[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.''.
                                 <all>