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                                                       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.
          * * * * * * *