[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2988 Introduced in Senate (IS)]







110th CONGRESS
  2d Session
                                S. 2988

 To amend the Public Health Service Act to enhance public and private 
   research efforts to develop new tools and therapies that prevent, 
                       detect, and cure diseases.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 7, 2008

 Mr. Lieberman 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 enhance public and private 
   research efforts to develop new tools and therapies that prevent, 
                       detect, and cure diseases.

    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 ``Accelerating Cures Act of 2008''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

                      ``Part J--Accelerating Cures

              ``subpart 1--pathways to cures subcommittee

``Sec. 499A. Pathways to Cures Subcommittee.
               ``subpart 2--clinical effectiveness; ffrdc

``Sec. 499B. Federally Funded Research and Development Center.
         ``subpart 3--health advanced research projects program

``Sec. 499C. Health Advanced Research Projects Program.
                      ``subpart 4--clinical trials

``Sec. 499D. Grants for quality clinical trial design and execution.
``Sec. 499D-1. Streamlining the regulatory process governing clinical 
                            research.
``Sec. 499D-2. Clinical research study and clinical trial.
  ``subpart 5--training clinical and translational researchers of the 
                                 future

``Sec. 499E. Training translational and clinical researchers of the 
                            future.
``Sec. 499E-1. Translational research training program.
                   ``subpart 6--the `valley of death'

``Sec. 499F. Small business partnerships.
``Sec. 499F-1. Rapid access to intervention development.
``Sec. 499F-2. Translational Development Program for New Innovations.
                ``subpart 7--translational research fund

``Sec. 449G. Translational Research Fund.
``Sec. 404I. Application of research requirement.''.

SEC. 3. FINDINGS; PURPOSE.

    (a) 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 
        $29,200,000,000.
            (2) The goals of the NIH are to--
                    (A) foster fundamental creative discoveries, 
                innovative research strategies, and their applications 
                as a basis to significantly advance the Nation's 
                capacity to protect and improve health;
                    (B) develop, maintain, and renew scientific human 
                and physical resources that will ensure the Nation's 
                capacity to prevent disease;
                    (C) expand the knowledge base in medical and 
                associated sciences in order to enhance the Nation's 
                economic well-being and ensure a continued high return 
                on the public investment in research; and
                    (D) exemplify and promote the highest level of 
                scientific integrity, public accountability, and social 
                responsibility in the conduct of science.
            (3) Thus, the NIH is tasked with applying basic science 
        discoveries to protect and improve health. This includes, 
        translational research, which is the scientific work necessary 
        to develop a clinical application from a basic science 
        discovery.
            (4) The United States translational research investment 
        will be key to the Nation responding effectively--
                    (A) to public and population health threats;
                    (B) to the complex nature of chronic diseases, 
                which are responsible for 7 out of 10 deaths in the 
                United States, for 75 percent of the $2,300,000,000,000 
                spent annually on healthcare in the United States, and 
                for 16 percent of gross domestic product;
                    (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, orphan drugs, and medical tools for 
                pediatric populations; and
                    (D) to facilitate the process of converting medical 
                innovations into commercial products.
            (5) Key components of the translational research process 
        include research prioritization, a strengthening and 
        maintenance of an expert workforce, multidisciplinary 
        collaborative work, 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 early 
        involvement of private entities that are skilled in the 
        manufacturing and marketing process in the translational 
        research endeavor.
            (6) A National Academy of Sciences/Institute of Medicine 
        report made recommendations for reorganizing NIH to meet new 
        challenges facing the biomedical research endeavor. The 
        committee report contained specific recommendations aimed at 
        strengthening clinical and translational research including: 
        increasing trans-NIH research, promoting innovation and risk 
        taking in intramural research, creating a ``special projects'' 
        program, and increasing funding for research management and 
        support.
            (7) The Government Accountability Office reported that 
        although the pharmaceutical industry has increased its research 
        and development investment by 147 percent from 1993 to 2004, 
        new drug applications to the Food and Drug Administration have 
        only increased by 39 percent; thus, the productivity of the 
        industry's research and development expenditures is declining. 
        The report cited that a limited scientific understanding of how 
        to translate research discoveries into safe and effective drugs 
        is contributing to the problem and recommended that training 
        researchers who can translate drug discoveries into effective 
        medicines is necessary.
            (8) It is estimated to take 17 years for a science 
        discovery to be translated from the point of proof of concept 
        to clinical application. The percent of physicians engaged in 
        research has declined steadily from a peak of 4.6 percent in 
        1985 to 1.8 percent in 2003.
            (9) A report by the Infectious Disease Society of America 
        cited concerns with the lack of new antibiotics to treat 
        infectious diseases. The report commended the NIH Roadmap, but 
        also recommended that NIH aggressively expand the translational 
        research components of the Roadmap, increase grants to small 
        businesses, universities, and nonprofits working in antibiotics 
        research and development, and seek more opportunities to 
        partner with pharmaceutical and biotech companies.
            (10) Clinical effectiveness results provide patients, 
        payers, and clinicians with tools to evaluate the benefits 
        versus risks of the ever evolving number of prevention, 
        diagnosis, and treatment strategies available.
            (11) The Common Fund is an annual set aside account created 
        from an agreed upon percentage of the annual budget that 
        supports innovative and trans-NIH initiatives to improve and 
        accelerate research to impact health.
            (12) The ``Valley of Death'' is a stage in biomedical 
        development between research and commercialization where the 
        success of a product is dependent on its profitability.
    (b) Purpose.--The purpose of this Act is to create a new pathway to 
curing disease by enhancing public and private research to translate 
new discoveries from bench to bedside.

SEC. 4. ACCELERATING CURES ACT OF 2008.

    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--ACCELERATING CURES

              ``Subpart 1--Pathways to Cures Subcommittee

``SEC. 499A. PATHWAYS TO CURES SUBCOMMITTEE.

    ``(a) Definition of Translational Research.--In this section, the 
term `translational research' means research that transforms scientific 
discoveries arising from laboratory, clinical, or population studies 
into clinical application to reduce disease incidence, morbidity, and 
mortality.
    ``(b) Establishment of Pathways to Cures Subcommittee.--There is 
established a Pathways to Cures Subcommittee within the Council of 
Councils of the Office of Portfolio Analysis and Strategic Initiatives 
of the National Institutes of Health that shall convene not less 
frequently than twice a year to help advise and direct the 
translational research priorities of the Office of Portfolio Analysis 
and Strategic Initiatives (referred to in this part as the `OPASI').
    ``(c) Membership.--
            ``(1) In general.--The subcommittee established under 
        subsection (b) may be composed of the following members:
                    ``(A) The Director of NIH and the Director of OPASI 
                who shall be subcommittee co-chairs.
                    ``(B) The heads of the institutes and centers of 
                the National Institutes of Health.
                    ``(C) Heads from 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.
            ``(2) Other members.--The subcommittee established under 
        subsection (b) shall also include not fewer than 3 leaders from 
        the small business medical research community, 3 leaders from 
        large pharmaceutical or biotechnology companies, and 3 leaders 
        from academia and patient advocacy organizations, all of whom 
        shall be appointed by the Director of NIH.
    ``(d) Recommendations; Coordination; Funding.--
            ``(1) Setting priorities.--The subcommittee established 
        under subsection (b) shall make recommendations to assist the 
        Director of OPASI in setting translational research priorities.
            ``(2) Recommendations.--In making recommendations, the 
        subcommittee shall--
                    ``(A) consider risk and burden of disease as well 
                as lines of research uniquely poised to deliver 
                effective diagnostics and therapies; and
                    ``(B) be mission-driven and identify research that 
                shows specific promise for a new treatment or cure for 
                a disease.
            ``(3) Coordination.--The subcommittee shall ensure sharing 
        of research agendas among the institutes and centers of the 
        National Institutes of Health for the purpose of coordinating 
        translational research priorities, where appropriate, across 
        such institutes and centers.
            ``(4) Funding.--The subcommittee and the Director of 
        OPASI--
                    ``(A) shall identify research with application or 
                commercialization potential; and
                    ``(B) may fund such research
    ``(e) Report.--The subcommittee established under subsection (b) 
shall submit an annual report to Congress on progress towards finding 
new treatments and cures.

               ``Subpart 2--Clinical Effectiveness; FFRDC

``SEC. 499B. FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTER.

    ``(a) Establishment of Center.--
            ``(1) In general.--The Director of NIH, in conjunction with 
        the Director of the Agency for Healthcare Research and Quality 
        (referred to in this subpart as the `AHRQ'), shall establish a 
        Federally Funded Research and Development Center (referred to 
        in this subpart as the `FFRDC') on clinical effectiveness 
        research.
            ``(2) Definition of clinical effectiveness research.--In 
        this section, the term `clinical effectiveness research' means 
        research that--
                    ``(A) provides information for health care decision 
                makers, including patients, providers, and public and 
                private payers, to make evidence-based decisions about 
                the delivery of health care; and
                    ``(B) considers specific subpopulations.
            ``(3) Director of the ffrdc.--The Director of NIH, in 
        conjunction with the Director of the AHRQ, shall appoint a 
        Director of the FFRDC.
    ``(b) Duties of the Director of the FFRDC.--The Director of the 
FFRDC shall--
            ``(1) review, synthesize, and disseminate clinical 
        effectiveness research;
            ``(2) set priorities for, and fund, trials, such as 
        randomized controlled trials, adaptive trials, and practical 
        trials, observational studies, secondary data analysis in areas 
        of clinical effectiveness research where evidence is lacking, 
        systematic reviews of existing research, as necessary, and 
        cost-effectiveness studies;
            ``(3) make recommendations regarding the findings of 
        paragraphs (1) and (2);
            ``(4) study the differential outcomes of interventions on 
        subpopulations within diseases;
            ``(5) use competitive award processes, including, but not 
        solely, competitive peer review, and examine methods of rapid 
        review cycles to reduce delays in funding decisions;
            ``(6) encourage the development and use of electronic 
        health data to conduct clinical effectiveness research for the 
        goal of improving clinical care delivery;
            ``(7) support the development of methodological standards 
        to be used when conducting studies of clinical effectiveness 
        and value in order to help ensure accurate and effective 
        comparisons and update such standards not less frequently than 
        annually;
            ``(8) include, and collaborate and consult with, as 
        necessary, the Food and Drug Administration, the Centers for 
        Medicare & Medicaid Services, the Centers for Disease Control 
        and Prevention, the Department of Defense, the Department of 
        Veterans Affairs, and other Federal agencies, and the Institute 
        of Medicine, as well as private payers, insurers, 
        pharmaceutical and device companies, patient advocacy and 
        public interest groups, professional societies, hospitals, 
        academic institutions, and health foundations;
            ``(9) establish a public review or hearing process, which 
        includes the Food and Drug Administration, to examine findings 
        of studies;
            ``(10) determine the best approach to make available the 
        findings resulting from subparagraphs (A) and (B) to relevant 
        Federal agencies, private and public stakeholders in the health 
        care system, and consumers;
            ``(11) provide a public forum for addressing conflicting 
        guidelines and recommendations; and
            ``(12) submit annual reports to Congress on the research 
        activities and findings of the FFRDC.
    ``(c) Clinical Effectiveness Advisory Board.--
            ``(1) Establishment and function.--The Director of the 
        FFRDC shall establish, in conjunction with the Director of NIH 
        and the Director of the AHRQ, an independent Clinical 
        Effectiveness Advisory Board (referred to in this section as 
        the `Advisory Board'), to include not more than 20 appointed 
        members, in order to provide expert advice and guidance on the 
        research priorities of the FFRDC.
            ``(2) Membership.--
                    ``(A) In general.--Membership on the Advisory Board 
                shall be comprised of--
                            ``(i) representatives of the National 
                        Institutes of Health, the AHRQ, the Food and 
                        Drug Administration, the Centers for Medicare & 
                        Medicaid Services, the Centers for Disease 
                        Control and Prevention, the Department of 
                        Defense, the Department of Veterans Affairs, 
                        and other Federal agencies, and the Institute 
                        of Medicine; and
                            ``(ii) private payers, insurers, 
                        pharmaceutical and device companies, patient 
                        advocacy and public interest groups, 
                        professional societies, hospitals, academic 
                        institutions, and health foundations.
                    ``(B) Experts.--Membership on the Advisory Board 
                shall consist of leading experts from diverse 
                disciplinary areas, including physicians, social 
                scientists, statisticians, health services researchers, 
                economists, and other health care professionals.
                    ``(C) Terms.--Terms for members of the Advisory 
                Board shall be fixed, multiyear, and staggered.
                    ``(D) Appointment.--The members of the Advisory 
                Board who are described in subparagraph (A)(ii) shall 
                be appointed by the Director of the FFRDC, the Director 
                of NIH, and the Director of the AHRQ.
                    ``(E) Chair.--The Director of the AHRQ shall be 
                chair of the Advisory Board.
            ``(3) Conflicts of interest.--Members of the Advisory Board 
        shall disclose any financial, political, or organizational 
        conflicts of interest in conducting the work of the Advisory 
        Board.
            ``(4) Duties.--The Advisory Board shall--
                    ``(A) recommend priorities for clinical 
                effectiveness research to be undertaken by the FFRDC, 
                taking into consideration significant gaps in clinical 
                effectiveness research, including research needs for 
                information on subpopulations and diverse populations, 
                including women, children, and racial and ethnic 
                minorities, and on individuals with comorbid diseases;
                    ``(B) identify existing and novel research designs 
                and methods that may be considered by the FFRDC in 
                conducting clinical effectiveness research;
                    ``(C) review clinical effectiveness research 
                methods;
                    ``(D) review the FFRDC processes to determine 
                whether the research conducted is objective, credible, 
                developed through a transparent process that includes 
                consultations with appropriate stakeholders, including 
                consumers, patient organizations, and the public, and 
                is clinically relevant;
                    ``(E) make recommendations to the AHRQ and the 
                National Institutes of Health for the effective 
                dissemination of the findings of the FFRDC supported 
                research to clinicians, payers, and consumers, and 
                patient organizations; and
                    ``(F) following the first year, review current and 
                previous research agendas and make recommendations 
                regarding research agendas.
            ``(5) Initial meeting.--The initial meeting of the Advisory 
        Board shall be no later than 6 months after the date of 
        enactment of the Accelerating Cures Act of 2008.
            ``(6) Advisory nature of board.--The recommendations of the 
        Advisory Board shall not be binding, but shall be considered by 
        the Director of the FFRDC when developing the clinical 
        effectiveness research agenda.
    ``(d) Research Agenda.--The Director of the FFRDC shall establish 
the research agenda of the FFRDC, based on the priorities established 
by the Advisory Board, and shall update such agenda not less frequently 
than annually, and shall--
            ``(1) focus on--
                    ``(A) identifying gaps in clinical effectiveness 
                research relating to medical procedures, medical 
                technologies, pharmaceuticals, health information 
                technologies, and other relevant services and products 
                that significantly contribute to health care outcomes 
                and expenditures;
                    ``(B) funding trials, studies, and reviews, and 
                coordinating these efforts with ongoing research 
                efforts in the Federal Government, academic 
                institutions, and private entities to fill gaps 
                identified under subparagraph (A);
                    ``(C) synthesizing and reviewing clinical 
                effectiveness research to fill gaps identified under 
                subparagraph (A); and
                    ``(D) supporting the development of an evidence 
                base for the development of clinical care guidelines 
                based on the results of clinical effectiveness 
                research;
            ``(2) convene such working groups on clinical effectiveness 
        research as the Director of the FFRDC determines necessary;
            ``(3) meet with members representing the National 
        Institutes of Health, the AHRQ, the Food and Drug 
        Administration, the Centers for Medicare & Medicaid Services, 
        the Centers for Disease Control and Prevention, the Department 
        of Defense, the Department of Veterans Affairs, and other 
        Federal agencies, and the Institute of Medicine, as well as 
        private payers, insurers, pharmaceutical and device companies, 
        patient advocacy and public interest groups, professional 
        societies, hospitals, academic institutions, practice based 
        research networks health foundations, and the general public to 
        promote communication and transparency; and
            ``(4) notify the public well in advance of any public 
        meetings.
    ``(e) Reports.--
            ``(1) Guidance or recommendations.--The Director of the 
        FFRDC, in conjunction with the Director of NIH and the Director 
        of the AHRQ, shall provide, not less frequently than annually, 
        guidance or recommendations to health care providers, payers, 
        and consumers, and Congressional committees of jurisdiction on 
        the comparative effectiveness of health care services.
            ``(2) Status reports.--The Director of the FFRDC shall 
        provide annual status reports on the work of the FFRDC to 
        Congressional committees of jurisdiction.
    ``(f) Availability of Research Findings.--The Director of the FFRDC 
shall develop and identify efficient and effective methods of 
disseminating the findings of the clinical effectiveness assessments of 
medical procedures, technologies, and therapeutics, including by making 
these available on the Internet. Any relevant reports (including 
interim progress reports, draft final clinical effectiveness reviews, 
and final progress reports on new research submitted for publication) 
on the results of clinical effectiveness research supported by the 
FFRDC shall be made available on the Internet, not later than 90 days 
after the report is completed.
    ``(g) Evaluations and Reports of FFRDC.--The Director of NIH, in 
conjunction with the Director of the AHRQ, shall enter into regular 
agreements with entities, such as the Institute of Medicine, to--
            ``(1) evaluate the FFRDC and its functioning; and
            ``(2) produce reports on priority setting for the FFRDC, 
        and on research methods developed and employed by the FFRDC, 
        among other purposes.

         ``Subpart 3--Health Advanced Research Projects Program

``SEC. 499C. HEALTH ADVANCED RESEARCH PROJECTS PROGRAM.

    ``(a) Establishment.--There is established within the OPASI, a 
Health Advanced Research Projects Program (referred to in this section 
as the `Research Projects Program') that shall be headed by a Director 
of the Research Projects Program who is appointed by the Director of 
NIH.
    ``(b) Composition.--The Research Projects Program shall be composed 
of portfolio managers in key health areas, which are determined by the 
Director of the Research Projects Program in conjunction with the 
Director of OPASI, the Director of NIH, and the Pathways to Cures 
Subcommittee established under section 499A.
    ``(c) Guidance.--The Research Projects Program shall be guided by 
and shall undertake grand challenges that encourage innovative, 
multidisciplinary, 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 Program shall be 
guided by the following management and organizing principles in 
directing the Research Projects Program:
            ``(1) Keep the Research Projects Program 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 Program 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 Program.
            ``(4) Use, whenever possible, research and development 
        investments by the Research Projects Program 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 
        nonprofit 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 efforts to encourage participation, 
        collaboration, and cross-fertilization of ideas across the 
        National Institutes of Health.
            ``(6) Utilize a challenge model in Research Projects 
        Program 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) Support risk-taking in research pursuits and tolerate 
        productive failure.
            ``(9) Ensure that revolutionary and breakthrough technology 
        research dominates the Research Projects Program's research 
        agenda and portfolio.
    ``(e) Activities.--Using the funds and authorities provided to the 
Director of NIH, the Research Projects Program shall carry out the 
following activities:
            ``(1) The Research Projects Program shall support basic and 
        applied health research to promote revolutionary technology 
        changes that promote health.
            ``(2) The Research Projects Program shall advance the 
        development, testing, evaluation, prototyping, and deployment 
        of critical health products.
            ``(3) The Research Projects Program, consistent with 
        recommendations of the Pathways to Cures Subcommittee 
        established under section 499A, with the priorities of OPASI, 
        and with the grand challenges that encourage innovative, 
        multidisciplinary, and collaborative research, shall 
        emphasize--
                    ``(A) translational research efforts, including 
                efforts conducted through collaboration with the 
                private sector, that pursue--
                            ``(i) innovative health products that could 
                        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 diseases for 
                        which the for-profit sector is not finding new 
                        treatments;
                            ``(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 Program 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 Program shall provide selected 
        research projects with single-year or multiyear funding and 
        require researchers for such projects to provide interim 
        progress reports, including milestones on progress, to the 
        Research Projects Program on not less frequently than a 
        biannual basis.
            ``(6) The Research Projects Program 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 Program shall provide advice to 
        the Director of OPASI concerning funding priorities.
            ``(8) The Research Projects Program may solicit proposals 
        for competitions to address specific health vulnerabilities 
        identified by the Director of NIH and the Director of OPASI and 
        award prizes for successful outcomes.
            ``(9) The Research Projects Program shall periodically hold 
        health research and technology demonstrations to improve 
        contact among researchers, technology developers, vendors, and 
        acquisition personnel.
            ``(10) The Research Projects Program shall carry out other 
        activities determined appropriate by the Director of NIH.
    ``(f) Employees.--
            ``(1) Hiring.--The Director of the Research Projects 
        Program, in hiring employees for positions with the Research 
        Projects Program, 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 Program may not 
                exceed 5 years.
                    ``(B) Extension.--The Director of the Research 
                Projects Program may, in the case of a particular 
                employee of the Research Projects Program, extend the 
                term to which employment is limited under subparagraph 
                (A) by not more than 2 years if the Director of the 
                Research Projects Program determines that such action 
                is necessary to promote the efficiency of the Research 
                Projects Program.
    ``(g) Flexibility.--The Director of the Research Projects Program 
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 Program and 
project manager.

                      ``Subpart 4--Clinical Trials

``SEC. 499D. GRANTS FOR QUALITY CLINICAL TRIAL DESIGN AND EXECUTION.

    ``The Director of OPASI--
            ``(1) shall award grants for clinical trial design and 
        execution to academic centers and practice-based research 
        networks to fund multidisciplinary clinical research teams, 
        which clinical research teams may be composed of members who 
        include project managers, clinicians, epidemiologists, social 
        scientists, and clinical research coordinators; and
            ``(2) may award grants for clinical trial design and 
        execution to researchers.

``SEC. 499D-1. STREAMLINING THE REGULATORY PROCESS GOVERNING CLINICAL 
              RESEARCH.

    ``(a) Establishment of Centralized Institutional Review Boards.--
            ``(1) In general.--
                    ``(A) Establishment and oversight.--The Director of 
                OPASI shall appoint a Director of Centralized 
                Institutional Review Boards (referred to in this part 
                as the `Director of CIRBs') who shall establish and 
                oversee the functioning and progress of a series of 
                Centralized Institutional Review Boards (referred to in 
                this part 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.
                    ``(B) Work with fda.--The Director of CIRBs shall 
                work with the Commissioner of Food and Drugs to make 
                regulations governing multi-site clinical trials and 
                the regulatory requirements of the Food and Drug 
                Administration more consistent in order to reduce 
                barriers to commercialization of new treatments.
            ``(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 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 National Institutes of 
Health's funds.
    ``(d) Review Process.--
            ``(1) In general.--Each CIRB shall review research 
        protocols and subject informed consent forms to ensure the 
        protection of safety and well-being 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) 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. If a local institutional review board elects to 
        decline participation in the CIRB, the local institutional 
        review board shall appoint a liaison to the CIRB.
    ``(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 requirements to 
change a research protocol in order 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 National Institutes of Health to use a CIRB.

``SEC. 499D-2. CLINICAL RESEARCH STUDY AND CLINICAL TRIAL.

    ``(a) In General.--The Director of NIH shall--
            ``(1) commission the Institute of Medicine 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 
        requirements governing research subject safety and privacy;
            ``(2) examine informed consent processes; and
            ``(3) request that the Institute of Medicine issue a 
        written report not later than 18 months after the date of 
        enactment of the Accelerating Cures Act of 2008 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 healthcare systems, including health 
                information technology, and to researcher practice that 
                facilitate the clinical research endeavor.

  ``Subpart 5--Training Clinical and Translational Researchers of the 
                                 Future

``SEC. 499E. TRAINING TRANSLATIONAL AND CLINICAL RESEARCHERS OF THE 
              FUTURE.

    ``(a) In General.--
            ``(1) Establishment of program.--The Director of OPASI 
        shall establish training programs to increase the number of, 
        and maintain existing, translational and clinical researchers, 
        including researchers trained in community-based research.
            ``(2) Purpose.--The purpose of the training programs 
        described in paragraph (1) shall be to train a cadre of 
        researchers in core competencies in the translational and 
        clinical sciences for the ultimate goal of improving healthcare 
        delivery, healthcare options to the public, the use of 
        healthcare by patients, and healthcare outcomes.
    ``(b) Grants.--
            ``(1) In general.--The Director of OPASI shall award grants 
        to, and enter into contracts with, public and nonprofit 
        educational entities to establish, strengthen, or expand 
        training programs for researchers to be trained in the 
        translational and clinical sciences.
            ``(2) Awarding of grants.--The Director of OPASI shall 
        award grants to, and enter into contracts with, applicants 
        that--
                    ``(A) support multidisciplinary approaches in 
                training;
                    ``(B) utilize collaborative strategies for 
                conducting research across various disciplines to 
                translate basic science discoveries; and
                    ``(C) train researchers focused on improving care 
                and patient outcomes.
            ``(3) Required use of funds.--The Director of OPASI shall 
        award grants to, and enter into contracts with, entities for 
        the following purposes:
                    ``(A) To establish training programs for M.D. and 
                Ph.D. researchers in translational or clinical 
                research.
                    ``(B) To establish training programs for 
                individuals at predoctoral levels, including those in 
                medical school, and for allied health professionals, in 
                translational or clinical research.
                    ``(C) To establish training programs for nurses in 
                translational and clinical research.
                    ``(D) To strengthen or expand existing training 
                programs for translational or clinical researchers.
                    ``(E) To establish a wide range of training 
                programs, including one-year training programs, summer 
                programs, pre- and postdoctoral clinical or 
                translational research fellowships, and advanced 
                research training programs for mid-career researchers 
                and clinicians.
                    ``(F) To provide stipends and allowances, including 
                for travel and subsistence expenses, in amounts the 
                Director of OPASI determines appropriate, to support 
                the training of translational or clinical researchers.
                    ``(G) To provide financial assistance to public and 
                nonprofit educational entities for the purpose of 
                supporting the training of translational or clinical 
                researchers, through clinical education, curricula, and 
                technological support, and other measures.
                    ``(H) To measure the impact of the translational 
                and clinical research training programs on the 
                biomedical sciences and on clinical practice.
    ``(c) Funds Available.--The Director of OPASI may make funds 
available to support training programs for translational or clinical 
researchers at the National Institutes of Health for entities awarded 
grants or contracts under subsection (b).
    ``(d) Novel and Best Practices.--The Director of OPASI shall 
convene, on not less frequently than a biannual basis, members of 
training institutions to share novel and best practices in training 
translational or clinical researchers.
    ``(e) Training.--A trainee of a program funded under a grant or 
contract awarded under this section may conduct part of the trainee's 
training at the Health Advanced Research Projects Program.
    ``(f) Consistent Definitions and Methodologies.--For the purposes 
of funding training programs for clinical researchers, the Director of 
NIH shall develop consistent definitions and methodologies to classify 
and report clinical research.

``SEC. 499E-1. 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--The `Valley of Death'

``SEC. 499F. SMALL BUSINESS PARTNERSHIPS.

    ``(a) In General.--An independent advisory board shall be 
established at the National Academy of Sciences to conduct periodic 
evaluations of the Small Business Innovation Research program (referred 
to in this subpart as the `SBIR program') and the Small Business 
Technology Transfer program (referred to in this subpart as the `STTR 
program') of the Office of Extramural Research in the Office of the 
Director of the National Institutes of Health for the purpose of 
improving management of the programs through data-driven assessment. 
The advisory board shall consist of the Director of NIH, the Director 
of the SBIR program, senior National Institutes of Health agency 
managers, university and industry experts, and program stakeholders.
    ``(b) SBIR and STTR Grants and Contracts.--
            ``(1) In general.--
                    ``(A) Program managers with sufficient expertise.--
                Not less than 25 percent of the grants and contracts 
                awarded by each of the SBIR and STTR programs shall be 
                awarded on a competitive basis by an SBIR or STTR 
                program manager who has sufficient managerial, 
                technical, and translational research expertise to 
                expertly assess the quality of a SBIR or STTR proposal.
                    ``(B) Experience of program managers.--In hiring 
                new SBIR or STTR program managers, the Director of NIH 
                shall consider experience in commercialization or 
                industry.
                    ``(C) Emphasis on grant and contract awards.--In 
                awarding grants and contracts under the SBIR program 
                and the STTR program--
                            ``(i) each SBIR and STTR program manager 
                        shall place an emphasis on applications that 
                        identify from the onset products with 
                        commercial potential to prevent, diagnose, and 
                        treat diseases, as well as promote health and 
                        well-being; and
                            ``(ii) risk-taking shall be supported and 
                        productive failure shall be tolerated.
            ``(2) Examination of commercialization and other metrics.--
        The independent advisory board described in subsection (a) 
        shall evaluate the success of the requirement under paragraph 
        (1)(A) by examining increased commercialization and other 
        metrics, to be determined and collected by SBIR and STTR 
        programs.
            ``(3) Success.--Each recipient of a SBIR or STTR grant or 
        contract, as a condition of receiving such grant or contract, 
        shall report to the SBIR or STTR program--
                    ``(A) whether there was eventual commercial success 
                of the product developed with the assistance of the 
                grant or contract; and
                    ``(B) on other metrics as determined by the SBIR or 
                STTR program to capture broader measures of success.
    ``(c) Potential Purchasers or Investors.--The SBIR and STTR 
programs shall administer nonpeer review grants and contracts pursuant 
to this section 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 product, including large pharmaceutical 
or biotechnology companies, venture capital firms, and Federal agencies 
(including the National Institutes of Health).
    ``(d) Phase I and II.--The SBIR and STTR programs shall reduce the 
time period between Phase I and Phase II funding of grants and 
contracts under the SBIR and STTR programs to--
            ``(1) 6 months; or
            ``(2) 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 development with the grant or contract.
    ``(e) Phase III.--A SBIR or STTR program manager may petition the 
Director of NIH for Phase III funding of a grant or contract for a 
project that requires a boost to finalize procurement of a product. The 
maximum funding for Phase III funding shall be $2,000,000 for each of a 
maximum of 2 years. Such Phase III funding may come from the Common 
Fund of the NIH.
    ``(f) Evaluation and Reporting Requirements.--In order to enhance 
the evidence base guiding SBIR and STTR program decisions and changes, 
the SBIR and STTR programs shall--
            ``(1) conduct regular internal and external evaluations of 
        the program;
            ``(2) review current data collection methods for the 
        purpose of identifying gaps and deficiencies, and develop a 
        formal plan for evaluation and assessment of program success, 
        including operational benchmarks for success; and
            ``(3) conduct a review on the number of SBIR and STTR 
        awards made to women and minorities and develop outreach and 
        review strategies to increase the number of awards to women and 
        minorities.
    ``(g) Pilot Programs.--
            ``(1) In general.--The SBIR and STTR programs may initiate 
        pilot programs, based on the development of a formal mechanism 
        for designing, implementing, and evaluating pilot programs, to 
        spur innovation and to test new strategies that may enhance the 
        effectiveness of the program.
            ``(2) Considerations.--The SBIR and STTR programs shall 
        consider, among other issues, conducting pilot programs on 
        including individuals with commercialization experience in 
        study sections, hiring individuals with industry experience for 
        staff positions, separating the commercial and scientific 
        review processes, and examining the impact of the trend toward 
        larger awards on the overall program.
    ``(h) Electronic Records.--
            ``(1) In general.--The SBIR and STTR programs shall keep a 
        publicly accessible electronic record of all SBIR or STTR 
        investments in research and development.
            ``(2) Content of record.--The record described in paragraph 
        (1) shall include, at a minimum, the following information:
                    ``(A) The grantee or entity awarded a grant or 
                contract.
                    ``(B) A description of the research being funded.
                    ``(C) The amount of money awarded in each phase of 
                SBIR or STTR funding.
                    ``(D) If applicable, the purchaser of the product, 
                current use of the product, and estimated annual 
                revenue resulting from the procurement.
                    ``(E) Dates of Phases I, II, and III awards, as 
                applicable.
                    ``(F) Other metrics as determined by the SBIR or 
                STTR programs.
    ``(i) Meeting.--The Director of NIH shall convene a meeting, not 
less frequently than annually, consisting of the National Institutes of 
Health SBIR/STTR program coordinator or manager and each institute and 
center of the National Institutes of Health to share best practices, 
report on program activities, and review existing policies.
    ``(j) Report to Congress.--The Director of NIH shall submit an 
annual report to Congress and the independent advisory board described 
in subsection (a) on the SBIR and STTR programs' activities.

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

    ``(a) In General.--The Director of OPASI shall expand the existing 
Rapid Access to Intervention Development Program (referred to in this 
subpart as the `RAID') that--
            ``(1) is designed to assist the translation of promising, 
        novel, and scientifically meritorious therapeutic interventions 
        to clinical use by helping 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;
            ``(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;
            ``(5) shall identify, for the OPASI, those research 
        projects with promise for clinical application or 
        commercialization; and
            ``(6) shall, in collaboration with the Translational 
        Development Program for New Innovations, facilitate the 
        translation of new innovations through the development process.
    ``(b) Projects.--
            ``(1) In general.--The RAID, in collaboration with the 
        Director of OPASI, shall carry out a program that shall select, 
        in accordance with paragraph (2), projects of eligible entities 
        to receive access to laboratories, facilities, and other 
        support resources of the National Institutes of Health for the 
        preclinical development of drugs, biologics, diagnostics, and 
        devices.
            ``(2) Selection.--Not less than 25 percent of the projects 
        selected under paragraph (1) shall be selected on a competitive 
        basis--
                    ``(A) by a program manager with sufficient 
                managerial, technical, and translational research 
                expertise to adequately assess the quality of a project 
                proposal; or
                    ``(B) 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 such as a community health center.
            ``(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 Clinical Practice.--The program under 
subsection (b) shall accelerate the process of bringing discoveries in 
medical technology and drugs from the laboratory to the clinic.
    ``(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. TRANSLATIONAL DEVELOPMENT PROGRAM FOR NEW INNOVATIONS.

    ``(a) In General.--The Director of OPASI shall develop a 
Translational Development Program for New Innovations to guide 
institutions of higher education, small businesses, for-profits, 
nonprofits, or other such entities through the translational research 
development process by facilitating the following:
            ``(1) Triage screening of applications for promising 
        innovations expected to reduce disease incidence, morbidity, 
        and mortality.
            ``(2) Outlining the tasks, timelines, and costs required to 
        navigate and complete the development process for such 
        innovations.
            ``(3) Providing project management support for the 
        recommended development tasks.
            ``(4) Interfacing with the Food and Drug Administration and 
        the entity to devise a plan that safely and rapidly brings new 
        drugs, biologics devices, diagnostics, and other interventions 
        to approval.
    ``(b) Coordination.--The Translational Development Program for New 
Innovations shall--
            ``(1) collaborate with the RAID; and
            ``(2) be comprised of personnel with extensive experience 
        with investigational new drug applications and in 
        commercialization.

                ``Subpart 7--Translational Research Fund

``SEC. 449G. TRANSLATIONAL RESEARCH FUND.

    ``(a) Account.--There is established an account to be known as the 
Translational Research Fund that shall consist of amounts appropriated 
for translational research priorities as described in subsection (b). 
Such account shall not be funded from amounts otherwise provided to the 
National Institutes of Health.
    ``(b) Authorization of Appropriations.--For each fiscal year, there 
is authorized to be appropriated for the Translational Research Fund to 
carry out the activities under this part an amount equal to the amount 
set aside for the Common Fund for such fiscal year.
    ``(c) Allotment to Health Advanced Research Projects Program.--Not 
less than half of the annual amount appropriated for the Translational 
Research Fund shall be allotted to the Health Advanced Research 
Projects Program.''.

SEC. 5. APPLICATION OF RESEARCH REQUIREMENT.

    Part A of title IV of the Public Health Service Act (42 U.S.C. 281 
et seq.) is amended by adding at the end the following:

``SEC. 404I. APPLICATION OF RESEARCH REQUIREMENT.

    ``Each application for, and summary of, a project, grant, or 
contract from the National Institutes of Health, shall include a 
statement on the possible application of the research for detecting, 
treating, or curing a health condition or disease state.''.
                                 <all>