[Congressional Record Volume 151, Number 160 (Wednesday, December 14, 2005)]
[Senate]
[Pages S13577-S13591]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. REID (for Mr. Lieberman (for himself, Mr. Cochran, Mr. 
        Carper, and Mrs. Hutchison)):
  S. 2104. A bill to amend the Public Health Service Act to establish 
the American Center for Cures to accelerate the development of public 
and private research efforts towards tools and therapies for human 
diseases with the goal of early disease detection, prevention, and 
cure, and for other purposes; to the Committee on Health, Education, 
Labor, and Pensions.

[[Page S13578]]

  (At the request of Mr. Reid, the following statement was ordered to 
be printed in the Record.)
  Mr. LIEBERMAN. Mr. President, today, Senator Cochran, Senator Carper, 
Senator Hutchison, and I are introducing the American Center for CURES 
Act of 2005, which would establish the American Center for Cures, 
within the National Institutes of Health (NIH). The purpose of the 
Center would be to bring promising and novel diagnostics, therapies, 
drugs, and tools to treat disease faster to the public.
  We continue to face significant health challenges. In the US today, 
chronic diseases account for 7 out of 10 deaths, with the major killers 
being heart attack, cancer and stroke. Seventy percent of the $1.7 
trillion dollars we spend on healthcare each year goes to chronic 
disease care. Around the world, HIV, tuberculosis, and malaria kill 4, 
3, and 2 million people a year. On the horizon are emerging manmade and 
natural threats such as SARS, flu and bioterrorism. There are other 
diseases that we need better treatments and cures for, but that we do 
not devote enough attention to. Diseases of social stigma, such as 
depression, which is the most frequent reason people visit their 
physician, and seizure disorder, which is the primary neurological 
disorder in children, are often neglected. We have bacteria growing and 
spreading in our hospitals that do not respond to our antibiotic 
supply. These are the health challenges facing us in the 21st century.
  Fortunately, the United States has no equal in the biomedical 
sciences. This is due in large part to our nation's premier biomedical 
research investment the--NIH, which receives $28 billion per year after 
a doubling of their budget of $14 billion from 1998 to 2003. The NIH is 
comprised of 27 major institutes and centers, leading the way for the 
world in cancer, cardiovascular, infectious disease and allergy 
advancements for health promotion and relief from the burdens of 
disease. US biomedical advances are also due to our dynamic 
biotechnology and pharmaceutical sectors.
  In our search for answers to our pressing health problems, the NIH 
has grown in the number of Institutes and Centers and in funding. At 
the same time, Congress and others have wanted to ensure that we are 
building on NIH's strengths to respond to complex health problems 
requiring interdisciplinary and collaborative work. Therefore, Congress 
commissioned the 2003 National Academy of Sciences report, ``Enhancing 
the Vitality of the National Institutes of Health: Organizational 
Change to Meet New Challenges'', that examined whether and how we could 
optimize the NIH's organizational structure to meet our next set of 
health challenges.
  The report stated that ``no organization as important as NIH should 
remain frozen in organization space''. At the same time, the report 
cautioned that any changes in organizational structure to achieve 
greater progress in chronic and emerging diseases were not without some 
difficulty and risk. The NAS report made a number of recommendations 
and our CURES legislation addresses the six major points.
  First, CURES seeks to strengthen the clinical research process by 
streamlining the clinical trials process by creating Centralized 
Internal Review Boards (CIRB). CIRB's would focus on simplifying the 
human subjects review processes for multi-institutional clinical 
trials. CURES also significantly augments current NIH investments to 
train the clinical research workforce of the future, and provides 
additional funding for multidisciplinary teams of researchers examining 
issues of quality and design of clinical trials. We need to continue to 
bring safe and effective diagnostics and therapeutics, but more 
efficiently.
  Secondly, our proposal enhances and increases trans-NIH strategic 
planning and funding. Currently, the NIH's 27 Centers and Institutes 
each have their own directors and budgets and thus, operate 
independently. The resulting structural and organizational stovepipes 
are limited in their ability to capitalize on the NIH's collective 
research capacity to address complex problems using the expertise of 
multiple fields. For example, the problem of diabetic retinopathy could 
be tackled by researchers in the Institutes of the Eye, Diabetes, 
Digestive and Kidney disease, Biomedical Imaging and Bioengineering, 
and Allergy Immunology and Infectious disease. However, there are few 
mechanisms for such trans-Institute initiatives that could lead to a 
cure or treatment. To address this problem, CURES has created multiple 
funding mechanisms for trans-Institute research and cross-fertilization 
of ideas. Strategic planning and prioritizing disease research is also 
integral to achieving progress more quickly. Therefore, the American 
Center for CURES Act would establish a CURES council, comprised of key 
health stakeholders to produce a translational research agenda for the 
Center based on research breakthroughs and areas of health need.
  Thirdly, the American Center for CURES Act of 2005 strengthens the 
Office of the NIH Director. Our legislation emphasizes the need for 
greater budgetary support and flexibility in the area of translational 
research. This follows much of the NIH Director's current efforts with 
the NIH Roadmap. Our legislation further supports the spirit of the NIH 
Roadmap with organizational and funding commitments that bring 
translational research investment to a necessary and appropriate scale, 
which has not been the case to date. The NIH Director, with the CURES 
Advisory Council, would play a key role in these efforts by 
recommending appointees for the Director of the American Center for 
CURES to the President. The NIH Director will also be a co-chair of the 
Center's Council and have a leading role in setting the research and 
funding priorities for translational research projects at the NIH. The 
NIH Director will also head other initiatives outlined in the 
legislation, such as launching a publicly accessible electronic 
database for all published NIH funded research.
  Fourth, our legislation creates a Director's Special Projects 
Program, called the Health Advanced Research Projects Agency (HARPA). 
The NAS committee recommended the creation of a program to support 
high-risk, high-potential payoff research. The Department of Defense 
has had significant success with its Defense Advanced Research Program 
Agency (DARPA), where a group of expert portfolio managers invest in 
and oversee innovative, multidisciplinary, collaborative projects to 
advance specific fields or to develop needed technologies. DARPA has 
lead to the creation of stealth technology, satellite surveillance, 
lasers, internet, and e-mail. Based on this model, HARPA would be 
housed within the Center and would help lead breakthrough advances 
using a translational ``challenge model'' in biomedical research. 
Breakthroughs could include a vaccine or other treatment against HIV or 
genetic probes pivotal to the elucidation of disease producing genes. 
HARPA would also be the key funding mechanism for trans-Institute 
research to prioritize and foster collaborative and trans-Institute 
research initiatives.

  Fifth, the NAS report recommended that the NIH intramural research 
program be more unique, innovative, and risk-taking. In response, CURES 
creates an Office of Intramural Risk Mapping, within the Office of 
Technology Transfer, which will oversee NIH's intramural research 
programs to help assure they are complementary to extramural and 
private sector research. The Office will also ensure that intramural 
research is also innovative and risk-taking to produce more novel and 
promising biomedical breakthroughs. The office will also make funds 
available to trans-Institute and center initiatives that focus on 
health risk analysis and corresponding scientific risk opportunity.
  Sixth, our legislation addresses the NAS report recommendation to 
standardize data and information management systems. The report was 
clear that the NIH must increase its capacity for data gathering and 
reporting to meet its obligations ``. . . for effective management, 
accountability, and transparency.'' Cures seek to improve the sharing 
of information by providing funding to the National Library of Medicine 
to create and maintain a publicly accessible database of all 
publications resulting from NIH-funded research and by establishing a 
national electronic registry and results database to increase 
enrollment in public and private clinical trials and to share

[[Page S13579]]

efficacy and safety outcomes emanating from NIH-funded clinical 
research endeavors. Cures focuses on the need to expand the NLM 
facilities according to the demands of new scientific discoveries and 
fields, especially within the areas of genomics and proteinomics.
  In addition to the NAS report recommendations, other changes in the 
biomedical research landscape demand more targeted investments in 
promising and novel treatments. Our current response to research on 
important health problems is arguably dichotomous. We invest public 
money into the NIH or we hope the private market will produce essential 
drugs and tools. However, there needs to be greater collaboration 
between the private and public sectors. Private sector investment in 
biomedical research has grown to approximately $46 billion per year--
far more than our public sector investment in NIH. For new and 
effective therapies to become available, we need to build better public 
and private partnerships. Cures includes key provisions to accomplish 
this. Cures promotes the innovative efforts of small to medium sized 
biotechnology and bioengineering firms who require additional support 
in key traditionally under-funded stages of product development--the so 
called R&D ``Valley of Death.'' It expands the NIH's current small 
business support and rapid access to interventional development 
programs to move basic science through the product development pipeline 
faster. These programs would facilitate NIH partnerships with private 
industry in the preclinical stage of the R&D process so as to formulate 
a plan for health research translation and commercialization from the 
outset. Additionally, our legislation would move the NIH's Office of 
Technology Transfer into the American Center for Cures, where it would 
survey research being conducted in the private and public sectors to 
avoid duplication, target promising research investments, and broker 
more flexible and productive agreements for licensing and patents 
between the public and private sectors. The HARPA entity within the 
center is also designed to promote public-private joint R&D efforts.
  Today, we are proposing the establishment of the American Center for 
Cures, whose mission would be to promote more rapid translation of 
public and private research into therapies, diagnostics and tools, 
which can effectively treat and possibly cure diseases of critical 
importance to domestic and global health. With more targeted investment 
in translating our basic science research into diagnostics and 
therapeutics, we hope to bring more tangible health benefits to 
Americans and people all over the world.
  I ask unanimous consent that explanatory materials on the legislation 
including, ``Short Summary of the American Center for CURES Act of 
2005,'' ``Explanation of How the American Center for CURES Act of 2005 
Addresses the Findings of the 2003 National Academy of Sciences Report: 
`Enhancing the Vitality of the National Institutes of Health: 
Organizational Change to Meet New Challenges','' ``Section by Section 
Summary of the American Center for CURES Act of 2005,'' the full text 
of the legislation, and ``Quotes in Support of the American Center for 
CURES Act of 2005'' be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

      A Short Summary of the American Center for CURES Act of 2005

       A bill to facilitate more rapid development of novel 
     diagnostics, therapies, and cures
       From 1998-2003, Congress doubled funding to the world's 
     leader in biomedical research, the National Institutes of 
     Health (NIH), to $28 billion per year. In order to meet 21st 
     century health challenges and optimize the use of this public 
     investment, Senators Lieberman and Cochran have introduced 
     legislation to increase the capacity of the NIH to produce 
     effective treatments, diagnostics and cures for our nation's 
     most burdensome diseases using a novel approach to publicly 
     funded research.
       Cures will do the following:
       Create an American Center for Cures (ACC) in the NIH to 
     orchestrate focused research and development of solutions to 
     pressing ailments. The ACC, led by a Center Director, will 
     identify and promote translational research, which involves 
     developing basic science research for application purposes, 
     in the public and private sectors. The ACC will fund 
     innovative and collaborative research, breakdown bottlenecks 
     in clinical research, and facilitate information exchange.
       Establish an advisory council comprised of key health 
     experts and stakeholders to advise the ACC on national 
     medical needs and novel developments in all sectors. To use 
     public funds effectively, a centralized mechanism to track 
     research on health threats is necessary. A Council will 
     inform the ACC on biomedical needs, technical feasibility 
     issues, and current research breakthroughs.
       Create a Health Advanced Projects Agency for research 
     promotion. A research projects agency will promote strategic 
     risk-taking and follow a ``challenge model'' to support 
     innovative multidisciplinary research between NIH Institutes, 
     other federal agencies, grantees and business partners, for 
     projects with the potential for significant health impact. 
     Funding for projects will be flexible and outcomes based.
       Promote the innovative efforts of small to medium sized 
     biotechnology and bioengineering firms. The ACC will support 
     firms requiring assistance in key traditionally underfunded 
     stages of research and development, the R&D ``Valley of 
     Death''. Funding will be available to assist companies with 
     promising and novel therapeutics and diagnostics in both 
     preclinical and clinical stages.
       Strengthen the clinical research process. Clinical trials 
     are essential to ensuring the safety and efficacy of new 
     products. The ACC will streamline clinical trial protocols to 
     supply the public with new treatments in a timelier, more 
     efficient, and more economical way. It will augment NIH 
     training funds to create a clinical research workforce of the 
     future. It will establish a clinical trial registry and 
     results database to promote information sharing and to avoid 
     duplicative efforts.
       Facilitate complete and efficient transfer of intellectual 
     property from development at the molecular level to clinical 
     trials and into production. Active participation of the 
     commercial sector in development is critical. An Office of 
     Technology Transfer in the ACC will catalog and disseminate 
     the NIH translational research portfolio and oversee NIH 
     intellectual property licensing.
                                  ____


Explanation of How the American Center for CURES Act of 2005 Addresses 
     the Findings of the 2003 National Academy of Sciences Report: 
    ``Enhancing the Vitality of the National Institutes of Health: 
             Organizational Change to Meet New Challenges''


                               Background

       The health challenges facing the U.S. and the world today 
     are a mix of infectious diseases, such as HIV, tuberculosis 
     and malaria, long-standing chronic such as diabetes and 
     cancer, and new emerging threats, such as SARS and avian 
     influenza. In the context of these growing concerns, Congress 
     commissioned the National Academy of Sciences (NAS) in 2001 
     to report on ``whether the current structure and organization 
     of NIH are optimally configured for the scientific needs of 
     the 21st century.'' Indeed, NIH is America's premier public 
     research investment and between 1998 and 2003, the NIH budget 
     of $14 billion dollars doubled to $28 billion. By 
     commissioning the NAS report, Congress asked how it might 
     optimize its burgeoning research investment. Congress 
     solidified its support for the NIH but simultaneously posed 
     questions of NIH can best address domestic and global health 
     needs:
       Are the 27 NIH Institutes and Centers able to coordinate 
     their research goals and priorities to reflect the 
     multidisciplinary nature of today's health problems?
       How is the NIH producing and sharing biomedical knowledge 
     from multiple disciplines to spur the development of clinical 
     tools, drugs, and other therapies to battle longstanding and 
     emerging diseases?
       Can the NIH respond effectively to acute health threats, 
     such as to burgeoning HIV infection rates and the threat of a 
     bioterrorism attack?
       Is the NIH cultivating the next generation of researchers 
     to build upon the great works of NIH past?
       The end result was the 2003 NAS and Institute of Medicine 
     (IOM) report, ``Enhancing the Vitality of the National 
     Institutes of Health: Organizational Change to Meet New 
     Challenges''. The report reinforced NIH successes over the 
     last 50 years as the national and global leader in biomedical 
     research. NIH accomplished this by developing a cutting edge 
     internal research infrastructure and a democratic extramural 
     grant program that almost single-handedly supports 
     University-based research in the biological sciences. 
     However, the report also cautioned that ``no organization as 
     important as NIH should remain frozen in organizational 
     space'' and any changes in organizational structure to 
     achieve greater progress in chronic and emerging diseases, 
     however essential, would face difficulty and risk.


                          NAS Report Findings

       The NAS report made a total of 14 recommendations. In the 
     final analysis, the NAS report recommended maintaining the 
     general structure of NIH to ensure NIH's strengths would be 
     protected: conducting essential basic science, and disease, 
     behavioral, organ, and system based research in its 
     intramural program and funding peer-reviewed grants to 
     University researches in its extramural program. However, the 
     report also recognized the need for organizational changes 
     which could help institutes work across their respective 
     stovepipes, foster a culture of risk-taking and innovation, 
     and

[[Page S13580]]

     give the NIH director, other leadership, and the public the 
     power to prioritize NIH research to solve the Nation's most 
     burdensome health problems. Collectively, these changes would 
     enhance the capacity of the NIH to not only pursue 
     fundamental knowledge about the nature and behavior of living 
     systems, but to apply that knowledge to extend healthy life 
     and reduce the burdens of illness and disability. This is 
     NIH's mission.


     CURES Addresses the Six Key Recommendations of the NAS Report

       1. Strengthen Clinical Research: The NAS report recommended 
     that the NIH ``pursue a new organizational strategy to better 
     integrate leadership, funding, and management of its clinical 
     research enterprise''. Senators Lieberman, Cochran, Carper, 
     and Hutchison are introducing a proposal that creates the 
     American Center for Cures (ACC), headed by a Cures Director. 
     One of the new Director's key charges will be to promote and 
     simplify the clinical research endeavor. The Director will 
     establish a national electronic registry and results database 
     for clinical trials in order to increase enrollment of 
     research subjects and improve sharing efficacy and safety 
     outcomes emanating from the clinical research endeavor. The 
     Director will fund multidisciplinary clinical research teams 
     in the academic and private sector, create Centralized 
     Internal Review Boards (CIRB) to simplify the human subjects 
     review processes for multi-institutional clinical trials, and 
     augment NIH investments in training the clinical research 
     workforce of the future.
       2. Enhance and Increase Trans-NIH Strategic Planning and 
     Funding: The 27 NIH Centers and Institutes with their own 
     directors and budgets generally operate independently. The 
     resulting structural and organizational stovepipes are 
     limited in their ability to capitalize on the NIH's 
     collective research capacity to address complex problems from 
     different fields. For example, the problem of diabetic 
     retinopathy could be tackled by researchers in the Institutes 
     of the Eye, Diabetes, Digestive and Kidney disease, 
     Biomedical Imaging and Bioengineering, and Allergy Immunology 
     and Infectious disease. To address this problem, Cures funds 
     innovative multidisciplinary collaborative research across 
     NIH institutes and centers. NIH Institute and Center 
     Directors on the Cures Council will be entrusted to 
     coordinate the intramural research agenda with that of the 
     ACC.
       3. Strengthen the Office of the NIH Director: The NAS 
     report emphasizes the need for the NIH Director to have more 
     budgetary support and flexibility. Dr. Zerhouni's office has 
     taken these steps with the NIH Roadmap. The Cures legislation 
     further supports the spirit of the NIH Roadmap with 
     organizational and funding commitments that bring the 
     translational research investment to necessary and 
     appropriate scale. The NIH Director and the Cures Advisory 
     Council will recommend appointees for the Cures Director to 
     the President. The NIH Director will be a co-chair of the ACC 
     Council that will set the research and funding priorities for 
     translational research projects at the NIH. The NIH Director 
     will head efforts to establish a publicly accessible 
     electronic database for all published NIH funded research, 
     among other initiatives.
       4. Create a Director's Special Projects Program: The NAS 
     committee recommended the creation of a program to support 
     high-risk, high-potential payoff research. The Department of 
     Defense has had significant success with its Defense Advanced 
     Research Program Agency (DARPA), where a group of expert 
     portfolio managers invest in and oversee innovative, 
     multidisciplinary, collaborative projects to advance specific 
     fields or to develop needed technologies. DARPA has lead to 
     the creation of the stealth technology, satellite 
     surveillance, lasers, internet, and email. A Health Advanced 
     Research Program Agency (HARPA) will be established within 
     the ACC to help lead breakthrough advances, using a 
     translational ``challenge'' model in biomedical research, 
     such as a vaccine against HIV or genetic probes pivotal to 
     the elucidation of disease producing genes.
       5. Promote Innovation and Risk-Taking in Intramural 
     Research: The NAS report recommended that the NIH intramural 
     research portfolio be distinct from that of the extramural 
     program and private sector. Cures creates an Office of 
     Intramural Risk Mapping which will oversee the intramural 
     research programs of the NIH to be certain they are 
     complementary to extramural and private programs. The office 
     will make funds available to groups of institutes and centers 
     to promote engagement in multi-institute projects that focus 
     on health risk analysis and corresponding scientific risk 
     opportunity.
       6. Standardize Data and Information Management Systems: The 
     NAS committee recommended that the NIH must increase its 
     capacity for data gathering and reporting to meet its 
     obligations ``. . . for effective management, accountability, 
     and transparency''. Cures seeks to improve the sharing of 
     information by providing funding to the National Library of 
     Medicine to create and maintain a publicly accessible 
     database of all publications resulting from NIH-funded 
     research and by establishing a national electronic registry 
     and results database to increase enrollment in public and 
     private clinical trials and to share efficacy and safety 
     outcomes emanating from the clinical research endeavor. Cures 
     focuses on the need to grow the NLM facilities according to 
     the demands of new scientific discoveries and fields, 
     especially within the areas of genomics and proteinomics.


                     CURES Build on the NIH Roadmap

       In response to the NAS report, NIH Director Dr. Elias 
     Zerhouni launched the NIH Roadmap in FY 2004 with $128 
     million in funding from existing NIH budget allocations. 
     Funding increases every year until FY 2009 and tops out at 
     $507 million. The NIH Roadmap consists of:
       New Pathways to Discovery to obtain a deeper understanding 
     of biological systems based on new models.
       Research Teams of the Future to facilitate collaboration 
     across institutes by awarding grants to support institutional 
     partnerships and cutting-edge research.
       Re-engineering the Clinical Research Enterprise reforms the 
     clinical trial process to allow for broader participation 
     from community-level patients and providers.
       While the NIH roadmap addresses some of the concerns of the 
     NAS report, it does not address key provisions including 
     increasing the power of the NIH Director, establishing an 
     advanced research projects agency, and establishing a new 
     leadership that can facilitate the research essential to 
     moving products faster from bench to bedside. Unlike CURES, 
     the roadmap relies on traditional academic-government 
     relationships. CURES builds on the Roadmap to cultivate new 
     relationships between NIH researchers and innovative 
     industrial partners. Unlike the roadmap, which asks the NIH 
     to focus on new priorities with old tools and funds, Cures 
     provides much higher levels of funding for a Center uniquely 
     devoted to translating research to produce new therapies and 
     even cures to the most important diseases.
                                  ____


Section by Section Summary of the American Center for CURES Act of 2005

   A bill to facilitate more rapid development of novel diagnostics, 
       therapies and cures critical to national and global health

     Background
       When it comes to investments and advancements in biomedical 
     research, the United States has no equal. Its National 
     Institutes of Health (NIH) is the world's largest public 
     source of biomedical research funding with an annual budget 
     of over $28 billion. The NIH is comprised of 27 major 
     institutes and centers, leading the way in cancer, 
     cardiovascular, infectious disease and allergy advancements 
     for health promotion and relief from the burdens of disease.
       The private sector is also investing substantial resources 
     in increasing both longevity and quality of life. These 
     companies now invest more than the federal government in 
     biomedical research and development (R&D). Potent 
     pharmaceuticals and cutting edge medical devices provide 
     health care professionals with a therapeutic arsenal that has 
     increased lifespan seven years since 1960 and dropped 
     neonatal mortality four fold. Partnerships between NIH and 
     private industry are not often recognized for their key roles 
     in bringing new treatments to the public, but are of great 
     importance as they have led to life-changing therapies from 
     to Taxol to Claritin to HIV anti-retrovirals.
       But how can biomedical R&D proceed even faster? How can 
     partnerships between NIH's Institutes and Centers, disease-
     based NGO's, biotech companies and small and large 
     pharmaceuticals occur even more frequently? Towards which 
     diseases should our resources be prioritized in the first 
     place? How can NIH and the private sector be more responsive 
     to emerging public health threats such as bioterrorism, an 
     avian flu pandemic, antibiotic resistance, and a waning 
     vaccine supply?
     Center for Cures
       In response to these pressing questions and the capacity of 
     the NIH to address our health needs, Senators Lieberman, 
     Cochran, Carper and Hutchison are proposing a $5 billion 
     dollar annual investment to create the American Center for 
     Cures (ACC). The mission of this new NIH Center will be to 
     promote more rapid translation of public and private research 
     into therapies, diagnostics and tools, which can effectively 
     treat and possibly cure diseases of critical importance to 
     domestic and global health. The ACC will enhance NIH's 
     ability to not only pursue fundamental knowledge about the 
     nature and behavior of living systems, but to apply that 
     knowledge to extend healthy life and reduce the burdens of 
     illness and disability. This is NIH's mission.
     Specifically, the American Center for Cures will:
       (1) Direct new resources towards the world's most 
     burdensome diseases and towards biomedical, bioengineering, 
     and biotechnological research with the greatest therapeutic 
     impact and promise.
       (2) Create an ACC national advisory board consisting of key 
     health experts and stakeholders, who will help identify the 
     critical diseases and health threats requiring greater public 
     and private investment.
       (3) Create a special Health Advanced Research Projects 
     Agency (HARPA) to support innovative multidisciplinary 
     collaborate research between NIH Institutes, between NIH and 
     other federal agencies and between NIH grantees and business 
     partners, for projects with the potential for significant 
     health impact.
       (4) Create health-centered Federally Funded Research and 
     Development Centers (FFRDC) which will bring together 
     interdisciplinary teams of experts including scientists, 
     clinicians, epidemiologists, and

[[Page S13581]]

     pharmacists for a time limited period to focus on developing 
     therapeutic breakthroughs for important disease entities.
       (5) Invest further in the development of an expert 
     workforce which will augment the nation's translational 
     research capacity. Such an effort will include training new 
     clinical researchers and bioinformatics professionals.
       (6) Promote risk-taking and collaboration between NIH 
     Institutes and Centers.
       (7) Streamline the clinical research process essential to 
     determining if new treatments are effective and safe.
       (8) Promote the innovative efforts of small to medium sized 
     biotechnology and bioengineering firms who require additional 
     support in key traditionally under-funded stages of product 
     development--the so called R&D ``Valley of Death''.
       (9) Facilitate NIH partnerships with private industry in 
     the preclinical stage of the R&D process so as to formulate a 
     plan for health research translation and commercialization 
     from the outset.
       (10) Standardize NIH information management systems and 
     reporting requirements of publicly funded research to improve 
     information sharing between the applied science, 
     translational research and business communities.
     A section by section summary of the legislation is included 
     below.
       Section 1: Short title.
       Section 2: Table of contents.
       Section 3: Findings.
       Section 4: Amends Title IV of the Public Health Services 
     Act to establish a new Center at the National Institutes of 
     Health (NIH) called the American Center for Cures (ACC).


                   Part J--American Center for Cures

       Section 499A: Definitions.
       Section 499B(a): States the mission of the proposed 
     American Center for Cures (ACC), which is to increase the 
     capacity of the NIH to promote translational research between 
     its Institutes and Centers, between the NIH and other Federal 
     agencies and between NIH grantees and business partners so as 
     to speed the development of effective diagnostics, therapies 
     and cures essential to human health and well being.
       The ACC shall formulate and implement a strategy for the 
     nation's translational research investment based on (1) a 
     prioritization of biomedical research based on disease burden 
     and research promise, and (2) funding for innovative, multi-
     disciplinary, and collaborative research.
       The ACC will be guided in part by a series of ``Grand 
     Challenges'' or strategic challenges that direct the health 
     research community towards multi-staged projects with the 
     potential to transform the healthcare landscape. Examples 
     include: the creation of laboratory diagnostics that enable 
     the country to detect quickly and accurately to acute health 
     threats, such as an avian flu pandemic or a bioterrorism 
     attack; a commitment by researchers and manufacturers from 
     public and private sectors to develop vaccines for the 
     world's most deadly infectious diseases including HIV, 
     tuberculosis, and malaria. Other examples are provided in 
     this section.
       Section 499B(b): Establishes a Director of Cures (to be 
     called in this document the ``Director'') who will administer 
     the ACC. The President of the United States will appoint the 
     Director. The NIH Director in consultation with the Cures 
     Advisory Council (Section 499B(c)) will recommend candidates 
     for the Director to the President. The NIH Director will work 
     with the Director to promote the nation's translational 
     research efforts.
       The Director will have at his disposal an annual 
     acceleration fund of $5 billion dollars to provide support 
     for research and development of breakthrough biomedical 
     discoveries and to carry out the purposes of the ACC. No less 
     than one half of the acceleration fund will be allocated to a 
     Health Advanced Research Projects Agency described in Subpart 
     II.
       Section 499B(c): Establishes a Cures Council to advise and 
     direct the translational research efforts of the ACC. The 
     Council will be co-chaired by the Director of Cures and the 
     Director of NIH. Membership will include NIH Institute and 
     Center Directors; leaders from at least 9 federal agencies 
     including the Director of the Agency for Healthcare Research 
     and Quality (AHRQ), the Director of the Defense Advanced 
     Research Projects Agency (DARPA), and the President of the 
     Institute of Medicine (IOM); no fewer than three leaders from 
     the small business community; three leaders from large 
     pharmaceutical or biotechnology companies; and three leaders 
     from academia. All Council members will be appointed by the 
     President.
       The Council shall establish subcommittees including one of 
     NIH Institute and Center Directors to coordinate research 
     priorities in, and ensure sharing of research agendas among, 
     the Institutes and Centers. The subcommittee shall also 
     coordinate the ACC research agenda with that of the NIH 
     Institutes and Centers.
       The Council will make recommendations that help the 
     Director set research priorities for the ACC. The Council 
     shall consider risk and burden of disease as well as lines of 
     research uniquely poised to deliver effective diagnostics and 
     therapies.
       The Council shall be aided by the Office of Intramural Risk 
     Opportunity and Mapping of the Office of Technology Transfer 
     established in subpart V.
       The Council shall conduct an annual assessment of ACC 
     priorities and progress and make this available to the public 
     in written and electronic forms.
       Section 499B(d): The Director of Cures shall prepare and 
     submit, directly to the President for review and transmittal 
     to Congress, an annual budget estimate for the Center.
       The Director will receive directly all funds appropriated 
     by Congress for obligation and expenditure by the Center.


      Subpart 1--Federally Funded Research and Development Centers

       Section 499C: Federally Funded Research and Development 
     Centers (FFRDC's) will serve as sites for multidisciplinary 
     and cross-scientific research within particular areas of 
     health. The Director may establish one or more FFRDC's to 
     carry out activities related to the mission of the ACC. These 
     Centers will establish, as appropriate, technology test beds 
     and incubators, utilize cooperative agreements with the 
     private sector, and conduct large-scale multi-disciplinary 
     translational research projects in health or disease areas 
     which are essential to medical advancement, but lack adequate 
     private sector funding.
       The FFRDC's shall consult widely with representatives from 
     private industry, institutions of higher education, nonprofit 
     institutions, other federal governmental agencies, and other 
     federally funded research and development centers.
       The Director shall ensure that competitive mechanisms are 
     used to select and to promote the ongoing quality and 
     performance of the FFRDC's.
       Contracts between the ACC and FFRDC's shall be for no 
     longer than 7 years, after which time refunding shall be 
     contingent upon approval by the Director and the Cures 
     Council.
       Each FFRDC shall biannually submit a report on the 
     activities carried out by the Centers under this section to 
     the Director and the appropriate committees of Congress.
       For any fiscal year, the Director may use not more than 25 
     percent of the funds available in the Director's Acceleration 
     Fund for FFRDC's.


          Subpart 2--Health Advanced Research Projects Agency

       Section 499d. Technological and scientific innovations 
     often require strategic risk taking and significant funding 
     streams that are rapid and are outcomes based. Funds must 
     also encourage expert multidisciplinary collaboration. This 
     section establishes at the ACC a Health Advanced Research 
     Projects Agency (HARPA) for these purposes.
       HARPA will be headed by a Director of the Research Projects 
     Agency who will be appointed by the Director of Cures.
       HARPA shall be composed of not more than 100 expert 
     portfolio managers in key health areas, as determined by the 
     Director of HARPA in conjunction with the Director and Cures 
     Council.
       HARPA shall undertake the grand challenges formulated by 
     the Center and encourage innovative, multidisciplinary, and 
     collaborative research between NIH Institutes and Centers, 
     between the NIH and other Federal agencies, and between NIH 
     grantees and business partners.
       Management and organizing principles include an agency 
     which is small, flexible, entrepreneurial, and non-
     hierarchical; which empowers portfolio managers to foster 
     research opportunities free from bureaucratic impediments; 
     which seeks to employ the strongest scientific and technical 
     talent in the Nation; which rotates a significant portion of 
     the staff every 3-5 years, which leverages comparable 
     matching investment from other NIH institutes and centers, 
     federal agencies, and from the private and non profit 
     sectors; which creates a translational research model that 
     supports fundamental research breakthroughs, early and late 
     stage applied development, prototyping, knowledge diffusion, 
     and technology deployment; which establishes metrics to 
     evaluate research success; which ensures that revolutionary 
     research dominates HARPA's agenda and portfolio. Other 
     management and organizing principles are provided.
       HARPA activities will include supporting basic and applied 
     research to promote revolutionary technology changes which 
     address health needs. It will advance the development, 
     testing, evaluation, prototyping and deployment of critical 
     health products. Multiple other activities are provided.
       HARPA will have flexible hiring practices as described in 
     the Strom Thurmond National Defense Authorization Act, 1999.
       HARPA will have the authority to flexibly fund projects, 
     including the prompt awarding, releasing, enhancing and 
     withdrawal of monies.
       HARPA will be funded through the Director's acceleration 
     fund at a minimum of $2.5 billion dollars annually.


                       Subpart 3--Clinical Trials

       Clinical trials are an essential part of the research and 
     development process. This is where the effectiveness and 
     safety of products are scientifically and systematically 
     investigated. However, clinical trials are complex, 
     expensive, and time-consuming, making it difficult for 
     individuals to perform all the functions necessary to 
     successfully organize and implement clinical trials. This 
     subpart improves how clinical trials are conducted and how 
     their results are disseminated. It also promotes the 
     development of a future clinical research workforce.
       Section 499E. Increasing Research Study Participation: The 
     Director of NIH shall create a national electronic clinical 
     trial registry with the National Library of Medicine

[[Page S13582]]

     (NLM) as specified in Subpart 6, Section 499H (b). The ACC 
     shall publicize the registry with special attention given to 
     minority groups, who are frequently underrepresented in 
     clinical trials.
       Section 499E-1. Grants for Quality Clinical Trial and 
     Execution: The Director shall provide grants for clinical 
     trial design and execution to academic centers or to private 
     firms with highly promising therapeutic entities to fund 
     multidisciplinary clinical research teams, whose members may 
     include project managers, clinicians, epidemiologists, and 
     nursing staff.
       Section 499E-2. Streamlining the Regulatory Process 
     Governing Clinical Research: This section streamlines the 
     regulatory process governing clinical research, which has 
     become increasingly unwieldy due to necessary but complex 
     patient privacy and safety rules. The ACC shall establish a 
     series of Centralized Institutional Review Boards (CIRB) to 
     ensure human subject safety and well-being for multi-
     institutional clinical trials. CIRB's shall be established in 
     accordance with professional best practices and Good Clinical 
     Practice (GCP) guidelines.
       A CIRB shall be housed at the Institute or Center with 
     expertise on the subject of the clinical trial or outside of 
     the NIH in a public or private institution with comparable 
     expertise and organizational capacity.
       CIRB's will be available at the request of public or 
     private institutions and funded through user fees or Center 
     funds.
       The CIRB shall act on behalf, in whole or in part, of the 
     bodies ordinarily responsible for the safety of research 
     subjects in a locality, on a contractual basis.
       The CIRB will review and package research applications for 
     facilitated electronic review by local IRB's participating in 
     multi-center clinical trials. Local IRB review can be 
     performed by a subcommittee that is empowered to make 
     decisions in a timely manner. Local IRB's can either accept 
     or reject the CIRB review.
       Local IRB's which are part of the CIRB network shall be 
     responsible for taking into consideration local 
     characteristics such as educational level of research 
     subjects to assure sound selection of research subjects and 
     to minimize risks to vulnerable populations.
       Each CIRB shall regularly communicate important information 
     electronically to the local institutional review boards.
       Section 499E-3. Training Clinical Researchers of the 
     Future: The ACC will augment NIH's investment into programs 
     developing the nation's clinical research workforce. These 
     programs include: the NIH's Mentored Patient-oriented 
     Research Career Development Award, NIH grants to help 
     institutions develop curricula for clinical researchers, and 
     NIH grants to fund participants in clinical science programs, 
     which shall include but not be limited to clinical science 
     certificates or clinical science Masters' Degrees.
       Section 499E-4. Clinical Research Study and Clinical Trial: 
     The Director shall commission the Institute of Medicine (IOM) 
     to study the regulations protecting patient safety and 
     anonymity so that in a contemporary clinical research 
     context, a more realistic balance can be achieved between 
     clinical research promotion and regulatory requirements 
     governing research subject safety and privacy. The IOM will 
     issue a written report within eighteen months of the passage 
     of the Cures act which shall consider changes to the current 
     Health Insurance Portability and Accountability Act (HIPAA) 
     to further promote the clinical research endeavor.
       Section 499E-5. Authorization of Appropriations from the 
     Directors Acceleration Fund. $100 million dollars for 
     Sections 499E-1(1), $50 million dollars for Section 499E-2, 
     $200 million dollars for Section 499E-3, $2.5 million dollars 
     for Section 499E-4.


                       Subpart 4--Valley of Death

       Small businesses are major drivers of innovation. Facile, 
     motivated, numerous, and creative, these small businesses can 
     extend the limits of R&D in a way large companies with secure 
     product lines are unable to do. However, small businesses 
     often encounter difficulty securing capital in the so called, 
     ``Valley of Death''--the period between a research idea with 
     possible application to the time the safety and efficacy of a 
     product is demonstrated in human clinical trials. Common end-
     pathways within the Valley of Death include development of 
     pharmacological assays, scale-up of production from lab-scale 
     to clinical-trials scale, development of suitable 
     formulations, evaluation of chemical stability, evaluation of 
     materials testing for durability or reactivity, undertaking 
     initial toxicology studies, and planning and implementation 
     of clinical trials.
       Section 499F. Small Business Partnerships: The Small 
     Business Innovation Research (SBIR) and Small Business 
     Technology Transfer (STTR) programs are effective major 
     investments in promoting the R&D portfolios of small 
     businesses. SBIR and STTR receive 2.5% and 0.3% of the 
     budgets, respectively, of federal agencies with R&D budgets 
     greater than $100 million dollars. SBIR/STTR grants and 
     contracts consist of three phases. Phase I plans for product 
     development and procurement. Phase II addresses 
     implementation of the plan. Phase III involves 
     commercialization yet by law is ineligible for SBIR/STTR 
     funding. Management and orientation of SBIR/STTR programs at 
     the NIH can be improved.
       This section moves the NIH's SBIR and STTR programs from 
     the Extramural Research Office to the new Office of 
     Bioscientific Enterprise Development (OBED) in the ACC Office 
     of Technology Transfer (OTT).
       The NIH currently awards its SBIR and STTR grants and 
     contracts through a peer review process. Now, not less than 
     35% of SBIR and STTR grants and contracts shall be rewarded 
     on a competitive basis by an OBED program manager with 
     significant managerial, technical, and translational research 
     experience to expertly assess the quality of a SBIR or STTR 
     proposal.
       Program managers will place special emphasis on partnering 
     grantees with potential purchasers or investors of technology 
     from the start of the research and development process with 
     potential purchasers or investors including federal agencies 
     such as the NIH.
       ACC shall reduce the time between Phase I and Phase II 
     funding to 6 months or less. Currently, grantees can wait up 
     to 5 years to learn whether or not they are a recipient of a 
     phase II grant.
       An SBIR/STTR project manager may petition the OTT for Phase 
     III funding from the Director's acceleration fund for 
     projects requiring a supplementary funds to finalize product 
     commercialization. The maximum funding for Phase III funding 
     of a project shall be $2,000,000 for a maximum of 2 years.
       All recipients of SBIR/STTR funding are required to report 
     to the OTT whether there was eventual commercial success of 
     the product. OTT shall keep a publicly accessible electronic 
     record of all SBIR/STTR investments in research and 
     development. The record shall include at minimum the 
     following information: the grantee, a description of the 
     funded research, the amount of money awarded in each phase of 
     SBIR/STTR research, and if applicable, the nature of the 
     products developed.
       For each fiscal year, the two grants program managers who 
     have had the greatest success in helping to commercialize 
     products may be awarded a bonus up to $10,000.
       Section 499F-1. Rapid Access to Intervention Development: 
     The National Cancer Institute of the NIH has a successful 
     translational research program called RAID (Rapid Access to 
     Interventional Development). RAID lends essential expertise 
     and resources including access to laboratories and facilities 
     to researchers outside of the NIH. OTT shall expand upon this 
     program and establish other RAID programs, designed to 
     accelerate the process of bringing promising and novel 
     discoveries from the laboratory to the pre-clinical trial 
     stage.
       RAID awardees have traditionally been selected to receive 
     access to laboratories, facilities and other NIH supports for 
     the pre-clinical development of drugs, biologics, diagnostics 
     and devices, using the peer review process. Now, not less 
     than 35% of RAID awards shall be awarded on a competitive 
     basis by a program manager with significant managerial, 
     technical, and translational research experience to 
     adequately assess the quality of a project proposal.
       Eligible awardees include university researchers, non-
     profit research organizations, and firms of less than 100 
     employees in collaboration with one or more university or 
     non-profit organizations.
       The Office may discontinue support at any point when the 
     entity fails to meet commercialization success criteria 
     established by the Office.
       Examples of RAID support are given. These include advice 
     regarding the investigational new drug or investigational new 
     device filing with the Food and Drug Administration.
       The Office shall not support products past proof-of-
     principle clinical trials.
       Section 499F-2. Toxicity Studies: Toxicity studies are 
     essential to the development of any drug therapy, but are 
     difficult to stage. The Center for Cures shall support 
     ongoing research into the most efficient methods of screening 
     for human toxicity, including using cell-based and animal 
     model technologies.
       OTT may offer support for toxicity studies to private 
     companies licensing NIH intellectual property.
       Section 499F-3. Additional funding sources and models: The 
     Director of the Center for Cures may provide acceleration 
     funds for flexible contracts for translational research 
     development to entities that license intellectual property 
     from NIH where such contracts support innovation and 
     commercialization.
       Section 499F-4. Authorization of Appropriations from the 
     Directors Acceleration Fund. $400 million dollars for 
     Sections 499F for $100 million dollars for 499F-1.


                Subpart 5--Office of Technology Transfer

       The Office of Technology Transfer (OTT) should be one of 
     the NIH's most active entities. It is within the process of 
     technology transfer where basic science research informs 
     applications to health and where ideas are brought from bench 
     to bedside and back to the bench. The OTT should be a library 
     of innovation administered by experts who have experience in 
     linking the translational research community with industry. 
     This subpart improves upon the current research translation 
     authorities of NIH's OTT.
       Section 499G. Restructuring: The NIH Office of Technology 
     Transfer in the NIH Director's Office shall be transferred to 
     a new OTT Office in the American Center for Cures.
       Section 499G-1. Marketing Function: The OTT office shall 
     create a program for transfer management & support that 
     cultivates industry interest in NIH funded research, reaches 
     out to potential industry partners, coordinates patents from 
     different NIH Institutes and Centers, and manages Cooperative 
     Research and Development Agreements (CRADA's), biological 
     licensing agreements,

[[Page S13583]]

     material transfer agreements, and intellectual property 
     licensing.
       To promote government-industry partnerships, the OTT shall 
     create an electronic database within the National Library of 
     Medicine that tabulates translational research efforts 
     occurring at the NIH. The OTT shall hold an annual 
     translational research conference the bring together public 
     and private stakeholders.
       The OTT shall develop a program for transfer management & 
     support which will be familiar with the NIH's intramural and 
     extramural research portfolio as well as with the interests 
     of small and large biotech and pharmaceutical industries. For 
     those Institutes or Centers with their own OTT offices, the 
     new OTT program for transfer management & support will work 
     closely with those offices to coordinate industry outreach 
     efforts.
       As appropriate, OTT shall register CRADA's within a 
     publicly accessible electronic database maintained by NLM.
       Section 499G-2. Office of Intramural Risk Opportunity and 
     Mapping: An Office of Intramural Risk Mapping within OTT 
     shall oversee the intramural research programs of the NIH to 
     be certain they are complementary, non-duplicative, and 
     distinct from extramural and private programs.
       The Office shall identify and map health risks and 
     scientific opportunities and update the data on these topics 
     as necessary to ensure they are current. This information is 
     to be provided to the Cures Council on a biannual basis to 
     help them prioritize the nation's translational research 
     investment.
       The Office shall make funds available to groups of NIH 
     Institutes and Centers to promote multidisciplinary projects 
     that focus on health risk analysis and corresponding 
     scientific risk opportunity. Preference will go to projects 
     that demonstrate a high degree of collaboration and which 
     address diseases with the great burden or research promise, 
     and that are most likely to result in the development of a 
     diagnostic or therapeutic prototype.
       $150 million dollars is authorized to be appropriated from 
     the Director's Acceleration Fund to fund the Office.
       Section 499G-3. Patenting and Licensing Incentives: The OTT 
     shall make every effort to increase licensing to stimulate 
     the availability of products for clinical use. The OTT shall 
     recommend to the Director incentives that create private 
     sector, financial, commercial, and academic interest in the 
     NIH's IP portfolio. These incentives may include extensions 
     of NIH health patents, restoration of NIH health patents, and 
     partnering options to pursue exclusive and nonexclusive 
     licensing to one or multiple partners in the government, 
     industrial, and/or academic sectors.
       The Director shall encourage OTT to develop flexible models 
     for contracts that fulfill the needs of industry and the 
     public.
       Section 499G-4. Translational Researcher Development: The 
     Director shall oversee development of a curriculum for 
     internships in translational research encompassing rotations 
     through multiple NIH Institutes and Centers, the clinical 
     trial design process, the NLM, and other related disciplines 
     with an emphasis on practical experience.
       Tuition grants for extramural translational research 
     programs shall be administered under the supervision of the 
     Director.
       The ACC shall train interdisciplinary scientists in the 
     science of risk analysis & mapping through a program of 
     internships and fellowships.
       Section 499G-6. Translational Research Training Program: 
     The NIH Director shall ensure that each NIH Institute or 
     Center establishes a translational research training program.


               Subpart 6--Developing Information Systems

       The NIH's National Center for Biotechnology Information 
     (NCBI) at the NLM provides essential information resources to 
     scientists worldwide and is the underpinning of much of NIH 
     conducted biomedical research. The NCBI's databases and 
     computational and linkage tools nurture information sharing 
     and are critical to identifying interconnections, developing 
     insights, and accelerating biomedical breakthroughs.
       Section 499H. Advancing National Health Information 
     Infrastructure.
       The NLM shall develop new computational methods to assist 
     in the processing of genomic data. There is authorized to be 
     appropriated $2.5 million dollars to support the 
     computational infrastructure and $5.5 million dollars to hire 
     expert biologists and computer scientists trained in 
     bioinformatics.
       Secretary of Health and Human Services acting through the 
     Director of NIH will work with the NLM to construct a 
     clinical trial registry and clinical results database 
     tracking all phase III clinical trials taking place in the 
     United States. This registry and database will expand upon 
     the NLM's current information system and database.
       The registry of clinical trials shall include at least the 
     following: clinical trial title, description of the product 
     under study, the hypothesis to be tested, brief description 
     of the intervention, the study design, methodology, duration 
     and location, participation criteria, contact information and 
     sponsoring organization.
       The databank of clinical trial results shall consist of at 
     least the following: trial start date and completion date, 
     summary of the results of the trial, summary data tables with 
     respect to the primary and secondary outcome measures, 
     information on the statistical significance of the results, 
     links to publications in peer reviewed journals relating to 
     the trial, a description of the process used to review the 
     results of the trial, and safety data concerning the trial.
       Public or private entities shall register a phase III 
     clinical trial not later than 3 months after submitting the 
     Food and Drug Administration (FDA) approves the clinical 
     trial protocol and report phase III clinical trial results 
     not later than 3 months after completing the trial. 
     Information provided to the NLM must be accurate and updated.
       Penalties for not registering clinical trials or reporting 
     clinical trial results can be loss of future public funding 
     or in cases where an entity does not receive public funding, 
     a fine of up to $2,000,000 dollars.
       The Secretary may waive clinical trial submission 
     requirements upon a written request from the responsible 
     person if the Secretary determines that providing the waiver 
     is in the public's interest or consistent with protection of 
     the public's health.
       Section 499H-1. Publication Requirement for Research: The 
     Director of the NIH shall require that for any research 
     funded by the NIH, Centers for Disease Control and Prevention 
     (CDC), and the Agency for Healthcare Research and Quality 
     (AHRQ), there will be a standardized report of this research 
     for public viewing. Department of Health and Human Services 
     (DHHS) grantees shall provide the NLM an electronic copy of 
     the final version of all peer-reviewed manuscripts accepted 
     for publication for display on their digital library archive, 
     PubMed Central, within 6 months from the date of its 
     publication.
       Failure to submit required information to the NLM within 6 
     months from the date of publication may result in loss of 
     public funding for investigators.
       Section 499H-2. Informatics Training and Workforce 
     Development. 21st Century technologies for analyzing DNA, 
     RNA, proteins, and other biologically important molecules are 
     generating a ``tsunami of data'' which are far beyond the 
     understanding of unaided human cognition, but hold the key to 
     improved understanding of human health and disease. Training 
     of individuals in ``clinical bioinformatics''--translational 
     research that applies computerized analytic methods of 
     molecules, cells, tissues, and body systems to the 
     prevention, diagnosis and treatment of human disease--will be 
     pivotal to fostering this emerging and important data-
     intensive field.
       The NIH shall develop a multi-faceted approach to 
     increasing the number of persons trained in clinical 
     bioinformatics. This shall include but not be limited to 
     augmenting secondary school science programs, undergraduate 
     degree programs in Bioinformatics, NIH bioinformatics 
     graduate training programs, and Centers of Excellence in 
     Clinical Bioinformatics.
       Authorization of Appropriations from the Cures Acceleration 
     Fund is $50 million dollars for this section.
       Section 499H-3. NLM Expansion of Facilities. In 2002, 
     Congress authorized an expansion of the NLM. These facilities 
     may be essential to the NLM's capacity to fill its numerous 
     informatics functions. The Director will commission the IOM 
     to report to Congress on the impact of not funding the 
     expansion of facilities.


                       Subpart 7--Research Tools

       Innovation requires proper tools for discovery. These 
     include animal models that can be surrogates for human 
     systems and markers that illuminate otherwise invisible 
     cells, DNA, proteins and viruses. Arguably, the development 
     of research tools is subject to the same market forces as 
     more common end products--drugs, medical devices, and 
     vaccines.
       Section 499I. NIH Research Tool Inventory: The Director of 
     NIH shall direct the head of each NIH Institute and Center to 
     perform an annual review of its research tool inventory for 
     the specific purpose of enabling each Institute and Center to 
     understand processes for research tool distribution, 
     frequency of use, IP status, and utility. Each NIH Institute 
     and Center shall also describe in its review the type and 
     quantity of research tools it desires to obtain in order to 
     better fulfill its R&D goals.
       The ACC shall enter this inventory into an electronic 
     research tool database and use this database to oversee the 
     prioritization and funding of new projects to fulfill 
     pressing needs and to encourage promising technologies.
       Section 499I-1. Exceptions to Tool Guidelines: The Director 
     of NIH may advise the OTT to provide exceptions to 
     prohibition against patenting and licensing research tools 
     under some appropriate circumstances when exclusive or non-
     exclusive licensing provides the swiftest, and most 
     efficacious final development of an important health care 
     technology.
                                  ____


                                S. 2104

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``American Center for Cures 
     Act of 2005''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents for this Act is as follows:


[[Page S13584]]


Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
Sec. 4. American Center for Cures.

                  ``Part J--American Center for Cures

``Sec. 499A. Definitions.
``Sec. 499B. Establishment of American Center for Cures.


     ``Subpart 1--Federally Funded Research and Development Centers

``Sec. 499C. Federally Funded Research and Development Centers.


             ``Subpart 2--Health Advanced Research Projects

``Sec. 499D. Health Advanced Research Projects Agency.


                      ``Subpart 3--Clinical Trials

``Sec. 499E. Increasing research study participation.
``Sec. 499E-1. Grants for quality clinical trial design and execution.
``Sec. 499E-2. Streamlining the regulatory process governing clinical 
              research.
``Sec. 499E-3. Training clinical researchers of the future.
``Sec. 499E-4. Clinical research study and clinical trial.
``Sec. 499E-5. Authorization of appropriations.


                      ``Subpart 4--Valley of Death

``Sec. 499F. Small business partnerships.
``Sec. 499F-1. Rapid access to intervention development.
``Sec. 499F-2. Toxicity studies.
``Sec. 499F-3. Additional funding sources and models.
``Sec. 499F-4. Authorization of appropriations.


               ``Subpart 5--Office of Technology Transfer

``Sec. 499G. Restructuring.
``Sec. 499G-1. Marketing function.
``Sec. 499G-2. Office of Intramural Risk Opportunity and Mapping.
``Sec. 499G-3. Patenting and licensing incentives.
``Sec. 499G-4. Translational researcher development.
``Sec. 499G-5. Translational research training program.


              ``Subpart 6--Developing Information Systems

``Sec. 499H. Advancing national health information infrastructure.
``Sec. 499H-1. Public access requirement for research.
``Sec. 499H-2. Informatics training and workforce development.
``Sec. 499H-3. National Library of Medicine expansion of facilities.


                      ``Subpart 7--Research Tools

``Sec. 499I. NIH research tool inventory.
``Sec. 499I-1. Exceptions to tool guidelines.

     SEC. 3. FINDINGS.

       Congress finds the following:
       (1) The National Institutes of Health (referred to in this 
     section as the ``NIH'') is the United States premier 
     biomedical research investment with annual appropriations 
     exceeding $28,000,000,000.
       (2) The mission of the NIH is science in pursuit of 
     fundamental knowledge about the nature and behavior of living 
     systems and the application of that knowledge to extend 
     healthy life and reduce the burdens of illness and 
     disability.
       (3) The pace of knowledge application to promote health and 
     reduce disease can be influenced through strategic funding 
     and reorganization of some aspects of the traditional 
     research endeavor. This process is known as translational 
     research investment.
       (4) The United States translational research investment 
     will be key to the Nation responding effectively--
       (A) to acute man-made or natural health threats;
       (B) to the complexity and multi-disciplinary nature of 
     chronic diseases, which are responsible for 7 out of every 10 
     deaths in the United States and for more than 70 percent of 
     the $1,700,000,000,000 spent in the United States on health 
     care each year; and
       (C) to research and development vacuums in the private for-
     profit market, such as in the fields of vaccine and 
     antibiotic production, drugs for Third World diseases, and 
     medical tools for pediatric populations.
       (5) Key components of the translational research process 
     include research prioritization, an expert workforce, multi-
     disciplinary collaborative work, facilitated information 
     exchange, strategic risk taking, support of small innovative 
     businesses caught along common pathways in the research and 
     development Valley of Death, simplification and promotion of 
     the clinical research endeavor, and involvement of private 
     entities early on in the translational research endeavor that 
     are skilled in the manufacturing and marketing process.

     SEC. 4. AMERICAN CENTER FOR CURES.

       (a) American Center for Cures.--Title IV of the Public 
     Health Service Act (42 U.S.C. 281 et seq.) is amended by 
     adding at the end the following:

                  ``PART J--AMERICAN CENTER FOR CURES

     ``SEC. 499A. DEFINITIONS.

       ``In this part:
       ``(1) Center.--The term `Center' means the American Center 
     for Cures established under section 499B.
       ``(2) Council.--The term `Council' means the Cures Council 
     established under section 499B.
       ``(3) Director.--The term `Director' means the Director of 
     the American Center for Cures.
       ``(4) Incubator.--The term `incubator' means an economic 
     development organization designed to accelerate the growth 
     and success of entrepreneurial individuals, concepts, and 
     companies.
       ``(5) Research tool.--The term `research tool' means a 
     resource that scientists use in their laboratories that has 
     no immediate therapeutic or diagnostic value, including cell 
     lines, monoclonal antibodies, reagents, laboratory equipment 
     and machines, databases, and computer software.
       ``(6) Test bed.--The term `test bed' means the pilot 
     environment to prototype innovation.
       ``(7) Translational research.--The term `translational 
     research' means investigation in which knowledge obtained 
     from fundamental research such as with genes, cells, or 
     animals, is transformed through early and late stage 
     development prototyping and testing into diagnostic or 
     therapeutic interventions that can be applied to the 
     treatment or prevention of disease or frailty.

     ``SEC. 499B. ESTABLISHMENT OF AMERICAN CENTER FOR CURES.

       ``(a) In General.--There is established within the National 
     Institutes of Health an American Center for Cures--
       ``(1) whose mission shall be to increase the capacity of 
     the National Institutes of Health to promote translational 
     research, including between the institutes and centers of the 
     National Institutes of Health, between the National 
     Institutes of Health and other Federal agencies, and between 
     grantees and business partners of the National Institutes of 
     Health, so as to speed the development of effective 
     therapies, diagnostics, and cures essential to human health 
     and well being;
       ``(2) that shall formulate and implement a strategy for the 
     Nation's translational research investment, which strategy 
     shall include--
       ``(A) a prioritization of biomedical research on diseases 
     based on disease burden and research promise; and
       ``(B) funding for innovative, multidisciplinary, and 
     collaborative research across the institutes and centers of 
     the National Institutes of Health, across Federal agencies, 
     and between public and private partners of the National 
     Institutes of Health;
       ``(3) that shall be guided, in part, by a series of `Grand 
     Challenges' formulated through collaboration between the 
     Director of Cures and the Council, that shall be strategic 
     challenges that direct the public and private health research 
     community towards collaborative multi-staged projects that 
     have the potential to transform the healthcare environment, 
     such as--
       ``(A) the creation of laboratory diagnostics that enable 
     the Nation to detect quickly and accurately acute health 
     threats such as an avian flu pandemic or a bioterrorism 
     attack;
       ``(B) a focus on therapeutic delivery systems targeting 
     individual viruses or hard to reach cells in the body, such 
     as the brain, using advances in nanotechnology;
       ``(C) accelerated research into the potential of stem cells 
     to replace the form and function of tissues lost to patients 
     suffering from diseases such as spinal cord injury, 
     Parkinson's disease, and insulin-dependent diabetes;
       ``(D) creation of a biomedical informatics infrastructure 
     that can organize the human genome and the proteins for which 
     the genome codes in ways that scientists can better 
     understand the genetic contribution to phenotypic disease;
       ``(E) the elaboration of adjuvant technology that can 
     bolster the effectiveness of vaccines;
       ``(F) development of antigen sparing vaccines such as those 
     based on triggering the innate immune response;
       ``(G) development of rapid vaccine manufacturing capacity 
     from new production methods such as viral cell culture or 
     bioengineering technology;
       ``(H) creation of a fast track clinical trial 
     infrastructure that incorporates a national doctor and 
     patient registry, centralized investigational review boards, 
     electronic medical records, and other health information 
     technologies;
       ``(I) a focus on addressing less profitable conditions for 
     which research and development efforts are insufficient, such 
     as--
       ``(i) orphan, small population, and third world diseases;
       ``(ii) antibiotic resistance;
       ``(iii) a threat of a flu epidemic or pandemic;
       ``(iv) diseases associated with social stigma such as 
     depression and seizure disorders; or
       ``(v) other comparable problems;
       ``(J) a commitment by researchers and manufacturers from 
     all sectors to develop vaccines for the world's most deadly 
     infectious diseases, including HIV, tuberculosis, and 
     malaria; and
       ``(K) other appropriate challenges; and
       ``(4) that shall have other appropriate purposes.
       ``(b) Director of the Center and the Director of NIH.--
       ``(1) In general.--The Center shall be administered by a 
     Director of Cures who shall be appointed by the President 
     with the advice and consent of the Senate. The Director of 
     the NIH, in consultation with the Council, shall recommend 
     candidates for the Director of Cures to the President.
       ``(2) Activities.--
       ``(A) Director of nih.--The Director of NIH shall--
       ``(i) work with the Director of Cures to promote 
     translational research efforts; and
       ``(ii) serve as a co-chair of the Council.

[[Page S13585]]

       ``(B) Director of cures.--
       ``(i) Acceleration fund.--

       ``(I) In general.--The Director of Cures shall have at the 
     Director's disposal an annual acceleration fund to provide 
     support for research and development of breakthrough 
     biomedical discoveries and to carry out the purpose of the 
     Center. Amounts in the fund may be available through grants, 
     contracts, and cooperative agreements to public sector 
     entities, private sector entities, and non-governmental 
     organizations. The Director of Cures shall allocate not less 
     than \1/2\ of the acceleration funds to the Health Advanced 
     Research Projects Agency described in subpart 2. The 
     remainder of such funds shall be available to the Federally 
     Funded Research and Development Centers described in subpart 
     1 and other activities of the Center.
       ``(II) Authorization of appropriations.--There are 
     authorized to be appropriated to fund the acceleration fund 
     under subclause (I) $5,000,000,000 for fiscal year 2007 and 
     each succeeding fiscal year.

       ``(ii) Direct other offices.--The Director of Cures shall 
     direct other offices within the Center that are established 
     under this part.
       ``(c) Council.--
       ``(1) Establishment.--There is established within the 
     Center a Cures Council that shall convene not less frequently 
     than twice a year to help advise and direct the translational 
     research efforts of the Center.
       ``(2) Membership.--
       ``(A) In general.--The Council shall be composed of the 
     following members:
       ``(i) The Director of NIH and the Director of Cures who 
     shall be Council co-chairs.
       ``(ii) The heads of the institutes and centers of the 
     National Institutes of Health.
       ``(iii) Heads from not less than 9 Federal agencies, 
     including--

       ``(I) the Administrator for the Substance Abuse and Mental 
     Health Services Administration;
       ``(II) the Under Secretary for Science and Technology of 
     the Department of Homeland Security;
       ``(III) the Commanding General for the United States Army 
     Medical Research and Materiel Command;
       ``(IV) the Director of the Centers for Disease Control and 
     Prevention;
       ``(V) the Commissioner of Food and Drugs;
       ``(VI) the Director of the Office of Science of the 
     Department of Energy;
       ``(VII) the President of the Institute of Medicine;
       ``(VIII) the Director of the Agency for Healthcare Research 
     and Quality; and
       ``(IX) the Director of the Defense Advanced Research 
     Projects Agency.

       ``(B) Other members.--Membership of the Council shall also 
     include not fewer than 3 leaders from the small business 
     community, 3 leaders from large pharmaceutical or 
     biotechnology companies, and 3 leaders from academia, all of 
     whom shall be appointed by the President.
       ``(3) Subcommittees.--The Council or the Council co-chairs 
     may form subcommittees of the Council as needed.
       ``(4) Recommendations; coordination.--The Council shall 
     make recommendations that help the Director of Cures set 
     research priorities for the Center. In making 
     recommendations, the Council shall consider risk and burden 
     of disease as well as lines of research uniquely poised to 
     deliver effective diagnostics and therapies. The Council 
     shall also coordinate research priorities in, and ensure 
     sharing of research agendas among, the institutes and centers 
     of the National Institutes of Health.
       ``(5) Office of intramural risk opportunity and mapping.--
     The Council shall be aided by the Office of Intramural Risk 
     Opportunity and Mapping of the Office of Technology Transfer 
     of the Center established in subpart 5.
       ``(6) Annual assessment.--The Council shall make an annual 
     assessment of the priorities and progress of the Center and 
     shall make the assessment available to the public in written 
     and electronic form.
       ``(d) Budget and Funds.--The Director of Cures shall--
       ``(1) prepare and submit, directly to the President for 
     review and transmittal to Congress, an annual budget estimate 
     for the Center, after reasonable opportunity for comment (but 
     without change) by the Secretary, the Director of NIH, and 
     the Council; and
       ``(2) receive from the President and the Office of 
     Management and Budget directly all funds appropriated by 
     Congress for obligation and expenditure by the Center.

     ``Subpart 1--Federally Funded Research and Development Centers

     ``SEC. 499C. FEDERALLY FUNDED RESEARCH AND DEVELOPMENT 
                   CENTERS.

       ``(a) In General.--The Director of Cures is authorized to 
     establish 1 or more Federally Funded Research and Development 
     Centers that shall carry out activities related to the 
     mission of the Center, as described in section 499B(a)(1).
       ``(b) Duties.--
       ``(1) In general.--The Federally Funded Research and 
     Development Centers shall serve as sites for the performance 
     of multidisciplinary and cross-disciplinary research and 
     shall--
       ``(A) establish, as appropriate, technology test beds and 
     incubators;
       ``(B) utilize cooperative agreements with the private 
     sector; and
       ``(C) conduct large-scale multidisciplinary translational 
     research projects in health or disease areas that are 
     essential to medical advancement but lack adequate private 
     sector funding.
       ``(2) Consultation.--In carrying out the duties described 
     in paragraph (1), the Federally Funded Research and 
     Development Centers shall consult widely with representatives 
     from private industry, institutions of higher education, 
     nonprofit institutions, other Federal governmental agencies, 
     and other federally funded research and development centers.
       ``(c) Competition.--The Director of Cures shall ensure that 
     competitive mechanisms are used to select and to promote the 
     ongoing quality and performance of the Federally Funded 
     Research and Development Centers.
       ``(d) Term of Funding.--Federally Funded Research and 
     Development Centers shall be funded for not more than 7 
     years, after which time the Federally Funded Research and 
     Development Centers' re-funding shall be contingent upon 
     approval by the Director of Cures and the Council.
       ``(e) Reports.--Each Federally Funded Research and 
     Development Center receiving funding under this section shall 
     submit a biannual report to the Director and the appropriate 
     committees of Congress on the activities carried out by the 
     Federally Funded Research and Development Center under this 
     section.
       ``(f) Funding for Support.--For any fiscal year, the 
     Director of Cures may use not more than 25 percent of the 
     funds available to the Director under the acceleration fund 
     under section 499B(b)(2)(B)(i)(II) to establish Federally 
     Funded Research and Development Centers under this section.

             ``Subpart 2--Health Advanced Research Projects

     ``SEC. 499D. HEALTH ADVANCED RESEARCH PROJECTS AGENCY.

       ``(a) Establishment.--There is established within the 
     Center a Health Advanced Research Projects Agency (referred 
     to in this section as the `Research Projects Agency') that 
     shall--
       ``(1) carry out activities related to the mission of the 
     Center, as described in section 499B(a)(1); and
       ``(2) be headed by a Director of the Research Projects 
     Agency who is appointed by the Director of Cures.
       ``(b) Composition.--The Research Projects Agency shall be 
     composed of not more than 100 portfolio managers in key 
     health areas, which areas are determined by the Director of 
     the Research Projects Agency in conjunction with the Director 
     of Cures and the Council.
       ``(c) Guidance.--The Research Projects Agency shall be 
     guided by and shall undertake grand challenges formulated by 
     the Center that encourage innovative, multi-disciplinary, and 
     collaborative research across institutes and centers of the 
     National Institutes of Health, across Federal agencies, and 
     between public and private partners of the National 
     Institutes of Health.
       ``(d) Management Guidance.--The Research Projects Agency 
     shall be guided by the following management and organizing 
     principles in directing the Research Projects Agency:
       ``(1) Keep the Research Projects Agency small, flexible, 
     entrepreneurial, and non-hierarchical, and empower portfolio 
     managers with substantial autonomy to foster research 
     opportunities with freedom from bureaucratic impediments in 
     administering the manager's portfolios.
       ``(2) Seek to employ the strongest scientific and technical 
     talent in the Nation in research fields in which the Research 
     Projects Agency is working.
       ``(3) Rotate a significant portion of the staff after 3 to 
     5 years of experience to ensure continuous entry of new 
     talent into the Research Projects Agency.
       ``(4) Use whenever possible research and development 
     investments by the Research Projects Agency to leverage 
     comparable matching investment and coordinated research from 
     other institutes and centers of the National Institutes of 
     Health, from other Federal agencies, and from the private and 
     non-profit research sectors.
       ``(5) Utilize supporting technical, contracting, and 
     administrative personnel from other institutes and centers of 
     the National Institutes of Health in administering and 
     implementing research effort to encourage participation, 
     collaboration, and cross-fertilization of ideas across the 
     National Institutes of Health.
       ``(6) Utilize a challenge model in Research Projects Agency 
     research efforts, creating a translational research model 
     that supports fundamental research breakthroughs, early and 
     late stage applied development, prototyping, knowledge 
     diffusion, and technology deployment.
       ``(7) Establish metrics to evaluate research success and 
     periodically revisit ongoing research efforts to carefully 
     weigh new research opportunities against ongoing research.
       ``(8) Tolerate risk-taking in research pursuits.
       ``(9) Ensure that revolutionary and breakthrough technology 
     research dominates the Research Projects Agency's research 
     agenda and portfolio.
       ``(e) Activities.--Using the funds and authorities provided 
     to the Director of Cures, and the authorities provided to the 
     Director of NIH, the Research Projects Agency shall carry out 
     the following activities:
       ``(1) The Research Projects Agency shall support basic and 
     applied health research to promote revolutionary technology 
     changes that promote health needs.

[[Page S13586]]

       ``(2) The Research Projects Agency shall advance the 
     development, testing, evaluation, prototyping, and deployment 
     of critical health products.
       ``(3) The Research Projects Agency, consistent with 
     recommendations of the Council, with the priorities of the 
     Director of Cures, and with the need to discuss challenges 
     described in section 499B(a)(3), shall emphasize--
       ``(A) translational research efforts, including efforts 
     conducted through collaboration with the private sector, that 
     pursue--
       ``(i) innovative health products that could significantly 
     and promptly address acute health threats such as a flu 
     pandemic, spread of antibiotic resistant hospital acquired 
     infections, or other comparable problems;
       ``(ii) remedies for diseases afflicting lesser developed 
     countries;
       ``(iii) remedies for orphan and small population diseases;
       ``(iv) alternative technologies with significant health 
     promise that are not well-supported in the system of health 
     research, such as adjuvant technology or technologies for 
     vaccines based on the innate immunological response; and
       ``(v) fast track development, including development through 
     accelerated completion of animal and human clinical trials, 
     for emerging remedies for significant public health problems; 
     and
       ``(B) other appropriate translational research efforts for 
     critical health issues.
       ``(4) The Research Projects Agency shall utilize funds to 
     provide support to outstanding research performers in all 
     sectors and encourage cross-disciplinary research 
     collaborations that will allow scientists from fields such as 
     information and computer sciences, nanotechnology, chemistry, 
     physics, and engineering to work alongside top researchers 
     with more traditional biomedical backgrounds.
       ``(5) The Research Projects Agency shall provide selected 
     research projects with single-year or multi-year funding and 
     require researchers for such projects to provide interim 
     progress reports to the Research Projects Agency on not less 
     frequently than a biannual basis.
       ``(6) The Research Projects Agency shall award competitive, 
     merit-reviewed grants, cooperative agreements, or contracts 
     to public or private entities, including businesses, 
     federally-funded research and development centers, and 
     universities.
       ``(7) The Research Projects Agency shall provide advice to 
     the Director of Cures concerning funding priorities.
       ``(8) The Research Projects Agency may solicit proposals 
     for competitions to address specific health vulnerabilities 
     identified by the Director and award prizes for successful 
     outcomes.
       ``(9) The Research Projects Agency shall periodically hold 
     health research and technology demonstrations to improve 
     contact among researchers, technology developers, vendors, 
     and acquisition personnel.
       ``(10) The Research Projects Agency shall carry out other 
     activities determined appropriate by the Director of Cures.
       ``(f) Employees.--
       ``(1) Hiring.--The Research Projects Agency, in hiring 
     employees for positions with the Research Projects Agency, 
     shall have the same hiring and management authorities as 
     described in section 1101 of the Strom Thurmond National 
     Defense Authorization Act for Fiscal Year 1999 (5 U.S.C. 3104 
     note).
       ``(2) Term.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the term of such appointments for employees of the Research 
     Projects Agency may not exceed 5 years.
       ``(B) Extension.--The Director of the Research Projects 
     Agency may, in the case of a particular employee of the 
     Research Projects Agency, extend the term to which employment 
     is limited under subparagraph (A) by up to 2 years if the 
     Director of the Research Projects Agency determines that such 
     action is necessary to promote the efficiency of the Research 
     Projects Agency.
       ``(g) Flexibility.--The Research Projects Agency shall have 
     the authority to flexibly fund projects, including the prompt 
     awarding, releasing, enhancing, or withdrawal of monies in 
     accordance with the assessment of the Research Projects 
     Agency and project manager.
       ``(h) Funding.--The Research Projects Agency shall utilize 
     funds received from the acceleration fund, described in 
     section 499B(b)(2)(B)(i), for the Agency's research and 
     development activities. There is authorized to be 
     appropriated from such fund $2,500,000,000 to carry out the 
     activities of the Research Projects Agency.

                      ``Subpart 3--Clinical Trials

     ``SEC. 499E. INCREASING RESEARCH STUDY PARTICIPATION.

       ``The Director of NIH shall establish a national clinical 
     study registry within the National Library of Medicine of the 
     National Institutes of Health in accordance with section 
     499H. The Center shall publicize the registry, with attention 
     given to minority groups that are frequently underrepresented 
     in clinical trials.

     ``SEC. 499E-1. GRANTS FOR QUALITY CLINICAL TRIAL DESIGN AND 
                   EXECUTION.

       ``The Director of Cures--
       ``(1) shall award grants for clinical trial design and 
     execution to academic centers to fund multi-disciplinary 
     clinical research teams, which clinical research teams may be 
     composed of members who include project managers, clinicians, 
     epidemiologists, social scientists, and nursing staff; and
       ``(2) may award grants for clinical trial design and 
     execution to researchers from small firms with highly 
     promising novel therapeutic entities.

     ``SEC. 499E-2. STREAMLINING THE REGULATORY PROCESS GOVERNING 
                   CLINICAL RESEARCH.

       ``(a) Establishment of Centralized Institutional Review 
     Boards.--
       ``(1) In general.--The Director of Cures shall establish a 
     series of Centralized institutional Review Boards (referred 
     to in this section as `CIRBs') to serve as human subject 
     safety and well being custodians for multi-institutional 
     clinical trials that are funded partially or in full by 
     public research dollars.
       ``(2) Existing guidelines and best practices.--CIRBs shall 
     be established in accordance with professional best practices 
     and Good Clinical Practice (GCP) guidelines so that 
     institutions involved in multi-institutional studies may--
       ``(A) use joint review;
       ``(B) rely upon the review of another qualified 
     institutional review board; or
       ``(C) use similar arrangements aimed to avoid duplication 
     of effort and to assure a high quality of expert oversight.
       ``(b) Housed.--Each CIRB shall be housed--
       ``(1) at the institute or center of the National Institutes 
     of Health with expertise on the subject of the clinical 
     trial; or
       ``(2) at a public or private institution with comparable 
     organizational capacity, such as the Department of Veterans 
     Affairs.
       ``(c) Service.--The use of CIRBs shall be available, as 
     appropriate, at the request of public or private institutions 
     and shall be funded through user fees of the CIRBs or the 
     Center's funds.
       ``(d) Review Process.--
       ``(1) In general.--Each CIRB shall review research 
     protocols and informed consent to ensure the protection and 
     safety of research participants enrolled in multi-
     institutional clinical trials.
       ``(2) Process.--The CIRB review process shall consist of 
     contractual agreements between the CIRB and the study sites 
     of multi-institutional clinical trials. The CIRB shall act on 
     behalf, in whole or in part, of the bodies ordinarily 
     responsible for the safety of research subjects in a 
     locality. In the case in which a locality does not have such 
     a body, the locality shall depend solely on the CIRB to 
     oversee the protection of human subjects and the CIRB shall 
     assume responsibility for ensuring adequate assessment of the 
     local research context.
       ``(e) Research Applications.--
       ``(1) In general.--Each CIRB shall review and package 
     research applications for facilitated electronic review by 
     local institutional review boards participating in a multi-
     institutional clinical trial.
       ``(2) Local review.--Local institutional review board 
     review may be performed by a subcommittee of the local 
     institutional review board that is empowered to make 
     decisions in a timely manner.
       ``(3) CIRB review.--A local institutional review board may 
     accept or reject a CIRB review. In the case in which a local 
     institutional review board accepts a CIRB review, the CIRB 
     shall assume responsibility for annual, amendment, and 
     adverse event reviews.
       ``(f) Work in Concert.--In the case in which a local 
     institutional review board works in concert with a CIRB, the 
     local institutional review board shall be responsible for 
     taking into consideration local characteristics (including 
     ethnicity, educational level, and other demographic 
     characteristics) of the population from which research 
     subjects will be drawn, which influence, among other things, 
     whether there is sound selection of research subjects or 
     whether adequate provision is made to minimize risks to 
     vulnerable populations.
       ``(g) Communication of Important Information.--Each CIRB 
     shall regularly communicate important information in 
     electronic form to the local institutional review boards or, 
     in cases where a local institutional review board does not 
     exist, to the principal investigator, including regular 
     safety updates or changes in research protocol to improve 
     safety.
       ``(h) Coordination.--Each CIRB shall fully coordinate with 
     the institute or center of the National Institutes of Health 
     that has specialized knowledge of the research area of the 
     clinical trial. Other Federal agencies and private entities 
     undertaking clinical trials may contract with the Center to 
     use a CIRB.

     ``SEC. 499E-3. TRAINING CLINICAL RESEARCHERS OF THE FUTURE.

       ``The Center shall augment the National Institutes of 
     Health's investment into programs dedicated to developing the 
     clinical research workforce for tomorrow. The programs shall 
     include:
       ``(1) The National Institutes of Health's Mentored Patient-
     Oriented Research Career Development Award to support the 
     career development of investigators who have made a 
     commitment to focus their research endeavors on patient-
     oriented research.
       ``(2) The National Institutes of Health's award to 
     encourage mentorship among particularly talented early- and 
     mid-career investigators doing clinical research who want to 
     train new investigators.
       ``(3) The National Institutes of Health grants to help 
     institutions develop curricula for clinical researchers 
     leading to a clinical science certificate or master's degree.
       ``(4) The National Institutes of Health grants to fund 
     participants in clinical science programs, including clinical 
     science certificates or clinical science masters' degrees.

[[Page S13587]]

     ``SEC. 499E-4. CLINICAL RESEARCH STUDY AND CLINICAL TRIAL.

       ``The Director of NIH shall--
       ``(1) commission the Institute of Medicine of the National 
     Academies to study the rules that protect patient safety and 
     anonymity so that in a contemporary clinical research 
     context, a better balance can be achieved between clinical 
     research promotion and regulatory requirement governing 
     research subject safety and privacy; and
       ``(2) request that the Institute of Medicine issue a 
     written report not later than 18 months after the date of 
     enactment of this part that shall--
       ``(A) consider changes to the Health Insurance Portability 
     and Accountability Act of 1996 (Public Law 104-191) and the 
     amendments made by such Act that further promote the clinical 
     research endeavor; and
       ``(B) include recommendations for changes that shall not be 
     limited to legislation but shall include changes to health 
     care systems and to researcher practice that facilitate the 
     clinical research endeavor.

     ``SEC. 499E-5. AUTHORIZATION OF APPROPRIATIONS.

       ``There are authorized to be appropriated from the 
     acceleration fund of the Director of Cures described in 
     section 499B(b)(2)(B)(i)--
       ``(1) $100,000,000 to carry out section 499E-1(1) for 
     fiscal year 2007 and each succeeding fiscal year;
       ``(2) $50,000,000 to carry out section 499E-2 for fiscal 
     year 2007 and each succeeding fiscal year;
       ``(3) $200,000,000 to carry out section 499E-3 for fiscal 
     year 2007 and each succeeding fiscal year; and
       ``(4) $2,500,000 to carry out section 499E-4.

                      ``Subpart 4--Valley of Death

     ``SEC. 499F. SMALL BUSINESS PARTNERSHIPS.

       ``(a) Establishment of the Office of Bioscientific 
     Enterprise Development.--
       ``(1) Establishment.--There is established within the 
     Office of Technology Transfer of the Center (as established 
     in subpart 5) an Office of Bioscientific Enterprise 
     Development (referred to in the subpart as the `OBED').
       ``(2) Transfers.--
       ``(A) In general.--The OBED shall include the functions 
     (including related personnel and resources) of the following 
     programs of the Office of Extramural Research in the Office 
     of the Director of the National Institutes of Health:
       ``(i) The Small Business Innovation Research program 
     (referred to in this subpart as the `SBIR').
       ``(ii) The Small Business Technology Transfer program 
     (referred to in this subpart as the `STTR').
       ``(B) Time for transfers.--The Secretary shall ensure that 
     the programs described in subparagraph (A) are transferred to 
     the OBED not later than 6 months after the date of enactment 
     of this part.
       ``(b) SBIR and STTR Grants and Contracts.--
       ``(1) In general.--Not less than 35 percent of the grants 
     and contracts awarded by the SBIR and STTR shall be awarded 
     on a competitive basis by an OBED program manager with 
     sufficient managerial, technical, and translational research 
     expertise to expertly assess the quality of a SBIR or STTR 
     proposal. The OBED, through such project manager, shall place 
     special emphasis on SBIR and STTR grant and contract 
     applications that identify from the onset products with 
     commercial potential that influence human health.
       ``(2) Potential purchasers or investors.--The OBED shall 
     administer non-peer reviewed grants and contracts under this 
     subsection through program managers who shall place special 
     emphasis on partnering grantees and entities awarded 
     contracts from the very beginning of the research and 
     development process with potential purchasers or investors of 
     the products, including large pharmaceutical or biotechnology 
     companies, venture capital firms, and Federal agencies 
     (including the National Institutes of Health).
       ``(3) Phase i and ii.--The OBED shall reduce the time 
     period between Phase I and Phase II funding of grants and 
     contracts under the SBIR and STTR to--
       ``(A) 6 months; or
       ``(B) less than 6 months if the grantee or entity awarded a 
     contract demonstrates that the grantee or entity awarded a 
     contract has interest from third parties to buy or fund the 
     product developed with the grant or contract.
       ``(4) Phase iii.--
       ``(A) Funding.--A program manager under this subsection may 
     petition the Director of Cures for Phase III funding of the 
     grant or contract for a project that requires a boost to 
     finalize procurement of a product. The maximum funding for 
     Phase III funding of a project shall be $2,000,000 for a 
     maximum of 2 years. Such Phase III funding shall come from 
     the acceleration fund, as described in section 
     499B(b)(2)(B)(i), of the Director of Cures.
       ``(B) Report success.--Each recipient of a SBIR or STTR 
     grant or contract, as a condition of receiving such grant or 
     contract, shall report to the OBED whether there was eventual 
     commercial success of the product developed with the 
     assistance of the grant or contract.
       ``(5) Record.--
       ``(A) In general.--The OBED shall keep a publicly 
     accessible electronic record of all SBIR or STTR investments 
     in research and development.
       ``(B) Contents.--The record described in subparagraph (A) 
     shall include, at minimum, the following information:
       ``(i) The grantee or entity awarded a contract.
       ``(ii) A description of the research being funded.
       ``(iii) The amount of money awarded in each phase of SBIR 
     or STTR funding.
       ``(iv) If applicable, the purchaser of the product, current 
     use of the product, and estimated annual revenue resulting 
     from the procurement.
       ``(6) Bonus.--For each fiscal year, for the non-peer 
     reviewed SBIR and STTR grants or contracts, the 2 program 
     managers who are most successful in terms of the number of 
     grantees or entities awarded a contract who complete Phase 
     III shall each be awarded a $10,000 bonus.

     ``SEC. 499F-1. RAPID ACCESS TO INTERVENTION DEVELOPMENT.

       ``(a) Establishment of Office.--The Office of Technology 
     Transfer of the Center shall establish an Office of Rapid 
     Access to Intervention Development (referred to in this 
     subpart as the `RAID') that--
       ``(1) is designed to assist translating promising, novel, 
     and scientifically meritorious therapeutic interventions to 
     clinical use by providing support to help investigators 
     navigate the product development pipeline;
       ``(2) shall aim to remove barriers between laboratory 
     discoveries and clinical trials of new molecular therapies, 
     technologies, and other clinical interventions;
       ``(3) shall aim to progress, augment, and complement the 
     innovation and research conducted in private entities to 
     reduce duplicative and redundant work using public funds; and
       ``(4) shall coordinate with the offices of the National 
     Institutes of Health that promote translational research in 
     the pre-clinical phase across the National Institutes of 
     Health.
       ``(b) Projects.--
       ``(1) In general.--The RAID, in collaboration with the 
     Director of Cures, shall carry out a program that shall 
     select, in accordance with paragraph (2), projects of 
     eligible entities that shall receive access to laboratories, 
     facilities, and other support resources of the National 
     Institutes of Health for the pre-clinical development of 
     drugs, biologics, diagnostics, and devices.
       ``(2) Selection.--Not less than 35 percent of the projects 
     selected under paragraph (1) shall be selected on a 
     competitive basis by a program manager with sufficient 
     managerial, technical, and translational research expertise 
     to adequately assess the quality of a project proposal. 
     Projects under paragraph (1) may also be selected from a peer 
     review process.
       ``(3) Eligible entities.--In this subsection, the term 
     `eligible entity' means--
       ``(A) a university researcher;
       ``(B) a nonprofit research organization; or
       ``(C) a firm of less than 100 employees in collaboration 
     with 1 or more universities or nonprofit organizations.
       ``(4) Discontinue support.--The RAID may discontinue 
     support of a project if the project fails to meet 
     commercialization success criteria established by the RAID.
       ``(c) Discoveries From Lab to Clinic.--The program under 
     subsection (b) shall accelerate the process of bringing 
     discoveries from the laboratory to the clinic through--
       ``(1) the development of pharmacological assays;
       ``(2) the scale-up of production from lab scale to 
     clinical-trials scale;
       ``(3) the development of suitable formulations;
       ``(4) the evaluation of chemical stability;
       ``(5) the evaluation of materials testing for durability or 
     reactivity;
       ``(6) undertaking initial toxicology studies;
       ``(7) planning clinical trials; and
       ``(8) advice regarding the investigational new drug or 
     investigational new device filing with the Food and Drug 
     Administration.
       ``(d) Ongoing Review.--The RAID shall review, on an ongoing 
     basis, potential products and may not support products past 
     the proof-of-principle stage.

     ``SEC. 499F-2. TOXICITY STUDIES.

       ``(a) Ongoing Research.--The Center shall support ongoing 
     research into the most efficient methods of screening for in 
     vivo toxicity, including using cell-based and animal model 
     technologies.
       ``(b) Offer of Studies.--The Director of Cures shall direct 
     the Office of Technology Transfer of the Center to offer 
     toxicity studies as an available feature to precede 
     completion of licensing agreement contracts because toxicity 
     studies are expensive and rate-limiting barriers to the 
     licensing of intellectual property from the National 
     Institutes of Health.

     ``SEC. 499F-3. ADDITIONAL FUNDING SOURCES AND MODELS.

       ``The Director of Cures may provide acceleration funds, 
     described in section 499B(b)(2)(B)(i), for innovative custom 
     contracts for translational research development to entities 
     that license intellectual property from the National 
     Institutes of Health where such contracts support innovation 
     and new models of cooperation and commercialization.

     ``SEC. 499F-4. AUTHORIZATION OF APPROPRIATIONS.

       ``There are authorized to be appropriated from the 
     acceleration fund of the Director of Cures described in 
     section 499B(b)(2)(B)(i)--
       ``(1) $400,000,000 to carry out section 499F for fiscal 
     year 2007 and each succeeding fiscal year; and

[[Page S13588]]

       ``(2) $100,000,000 to carry out section 499F-1 for fiscal 
     year 2007 and each succeeding fiscal year.

               ``Subpart 5--Office of Technology Transfer

     ``SEC. 499G. RESTRUCTURING.

       ``(a) Establishment.--There is established within the 
     Center an Office of Technology Transfer (referred to in this 
     subpart as the `OTT').
       ``(b) Transfers.--The OTT shall include the functions (and 
     related personnel and resources) of the Office of Technology 
     Transfer in the Office of the Director of the National 
     Institutes of Health.

     ``SEC. 499G-1. MARKETING FUNCTION.

       ``(a) In General.--The OTT shall establish a program that--
       ``(1) cultivates industry interest in funded research of 
     the National Institutes of Health;
       ``(2) reaches out to potential industry partners;
       ``(3) coordinates patents from the other institutes and 
     centers of the National Institutes of Health; and
       ``(4) manages Cooperative Research and Development 
     Agreements, biological licensing agreements, material 
     transfer agreements, and intellectual property licensing.
       ``(b) Promotion.--The program under subsection (a) shall 
     assist in promoting the success of government and industry 
     partnerships for the development of new technologies by 
     soliciting involvement of the private sector from the 
     beginning of the translational research process, including by 
     creating an electronic database within the National Library 
     of Medicine, which shall be updated regularly, that tabulates 
     translational research efforts occurring at the National 
     Institutes of Health. The OTT shall hold an annual national 
     translational research conference that brings together 
     researchers and industry representatives from across fields 
     from both the private and public sectors.
       ``(c) Transfer Management and Support.--The OTT shall 
     develop a program for transfer management and support that is 
     familiar with the National Institutes of Health's intramural 
     and extramural research portfolio, which program's mission is 
     to reach out to potential industry partners to cultivate 
     interest in collaboration with public researchers with the 
     goal of product development and procurement. For those 
     Institutes or Centers with their own Office of Technology 
     Transfer Offices, the OTT shall work closely with those 
     offices to coordinate industry outreach efforts. Those 
     offices, on a biannual basis, shall meet with the OTT and 
     shall submit a report to the OTT describing the translational 
     research efforts of the Center or Institute and corresponding 
     efforts to attract commercial interest in their research 
     portfolio.
       ``(d) Management.--
       ``(1) In general.--The OTT shall manage the Cooperative 
     Research and Development Agreements between industry and 
     public research partners.
       ``(2) Registration.--The OTT shall--
       ``(A) as appropriate, register the agreements within a 
     publicly accessible electronic database maintained by the 
     National Library of Medicine of the National Institutes of 
     Health; and
       ``(B) oversee the collaborative process in terms of pre-
     determined outputs, negotiating problems that may occur 
     between collaborating entities, and assuring intellectual 
     property protections necessary for successful product 
     development.

     ``SEC. 499G-2. OFFICE OF INTRAMURAL RISK OPPORTUNITY AND 
                   MAPPING.

       ``(a) Establishment.--There is established in the Office of 
     Technology Transfer of the Center, an Office of Intramural 
     Risk Opportunity and Mapping that shall oversee the 
     intramural research programs of the National Institutes of 
     Health to be certain they are complementary and distinct from 
     extramural and private programs.
       ``(b) Reviews and Reports.--The Office of Intramural Risk 
     Opportunity and Mapping shall--
       ``(1) conduct regular reviews of the intramural research 
     programs of the National Institutes of Health; and
       ``(2) report every 2 years on such reviews.
       ``(c) Health Risks and Opportunities.--The Office of 
     Intramural Risk Opportunity and Mapping shall--
       ``(1) identify and map public health risks and scientific 
     opportunities and keep data on such topics current and 
     updated; and
       ``(2) provide the information described in paragraph (1) to 
     the Council on a biannual basis to help the Council 
     prioritize the Nation's translation research investment.
       ``(d) Trans-NIH Collaborative Research.--
       ``(1) In general.--The Office of Intramural Risk 
     Opportunity and Mapping shall make, in coordination with the 
     Director of Cures and the Director of NIH, funds available to 
     groups of institutes and centers of the National Institutes 
     of Health to promote engagement in multi-institute projects 
     that focus on translational research endeavors.
       ``(2) Funding.--Funding levels and periods of funding under 
     paragraph (1) shall be flexible as necessary to achieve 
     trans-institute project objectives. Preference for funding 
     shall be given to projects that promote high levels of cross-
     disciplinary collaboration, that address diseases with the 
     greatest burden or research promise, and that are most likely 
     to result in the development of a diagnostic or therapeutic 
     prototype.
       ``(3) Authorization of appropriations.--There is authorized 
     to be appropriated, from the acceleration fund of the 
     Director of Cures described in section 499B(b)(2)(B)(i), to 
     carry out this subsection $150,000,000.

     ``SEC. 499G-3. PATENTING AND LICENSING INCENTIVES.

       ``(a) In General.--The OTT shall make every effort to 
     increase licensing throughput in order to stimulate the 
     availability of useful products for patients.
       ``(b) Incentives.--The OTT shall develop incentives that 
     create private sector, financial, commercial, and academic 
     interest in the National Institutes of Health's intellectual 
     property portfolio, which incentives may include the 
     following:
       ``(1) The patent extension of National Institutes of 
     Health's health patents, in which there is an extension of 
     the time during which the licensee has exclusive right to the 
     intellectual property.
       ``(2) The patent restoration of National Institutes of 
     Health's health patents, in which there is restoration of the 
     full patent life, or another agreed upon term, of a 
     technology to the licensee from the time of Food and Drug 
     Administration passage or other agreed upon milestone.
       ``(3) Partnering options, which are options to pursue 
     exclusive and nonexclusive licensing to 1 or more partners in 
     the government, industrial, or academic sectors.
       ``(c) Customized Models.--The Director of Cures shall 
     encourage the OTT to cultivate customized models for 
     contracts that fulfill the needs of industry and the public.

     ``SEC. 499G-4. TRANSLATIONAL RESEARCHER DEVELOPMENT.

       ``(a) In General.--The Director of Cures shall oversee the 
     development of a curriculum for internships in 
     interdisciplinary research that will encompass rotations 
     through multiple institutes and centers of the National 
     Institutes of Health (including the National Library of 
     Medicine), the clinical trial design process, and other 
     related disciplines with an emphasis on practical experience.
       ``(b) Tuition Grants.--The Director of Cures shall award 
     tuition grants for extramural interdisciplinary research 
     programs.
       ``(c) Training.--The Center shall train interdisciplinary 
     scientists in the science and art of risk analysis and 
     mapping through a program of internships and fellowships.

     ``SEC. 499G-5. TRANSLATIONAL RESEARCH TRAINING PROGRAM.

       ``The Director of NIH shall ensure that each institute and 
     center of the National Institutes of Health has established, 
     or contracted for the establishment of, a translational 
     research training program at the institute or center.

              ``Subpart 6--Developing Information Systems

     ``SEC. 499H. ADVANCING NATIONAL HEALTH INFORMATION 
                   INFRASTRUCTURE.

       ``(a) Genomic Data.--
       ``(1) In general.--The National Center for Biotechnology 
     Information of the National Library of Medicine of the 
     National Institutes of Health shall develop new computational 
     methods to aid in the processing of genomic data by novice 
     and experienced researchers.
       ``(2) Authorization of appropriations.--There is authorized 
     to be appropriated, from the acceleration fund of the 
     Director of Cures described in section 499B(b)(2)(B)(i), to 
     carry out paragraph (1) $8,000,000, of which--
       ``(A) $2,500,000 is authorized to be appropriated to 
     support the program's computational infrastructure; and
       ``(B) $5,500,000 is authorized to be appropriated for 
     hiring biologists and computer scientists who are trained in 
     bioinformatics.
       ``(b) Database.--The Secretary, acting through the Director 
     of NIH, shall undertake, in collaboration with the National 
     Library of Medicine of the National Institutes of Health, 
     construction of a clinical study registry and results 
     database that may expand upon the National Library of 
     Medicine's information system and database.
       ``(c) Clinical Trial Information.--
       ``(1) In general.--
       ``(A) In general.--The clinical study registry and results 
     database, described in subsection (b), shall consist of a 
     registry of phase III clinical trials taking place in the 
     United States and a database of their results.
       ``(B) Clinical study registry.--Participation in the 
     clinical study registry shall be mandatory for both public 
     and private entities.
       ``(C) Results database.--Participation in the clinical 
     trial results database shall be mandatory for both public and 
     private entities. The clinical trial results database shall 
     include even negative studies, which demonstrate no 
     therapeutic effect.
       ``(2) Registry of clinical trials.--The registry of 
     clinical trials shall include not less than the following:
       ``(A) The clinical trial title.
       ``(B) A description of the product under study.
       ``(C) The hypothesis to be tested.
       ``(D) The intervention.
       ``(E) The study design, methodology, duration, and 
     location.
       ``(F) Participation criteria.
       ``(G) Contact information.
       ``(H) Sponsoring organization.
       ``(3) Clinical trial results.--The database of clinical 
     trial results shall consist of not less than the following:
       ``(A) The trial start date and completion date.
       ``(B) A summary of the results of the trial in a standard, 
     non-promotional summary format.

[[Page S13589]]

       ``(C) Summary data tables with respect to the primary and 
     secondary outcome measures.
       ``(D) Information on the statistical significance of the 
     results and publications in peer reviewed journals relating 
     to the trial, with, when available, an electronic link to the 
     journal article.
       ``(E) A description of the process used to review the 
     results of the trial, including a statement about whether the 
     results have been peer reviewed by reviewers independent of 
     the trial sponsor.
       ``(F) Safety data concerning the trial, including a summary 
     of all adverse events specifying the number and type of 
     events.
       ``(G) Reference information to the clinical trial in the 
     clinical registry.
       ``(d) Registration of Trials and Reporting of Results.--
       ``(1) Website publication.--Each principal investigator of 
     a public clinical trial or responsible person for a private 
     clinical trial shall register phase III clinical trials in 
     accordance with paragraph (2) and report phase III clinical 
     trial results in accordance with paragraph (2) with the 
     National Library of Medicine of the National Institutes of 
     Health. The National Library of Medicine shall make the 
     information available for viewing on the Library's Website, 
     www.clinicaltrials.gov. The National Library of Medicine 
     shall electronically link each registered clinical trial with 
     its database of results and link each database of results 
     with its registered clinical trial.
       ``(2) Timeline of registration.--
       ``(A) In general.--An entity described in paragraph (1) 
     shall register a clinical trial not later than 3 months after 
     the Food and Drug Administration has approved the entity's 
     clinical trial protocol and report clinical trial results not 
     later than 3 months after completing the clinical trial, 
     which shall be defined as the point where the specified trial 
     duration has been surpassed and the analysis of the data is 
     complete or the trial is stopped because of vital positive or 
     negative findings, or as the point determined by the judgment 
     of the Secretary. All information submitted to the National 
     Library of Medicine shall be accurate and updated
       ``(B) Loss of funding.--In the case in which an entity 
     described in paragraph (1) does not register a clinical trial 
     or report on clinical trial results in accordance with 
     subparagraph (A), the Secretary may--
       ``(i) not award a grant, contract, cooperative agreements, 
     or any other award to the principal investigators of such 
     entity until the principal investigators comply with the 
     requirements under subparagraph (A); and
       ``(ii) in the case of an entity that does not receive 
     Federal funding for the clinical trial, fine the entity 
     $10,000 a day for a sum not to exceed $2,000,000 until the 
     responsible person for the clinical trial complies with the 
     requirements under subparagraph (A).
       ``(C) Waiver.--The Secretary may waive the requirements of 
     subparagraph (A) upon a written request from the responsible 
     person if the Secretary determines that extraordinary 
     circumstances justify the waiver and that providing the 
     waiver is in the public's interest or consistent with the 
     protection of public health.

     ``SEC. 499H-1. PUBLIC ACCESS REQUIREMENT FOR RESEARCH.

       ``(a) In General.--The Secretary shall require all funded 
     investigators, whether direct employees of the Department of 
     Health and Human Services or recipients of grants, contracts, 
     or other support of the National Institutes of Health, the 
     Centers for Disease Control and Prevention, or the Agency for 
     Healthcare Research and Quality, to submit to the National 
     Library of Medicine of the National Institutes of Health 
     (referred to in this section as the `National Library of 
     Medicine'), upon acceptance for publication in a journal or 
     other publication included in the PubMed directory, final 
     manuscripts resulting from research in which direct costs are 
     supported in whole or in part by the National Institutes of 
     Health, the Centers for Disease Control and Prevention, or 
     the Agency for Healthcare Research and Quality.
       ``(b) Public Availability.--
       ``(1) In general.--The National Library of Medicine shall 
     include all such manuscripts described in subsection (a), 
     after peer review, for display in the National Library of 
     Medicine's digital library archive, PubMed Central. The 
     copyright holder of a manuscript described in subsection (a) 
     may request the author's manuscript be replaced with final 
     published text.
       ``(2) Timeline.--A manuscript described in subsection (a) 
     shall become publicly available on the Internet through 
     PubMed Central not later than 6 months after the date of 
     publication of the manuscript.
       ``(3) Loss of funding for failure to submit on time.--
     Failure to submit required information under this section to 
     the National Library of Medicine within 6 months of the date 
     of publication of the manuscript involved shall be considered 
     by the Secretary in the context of grant compliance review 
     and may result in the loss of public funding for the 
     investigators involved as determined appropriate by the 
     agency involved.

     ``SEC. 499H-2. INFORMATICS TRAINING AND WORKFORCE 
                   DEVELOPMENT.

       ``(a) In General.--The Director of NIH shall develop a 
     multi-faceted approach to increasing the number of persons 
     trained in clinical bioinformatics by implementing 
     appropriate programs, including the programs described in 
     subsection (b).
       ``(b) Programs.--The programs under this subsection are the 
     following:
       ``(1) K-12 science program.--The National Library of 
     Medicine of the National Institutes of Health shall develop 
     with the National Science Foundation a kindergarten through 
     grade 12 clinical informatics education curriculum that shall 
     include an assessment component. The National Library of 
     Medicine shall award not more than 500 schools each $30,000 
     to implement the curriculum.
       ``(2) Undergraduate degree programs in bioinformatics.--The 
     National Library of Medicine of the National Institutes of 
     Health shall--
       ``(A) award grants to academic health centers and graduate 
     training programs to collaborate with an undergraduate 
     institution of higher education's department of biology, 
     chemistry, or computer science to develop curricula leading 
     to a bachelor's degree in bioinformatics; and
       ``(B) encourage grantees to form an inter-institutional 
     consortium.
       ``(3) Increasing the number of nih bioinformatics graduate 
     training programs.--The National Library of Medicine of the 
     National Institutes of Health shall increase the number of 
     bioinformatics graduate training programs through funding 
     existing graduate training programs of the National 
     Institutes of Health to meet the expanding needs for training 
     and outreach to the biomedical community. The programs shall 
     focus on the skills needed to apply bioinformatics methods 
     specifically to problems of human health and disease. The 
     Director of NIH shall hire 12 individuals with a doctorate in 
     molecular biology and expertise in training and developing 
     educational programs to assist in carrying out the programs 
     under this paragraph.
       ``(4) Centers of excellence in clinical bioinformatics.--
     The National Library of Medicine of the National Institutes 
     of Health, through the Center, shall establish Centers of 
     Excellence in Clinical Bioinformatics that shall have state-
     of-the-art computational methods and tools applicable to 
     human disease prevention, diagnosis, and treatment. The 
     Centers of Excellence in Clinical Bioinformatics shall 
     provide graduate student and postdoctoral support, through 
     distinguished faculty, in order to contribute to the highest 
     level of training in the bioinformatics workforce pipeline.
       ``(c) Authorization of Appropriations.--There is authorized 
     to be appropriated, from the acceleration fund of the 
     Director of Cures described in section 499B(b)(2)(B)(i), to 
     carry out this section $50,000,000 for fiscal year 2007 and 
     each succeeding fiscal year of which--
       ``(1) $15,000,000 is authorized to be appropriated for 
     fiscal year 2007 and each succeeding fiscal year to carry out 
     subsection (b)(1); and
       ``(2) $2,000,000 is authorized to be appropriated to carry 
     out subsection (b)(3).

     ``SEC. 499H-3. NATIONAL LIBRARY OF MEDICINE EXPANSION OF 
                   FACILITIES.

       ``(a) Sense of Congress.--It is the sense of Congress that 
     Congress should make special effort to fund the expansion of 
     facilities of the National Library of Medicine of the 
     National Institutes of Health. These facilities are essential 
     to the National Library of Medicine being able to fulfill its 
     many informatics functions, which include providing essential 
     informational resources to scientists worldwide and advancing 
     the underpinning of much of the National Institutes of Health 
     conducted biomedical research.
       ``(b) Report.--The Director shall request that the 
     Institute of Medicine of the National Academies report to 
     Congress on the impact of not providing funding for the 
     expansion of facilities described in subsection (a).

                      ``Subpart 7--Research Tools

     ``SEC. 499I. NIH RESEARCH TOOL INVENTORY.

       ``(a) Annual Review.--The Director of NIH shall direct the 
     head of each institute and center of the National Institutes 
     of Health to perform an annual review of the institute or 
     center's research tool inventory for the specific purpose of 
     enabling each institute or center to understand the research 
     tool distribution, frequency of use, intellectual property 
     status, and utility. Each institute and center of the 
     National Institutes of Health shall describe in the institute 
     or center's annual review the type and quantity of research 
     tools the institute or center desires to obtain to better 
     fulfill the institute or center's research and development 
     goals.
       ``(b) Database.--The Director of Cures shall--
       ``(1) enter the information obtained from the annual review 
     under subsection (a) into an electronic research tool 
     database; and
       ``(2) use such database to oversee the prioritization and 
     funding of new projects to fulfill pressing needs and 
     promising technologies.

     ``SEC. 499I-1. EXCEPTIONS TO TOOL GUIDELINES.

       ``The Director of Cures may advise the Office of Technology 
     Transfer of the Center to provide exceptions to prohibitions 
     against patenting and licensing research tools under some 
     circumstances of customized contracts when exclusive or non-
     exclusive licensing provides the swiftest and most 
     efficacious final development of an important health care 
     technology.''.
       (b) Conforming Amendment.--Section 401(b)(1) of the Public 
     Health Service Act (42 U.S.C. 281(b)(1)) is amended by adding 
     at the end the following:
       ``(S) The American Center for Cures.''.

[[Page S13590]]

     
                                  ____
     Quotes in Support of the American Center for CURES Act of 2005

       ``The American Center for Cures will be a tremendous 
     addition to our nation's valuable tradition of biomedical 
     research. By emphasizing translational and applications 
     research as well as discovery of diagnostic markers, the ACC 
     will bring the hope of basic science discovery to the reality 
     of patient care. The mandate and goal will be to prevent, 
     early diagnose, or cure the diseases that cause such 
     suffering to humanity. This effort will promote health 
     diplomacy that will bring the genius and resources of our 
     nation to better the health of all Americans.''--Secretary 
     Tommy Thompson, Former Secretary, Department of Health and 
     Human Services, Former Governor, State of Wisconsin.
       ``The need for a federal focus on finding cures has long 
     been a top priority for all of us who seek the rapid 
     translation of scientific advances into personal health 
     benefits. With their landmark legislative proposal, Senators 
     Cochran and Lieberman have taken a critical step along our 
     path to cures.''--S. Robert Levine MD, Chairman of the Health 
     Priorities Project of the Progressive Policy Institute.
       ``As Governors around the country look to transform our 
     complex health care system, we must seek new cost-effective 
     solutions that continue to improve our overall health and 
     productivity,'' said Michigan Governor Jennifer M. Granholm. 
     ``The American Center for Cures represents a bi-partisan 
     effort to devote significant and lasting resources toward an 
     innovative approach to disease treatment and management, 
     offering Americans grappling with chronic and debilitating 
     diseases the lasting gift of hope.''--Governor Jennifer 
     Granholm, Michigan.
       ``Finding cures will improve the health of mankind. As an 
     example, by simply delaying the onset of Alzheimer's disease 
     by five years, the health and productivity of older Americans 
     will be enhanced. Developing cures will provide American 
     families with a better quality of health care that can be 
     sustained over a longer period of time. That is why I urge 
     the establishment of the American Center for Cures.''--
     Governor Tom Vilsack, Iowa.
       The American Center for Cures is a timely and creative 
     proposal for tackling an urgent national challenge: the 
     skyrocketing costs of treating and preventing chronic 
     diseases. The confluence of such diseases and a graying 
     population not only threatens to make health care 
     unaffordable, but also jeopardizes prospects for healthy and 
     successful aging. The Center would focus the prodigious 
     talents of our scientific community on specific strategies to 
     cure disease, saving lives and money over the long run.--Will 
     Marshall, President, Progressive Policy Institute.
       ``The American Center for Cures is a simple, bold, 
     breakthrough idea: A can-do country ought to have the 
     capacity to solve chronic problems, not just treat them.''--
     Bruce Reed, President, Democratic Leadership Council.
       ``I think this goes a long way toward improving NIH's 
     ability to do large projects across institutes and to 
     facilitate translational research. I am happy to support this 
     concept . . . there are already a lot of good ideas here.''--
     Leland Hartwell, Ph.D., Nobel Laureate, Medicine and 
     Physiology, President, Fred Hutchinson Cancer Research 
     Center.
       ``I believe the American Center for Cures (ACC) is a 
     wonderful effort that focuses physicians and scientists on 
     bringing the discoveries of the laboratory to the patient. 
     The lives of many Americans will be improved by having the 
     ACC bring to bear new resources in the fight against chronic 
     neurological diseases such as Alzheimer's, Parkinson's, 
     multiple sclerosis, and other neurodegenerative disorders. I 
     enthusiastically support the American Center for Cures and 
     hope that my colleagues in biomedical research will join 
     me.''--Stanley Prusiner, M.D., Nobel Laureate, Medicine and 
     Physiology, University of California, San Francisco.
       ``The proposed ACC offers a blend of existing federal 
     activities in health research with several new initiatives, 
     all aimed at speeding the move from discovery to products 
     that help human health. The proposal has multiple components 
     including strengthening existing NIH authorities in support 
     of small business. When enacted and in operation the results 
     of this new focused activity should be very visible with 
     improvements to the public health that would not be possible 
     without this new money with mandates on how it is spent.''--
     Robert Day, M.D., Ph.D., M.P.H., Emeritus Professor and Dean, 
     University of Washington School of Public Health and 
     Community Medicine, Emeritus Professor and Director, Fred 
     Hutchinson Cancer Research Center, Member, Public Health 
     Sciences, Member, National Cancer Advisory Board, National 
     Cancer Policy Board.
       ``The establishment of an American Center for Cures with 
     its emphasis, prominence and integration into the rest of the 
     United States organization of health care related ventures 
     would represent an enormous step forward. The focus of the 
     Center on translation of basic science initiatives to the 
     clinical arena will benefit those whose support has taken us 
     to the present date. I applaud the initiative.''--Fritz H 
     Bach, M.D., Lewis Thomas Distinguished Professor, Harvard 
     Medical School.
       ``Medical discoveries over the past century have greatly 
     increased the quality and quantity of human life. New 
     insights into biology will make even more advances possible. 
     The American Center for Cures will make the translation of 
     biological discoveries to the patient occur not only faster 
     but much more likely to happen. It is hard to imagine another 
     investment that would extend the quality and quantity of life 
     than fully funding the American Center for Cures.''--James O. 
     Armitage, M.D., Joe Shapiro Professor of Medicine, University 
     of Nebraska College of Medicine, Member, National Cancer 
     Advisory Board.
       ``I am pleased to support the American Center for Cures 
     (ACC) proposed legislation that you introduced to the United 
     Sates Senate on Wednesday, December 7. This legislation is 
     critical and in the translation of advances in fundamental 
     biomedical science to improvements in the care of people. 
     Please let me know if I can help make this dream a 
     reality.''--Lee Goldman, M.D., MPH, Julius R. Krevans 
     Distinguished Professor and Chair, Associate Dean for 
     Clinical Affairs, University of California San Francisco 
     School of Medicine, President, Association of Professors of 
     Medicine.
       ``I enthusiastically support The American Center for Cures 
     (ACC) Senate legislation. The ACC will focus our nation's 
     scientists and doctors on applying basic scientific 
     discoveries to help the patient. This critical approach to 
     research will not only help our friends and loved ones with 
     their health, it will be the 21st Century American approach 
     to solving the health care financial crisis. By eliminating 
     or reducing certain diseases for all Americans, the looming 
     federal and state Medicare and Medicaid financial tsunami 
     will be markedly reduced. There is no time to lose. I urge 
     the immediate passage of the ACC legislation.'' --Stephen 
     Gleason, D.O., Ph.D., Former CEO Mercy Clinics, Former VP 
     Medical Operations for Catholic Health Initiatives, Former 
     White House advisor, Former chief of staff, Governor Tom 
     Vilsack, Former Presidential Representative to the World 
     Health Organization, Assistant Professor, Mayo Graduate 
     School of Medicine.
       ``The American Center for Cures will be the engine that 
     brings basic science discoveries and apply them to the 
     patient. It has been said that women and minorities are not 
     dying from the lack of research, they are dying from the lack 
     of research being applied to them. The ACC will focus the 
     talent of the greatest scientists and clinicians for one 
     singular purpose: to cure, prevent, or diagnose earlier 
     diseases that afflict so many in the world. As a mother, 
     nurse, researcher, and educator, I believe that the ACC will 
     bring better health to all of us. The time is now . . . let 
     us not waste another moment.''-- Sandra Underwood, RN, PhD, 
     University of Wisconsin School of Nursing.
       ``The American Center for Cures is a remarkable idea that 
     will be the bridge between the promise of scientific 
     opportunities and the reality of our nation's health needs--
     to deliver cures. Americans deserve a center that is totally 
     dedicated to finding cures for our most devastating and 
     debilitating chronic diseases. The ACC is the natural 
     extension of the doubling of the NIH budget. Now we must have 
     as a top national priority an accountable, mission-driven 
     Center for Cures to rapidly identify ``cure opportunities'' 
     already created by federal, academic and private research 
     laboratories and proactively accelerate and rapidly translate 
     these opportunities into real cures.
       In an era of expanding needs, exploding knowledge of the 
     biomedical sciences, and demands of the public to have the 
     knowledge applied to their loved ones' ailments, the American 
     Center for Cures offers new hope and dynamic reality to 
     Americans. The American Center for Cures is the opportunity 
     to commit the American genius, resources, and ethic to a 
     greater cause in a ``moonshot'' approach to diseases.''--
     Richard J. Boxer, M.D., Clinical Professor, Health Policy, 
     Medical College of Wisconsin, Clinical Professor, Family and 
     Community Medicine, Medical College of Wisconsin, Clinical 
     Professor, Surgery/Urology, University of Wisconsin-Madison.
       ``Having reviewed the material you so kindly sent me, I 
     want to applaud this pioneering, entrepreneurial approach 
     which will undoubtedly accelerate the process by which we 
     discover and implement cures for diseases and improve and 
     enrich the quality of life of tens of millions of Americans. 
     I hope that this bold solutions-oriented approach will have 
     overwhelmingly bi-partisan support in Congress and that it 
     will be signed into law by the President at the earliest 
     possible moment.''--Steve Grossman, Former Chair, Democratic 
     National Committee, C.E.O. Massachusetts Envelope Company.
       ``The American Center for Cures is the best new idea in 
     Washington DC in a generation. It is timely, creative and 
     compelling.''--Joe Andrew, Former Chair, Democratic National 
     Committee, Sonnenschein, Nath and Rosenthal, LLP.
       ``The combination of NIH and industry-supported research, 
     combined with venture capital, has been very successful in 
     bringing new drugs based on fundamental biological 
     discoveries into commercial reality. In areas that combine 
     fundamental biology and physical science and engineering--
     biomedical devices, analytical, genomic, and diagnostic 
     tools, bioinformation systems, tissue engineering--the 
     current system works substantially less well.''--George 
     Whitesides, Ph.D., Professor of Chemistry, Harvard Medical 
     School, (given in 2004).
       ``The concept of the new institute is exciting.''--Arthur 
     W. Nienhuis, M.D., Director,

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     St. Jude Children's Research Hospital, (given in 2004).
       ``The concept and its underlying philosophy are right on 
     target. We need to open cancer research in prevention, early 
     diagnosis, and cure to scientists in diverse fields that 
     include physicists, chemists, computer scientists and 
     mathematicians.''--Frederick P. Li, M.D., Director, Division 
     of Cancer Epidemiology and Control, Dana-Farber Cancer 
     Institute, (given in 2004).
       ``The 20th Century saw a 100-percent increase in worldwide 
     life expectancy--one of the greatest achievements in history. 
     Today's children face different challenges, including a 
     higher risk of dying from cancer and other diseases of aging 
     than their grandparents did. In the 21st Century, our 
     challenge is to use incredible advancements in information 
     technology and biology to defeat such diseases as cancer, 
     Alzheimer's, diabetes, Parkinson's and many other afflictions 
     that take years of quality life from our loved ones. The 
     most-important benefit will be reduced human suffering. And 
     the value to our economy will be measured in trillions of 
     dollars. The American Center for Cures (ACC) legislation 
     recognizes and responds to the imperative of defeating these 
     deadly diseases in our lifetimes. I believe we can do that if 
     we summon the will to change the way we pursue new medical 
     solutions. FasterCures supports passage of the ACC 
     legislation and urges its rapid implementation. There is not 
     a moment to lose.''--M. Millken, Chairman, FasterCures/The 
     Center for Accelerating Medical Solutions.
       ``The American Center for Cures will be extraordinarily 
     important for all Americans, and indeed all humanity. The new 
     Center will combine scientific disciplines that have 
     previously not been brought to bear upon biomedical problems. 
     This is a unique and desperately needed approach will break 
     through the impasse and finally bring the formidable power of 
     all science to focus and solve the diseases that plague the 
     world. The American Center for Cures has been designed to 
     bring accountability and responsibility for ultimate cures. 
     Its success will be measured by cures and cures alone. As a 
     father, husband, entrepreneur, and one who has seen too much 
     suffering, I believe it is incumbent upon us to take a bold 
     approach to biomedical research that will make our children 
     and future generations free of the diseases that have 
     afflicted us and our ancestors. Let our descendents look back 
     at our generation and say, `They reached for the stars, and 
     found they were capable of conquering old paradigms, fears, 
     and diseases.' ''--Lou Weisbach, C.E.O. Stadium Capital 
     Associates, Founder, HA-LO Industries, Inc.
       ``Oscar Wilde once wrote, ``Morality, like art, begins with 
     a line being drawn someplace.'' With tremendous suffering and 
     disease so prevalent in our country, the American Center for 
     Cures' (ACC) proposed legislation being introduced by 
     Senators Lieberman and Cochran draws a line in the sand for 
     health and extending the lifetime of every individual. From a 
     religious point of view, this certainly responds to the 
     notion that we are identified with life affirmation. I 
     heartily endorse this legislation.''--Rabbi Steven B. Jacobs, 
     Temple Kol Tikvah, Woodland Hills, CA--Rabbi Michael Lerner, 
     Editor, Tikkun Magazine, Rabbi, Beyt Tikkun Synagogue, San 
     Francisco, California.

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