at the
call of the chairman [, but not less often than four times a
year].
* * * * * * *
Sec. 464E(d) Chairman; Meetings.--The Coordinating
Committee shall be chaired by the Director of NIH (or the
designee of the Director). The Committee shall meet at the call
of the chair [, but not less often than four times a year].
* * * * * * *
Sec. 464X(e) Meetings.--The advisory council shall meet at
the call of the chairman or upon the request of the Director of
the Institute [, but at least three times each fiscal year].
The location of the meetings of the advisory council is subject
to the approval of the Director of the Institute.
* * * * * * *
Sec. 480(e) Meetings.--The advisory council shall meet at
the call of the chairman or upon the request of the Director of
the Center [, but at least three times each fiscal year). The
location of the meetings of the advisory council is subject to
the approval of the Director of the Center.
* * * * * * *
title iv, part b
* * * * * * *
SEC. 409B. APPLICATION OF FEDERAL ADVISORY COMMITTEE ACT.
Notwithstanding any other provision of law, the provisions
of the Federal Advisory Committee At (5 U.S.C. Ap. 2) shall not
apply to a scientific or technical peer review group,
established under this title.
* * * * * * *
[SEC. 403. BIENNIAL REPORT OF DIRECTOR TO PRESIDENT AND CONGRESS;
CONTENTS.
[The Secretary shall transmit to the President and to the
Congress a biennial report which shall be prepared by the
Director of NIH and which shall consist of--
[(1) a description of the activities carried out by
and through the National Institutes of Health and the
policies respecting the programs of the National
Institutes of Health and such recommendations
respecting such policies as the Secretary considers
appropriate;
[(2) a description of the activities undertaken to
improve grants and contracting accountability and
technical and scientific peer review procedures of the
National Institutes of Health and the national research
institutes;
[(3) the reports made by the Associate Director for
Prevention under section 402(f) during the period for
which the biennial report is prepared;
[(4) a description of the health related behavioral
research that has been supported by the National
Institutes of Health in the preceding 2-year period,
and a description of any plans for future activity in
such area; and
[(5) the biennial reports of the Directors of each of
the national research institutes, the Director of the
Division of Research Resources, and the Director of the
National Center for Nursing Research.
The first report under this section shall be submitted not
later than July 1, 1986, and shall relate to the fiscal year
ending September 30, 1985. The next report shall be submitted
not later than December 30, 1988, and shall relate to the two-
fiscal-year period ending on the preceding September 30. Each
subsequent report shall be submitted not later than 90 days
after the end of the two-fiscal-year period for which the
report is to be submitted.]
* * * * * * *
Sec. 439 [(c) Annual Report.--Not later than 120 days after
the end of each fiscal year, each Committee shall prepare and
transmit to the Secretary, the Director of NIH, the Director of
the Institute, and the advisory council for the Institute a
report detailing the activities of the Committee in such fiscal
year in carrying out paragraphs (1) and (2) of subsection (a).]
* * * * * * *
Sec. 442 [(j) Annual Report.--The Advisory Board shall
prepare an annual report for the Secretary which--
[(1) describes the Advisory Board's activities in the
fiscal year for which the report is made;
[(2) describes and evaluates the progress made in
such fiscal year in research, treatment, education, and
training with respect to arthritis, musculoskeletal
diseases, and skin diseases;
[(3) summaries and analyzes expenditures made by the
Federal Government for activities respecting such
diseases in such fiscal year for which the report is
made;
[(4) contains the Advisory Board's recommendations
(if any) for changes in the plan prepared under section
436(a); and
[(5) contains recommendations for expanding the
Institute's funding of research directly applicable to
the cause, diagnosis, early detection, prevention,
control, and treatment of, and rehabilitation of
children with arthritis and musculosketal diseases.]
* * * * * * *
Sec. 494A [(b) Report.--Not later than December 30, 1993,
and each December 30 thereafter, the Secretary shall prepare
and submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Labor and Human
Resources of the Senate, a report concerning the activities
carried out with the amounts referred to in subsection (a).]
* * * * * * *
Sec. 503 [(b) Drug Abuse.--The Secretary shall submit to
Congress on or before January 15, 1984, and every three years
thereafter a report--
[(1) describing the health consequences and extent of
drug abuse in the United States;
[(2) describing current research findings made with
respect to drug abuse, including current findings on
the health effects of marihuana and the addictive
property of tobacco; and
[(3) containing such recommendations for legislation
and administrative action as the Secretary may deem
appropriate.]
* * * * * * *
Sec. 402(f)(3) [annually] biennially prepare and submit to
the Director of NIH a report concerning the prevention and
dissemination activities undertaken by the Associate Director,
including--
* * * * * * *
Sec. 429 [(c) Annual Report.--Each Committee shall prepare
an annual report for--
[(1) the Secretary;
[(2) the Director of NIH; and
[(3) the Advisory Board established under section 430
for the diseases for which the Committee was
established, detailing the work of the Committee in
carrying out paragraphs (1) and (2) of subsection (a)
in the fiscal year for which the report was prepared.
Such report shall be submitted not later than 120 days
after the end of each fiscal year.]
* * * * * * *
[Sec. 304(a) In General.--Not later than 1 year after the
date of the enactment of this Act (Nov. 15, 1990), and annually
thereafter, the Task Force shall prepare and submit to the
Secretary, and to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Labor and Human
Resources of the Senate, a report providing the recommendations
required in section 301(b).
[(b) Availability to Public.--The Task Force may make
available to the public copies of the reports required in
subsection (a).]
* * * * * * *
SEC. 1122. [SUDDEN INFANT DEATH SYNDROME RESEARCH AND RESEARCH
REPORTS.]
(a) Adequate amounts for identification and prevention
progress. From the sums appropriated to the National Institute
of Child Health and Human Development, the Secretary shall
assure that there are applied to research [of the type
described in subparagraphs (A) and (B) of subsection (b)(1) of
this section such amounts each year as will be adequate,], such
amounts each year as will be adequate for research which
relates generally to sudden infant death syndrome, including
high-risk pregnancy and high-risk infancy research which
directly relates to sudden infant death syndrome, and to the
relationship of the high-risk pregnancy and high-risk infancy
research to sudden infant death syndrome, given the leads and
findings then available from such research, in order to make
maximum feasible progress toward identification of infants at
risk of sudden infant death syndrome and prevention of sudden
infant death syndrome.
[(b) Reports to Congressional committees; contents; data as
to applications and funds for specific and general research,
summary of findings and plan for advantage of research leads
and findings.
[(1) Not later than ninety days after the close of
the fiscal year ending September 30, 1979, and of each
fiscal year thereafter, the Secretary shall report to
the Committees on Appropriations of the Senate and the
House of Representatives, the Committee on Labor and
Human Resources of the Senate, and the Committee on
Energy and Commerce of the House of Representatives
specific information for such fiscal year on--
[(A) the (i) number of applications approved
by the Secretary in the fiscal year reported on
for grants and contracts under this Act for
research which relates specifically to sudden
infant death syndrome, (ii) total amount
requested under such applications, (iii) number
of such applications for which funds were
provided in such fiscal year, and (iv) total
amount of such funds; and
[(B) the (i) number of applications approved
by the Secretary in such fiscal year for grants
and contracts under this Act for research which
relates generally to sudden infant death
syndrome, including high-risk pregnancy and
high-risk infancy research which directly
relates to sudden infant death syndrome, (ii)
relationship of the high-risk pregnancy and
high-risk infancy research to sudden infant
death syndrome, (iii) total amount requested
under such applications, (iv) number of such
applications for which funds were provided in
such fiscal year, and (v) total amount of such
funds.
[(2) Each report submitted under paragraph (1) of
this subsection shall--
[(A) contain a summary of the findings of
intramural and extramural research supported by
the National Institute of Child Health and
Human Development relating to sudden infant
death syndrome as described in subparagraphs
(A) and (B) of such paragraph (1), and the plan
of such Institute for taking maximum advantage
of such research leads and findings; and
[(B) provide an estimate of the need for
additional funds over each of the next five
fiscal years for grants and contracts under
this Act for research activities described in
such subparagraphs.
[(c) Reports to Congressional Committees, current and past
estimates for research. Within five days after the Budget is
transmitted by the President to the Congress for each fiscal
year after fiscal year 1980, the Secretary shall transmit to
the Committees on Appropriations of the Senate and the House of
Representatives, the Committee on Labor and Human Resources of
the Senate, and the Committee on Energy and Commerce of the
House of Representatives an estimate of the amounts requested
for the National Institute of Child Health and Human
Development and any other Institutes of the National Institutes
of Health, respectively, for research relating to sudden infant
death syndrome as described in subparagraphs (A) and (B) of
subsection (b)(1) of this section, and a comparison of such
amounts with the amounts requested for the preceding fiscal
year.]
* * * * * * *
INTERNATIONAL HEALTH RESEARCH ACT OF 1960
* * * * * * *
SEC. 5. AUTHORITY OF PRESIDENT.
* * * * * * *
[(h) Report to Congress.--
[The President shall transmit to the Congress at the
beginning of each regular session, a report summarizing
activities under this section and making such recommendations
as he may deem appropriate.]
* * * * * * *
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE IV
* * * * * * *
Sec. 404C(c) Revisions of Plan.--The Director of NIH shall
periodically review, and as appropriate, make revisions in the
plan required under subsection (a). A description of any
revision made in the plan shall be [included in the first
biennial report under section 403 that is submitted after the
revision if made.] made available to the committee established
under subsection (e) and included in the official minutes of
the committee.
* * * * * * *
Sec. 404E(d)(3)(B) submit each such report to the Director
of NIH [for inclusion in the biennial report under section
403].
* * * * * * *
Sec. 406(g) Comments and Recommendations for Inclusion in
Biennial Report; Additional Reports.--Each advisory council may
prepare, [for inclusion in the biennial report made under
section 407] as it may determine appropriate, (1) comments
respecting the activities of the advisory council in the fiscal
years respecting which the report is prepared, (2) comments on
the progress of the national research institute for which it
was established in meeting its objectives, and (3)
recommendations respecting the future directions and program
and policy emphasis of the institute. [Each advisory council
may prepare such additional reports as it may determine
appropriate.]
* * * * * * *
SEC. 407. [BIENNIAL REPORT] REPORTS.
The Director of each national research institute, after
consultation with the advisory council for the institute,
[shall prepare for inclusion in the biennial report made under
section 403 a biennial] may prepare a report which shall
consist of a description of the activities of the institute and
program policies of the Director of the institute in the fiscal
years respecting which the report is prepared. The Director of
each national research institute may prepare such additional
reports as the Director determines appropriate. The Director of
each national research institute shall provide the advisory
council for the institute an opportunity for the submission of
the written comments referred to in section 406(g).
* * * * * * *
Sec. 416(b) The Associate Director for Prevention shall
prepare for inclusion in the biennial report made under section
[407] 402(f)(3) a description of the prevention activities of
the Institute, including a description of the staff and
resources allocated to those activities.
* * * * * * *
Sec. 417 [(e) Report.--The Director of the Institute shall
prepare, for inclusion in the biennial report submitted under
section 407, a report that describes the activities of the
National Cancer Institute under the research programs referred
to in subsection (a), that shall include--
[(1) a description of the research plan with respect
to breast cancer prepared under subsection (c);
[(2) an assessment of the development, revision, and
implementation of such plan;
[(3) a description and evaluation of the progress
made, during the period for which such report is
prepared, in the research programs on breast cancers
and cancers of the reproductive system of women;
[(4) a summary and analysis of expenditures made,
during the period for which such report is made, for
activities with respect to breast cancer and cancers of
the reproductive system of women conducted and
supported by the National Institutes of Health; and
[(5) such comments and recommendations as the
Director considers appropriate.]
* * * * * * *
Sec. 423(b) The Associate Director for Prevention shall
prepare for inclusion in the biennial report made under section
[407] 402(f)(3) a description of the prevention activities of
the Institute, including a description of the staff and
resources allocated to those activities.
* * * * * * *
[SEC. 433. BIENNIAL REPORT.
[The Director of the Institute shall prepare for inclusion
in the biennial report made under section 407 a description of
the Institute's activities--
[(1) under the current diabetes plan under the
National Diabetes Mellitus Research and Education Act;
and
[(2) under the current digestive diseases plan
formulated under the Arthritis, Diabetes, and Digestive
Diseases Amendments of 1976
[The description submitted by the Director shall include an
evaluation of the activities of the centers supported under
section 431].
* * * * * * *
Sec. 451(b) The Associate Director for Prevention shall
prepare for inclusion in the biennial report made under section
[407] 402(f)(3) a description of the prevention activities of
the Institute, including a description of the staff and
resources allocated to those activities.
* * * * * * *
Sec. 452(d)(3) [(A) Not] Not later than 18 months after the
date of the enactment of the National Institutes of Health
Revitalization Amendments of 1990, the Director of the
Institute shall transmit the Research Plan to the Director of
NIH, who shall submit the Plan to the President and the
Congress.
[(B) Subparagraph (a) shall be carried out independently of
the process of reporting that is required in sections 403 and
407.]
(4) The Director of the Institute shall periodically revise
and update the Research Plan as appropriate, after consultation
with the Director of the Center, the coordinating committee
established under subsection (e), and the advisory board
established under subsection (f). A description of any
revisions in the Research Plan shall be [contained in each
report prepared under section 407 by the Director of the
Institute.] transmitted to the Director of NIH.
* * * * * * *
Sec. 4641(b) Biennial Report.--The Associate Director for
Prevention shall prepare for inclusion in the biennial report
made under section [407] 402(f)(3) a description of the
prevention activities of the Institute, including a description
of the staff and resources allocated to those activities.
* * * * * * *
Sec. 464S(b) Report.--The Associate Director for Prevention
shall prepare for inclusion in the biennial report made under
section [407] 402(f)(3) a description of the prevention
activities of the Institute, including a description of the
staff and resources allocated to those activities.
* * * * * * *
Sec. 464X(g) Materials for Inclusion in the Biennial
Report; Additional Reports.--The advisory council may prepare,
[for inclusion in the biennial report made under section 464Y]
as it may determine appropriate, (1) comments respecting the
activities of the advisory council in the fiscal years
respecting which the report is prepared, (2) comments on the
progress of the Institute in meeting its objectives, and (3)
recommendations respecting the future directions and program
and policy emphasis of the Institute. [The advisory council may
prepare such additional reports as it may determine
appropriate.]
* * * * * * *
SEC. 464Y. [BIENNIAL REPORT] REPORTS.
The Director of the Institute after consultation with the
advisory council for the Institute, [shall prepare for
inclusion in the biennial report made under section 403 a
biennial] may prepare a report which shall consist of a
description of the activities of the Institute and program
policies of the Director of the Institute in the fiscal years
respecting which the report is prepared. The Director of the
Institute may prepare such additional reports as the Director
determines appropriate. The Director of the Institute shall
provide the advisory council of the Institute an opportunity
for the submission of the written comments referred to in
section 464X(g).
* * * * * * *
SEC. 480(g) MATERIAL FOR INCLUSION IN BIENNIAL REPORT; ADDITIONAL
REPORTS.
The advisory council may prepare, [for inclusion in the
biennial report made under section 481] as it may determine
appropriate, (1) comments respecting the activities of the
advisory council in the fiscal years respecting which the
report is prepared, (2) comments on the progress of the Center
in meeting its objectives, and (3) recommendations respecting
the future directions and program and policy emphasis of the
Center. [The advisory council may prepare such additional
reports as it may determine appropriate.]
* * * * * * *
SEC. 481. [BIENNIAL REPORT] REPORTS.
The Director of the Center, after consultation with the
advisory council for the Center, [shall prepare for inclusion
in the biennial report made under section 403 a biennial] may
prepare a report which shall consist of a description of the
activities of the Center and program policies of the Director
of the Center in the fiscal years respecting which the report
is prepared. The Director of the Center may prepare such
additional reports as the Director determines appropriate. The
Director of the Center shall provide the advisory council for
the Center an opportunity for the submission of the written
comments referred to in section 480(g).
* * * * * * *
Sec. 486(d)(5)(B) The report required in subparagraph (A)
shall be submitted to the Director of NIH [for inclusion in the
report required in section 403].
* * * * * * *
Sec. 486B. [(b) Inclusion in Biennial Report of Director of
NIH.--The Director of the Office shall submit each report
prepared under subsection (a) to the Director of NIH for
inclusion in the report submitted to the President and the
Congress under section 4030.]
(b) Submission.--The Director of the Office shall submit
each report prepared under subsection (a) to the Director of
NIH.
* * * * * * *
SEC. 492B. (f) REPORTS BY ADVISORY COUNCILS.
The advisory council of each national research institute
shall prepare biennial reports describing the manner in which
the institute has complied with this section. Each such report
shall be submitted to the Director of the institute involved
[for inclusion in the biennial report under section 403.] and
the Director of NIH.
* * * * * * *
Sec. 417B. (a) Activities Generally.--For the purpose of
carrying out this subpart, there are authorized to be
appropriated [$2,728,000 for fiscal year 1994, and such sums as
may be necessary for each of the fiscal years 1995 and 1996.]
$3,000,000,000 for fiscal year 1997, and such sums as may be
necessary for each of the fiscal years 1998 and 1999.
(b)(1)(A) For the purpose of carrying out subparagraph (A)
of section 417(c)(1), there are authorized to be appropriated
[$225,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996.] such
sums as may be necessary for each of the fiscal years 1997
through 1999. Such authorizations of appropriations are in
addition to the authorizations of appropriations established in
subsection (a) with respect to such purposes.
(B) For the purpose of carrying out subparagraphs (B)
through (E) of section 417(c)(1), there are authorized to be
appropriated [$100,000,000 for fiscal year 1994, and such sums
as may be necessary for each of the fiscal years 1995 and
1996.] such sums as may be necessary for each of the fiscal
years 1997 through 1999. Such authorizations of appropriations
are in addition to the authorizations of appropriations
established in subsection (a) with respect to such purposes.
(2) Other cancers.--For the purpose of carrying out
subsection (d) of section 417, there are authorized to be
appropriated [$75,000,000 for fiscal year 1994, and such sums
as may be necessary for each of the fiscal years 1995 and
1996.] such sums as may be necessary for each of the fiscal
years 1997 through 1999. Such authorizations of appropriations
are in addition to the authorizations of appropriations
established in subsection (a) with respect to such purposes.
(c) Prostate Cancer.--For the purpose of carrying out
section 417A, there are authorized to be appropriated
[$72,000,000 for fiscal year 1994, and such sums as may be
necessary for each of the fiscal years 1995 and 1996.] such
sums as may be necessary for each of the fiscal years 1997
through 1999. Such authorizations of appropriations are in
addition to the authorizations of appropriations established in
subsection (a) with respect to such purposes.
* * * * * * *
SEC. 403A. (e) AUTHORIZATION OF APPROPRIATIONS.
In addition to any other authorization of appropriations
available for the purpose of carrying out this section, there
are authorized to be appropriated for such purpose such sums as
may be necessary for each of the fiscal years 1993 through
[1996] 1999.
* * * * * * *
SEC. 425. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this subpart, there are
authorized to be appropriated [$1,500,000,000 for fiscal year
1994, and such sums as may be necessary for each of the fiscal
years 1995 and 1996.] $1,600,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the fiscal years 1998
and 1999.
* * * * * * *
TITLE IV, PART C, Subpart 6
* * * * * * *
Sec. 447(b) For the purpose of carrying out subsection (a),
there are authorized to be appropriated [$50,000,000 for fiscal
year 1994, and such sums as may be necessary for each of the
fiscal years 1995 through 1998.] such sums as may be necessary
for each of the fiscal years 1997 through 1999. Such
authorization is in addition to any other authorization of
appropriations that is available for such purpose.
* * * * * * *
Sec. 2313(e). Authorization of Appropriations.--
(1) For the purpose of carrying out subsection
(b)(1), there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
1989 through [1996] 1999.
(2) For the purpose of carrying out subsection
(b)(2), there are authorized to be appropriated such
sums as may be necessary for each of the fiscal years
1989 through [1996] 1999.
* * * * * * *
Sec. 452A(g) For the purpose of carrying out this section,
there are authorized to be appropriated [$30,000,000 for fiscal
year 1994, and such sums as may be necessary for each of the
fiscal years 1995 and 1996.] such sums as may be necessary for
each of the fiscal years 1997 through 1999.
* * * * * * *
SEC. 445I. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this subpart, there are
authorized to be appropriated [$500,000,000 for fiscal year
1994, and such sums as may be necessary for each of the fiscal
years 1995 and 1996.] $550,000,000 for fiscal year 1997, and
such sums as may be necessary for each of the fiscal years 1998
and 1999.
* * * * * * *
SEC. 464H(d)(1). AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this subpart, there are
authorized to be appropriated [$300,000,000 for fiscal year
1993, and such sums as may be necessary for fiscal year 1994.]
$330,000,000 for fiscal year 1997, and such sums as may be
necessary for each of the fiscal years 1998 and 1999.
* * * * * * *
Sec. 464I. [(b) The] (b)(1) The Secretary shall, under such
conditions as the Secretary may reasonably require, make annual
grants to Centers which have been designated under this
section. No funds provided under a grant under this subsection
may be used for the purpose of any land or the purpose,
construction, preservation, or repair of any building. [For the
purposes of the preceding sentence, the term ``construction''
has the meaning given that term by section 701(1).]
(2) As used in paragraph (1), the terms ``construction''
and ``cost of construction'' include--
(A) the construction of new buildings, the expansion
of existing buildings, and the acquisition, remodeling,
replacement, renovation, major repair (to the extent
permitted by regulations), or alteration of existing
buildings, including architects' fees, but not
including the cost of the acquisition of land or
offsite improvements; and
(B) the initial equipping of new buildings and of the
expanded, remodeled, repaired, renovated, or altered
part of existing buildings; except that
such term shall not include the construction or cost of
construction of so much of any facility as is used or is to be
used for sectarian instruction or as a place for religious
worship.
* * * * * * *
Sec. 464L(d)(1) Authorization of appropriations.--For the
purpose of carrying out this subpart, other than section 464P,
there are authorized to be appropriated [$440,000,000 for
fiscal year 1993, and such sums as may be necessary for fiscal
year 1994.] $480,000,000 for fiscal year 1997, and such sums as
may be necessary for each of the fiscal years 1998 and 1999.
* * * * * * *
Sec. 464P(e) Authorization of appropriations.--For the
purpose of carrying out this section, there are authorized to
be appropriated [$85,000,000 for fiscal year 1993, and
$95,000,000 for fiscal year 1994.] such sums as may be
necessary for each of the fiscal years 1997 through 1999.
* * * * * * *
Sec. 464N [(b)The] (b)(1) The Director of the Institute
shall, under such conditions as the Secretary may reasonably
require, make annual grants to Centers which have been
designated under this section. No funds provided under a grant
under this subsection may be used for the purchase of any land
or the purchase, construction, preservation, or repair of any
building. [For the purposes of the preceding sentence, the term
``construction'' has the meaning given that term by section
701(1).]
(2) As used in paragraph (1), the terms ``construction''
and ``cost of construction'' include--
(A) the construction of new buildings, the expansion
of existing buildings, and the acquisition, remodeling,
replacement, renovation, major repair (to the extent
permitted by regulations), or alternation of existing
buildings, including architects' fees, but not
including the cost of the acquisition of land or
offsite improvements; and
(B) the initial equipping of new buildings and of the
expanded, remodeled, repaired, renovated, or altered
part of existing buildings; except that
such term does not include the construction or cost of
construction of so much of any facility as is used or is to be
used for sectarian instruction or as a place for religious
worship.
* * * * * * *
Sec. 464R(f)(1) Authorization of appropriations.--For the
purpose of carrying out this subpart, there are authorized to
be appropriated [$675,000,000 for fiscal year 1993, and such
sums as may be necessary for fiscal year 1994.] $750,000,000
for fiscal year 1997, and such sums as may be necessary for
each of the fiscal years 1998 and 1999.
* * * * * * *
Sec. 481A(h) For the purpose of carrying out this section,
there are authorized to be appropriated [$150,000,000 for
fiscal year 1994, and such sums as may be necessary for each of
the fiscal years 1995 and 1996.] such sums as may be necessary
for each of the fiscal years 1997 through 1999.
* * * * * * *
Sec. 481B(a) With respect to activities carried out by the
National Center for Research Resources to support regional
centers for research on primates, the Director of NIH [shall]
may for each of the fiscal years [1994 through 1996] 1997
through 1999, reserve from the amounts appropriated under
section 481A(h) [$5,000,000] such sums as may be necessary for
each such fiscal year for the purpose of making awards of
grants and contracts to public or nonprofit private entities to
construct, renovate, or otherwise improve such regional
centers. The reservation of such amounts for any fiscal year is
subject to the availability of qualified applicants for such
awards.
* * * * * * *
title IV, part b
* * * * * * *
SEC. 409C. GENERAL CLINICAL RESEARCH CENTERS.
(a) Grants.--The Director of the National Center for
Research Resources shall award grants for the establishment of
general clinical research centers to provide the infrastructure
for clinical research including clinical research training and
career enhancement. Such centers shall support clinical studies
and career development in all settings of the hospital or
academic medical center involved.
(b) Activities.--In carrying out subsection (a), the
Director of NIH shall expand the activities of the general
clinical research centers through the increased use of
telecommunications and telemedicine initiatives.
(c) Authorization of Appropriations.--There are authorized
to be appropriated to make grants under subsection (a), such
sums as may be necessary for each of the fiscal years 1996 and
1999.
SEC. 409D. ENHANCEMENT AWARDS.
(a) Clinical Research Career Enhancement Award.--
(1) In general.--The Director of the National Center
for Research Resources shall make grants (to be
referred to as ``clinical research career enhancement
awards'') to support individual careers in clinical
research.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director may require.
(3) Limitations.--The amount of a grant under this
subsection shall not exceed $130,000 per year per
grant. Grants shall be for terms of 5 years. The
Director shall award not more than 20 grants in the
first fiscal year in which grants are awarded under
this subsection. The total number of grants awarded
under this subsection for the first and second fiscal
years in which such grants are awarded shall not exceed
40 grants.
(4) Authorization of appropriations.--There are
authorized to be appropriated to make grants under
paragraph (1), such sums as may be necessary for each
of the fiscal years 1997 through 1999.
(b) Innovative Medical Science Award.--
(1) In general.--The Director of the National Center
for Research Resources shall make grants (to be
referred to as ``innovative medical science awards'')
to support individual clinical research projects.
(2) Applications.--An application for a grant under
this subsection shall be submitted by an individual
scientist at such time as the Director requires.
(3) Limitations.--The amount of a grant under this
subsection shall not exceed $100,000 per year per
grant.
(4) Authorization of appropriations.--There are
authorized to be appropriated to make grants under
paragraph (1), such sums as may be necessary for each
of the fiscal years 1997 through 1999.
(c) Peer Review.--The Director of NIH, in cooperation with
the Director of the National Center for Research Resources,
shall establish peer review mechanisms to evaluate application
for clinical research fellowships, clinical research career
enhancement awards, and innovative medical science award
programs. Such review mechanisms shall include individuals who
are exceptionally qualified to appraise the merits of potential
clinical research trainees.
* * * * * * *
Sec. 481A(b)(3)(A) Subject to subparagraph (B), the Board
shall be composed of [9] 12 appointed members, and such ex
officio members as the Director of the Center determines to be
appropriate.
* * * * * * *
(e)(1)(A) [50] 40 percent of the necessary cost of the
construction of a proposed facility as determined by the
Director; or
(B) in the case of a multipurpose facility, [40] 30 percent
of that part of the necessary cost of construction that the
Director determines to be proportionate to the contemplated use
of the facility.
* * * * * * *
(4) The limitations imposed by paragraph (1) may be waived
at the discretion of the Director [for applicants meeting the
conditions described in paragraphs (1) and (2) of subsection
(c)].
* * * * * * *
(h) For the purpose of carrying out this section, there are
authorized to be appropriated [$150,000,000 for fiscal year
1994, and such sums as may be necessary for each of the fiscal
years 1995 and 1996] such sums as may be necessary for each of
the fiscal years 1997 through 1999.
* * * * * * *
Sec. 468(a) For the purpose of carrying out this part,
there are authorized to be appropriated [$150,000,000 for
fiscal year 1994, and such sums as may be necessary for each of
the fiscal years 1995 and 1996.] $160,000,000 for fiscal year
1997, and such sums as may be necessary for each of the fiscal
years 1998 and 1999.
* * * * * * *
Sec. 474(b)(2) Grant to such medical libraries or related
instrumentalities under this section shall be in such amounts
as the Secretary may be regulation prescribe with a view to
assuring adequate continuing financial support for such
libraries or instrumentalities from other sources during and
after the period for which grants are provided, except that in
no case shall any grant under this section to a medical library
or related instrumentality for any fiscal year exceed
[$1,000,000] $1,250,000.
* * * * * * *
Sec. 487A(a) The Secretary shall carry out a program of
entering into agreements with appropriately qualified health
professionals under which such health professionals agree to
conduct, as employees of the National Institutes of health,
research with respect to acquired immune deficiency syndrome in
consideration of the Federal Government agreeing to repay, for
each year of such service, not more than [$20,000] $35,000 of
the principal and interest of the educational loans of such
health professionals.
* * * * * * *
(c) For the purpose of carrying out this section, there are
authorized to be appropriated such sums as may be necessary for
each of the fiscal years 1994 through [1996] 1999.
* * * * * * *
Sec. 487B(a) The Secretary, in consultation with the
Director of the National Institute of Child Health and Human
Development, shall establish a program of entering into
contracts with qualified health professionals (including
graduate students) under which such health professionals agree
to conduct research with respect to contraception, or with
respect to infertility, in consideration of the Federal
Government agreeing to repay, for each year of such service,
not more than [$20,000] $35,000 of the principal and interest
of the educational loans of such health professionals.
* * * * * * *
Sec. 487C(a)(1) Subject to paragraph (2), the Secretary
shall carry out a program of entering into contracts with
appropriately qualified health professionals under which such
health professionals agree to conduct research, as employees of
the National Institutes of Health, in consideration of the
Federal Government agreeing to repay, for each year of such
service, not more than [$20,000] $35,000 of the principal and
interest of the educational loans of such health professionals.
* * * * * * *
Sec. 487E(a)(1) Subject to section 487(a)(1)(C), the
Secretary, acting through the Director of NIH may, subject to
paragraph (2), carry out a program of entering into contracts
with appropriately qualified health professionals who are from
disadvantaged backgrounds under which such health professionals
agree to conduct clinical research as employees of the National
Institutes of Health in consideration of the Federal Government
agreeing to pay, for each year of such service, not more than
[$20,000] 35,000 of the principal and interest of the
educational loans of the health professionals.
* * * * * * *
(3) Except to the extent inconsistent with this section,
the provisions of sections [338C] 338B, 338C and 338E shall
apply to the program established in paragraph (1) to the same
extent and in the same manner as such provisions apply to the
National Health Service Corps Loan Repayment Program
established in section 338B.
* * * * * * *
TITLE IV, PART G
* * * * * * *
SEC. 487F. GENERAL LOAN REPAYMENT PROGRAM.
(a) Establishment.--
(1) In general.--The Secretary, acting through the
Director of NIH, shall carry out a program of entering
into agreements with appropriately qualified health
professionals under which such health professionals
agree to conduct research with respect to the areas
identified under paragraph (2) in consideration of the
Federal Government agreeing to repay, for each year of
such service, not more than $35,000 of the principal
and interest of the educational loans of such health
professionals.
(2) Research areas.--In carrying out the program
under paragraph (1), the Director of NIH shall annually
identify areas of research for which loan repayments
made be awarded under paragraph (1).
(3) Term of agreement.--A loan repayment agreement
under paragraph (1) shall be for a minimum of two
years.
(b) Applicability of Certain Provisions.--With respect to
the National Health Service Corps Loan Repayment Program
established in subpart III of part D of title III, the
provisions of such subpart shall, except as inconsistent with
subsection (a) of this section, apply to the program
established in such subsection (a) in the same manner and to
the same extent as such provisions apply to the National Health
Service Corps Loan Repayment Program established in such
subpart.
(c) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 1997 through 1999.
* * * * * * *
Sec. 487(a)(1)(C) provide contracts for scholarships and
loan repayments in accordance with sections 487D and 487E,
subject to providing not more than an aggregate [50 such] 100
such contracts during the fiscal years 1994 through [1996]
1999.
* * * * * * *
SEC. 487E. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS [FROM
DISADVANTAGED BACKGROUNDS].
(a)(1) In General.--Subject to section 487(a)(1)(C), the
Secretary, acting through the Director of NIH may, subject to
paragraph (2), carry out a program of entering into contracts
with appropriately qualified health professionals [who are from
disadvantaged backgrounds] under which such health
professionals agree to conduct clinical research as employees
of the National Institutes of Health in consideration of the
Federal Government agreeing to pay, for each year of such
service, not more than $20,000 of the principal and interest of
the educational loans of the health professionals.
* * * * * * *
(b) Availability of Authorization of Appropriations.
[Amounts] (1) In General._Amounts appropriated for a fiscal
year for contracts under subsection (a) shall remain available
until the expiration of the second fiscal year beginning after
the fiscal year for which the amounts were appropriated.
(2) Disadvantaged backgrounds set-aside.--In carrying out
this section, the Secretary shall ensure that not less than 50
percent of the amounts appropriated for a fiscal year are used
for contracts involving those appropriately qualified health
professionals who are from disadvantaged backgrounds.
(c) Clinical Research Training Position.--A position shall
be considered a clinical research training position under
subsection (a)(1) if such position involves an individual
serving in a general clinical research center or other
organizations and institutions determined to be appropriate by
the Director of NIH, or a physician receiving a clinical
research career enhancement award or NIH intramural research
fellowship.
(d) Authorization of Appropriations.--There are authorized
to be appropriated to carry out this section such sums as may
be necessary for each fiscal year.
* * * * * * *
Sec. 2353(d)(1) For the purpose of carrying out AIDS
activities under the Plan, there are authorized to be
appropriated such sums as may be necessary for each of the
fiscal years 1994 [through 1996] through 1999.
Sec. 2356(g)(1) For the purpose of providing amounts for
the Fund, there is authorized to be appropratied [$100,000,000
for each of the fiscal years 1994 through 1996.] such sums as
may be necessary for each of the fiscal years 1997 through
1999.
* * * * * * *
Sec. 402(b)(11) may perform such other administrative
functions as the Secretary determines are needed to effectively
carry out this title; [and]
(12) after consultation with the Director of the Office of
Research on Women's Health, shall ensure that resources of the
National Institutes of Health are sufficiently allocated for
projects of research on women's health that are identified
under section 486(b)[.];
(13) may conduct and support research training--
(A) for which fellowship support is not provided
under section 487; and
(B) which does not consist of residency training of
physicians or other health professionals; and
(14) may appoint physicians, dentists, and other health
care professionals, subject to the provisions of title 5,
United States Code, relating to appointments and
classifications in the competitive service, and may compensate
such professionals subject to the provisions of chapter 74 of
title 38, United States Code.
* * * * * * *
title iv, part a
* * * * * * *
SEC. 404F. OFFICE FOR RARE DISEASE RESEARCH.
(a) Establishment.--There is established within the Office
of the Director of the National Institutes of Health an office
to be known as the Office for Rare Disease Research (in this
section referred to as the ``Office''). The Office shall be
headed by a director, who shall be appointed by the Director of
the National Institutes of Health.
(b) Purpose.--The purpose of the Office is to promote and
coordinate the conduct of research on rare diseases through a
strategic research plan and to establish and manage a rare
disease research clinical database.
(c) Advisory Council.--The Secretary shall establish an
advisory council for the purpose of providing advice to the
director of the Office concerning carrying out the strategic
research plan and other duties under this section. Section 222
shall apply to such council to the same extent and in the same
manner as such section applies to committees or councils
established under such section.
(d) Duties.--In carrying out subsection (b), the director
of the Office shall--
(1) develop a comprehensive plan for the conduct and
support of research on rare diseases;
(2) coordinate and disseminate information among the
institutes and the public on rare diseases;
(3) support research training and encourage the
participation of a diversity of individuals in the
conduct of rare disease research;
(4) identify projects or research on rare diseases
that should be conducted or supported by the National
Institutes of Health;
(5) develop and maintain a central database on
current government sponsored clinical research projects
for rare diseases;
(6) determine the need for registries of research
subjects and epidemiological studies of rare disease
populations; and
(7) prepare biennial reports on the activities
carried out or to be carried out by the Office and
submit such reports to the Secretary and the Congress.
* * * * * * *
Sec. 487(d) For the purpose of carrying out this section,
there are authorized to be appropriated [$400,000,000 for
fiscal year 1994, and such sums as may be necessary for each of
the fiscal years 1995 and 1996.] such sums as may be necessary
for each of the fiscal years 1997 through 1999. Of the amounts
appropriated under this subsection--
* * * * * * *
Sec. 499(m)(1) For the purpose of carrying out this part,
there is authorized to be appropriated [an aggregate $200,000
for the fiscal years 1994 and 1995.] such sums as may be
necessary for each of the fiscal years 1997 through 1999.
* * * * * * *
title iv, part a
* * * * * * *
SEC. 404G. ESTABLISHMENT OF NATIONAL FUND FOR HEALTH RESEARCH.
(a) Establishment.--There is established in the Treasury of
the United States a fund, to be known as the ``National Fund
for Health Research'' (hereafter in this section referred to as
the ``Fund''), consisting of such amounts as are transferred to
the Fund and any interest earned on investment of amounts in
the Fund.
(b) Obligations From Fund.--
(1) In general.--Subject to the provisions of
paragraph (2), with respect to the amounts made
available in the Fund in a fiscal year, the Secretary
shall distribute all of such amounts during any fiscal
year to research institutes and centers of the National
Institutes of Health in the same proportion to the
total amount received under this section, as the amount
of annual appropriations under appropriations Acts for
each member institute and centers for the fiscal year
bears to the total amount of appropriations under
appropriations Acts for all research institutes and
centers of the National Institutes of Health for the
fiscal year.
(2) Trigger and release of monies.--No expenditure
shall be made under paragraph (1) during any fiscal
year in which the annual amount appropriated for the
National Institutes of Health is less than the amount
so appropriated for the prior fiscal year.
SEC. 404H. DEFINITION OF CLINICAL RESEARCH.
As used in this title, the term ``clinical research'' means
patient oriented clinical research conducted with human
subjects, or research on the causes and consequences of disease
in human populations, or on material of human origin (such as
issue specimens and cognitive phenomena) for which an
investigator or colleague directly interacts with human
subjects in an outpatient or inpatient setting to clarify a
problem in human physiology, pathophysiology, or disease,
epidemiologic or behavioral studies, outcomes research, or
health services research.
* * * * * * *
Sec. 288 * * *
* * * * * * *
(h) Notwithstanding any other provision of law, the
Secretary shall be treated as a non-profit entity for the
purposes of making contributions to the retirement systems of
appointees under this section in a manner that will permit such
appointees to continue to be fully covered under the retirement
systems that such appointees were members of immediately prior
to their appointment under this section.
* * * * * * *
title iv, part a
* * * * * * *
SEC. 404I. PEDIATRIC RESEARCH INITIATIVE.
(a) Establishment.--The Secretary shall establish within
the Office of the Director of NIH a Pediatric Research
Initiative (hereafter in this section referred to as the
``Initiative''). The Initiative shall be headed by the Director
of NIH.
(b) Purpose.--The purpose of the Initiative is to provide
funds to enable the Director of NIH to encourage--
(1) increased support for pediatric biomedical
research within the National Institutes of Health to
ensure that the expanding opportunities for advancement
in scientific investigations and care for children are
realized;
(2) enhanced collaborative efforts among the
Institutes to support multidisciplinary research in the
areas that the Director deems most promising;
(3) increased support for pediatric outcomes and
medical effectiveness research to demonstrate how to
improve the quality of children's health care while
reducing cost;
(4) the development of adequate pediatric clinical
trials and pediatric use information to promote the
safer and more effective use of prescription drugs in
the pediatric population; and
(5) recognition of the special attention pediatric
research deserves.
(c) Duties.--In carrying out subsection (b), the Director
of NIH shall--
(1) consult with the Institutes and other advisors as
the Director determines appropriate when considering
the role of the Institute for Child Health and Human
Development;
(2) have broad discretion in the allocation of any
Initiative assistance among the Institutes, among types
of grants, and between basic and clinical research so
long as the--
(A) assistance is directly related to the
illnesses and diseases of children; and
(B) assistance is extramural in nature; and
(3) be responsible for the oversight of any newly
appropriated Initiative funds and be accountable with
respect to such funds to Congress and to the public.
(d) Authorization.--There is authorized to be appropriated
to carry out this section, $50,000,000 for fiscal years 1997
through 1999.
(e) Transfer of funds.--The Director of NIH may transfer
amounts appropriated to any of the Institutes for a fiscal year
to the Initiative to carry out this section.
* * * * * * *
title iv, part b
* * * * * * *
parkinson's disease
Sec. 409E. (a) In General.--The Director of NIH shall
establish a program for the conduct and support of research and
training with respect to Parkinson's disease.
(b) Inter-Institute Coordination.--
(1) In general.--The Director of NIH shall provide
for the coordination of the program established under
subsection (a) among all of the national research
institutes conducting Parkinson's research.
(2) Conference.--Coordination under paragraph (1)
shall include the convening of a research planning
conference not less frequently than once every 2 years.
Each such conference shall prepare and submit to the
Committee on Appropriations and the Committee on Labor
and Human Resources of the Senate and the Committee on
Appropriations and the Committee on Commerce of the
House of Representatives a report concerning the
conference.
(c) Morris K. Udall Research Centers.--
(1) In general.--The Director of NIH shall award Core
Center Grants to encourage the development of
innovative multidisciplinary research and provide
training concerning Parkinson's. The Director shall
award not more than 10 Core Center Grants and designate
each center funded under such grants as a Morris K.
Udall Center for Research on Parkinson's Disease.
(2) Requirements.--
(A) In general.--With respect to Parkinson's,
each center assisted under this subsection
shall--
(i) use the facilities of a single
institution or a consortium of
cooperating institutions, and meet such
qualifications as may be prescribed by
the Director of the NIH; and
(ii) conduct basic and clinical
research.
(B) Discretionary requirements.--With respect
to Parkinson's, each center assisted under this
subsection may--
(i) conduct training programs for
scientists and health professionals;
(ii) conduct programs to provide
information and continuing education to
health professionals;
(iii) conduct programs for the
dissemination of information to the
public;
(iv) develop and maintain, where
appropriate, a brain bank to collect
specimens related to the research and
treatment of Parkinson's;
(v) separately or in collaboration
with other centers, establish a
nationwide data system derived from
patient populations with Parkinson's,
and where possible, comparing relevant
data involving general populations;
(vi) separately or in collaboration
with other centers, establish a
Parkinson's Disease Information
Clearinghouse to facilitate and enhance
knowledge and understanding of
Parkinson's disease; and
(vii) separately or in collaboration
with other centers, establish a
national education program that
foster's a national focus on
Parkinson's and the care of those with
Parkinson's.
(3) Stipends regarding training programs.--A center
may use funds provided under paragraph (1) to provide
stipends for scientists and health professionals
enrolled in training programs under paragraph (2)(B).
(4) Duration of support.--Support of a center under
this subsection may be for a period not exceeding five
years. Such period may be extended by the Director of
NIH for one or more additional periods of not more than
five years if the operations of such center have been
reviewed by an appropriate technical and scientific
peer review group established by the Director and if
such group has recommended to the Director that such
period should be extended.
(d) Morris K. Udall Award for Innovation in Parkinson's
Disease Research.--The Director of NIH shall establish a grant
program to support innovative proposals leading to significant
breakthroughs in Parkinson's research. Grants under this
subsection shall be available to support outstanding
neuroscientists and clinicians who bring innovative ideas to
bear on the understanding of the pathogenesis, diagnosis and
treatment of Parkinson's disease.
(e) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $80,000,000 for fiscal year 1997, and such sums as
may be necessary for each of the fiscal years 1998 and 1999.
* * * * * * *
Sec. 403(5) the biennial reports of the Directors of each
of the national research institutes, the Director of the
[Division of Research Resources] National Center for Research
Resources, and the Director of the [National Center for Nursing
Research] National Institute of Nursing Research.
* * * * * * *
Sec. 408(a)(2) Paragraph (1) does not apply to the National
Library of Medicine, the [National Center for Nursing Research]
National Institute of Nursing Research, the John E. Forgarty
International Center for Advanced Study in the Health Sciences,
the Warren G. Magnuson Clinical Center, and the Office of
Medical Applications of Research.
* * * * * * *
Sec. 406(b)(2)(A) the Secretary, the Director of NIH, the
Director of the national research institute for which the
council is established, the [Chief Medical Director of the
Department of Veterans Affairs or the Chief Dental Director of
the Department of Veterans Affairs] Under Secretary for Health
of the Department of Veterans Affairs, and the Assistant
Secretary of Defense of Health Affairs (or the designees of
such officers), and
* * * * * * *
(h)(2)(A)(v) the ex officio members of the board shall be
nonvoting members and shall be the Secretary, the Director of
the Office of Science and Technology policy, the Director of
NIH, the [Chief Medical Director of the Department of Veterans
Affairs] Under Secretary for Health of the Department of
Veterans Affairs, the Director of the National Institute for
Occupational Safety and Health, the Director of the National
Institute of Environmental Health Sciences, the Secretary of
Labor, the Commissioner of the Food and Drug Administration,
the Administrator of the Environmental Protection Agency, the
Chairman of the Consumer Product Safety Commission, the
Assistant Secretary of Defense for Health Affairs, and the
Director of the Office of Energy Research of the Department of
energy (or the designees of such officers); and
* * * * * * *
Sec. 424(c)(3)(B)(x) The [Chief Medical Director of the
Veterans' Administration] Under Secretary for Health of the
Department of Veterans Affairs.
* * * * * * *
Sec. 429(b) Each Committee shall be composed of the
Directors of each of the national research institutes and
divisions involved in research with respect to the diseases for
which the Committee is established, the division director of
the Institute for the diseases for which the Committee is
established [Chief Medical Director of the Veterans'
Administration] Under Secretary for Health of the Department of
Veterans Affairs, and the Assistant Secretary of Defense for
Health Affairs (or the designees of such officers) and shall
include representation from all other Federal departments and
agencies whose programs involve health functions or
responsibilities relevant to such diseases, as determined by
the Secretary. Each Committee shall be chaired by the Director
of NIH (or the designee of the Director). Each Committee shall
meet at the call of the chairman, but not less often than four
times a year.
* * * * * * *
Sec. 430(b)(2)(A)(i) The Assistant Secretary for Health,
the Director of NIH, the Director of the National Institute of
Diabetes and Digestive and Kidney Diseases, the Director of the
Centers for Disease Control and Prevention, the [Chief Medical
director of the Department of Veterans Affairs] Under Secretary
for Health of the Department of Veterans Affairs, the Assistant
Secretary of Defense for Health Affairs, and the Division
Director of the National Institute of Diabetes and Digestive
and Kidney Diseases for the diseases for which the Board is
established (or the designees of such officers).
* * * * * * *
Sec. 439(b) Each committee shall be composed of the
Directors of each of the national research institutes and
divisions involved in research regarding the diseases with
respect to which the Committee is established, the [Chief
Medical Director of the Department of Veterans Affairs] Under
Secretary for Health of the Department of Veterans Affairs, the
Assistant Secretary of Defense for Health Affairs (or the
designees of such officers), and representatives of all other
Federal departments and agencies (as determined by the
Secretary) whose programs involve health functions or
responsibilities relevant to arthritis and musculoskeletal
diseases or skin diseases, as the case may be. Each committee
shall be chaired by the Director of NIH (or the designee of the
Director). Each Committee shall meet at the call of the
Chairman, but not less often than four times a year.
* * * * * * *
Sec. 452(f)(3)(B)(xi) The [Chief Medical Director of the
Department of Veterans Affairs] Under Secretary for Health of
the Department of Veterans Affairs.
* * * * * * *
Sec. 466(a)(1)(B) The ex officio members are the Surgeons
General of the Public Health Service, the Army, the Navy, and
the Air Force, the [Chief Medical Director of the Department of
Veterans Affairs] Under Secretary for Health of the Department
of Veterans Affairs the Dean of the Uniformed Services
University of the Health Sciences, the Assistant Director for
Biological, Behavioral, and Social Sciences of the National
Science Foundation, the Director of the National Agricultural
Library, and the Librarian of Congress (or their designees).
* * * * * * *
Sec. 480(b)(2)(A) the Secretary, the Director of NIH, the
Director of the Center, the [Chief Medical Director of the
Department of Veterans Affairs] Under Secretary for Health of
the Department of Veterans Affairs, and the Assistant Secretary
of Defense for Health Affairs (or the designees of such
officers), and
* * * * * * *
Sec. 406(h)[(1) Except as provided in paragraph (2), this
section does not terminate the membership of any advisory
council for a national research institute which was in
existence on the date of enactment of the Health Research
Extension Act of 1985 (Nov. 20, 1985). After such date--
[(A) the Secretary shall make appointments to each
such advisory council in such a manner as to bring
about as soon as practicable the composition for such
council prescribed by this section;
[(B) each advisory council shall organize itself in
accordance with this section and exercise the functions
prescribed by this section; and
[(C) the Director of each national research institute
shall perform for such advisory council the functions
prescribed by this section.]
[(2)(A) The] (1) The National Cancer Advisory Board shall
be the advisory council for the National Cancer Institute. This
section applies to the National Cancer Advisory Board, except
that--
[(i)] (A) appointments to such Board shall be made by
the President;
[(ii)] (B) the term of office of an appointed member
shall be 6 years;
[(iii)] (C) of the members appointed to the Board not
less than five members shall be individuals
knowledgeable in environmental carcinogenesis
(including carcinogenesis involving occupational and
dietary factors);
[(iv)] (D) the chairman of the Board shall be
selected by the President from the appointed members
and shall serve as chairman for a term of two years;
[(v)] (E) the ex officio members of the Board shall
be nonvoting members and shall be the Secretary, the
Director of the Office of Science and Technology
Policy, the Director of NIH, the Chief Medical Director
of the Department of Veterans Affairs, the Director of
the National Institute for Occupational Safety and
Health, the Director of the National Institute of
Environmental Health Sciences, the Secretary of Labor,
the Commissioner of the Food and Drug Administration,
the Administrator of the Environmental Protection
Agency, the Chairman of the Consumer Product Safety
Commission, the Assistant Secretary of Defense for
Health Affairs, and the Director of the Office of
Energy Research of the Department of Energy (or the
designees of such officers); and
[(vi)] (F) the Board shall meet at least four times
each fiscal year.
[(B)] (2) This section applies to the advisory council to
the National Heart, Lung, and Blood Institute, except that the
advisory council shall meet at least four times each fiscal
year.
* * * * * * *
[SEC. 430. ADVISORY BOARDS.
[(a) Establishment.--The Secretary shall establish in the
Institute the National Diabetes Advisory Board, the National
Digestive Diseases Advisory Board, and the National Kidney and
Urologic Diseases Advisory Board (hereafter in this section
individually referred to as an ``Advisory Board'').
[(b) Membership; Ex Officio Members.--Each Advisory Board
shall be composed of eighteen appointed members and nonvoting
ex officio members as follows:
[(1) The Secretary Shall Appoint--
[(A) twelve members from individuals who are
scientists, physicians, and other health
professionals, who are not officers or
employees of the United States, and who
represent the specialties and disciplines
relevant to the diseases with respect to which
the Advisory Board is established; and
[(B) six members from the general public who
are knowledgeable with respect to such
diseases, including at least one member who is
a person who has such a disease and one member
who is a parent of a person who has such a
disease.
Of the appointed members at least five shall by virtue
of training or experience be knowledgeable in the
fields of health education, nursing, data systems,
public information, and community program development.
[(2)(A) The following shall be ex officio members of
each Advisory Board:
[(i) The Assistant Secretary for Health, and
Director of NIH, the Director of the National
Institute of Diabetes and Digestive and Kidney
Diseases, the Director of the Centers for
Disease Control and Prevention, the Chief
Medical Director of the Department of Veterans
Affairs (Under Secretary for Health of the
Department of Veterans Affairs), the Assistant
Secretary of Defense for Health Affairs, and
the Division Director of the National Institute
of Diabetes and Digestive and Kidney Diseases
for the diseases for which the Board is
established (or the designees of such
officers).
[(ii) Such other officers and employees of
the United States as the Secretary determines
necessary for the Advisory Board to carry out
its functions.
[(B) In the case of the National Diabetes Advisory
Board, the following shall also be ex officio members:
The Director of the National Heart, Lung, and Blood
Institute, the Director of the National Eye Institute,
the Director of the National Institute of Child Health
and Human Development, and the Administrator of the
Health Resources and Services Administration (or the
designees of such officers).
[(c) Compensation.--Members of an Advisory Board who are
officers or employees of the Federal Government shall serve as
members of the Advisory Board without compensation in addition
to that received in their regular public employment. Other
members of the Board shall receive compensation at rates not to
exceed the daily equivalent of the annual rate in effect for
grade GS-18 of the General Schedule for each day (including
traveltime) they are engaged in the performance of their duties
as members of the Board.
[(d) Term of Office; Vacancy.--The term of office of an
appointed member of an Advisory Board is four years, except
that no term of office may extend beyond the expiration of the
Advisory Board. Any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such
term. A member may serve after the expiration of the member's
term until a successor has taken office. If a vacancy occurs in
an Advisory Board, the Secretary shall make an appointment to
fill the vacancy not later than 90 days from the date the
vacancy occurred.
[(e) Chairman.--The members of each Advisory Board shall
select a chairman from among the appointed members.
[(f) Executive Director; Professional and Clerical Staff;
Administrative Support Services and Facilities.--The Secretary
shall, after consultation with and consideration of the
recommendations of an Advisory Board, provide the Advisory
Board with an executive director and one other professional
staff member. In addition, the Secretary shall, after
consultation with and consideration of the recommendations of
the Advisory Board, provide the Advisory Board with such
additional professional staff members, such clerical staff
members, such services of consultants, such information, and
(through contracts or other arrangements) such administrative
support and services and facilities, as the Secretary
determines are necessary for the Advisory Board to carry out
its functions.
[(g) Meetings.--Each Advisory Board shall meet at the call
of the chairman or upon request of the Director of the
Institute, but not less often than four times a year.
[(h) Functions of National Diabetes Advisory Board and
National Digestive Diseases Advisory Board.--The National
Diabetes Advisory Board and the National Digestive Diseases
Advisory Board shall--
[(1) review and evaluate the implementation of the
plan (referred to in section 433) respecting the
diseases with respect to which the Advisory Board was
established and periodically update the plan to ensure
its continuing relevance;
[(2) for the purpose of assuring the most effective
use and organization of resources respecting such
diseases, advise and make recommendations to the
Congress, the Secretary, the Director of NIH, the
Director of the Institute, and the heads of other
appropriate Federal agencies for the implementation and
revision of such plan; and
[(3) maintain liaison with other advisory bodies
related to Federal agencies involved in the
implementation of such plan, the coordinating committee
for such diseases, and with key non-Federal entities
involved in activities affecting the control of such
diseases.
[(i) Subcommittees; establishment and membership. In
carrying out its functions, each Advisory Board may establish
subcommittees, convene workshops and conferences, and collect
data. Such subcommittees may be composed of Advisory Board
members and nonmember consultants with expertise in the
particular area addressed by such subcommittees. The
subcommittees may hold such meetings as are necessary to enable
them to carry out their activities.
[(j) Annual Report.--Each Advisory Board shall prepare an
annual report for the Secretary which--
[(1) describes the Advisory Board's activities in the
fiscal year for which the report is made;
[(2) describes and evaluates the progress made in
such fiscal year in research, treatment, education, and
training with respect to the diseases with respect to
which the Advisory Board was established;
[(3) summarizes and analyzes expenditures made by the
Federal Government for activities respecting such
diseases in such fiscal year; and
[(4) contains the Advisory Board's recommendations
(if any) for changes in the plan referred to in section
433.
[(k) Termination of Predecessor Boards; Time Within Which
to Appoint Members.--The National Diabetes Advisory Board and
the National Digestive Diseases Advisory Board in existence on
the date of enactment of the Health Research Extension Act of
1985 shall terminate upon the appointment of a successor Board
under subsection (a). The Secretary shall make appointments to
the Advisory Boards established under subsection (a) before the
expiration of 90 days after such date. The members of the
Boards in existence on such date may be appointed, in
accordance with subsections (b) and (d), to the Board's
established under subsection (a) for diabetes and digestive
diseases, except that at least one-half of the members of the
National Diabetes Advisory Board in existence in the date of
enactment of the Health Research Extension Act of 1985 shall be
appointed to the National Diabetes first established under
subsection (a).]
* * * * * * *
[SEC. 442. ADVISORY BOARD.
[(a) Establishment.--The Secretary shall establish in the
Institute the National Arthritis and Musculoskeletal and Skin
Diseases Advisory Board (hereafter in this section referred to
as the ``Advisory Board'').
[(b) Membership, Ex Officio Members.--The Advisory Board
shall be composed of twenty appointed members and nonvoting, ex
officio members, as follows:
[(1) the Secretary shall appoint--
[(A) twelve members from individuals who are
scientists, physicians, and other health
professionals, who are not officers or
employees of the United States, and who
represent the specialties and disciplines
relevant to arthritis, musculoskeletal
diseases, and skin diseases; and
[(B) eight members from the general public
who are knowledgeable with respect to such
diseases, including one member who is a person
who has such a disease, one person who is the
parent of an adult with such a disease, and two
members who are parents of children with
arthritis.
Of the appointed members at least five shall by virtue
of training or experience be knowledgeable in health
education, nursing, data systems, public information,
or community program development.
[(2) The following shall be ex officio members of the
Advisory Board:
[(A) The Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute of Arthritis and Musculoskeletal and
Skin Diseases, the Director of the Centers for
Disease Control and Prevention, the Chief
Medical Director of the Department of Veterans
Affairs (Under Secretary for Health of the
Department of Veterans Affairs), and the
Assistant Secretary of Defense for Health
Affairs (or the designees of such officers),
and
[(B) such other officers and employees of the
United States as the Secretary determines
necessary for the Advisory Board to carry out
its functions.
[(c) Compensation.--Members of the Advisory Board who are
officers or employees of the Federal Government shall serve as
members of the Advisory Board without compensation in addition
to that received in their regular public employment. Other
members of the Advisory Board shall receive compensation at
rates not to exceed the daily equivalent of the annual rate in
effect for grade GS-18 of the General Schedule for each day
(including traveltime) they are engaged in the performance of
their duties as members of the Advisory Board.
[(d) Term of Office; Vacancy.--The term of office of an
appointed member of the Advisory Board is four years. Any
member appointed to fill a vacancy for an unexpired term shall
be appointed for the remainder of such term. A member may serve
after the expiration of the member's term until a successor has
taken office. If a vacancy occurs in the Advisory Board, the
Secretary shall make an appointment to fill the vacancy not
later than 90 days after the vacancy occurred.
[(e) Chairman.--The members of the Advisory Board shall
select a chairman from among the appointed members.
[(f) Executive Director, Professional and Clerical Staff,
Administrative Support, Services and Facilities.--The Secretary
shall, after consultation with and consideration of the
recommendations of the Advisory Board, provide the Advisory
Board with an executive director and one other professional
staff member. In addition, the Secretary shall, after
consultation with and consideration of the recommendations of
the Advisory Board, provide the Advisory Board with such
additional professional staff members, such clerical staff
members, and (through contracts or other arrangements) with
such administrative support services and facilities, such
information, and such services of consultants, as the Secretary
determines are necessary for the Advisory Board to carry out
its functions.
[(g) Meetings.--The Advisory Board shall meet at the call
of the chairman or upon request of the Director of the
Institute, but not less often than four times a year.
[(h) Duties and Functions.--The Advisory Board shall--
[(1) review and evaluate the implementation of the
plan prepared under section 436(a) periodically update
the plan to ensure its continuing relevance;
[(2) for the purpose of assuring the most effective
use and organization of resources respecting arthritis,
musculoskeletal diseases and skin diseases, advise and
make recommendations to the Congress, the Secretary,
the Director of NIH, the Director of the Institute, and
the heads of other appropriate Federal agencies for the
implementation and revision of such plan; and
[(3) maintain liaison with other advisory bodies for
Federal agencies involved in the implementation of such
plan, the interagency coordinating committees for such
diseases established under section 439, and with key
non-Federal entities involved in activities affecting
the control of such diseases.
[(i) Subcommittees Establishment and Membership.--In
carrying out its functions, the Advisory Board may establish
subcommittees, convene workshops and conferences, and collect
data. Such subcommittees may be composed of Advisory Board
members and nonmember consultants with expertise in the
particular area addressed by such subcommittees. The
subcommittees may hold such meetings as are necessary to enable
them to carry out their activities.
[(j) Annual Report.--The Advisory Board shall prepare an
annual report for the Secretary which--
[(1) describes the Advisory Board's activities in the
fiscal year for which the report is made;
[(2) describes and evaluates the progress made in
such fiscal year in research, treatment, education, and
training with respect to arthritis, musculoskeletal
diseases, and skin diseases;
[(3) summarizes and analyzes expenditures made by the
Federal Government for activities respecting such
diseases in such fiscal year for which the report is
made;
[(4) contains the Advisory Board's recommendations
(if any) for changes in the plan prepared under section
436(a); and
[(5) contains recommendations for expanding the
Institute's funding of research directly applicable to
the cause, diagnosis, early detection, prevention,
control, and treatment of, and rehabilitation of
children with arthritis and musculoskeletal disease.
[(k) Termination of Predecessor Board; Time Within Which to
Appoint Members.--The National Arthritis Advisory Board in
existence on the date of enactment of the Health Research
Extension Act of 1985 shall terminate upon the appointment of a
successor Board under subsection (a). The Secretary shall make
appointments to the Advisory Board established under subsection
(a) before the expiration of 90 days after such date. The
member of the Board in existence on such date may be appointed,
in accordance with subsections (b) and (d), to the Advisory
Board established under subsection (a).]
* * * * * * *
TITLE IV, PART C, Subpart 6
* * * * * * *
SEC. [447] 447A RESEARCH CENTERS REGARDING CHRONIC FATIGUE SYNDROME.
* * * * * * *
[SEC. 464D. NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION
DISORDERS ADVISORY BOARD.
[(a) Establishment.--the Secretary shall establish in the
Institute the National Deafness and Other communication
Disorders Advisory Board (hereafter in this section referred to
as the ``Advisory Board'').
[(b) Composition; Qualifications; Appointed and Ex Officio
Members.--The Advisory Board shall be composed of eighteen
appointed members and nonvoting ex officio members as follows:
[(1) The Secretary shall appoint--
[(A) twelve members from individuals who are
scientists, physicians, and other health and
rehabilitation professionals, who are not
officers or employees of the United States, and
who represent the specialities and disciplines
relevant to deafness and other communication
disorders, including not less than two persons
with a communication disorder; and
[(B) six members from the general public who
are knowledgeable with respect to such
disorders, including not less than one person
with a communication disorder and not less than
one person who is a parent of an individual
with such a disorder.
Of the appointed members, not less than five shall by
virtue of training or experience by knowledgeable in
diagnoses and rehabilitation of communication
disorders, education of the hearing, speech, or
language impaired, public health, public information,
community program development, occupational hazards to
communications senses, or the aging process.
[(2) The following shall be ex officio members of
each Advisory Board:
[(A) The Assistant Secretary for Health, the
Director of NIH, the Director of the National
Institute on Deafness and Other Communication
Disorders, the Director of the Centers for
Disease Control and Prevention, the Chief
Medical Director of the Department of Veterans
Affairs (Under Secretary for Health of the
Department of Veterans Affairs), and the
Assistant Secretary of Defense for Health
Affairs (or the designees of such officers).
[(B) Such other officers and employees of the
United States as the Secretary determines
necessary for the Advisory Board to carry out
its functions.
[(c) Compensation.--Members of an Advisory Board who are
officers or employees of the Federal Government shall serve as
members of the Advisory Board without compensation in addition
to that received in their regular public employment. Other
members of the Board shall receive compensation at rates not to
exceed the daily equivalent of the annual rate in effect for
grade GS-18 of the General Schedule for each day (including
traveltime) they are engaged in the performance of their duties
as members of the Board.
[(d) Term of Office; Vacancies.--The term of office of an
appointed member of the Advisory Board is four years, except
that no term of office may extend beyond the expiration of the
Advisory Board. Any member appointed to fill a vacancy for an
unexpired term shall be appointed for the remainder of such
term. A member may serve after the expiration of the member's
term until a successor has taken office. If a vacancy occurs in
the Advisory Board, the Secretary shall make an appointment to
fill the vacancy not later than 90 days from the date the
vacancy occurred.
[(e) Chairman.--The members of the Advisory Board shall
select a chairman from among appointed members.
[(f) Personnel; Executive Director; Professional and
Clerical Staff Members; Consultants; and Administrative Support
Services and Facilities.--The Secretary shall, after
consultation with and consideration of the recommendations of
the Advisory Board, provide the Advisory Board with an
executive director and one other professional staff member. In
addition, the Secretary shall, after consultation with and
consideration of the recommendations of the Advisory Board,
provide the Advisory Board with such additional professional
staff members, such clerical staff members, such services of
consultants, such information, and (through contracts or other
arrangements) such administrative support services and
facilities, as the Secretary determines are necessary for the
Advisory Board to carry out its functions.
[(g) Meetings.--The Advisory Board shall meet at the call
of the chairman or upon request of the Director of the
Institute, but not less often than four times a year.
[(h) Functions.--The Advisory Board shall--
[(1) review and evaluate the implementation of the
plan prepared under section 464A(a) and periodically
update the plan to ensure its continuing relevance;
[(2) for the purpose of assuring the most effective
use and organization of resources respecting deafness
and other communication disorders, advise and make
recommendations to the Congress, the Secretary, the
Director of NIH, the Director of the Institute, and the
heads of other appropriate Federal agencies for the
implementation and revision of such plan; and
[(3) maintain liaison with other advisory bodies
related to Federal agencies involved in the
implementation of such plan and with key non-Federal
entities involved in activities affecting the control
of such disorders.
[(i) Subcommittee activities; workshops and conferences;
collection of data. In carrying out its functions, the Advisory
Board may establish subcommittees, convene workshops and
conferences, and collect data. Such subcommittees may be
composed of Advisory Board members and nonmember consultants
with expertise in the particular area addressed by such
subcommittees. The subcommittees may hold such meetings as are
necessary to enable them to carry out their activities.
[(j) Annual Report.--The Advisory Board shall prepare an
annual report for the Secretary which--
[(1) describes the Advisory Board's activities in the
fiscal year for which the report is made;
[(2) describes and evaluates the progress made in such
fiscal year in research, treatment, education, and
training with respect to the deafness and other
communication disorders;
[(3) summarizes and analyzes expenditures made by the
Federal Government for activities respecting such
disorders in such fiscal year; and
[(4) contains the Advisory Board's recommendations (if
any) for changes in the plan prepared under section
464A(a).
[(k) Commencement of Existence.--The National Deafness and
Other Communication Disorders Advisory Board shall be
established not later than April 1, 1989.]
* * * * * * *
Sec. 489 [(b) Arrangement With National Academy of Sciences
or Other Nonprofit Private Groups or Associations.
[(1) The Secretary shall request the National Academy
of Sciences to conduct the study required by subsection
(a) under an arrangement under which the actual
expenses incurred by such Academy in conducting such
study will be paid by the Secretary. If the National
Academy of Sciences is willing to do so, the Secretary
shall enter into such an arrangement with such Academy
for the conduct of such study.
[(2) If the National Academy of Sciences is unwilling
to conduct such study under such an arrangement, then
the Secretary shall enter into a similar arrangement
with other appropriate nonprofit private groups or
associations under which such groups or associations
will conduct such study and prepare and submit the
reports thereon as provided in subsection (c).
[(3) The National Academy of Sciences or other group
or association conducting the study required by
subsection (a) shall conduct such study in consultation
with the Director of NIH.]
[(c)] (b) Report to Congressional Committees.--A report on
the results of the study required under subsection (a) shall be
submitted by the Secretary to the Committee on Energy and
Commerce of the House of Representatives and the Committee on
Labor and Human Resources of the Senate at least once every
four years.
* * * * * * *
COMPREHENSIVE ALCOHOL ABUSE AND ALCOHOLISM PREVENTION, TREATMENT, AND
REHABILITATION ACT AMENDMENTS OF 1979
* * * * * * *
[National Commission on Alcoholism and Other Alcohol
Related Problems, establishment; Executive Secretary; interim
and final reports of study; termination; authorization of
appropriations.
[Section 18. Jan. 2, 1980, P.L. 96-180, Sec. 18, 93 Stat.
1306; Apr. 26, 1983, P.L. 98-24, Sec. 5(a)(2), 97 Stat. 183,
provided that:
[``(a)(1) There is established a Commission to be known as
the National Commission on Alcoholism and Other Alcohol-Related
Problems (hereinafter in this section referred to as the
`Commission'). The Commission shall be composed of --
[``(A) four Members of the Senate appointed by the
President of the Senate upon the recommendation of the
majority and minority leaders;
[``(B) four Members of the House of Representatives
appointed by the Speaker of the House of
Representatives upon the recommendation of the majority
and minority leaders;
[``(C) nine public members appointed by the
President; and
[``(D) not more than four nonvoting members appointed
by the President from individuals employed in the
administration of programs of the Federal Government
which affect the prevention and treatment of alcoholism
and the rehabilitation of alcoholics and alcohol
abusers. At no time shall more than two members
appointed under subparagraph (A), more than two of the
members appointed under subparagraph (B), or more than
five of the members appointed under subparagraph (C) be
members of the same political party.
[``(2)(A) The President shall designate one of the members
of the Commission as Chairman, and one as Vice Chairman. Nine
members of the Commission shall constitute a quorum, but a
lesser number may conduct hearings. Members appointed under
paragraph (1)(D) shall not be considered in determining a
quorum of the Commission.
[``(B) Members of the Commission shall serve without
compensation, but shall be reimbursed for travel, subsistence,
and other necessary expenses incurred in the performance of the
duties vested in the Commission.
[``(C) The Commission shall meet at the call of the
Chairman or at the call of the majority of the members thereof.
[``(3)(A) The Commission may appoint, without regard to the
provisions of title 5, United States Code, governing
appointments in the competitive service, an executive secretary
to assist the Commission in carrying out its functions.
[``(B) The Secretary shall provide the Commission with such
additional professional and clerical staff, such information,
and the services of such consultants as the Secretary
determines necessary for the Commission to carry out
effectively its functions.
[``(C) The Commission may secure directly from any
department or agency of the United States information necessary
to enable it to carry out its duties under this section. Upon
request of the Chairman of the Commissions, the head of such
department or agency shall furnish such information to the
Commission consistent with applicable laws and regulations with
respect to the privacy of medical records.
[``(b) The Commission shall conduct a study of alcoholism
and alcohol-related problems and shall include in the study--
[``(1) an assessment of unmet treatment and
rehabilitation needs of alcoholics and their families;
[``(2) an assessment of personnel needs in the fields
of research, treatment, rehabilitation, and prevention;
[``(3) an assessment of the integration and financing
of alcoholism treatment and rehabilitation into health
and social health care services within communities;
[``(4) a study of the relationship of alcohol use to
aggressive behavior and crime;
[``(5) a study of the relationship of alcohol use to
family violence;
[``(6) a study of the relationship of alcoholism to
illnesses, particularly those illnesses with a high
stress component, among family members of alcoholics;
[``(7) an evaluation of the effectiveness of
prevention programs, including the relevance of alcohol
control laws and regulations to alcoholism and alcohol-
related problems;
[``(8) a survey of the unmet research needs in the
area of alcoholism and alcohol-related problems;
[``(9) a survey of the prevalence of occupational
alcoholism and alcohol abuse programs offered by
Federal contractors; and
[``(10) an evaluation of the needs of special and
underserved population groups, including American
Indians, Alaskan Natives, native Hawaiians, Native
American Pacific Islanders, youth, the elderly, women,
and the handicapped and assess the adequacy of existing
services to fulfill such needs.
[``(c) The Commission shall submit to the President and the
Congress such interim reports as it deems advisable and shall
within two years after the date on which funds first become
available to carry out this section submit to the President and
the Congress a final report which shall contain a detailed
statement of its findings and conclusions and also such
recommendations for legislation and administrative actions as
it deems appropriate. The Commission shall cease to exist sixty
days after the final report is submitted under this subsection.
[``(d) The Secretary of Health, Education, and Welfare
shall be responsible for the coordination of the activities of
the Commission.
[``(e) There are authorized to be appropriated for the
purposes of this section $1,000,000 to remain available until
the expiration of the Commission.''.]
* * * * * * *
COMPREHENSIVE ENVIRONMENTAL RESPONSE, COMPENSATION AND LIABILITY ACT OF
1980
* * * * * * *
Sec. 311(a) [(5) Advisory council.--To assist in the
implementation of this subsection and to aid in the
coordination of research and demonstration and training
activities funded from the Fund under this section, the
Secretary shall appoint an advisory council (hereinafter in
this subsection referred to as the ``Advisory Council'') which
shall consist of representatives of the following:
[(A) The relevant Federal agencies.
[(B) The chemical industry.
[(C) The toxic waste management industry.
[(D) Institutions of higher education.
[(E) State and local health and environmental
agencies.
[(F) The general public.
(6) Planning.--Within nine months after the date of the
enactment of this subsection (enacted Oct. 17, 1986), the
Secretary, acting through the Director of the National
Institute for Environmental Health Sciences, shall issue a plan
for the implementation of paragraph (1). The plan shall include
priorities for actions under paragraph (1) and include research
and training relevant to scientific and technological issues
resulting from the site specific hazardous substance response
experience. The Secretary shall, to the maximum extent
practicable, take appropriate steps to coordinate program
activities under this plan with the activities of other Federal
agencies in order to avoid duplication of effort. The plan
shall be consistent with the need for the development of new
technologies for meeting the goals of response actions in
accordance with the provisions of this Act. The Advisory
Council shall be provided an opportunity to review and comment
on the plan and priorities and assist appropriate coordination
among [the relevant Federal agencies referred to in
subparagraph (A) of paragraph (5)] relevant Federal agencies.
* * * * * * *