[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 2104 Introduced in Senate (IS)]
109th CONGRESS
1st Session
S. 2104
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 14, 2005
Mr. Reid (for Mr. Lieberman (for himself, Mr. Cochran, Mr. Carper, and
Mrs. Hutchison)) introduced the following bill; which was read twice
and referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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.
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:
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.
``subpart 1--federally funded research and development centers
``Sec``subpart 2--health advanced research projectsent Centers.
``Sec. 499D. H``subpart 3--clinical trialsects Agency.
``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.``subpart 4--valley of deathions.
``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. ``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.``subpart 6--developing information systemsogram.
``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
``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.
``(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.
``(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.
``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
``(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.
``(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.''.
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