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**Section by Section**

Senators Lieberman, Cochran, Carper & Hutchison

[Background]{.underline}

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 bioterroism, an
avian flu pandemic, antibiotic resistance, and a waning vaccine supply?

[Center for Cures]{.underline}

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
    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. If
you have any questions about this legislation or would like to be an
original cosponsor, please contact Wilson Wang (202-224-4042) in the
Office of Senator Lieberman or David McClendon in the Office of Senator
Cochran (224-5054).

**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 innovation 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 (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 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, 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.**
21^st^ 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.