[Congressional Record (Bound Edition), Volume 154 (2008), Part 6]
[Senate]
[Pages 7951-7965]
[From the U.S. Government Publishing Office, www.gpo.gov]




          STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS

      By Ms. LANDRIEU:
  S. 2985. A bill to amend the Safe, Accountable, Flexible, Efficient 
Transportation Equity Act: A Legacy for Users to correct a reference 
relating to a transit project in Orleans Parish, Louisiana; to the 
Committee on Environment and Public Works.
  Ms. LANDRIEU. Mr. President, I rise today to ask that the Senate 
support technical corrections to a few highway bill projects in 
Louisiana. Specifically, a modified alignment to a project in Lake 
Charles, an expanded project area for Jefferson Parish and expanded use 
for a project in New Orleans.
  These limited technical corrections will improve transportation in 
Louisiana and get the dollars previously directed toward this work into 
the economy. Notably, the corrections do not change the previously 
authorized level of spending, nor do they fundamentally alter the scope 
of the project.
  I look forward to working with the Environment and Public Works 
Committee to address these technical corrections.
                                 ______
                                 
      Mr. LIEBERMAN:
  S. 2988. 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; to the Committee on Health, 
Education, Labor, and Pensions.

[[Page 7952]]


  Mr. LIEBERMAN. Mr. President, I rise today to introduce a new bill, 
the Accelerating Cures Act of 2008, to enhance public and private 
research efforts to develop new tools and therapies that prevent, 
detect, and cure diseases more quickly from bench to bedside. I 
introduced an earlier version of this legislation in December 2005, the 
American Center for Cures Act of 2005, S. 2104. Fundamentally, the 
Accelerating Cures Act of 2008 has the same intent to promote clinical 
and translational research within the National Institutes of Health 
while incorporating many of the recommendations made from the 2003 
National Academy of Sciences Report, ``Enhancing the Vitality of the 
National Institutes of Health: Organizational Change to Meet New 
Challenges.''
  The NIH is a successful, worldwide leader in biomedical research 
whose mission is to support ``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.'' Our national investment in NIH is 
integral to our Nation's capacity to respond safely and effectively to 
public and population health threats, chronic disease prevention and 
management, and burdensome orphan diseases. The 2006 NIH 
reauthorization strengthened the agency even further, and also brought 
a greater focus on clinical and translational research to its mission.
  The Accelerating Cures Act of 2008 would build upon the progress of 
NIH reauthorization and further enhance the ability of the agency to 
address clinical and translational research barriers. For example, it 
is estimated to take up to 17 years for a scientific discovery to be 
translated into a clinical application. This gap will not be resolved 
unless we take serious action to implement clinical and translational 
research initiatives, critically evaluate the impact of health care 
delivery, promote multi- and cross-disciplinary collaboration, increase 
the number of clinicians engaged in clinical and translational 
research, and foster efforts that streamline the translational 
development process to result in product commercialization.
  The Accelerating Cures Act of 2008 would address these issues by 
creating new programs that fund high-risk, high-reward research, to 
oversee and direct promising avenues of translational research, to 
increase the translational and clinical research workforce, and to 
provide new funds and authorities to evaluate the clinical 
effectiveness of various treatments and procedures at the NIH. The bill 
expands upon existing infrastructure in the Office of Portfolio 
Analysis and Strategic Initiatives and encourages intra- and inter-
agency collaboration to build on strengths of NIH's 27 institutes and 
centers and other Federal agencies such as the Department of Defense, 
Food and Drug Administration, and the Agency for Healthcare Research 
and Quality. Lastly, the Accelerating Cures Act of 2008 uniquely adds 
resources to guide researchers through the `Valley of Death,' a stage 
in biomedical development between research and commercialization where 
the success of an initiative is dependent on feasibility and 
profitability that can only be established by a market that, by 
definition, has not yet developed. With the bill's strengthening and 
broadening of the Small Business Innovation Research and Small Business 
Technology Transfer programs and making available resources such as the 
Rapid Access to Intervention Development and Translational Development 
programs, investigators, institutions, small businesses, and other 
entities, will be better suited to navigate the regulatory and 
commercialization processes.
  To summarize, the NIH has been and continues to be our Nation's 
premier biomedical research investment in areas of basic science and 
clinical and translational research. My legislation seeks to expand 
upon existing clinical and translational research efforts not only to 
meet the healthcare needs of this Nation, but to maintain the NIH's 
status as the most respected research institution in the World. This 
bill will not only increase our overall Federal investment in the NIH, 
but enhance our translational and clinical research capacities overall. 
I urge my Senate colleagues, patient advocacy groups, and researchers 
to work together to bring new hope to Americans that we can fight and 
conquer disease.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2988

       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

[[Page 7953]]

     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

[[Page 7954]]

       ``(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.

[[Page 7955]]

       ``(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

[[Page 7956]]

     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

[[Page 7957]]

       ``(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.''.
                                 ______
                                 
      By Mrs. MURRAY (for herself and Mr. Domenici):
  S. 2989. A bill to direct the Secretary of Health and Human Services 
to implement a National Neurotechnology Initiative, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Mrs. MURRAY. Mr. President, it is estimated that 100 million 
Americans--or one in three--suffer from some kind of brain or nervous 
system illness, injury or disorder. Among these illnesses are 
debilitating diseases and conditions, including: Alzheimer's, multiple 
sclerosis, epilepsy, Parkinson's disease, and traumatic brain injury. 
These diseases are challenging for the patients and for their loved 
ones, who often have intense caretaker burdens.
  In addition, our men and women fighting overseas are suffering from 
these conditions in record numbers. The signature injuries of the 
current conflicts in Iraq and Afghanistan are brain and spinal cord 
injuries, such as traumatic brain injury, post-traumatic stress 
disorder, and paralysis. For example, it is estimated that as many as 
12 percent to 20 percent of servicemembers who have served in Iraq 
suffer from PTSD alone.
  The combined economic burden of these illnesses and disorders is 
estimated at $1 trillion annually--and this cost is rising quickly as 
our population ages and our military conflicts continue. Recent 
discoveries are revolutionizing our understanding of the human brain, 
and new uses for these discoveries are emerging almost every day. At 
the same time, researchers still have a limited understanding of the 
human brain and how best to diagnose, treat, and cure its diseases. The 
current research system for neurological diseases is disjointed and 
often limits

[[Page 7958]]

this life altering research from reaching the patients in need. For 
example, compared to the average drug, it costs nearly $100 million 
more--and takes 2 years longer--to bring a drug that treats a 
neurological disease to the market.
  We need a targeted, coordinated, national effort to support the 
development of neurotechnology. It is vitally important that public 
infrastructure be developed to ensure that today's neurotechnology 
discoveries quickly become tools to improve the human condition. This 
research has the potential to transform highly specialized areas of 
medicine, computing, and defense. It could dramatically change 
Americans' everyday lives.
  The National Neurotechnology Initiative Act addresses each of these 
issues. I am proud to be an original cosponsor with my colleague from 
New Mexico. Under this proposal, the National Institutes of Health 
would receive funds to coordinate research and move research into 
innovative companies developing the next generation of treatments.
  This legislation will also accelerate research and treatment of 
neurological diseases by removing key bottlenecks in the system. It 
will coordinate neurological research across Federal agencies, create a 
coordinated blueprint for neuroscience at the NIH, and streamline the 
FDA approval process for life changing neuro drugs--without sacrificing 
safety. All of this will mean more treatments faster for millions of 
Americans.
  This act is an investment in America's neurological health. 
Investigation into the mechanisms and functions of the brain will lead 
to vastly improved understanding of brain disease and injuries and 
human behavior. It will give us an unprecedented ability to treat and 
heal those in need. The act also will dramatically reduce healthcare 
costs while expanding the American neurotechnology industry and 
creating good American jobs. Finally, this bill will help us honor our 
debt to the brave men and women of America's armed forces.
  Today, I am proud to introduce this legislation with Senator 
Domenici. I thank him for his leadership on this issue, and I look 
forward to working with him and my other colleagues to pass this 
important legislation.
  Mr. DOMENICI. Mr. President, I rise today to join my colleague, 
Senator Murray, to introduce the National Neurotechnology Initiative 
Act of 2008. Our bill will coordinate and accelerate federal brain and 
nervous system research, and will help move that research from the 
laboratory into the hands of patients.
  It is estimated that approximately 100 million Americans--one in 
three--suffer from some kind of neurological illness, disorder, or 
injury. These include some of the most debilitating illnesses, such as 
Alzheimer's disease, Parkinson's disease, multiple sclerosis, autism, 
schizophrenia, and stroke. They include issues with a neurological 
basis that often goes unnoticed, such as obesity and hearing loss. They 
also include issues of particular importance to Senator Murray and me: 
traumatic brain injury, spinal cord injury, post-traumatic stress 
disorder, and other neurological effects suffered by the brave men and 
women of our armed forces as they execute their missions throughout the 
world.
  The total economic burden of these neurological illnesses, disorders, 
and injuries is estimated to be more than one trillion dollars every 
year. These costs include direct medical treatment, long-term care for 
senior citizens who have been incapacitated by a neurological disease, 
addiction-related costs, secondary medical costs related to obesity, 
and so on.
  As the baby boom generation ages, the cost associated with these 
illnesses will increase rapidly, straining our healthcare resources 
even further than they already are. Now is the time to act to promote 
the development of diagnostics, treatments, and cures that will restore 
health and reduce costs.
  Our armed forces too often suffer from a traumatic brain injury, 
which is among the primary types of casualty that disables our service 
members. Some soldiers also suffer from post-traumatic stress disorder 
as well. We owe it to these heroic warriors to help them heal as 
quickly and as completely as possible.
  The National Neurotechnology Initiative Act is designed to address 
four key issues currently slowing the development of neurological 
treatments, and to rapidly accelerate R&D for only three percent of the 
annual NIH brain research budget. The first is a lack of coordination 
between the many agencies that conduct brain research. The bill creates 
a coordinating office that will help ensure that the Department of 
Defense, the Department of Veterans Affairs, the National Institutes of 
Health, and other agencies know what every other agency is doing, and 
that they work together toward common goals.
  The second issue is insufficient coordination within the National 
Institutes of Health. Sixteen different Institutes, Centers, and 
offices within NIH conduct research on the brain and nervous system, 
and they have begun to work together through a program called the 
Blueprint for Neuroscience Research. This bill authorizes and fully 
funds that program.
  The third issue is the need to translate basic research into 
treatments. Advances in neurotechnology are useless if they merely sit 
in the lab. This bill boosts neuroscience-related technology transfer 
through the SBIR and STTR programs.
  The fourth issue is regulatory approval of new neurotechnology drugs, 
diagnostics, and devices. Brain-related treatments take much longer and 
cost much more to approve than other treatments. This bill will 
increase the timeliness and safety of the neurotechnology review 
process by allowing the FDA to hire and train neuroscience experts and 
to work with industry to develop neurotechnology standards.
  The bill also supports the analysis of societal implications of 
neuroscience and neurotechnology, so that we know we are proceeding 
thoughtfully and carefully in our research.
  Brain and nervous system research is an issue that has been extremely 
important to me throughout my time in the Senate. I have long been a 
supporter of the MIND Research Network, which does amazing work on 
these issues in New Mexico; and I have worked hard to advance our 
ability to treat and cure brain and nervous system diseases and 
disorders. I hope that this legislation will be part of my legacy in 
this area.
  I want to thank my good friend Senator Murray for asking me to join 
her on this very important issue. I appreciate her commitment to 
advancing this important research and I look forward to working with 
her to pass this legislation this Congress.
                                 ______
                                 
      By Mr. KERRY (for himself, Mr. Alexander, and Ms. Stabenow):
  S 2990. A bill to amend title XVIII of the Social Security Act to 
improve access of Medicare beneficiaries to intravenous immune 
globulines; to the Committee on Finance.
  Mr. KERRY. Mr. President, we have the opportunity this year to help a 
group of Medicare beneficiaries who are currently subject to costly, 
bureaucratic red tape which is delaying essential, life-saving 
treatments to some of our most vulnerable citizens. Addressing this 
problem will increase the quality of life for many patients and ease 
financial burdens for their medical providers.
  Between 6,000 and 10,000 Medicare beneficiaries have primary 
immunodeficiency diseases, PIDD, and require intravenous 
immunoglobulin, IVIG treatment to maintain a healthy immune system.
  Primary Immunodeficiency Diseases are disorders in which part of the 
body's immune system is missing or does not function properly. These 
disorders are caused by intrinsic or genetic defects in the immune 
system. Untreated primary immune deficiencies result in frequent life-
threatening infections and debilitating illnesses. Even illnesses such 
as the common cold or the flu, while unpleasant for most of us, can be 
deadly for someone with PIDD.

[[Page 7959]]

  Because of advances in our medical understanding and treatment of 
primary immune deficiency diseases, individuals who in the past would 
not have survived childhood are now able to live nearly normal lives. 
While there is still no cure for PIDD, there are effective treatments 
available. Nearly 70 percent of primary immune deficient patients use 
intravenous immunoglobulin to maintain their health.
  Immunoglobulin is a naturally occurring collection of highly 
specialized proteins, known as antibodies, which strengthen the body's 
immune response. It is derived from human plasma donations and is 
administered through an IV to the patient every three to four weeks.
  Currently, Medicare beneficiaries needing IVIG treatments are 
experiencing access problems--an unintended result of the way Medicare 
has determined the payment for IVIG. The current IVIG access and care 
issue began in January 2005 as a result of the Medicare Modernization 
Act under Part B, which changed the way physicians and hospital 
outpatient departments were paid under Medicare. The law reduced IVIG 
reimbursement rates such that most physicians in outpatient settings 
could no longer afford to treat Medicare patients requiring IVIG. In 
addition, access to home based infusion therapy is limited since 
Medicare currently pays only for the cost of IVIG, and not nursing 
services and supplies required for infusion.
  As a result, patients are experiencing delays in receiving this life 
saving treatment and are being shifted to more expensive care settings 
such as inpatient hospitals. In addition to incurring extra expenses, 
hospital-based care results in patients being in close proximity to 
countless microorganisms, an unsafe prospect for those who have 
suppressed immune systems.
  In April 2007, the U.S. Department of Health and Human Services 
Office of the Inspector General, OIG,reported that Medicare 
reimbursement for IVIG was inadequate to cover the cost many providers 
must pay for the product. In fact, the OIG found that 44 percent of 
hospitals and 41 percent of physicians were unable to purchase IVIG at 
the Medicare reimbursements rate during the 3rd quarter of 2006. The 
previous quarter had been even worse--77.2 percent of hospitals and 
96.5 percent of physicians were unable to purchase IVIG at the Medicare 
reimbursement rate.
  We have a rare opportunity to fix this very real problem with a 
compassionate and common sense solution. We can improve the quality of 
life for PIDD patients and cut inpatient expenses by improving 
reimbursement procedures for IVIG treatments for physicians and 
outpatient facilities and allowing for home treatments and coverage for 
related services.
  Today, I am introducing--along with Senators Alexander and Stabenow--
the bipartisan Medicare IVIG Access Act, a bill that will grant the 
Secretary of Health & Human Services temporary authority to update the 
payment for IVIG, if necessary based on new or existing data, and to 
provide coverage for related items and services currently excluded from 
the existing Medicare home infusion therapy benefit. This bill is 
endorsed by several national organizations from the patient and 
physician communities, including the Immune Deficiency Foundation, IDF, 
GBS/CIDP Foundation International, the Jeffrey Modell Foundation JMF, 
the Platelet Disorder Support Association, PDSA, the National Patient 
Advocate Foundation, NPAF, and the Clinical Immunology Society, CIS.
  The patients, physicians, caretakers, researchers, and plasma donors 
have all done their part--now it's time for us to do ours.
  Mr. President, I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 2990

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

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Medicare 
     IVIG Access Act of 2008''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Medicare payment for intravenous immune globulins.
Sec. 4. Coverage and payment of intravenous immune globulin in the 
              home.
Sec. 5. Reports.
Sec. 6. Offset.

     SEC. 2. FINDINGS.

       Congress makes the following findings:
       (1) Intravenous immune globulin (IVIG) is a human blood 
     plasma derived product, which over the past 25 years has 
     become an invaluable therapy for many primary 
     immunodeficiency diseases, as well as a number of 
     neurological, autoimmune, and other chronic conditions and 
     illnesses. For many of these disorders, IVIG is the most 
     effective and viable treatment available, and has 
     dramatically improved the quality of life for persons with 
     these conditions and has become a life-saving therapy for 
     many.
       (2) The Food and Drug Administration recognizes each IVIG 
     brand as a unique biologic. The differences in basic 
     fractionation and the addition of various modifications for 
     further purification, stabilization, and virus inactivation/
     removal yield clearly different biological products. As a 
     result, IVIG therapies are not interchangeable, with patient 
     tolerance differing from one IVIG brand to another.
       (3) The report of the Office of the Assistant Secretary for 
     Planning and Evaluation of the Department of Health and Human 
     Services, ``Analysis of Supply, Distribution, Demand, and 
     Access Issues Associated with Immune Globulin Intravenous 
     (IGIV)'', that was issued in May 2007, found that IVIG 
     manufacturing is complex and requires substantial up-front 
     cash outlay and planning and takes between 7 and 12 months 
     from plasma collection at donor centers to lot release by the 
     Food and Drug Administration.
       (4) The Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003 (Public Law 108-173; 117 Stat. 
     2066) changed Medicare's reimbursement methodology for IVIG 
     from average wholesale price (AWP) to average sales price 
     plus 6 percent (ASP+6 percent), effective January 1, 2005, 
     for physicians, and January 1, 2006, for hospital outpatient 
     departments, thereby reducing reimbursement rates paid to 
     those providers of IVIG on behalf of Medicare beneficiaries.
       (5) An April 2007 report of the Office of Inspector General 
     of the Department of Health and Human Services, ``Intravenous 
     Immune Globulin: Medicare Payment and Availability'', found 
     that Medicare reimbursement for IVIG was inadequate to cover 
     the cost many providers must pay for the product. During the 
     third quarter of 2006, 44 percent of IVIG sales to hospitals 
     and 41 percent of sales to physicians by the 3 largest 
     distributors occurred at prices above Medicare payment 
     amounts.
       (6) The report of the Office of the Assistant Secretary for 
     Planning and Evaluation of the Department of Health and Human 
     Services, ``Analysis of Supply, Distribution, Demand, and 
     Access Issues Associated with Immune Globulin Intravenous 
     (IGIV)'' notes that, after the new reimbursement rules for 
     physicians were instituted in 2005, 42 percent of Medicare 
     beneficiaries who had received their IVIG treatment in their 
     physician's office at the end of 2004 were shifted to the 
     hospital outpatient setting by the beginning of 2006. This 
     shift in site of care has resulted in a lack of continuity of 
     care and has had an adverse impact on health outcomes and 
     quality of life.
       (7) The Office of Inspector General of the Department of 
     Health and Human Services also reported that 61 percent of 
     responding physicians indicated that they had sent patients 
     to hospitals for IVIG treatment, largely because of their 
     inability to purchase IVIG at prices below the Medicare 
     payment amounts. In addition, the Office of Inspector General 
     found that some physicians had stopped providing IVIG to 
     Medicare beneficiaries altogether.
       (8) The Office of Inspector General's 2007 report concluded 
     that whatever improvement some providers saw in the 
     relationship of Medicare reimbursement for IVIG to prices 
     paid during the first 3 quarters of 2006 would be eroded if 
     manufacturers were to increase prices for IVIG in the future.
       (9) The Centers for Medicare & Medicaid Services, in 
     recognition of dislocations experienced by patients and 
     providers in obtaining IVIG since the change to the ASP+6 
     reimbursement methodology, has provided a temporary 
     additional payment during 2006 and 2007 for IVIG 
     preadministration-related services to compensate physicians 
     and hospital outpatient departments for the extra resources 
     they have had to expend in locating and obtaining appropriate 
     IVIG products and in scheduling patient infusions.
       (10) Approximately 10,000 Medicare beneficiaries receive 
     IVIG treatment for their primary immunodeficiency disease in 
     a variety of different settings. Those beneficiaries have no 
     other effective treatment for their condition.
       (11) The Medicare Prescription Drug, Improvement, and 
     Modernization Act of 2003 established an IVIG home infusion 
     benefit for

[[Page 7960]]

     persons with primary immune deficiency disease, paying only 
     for IVIG and specifically excluding coverage of items and 
     services related to administration of the product.
       (12) The report of the Office of the Assistant Secretary 
     for Planning and Evaluation of the Department of Health and 
     Human Services, ``Analysis of Supply, Distribution, Demand, 
     and Access Issues Associated with Immune Globulin Intravenous 
     (IGIV)'', noted that, because of limitations in the Medicare 
     Prescription Drug, Improvement, and Modernization Act of 2003 
     provision, Medicare's IVIG home infusion benefit is not 
     designed to provide reimbursement for more than the cost of 
     IVIG and does not cover the cost of infusion services (such 
     as nursing and clinical services and supplies) in the home. 
     As a consequence, the report found that home infusion 
     providers generally do not accept new patients who have 
     primary immune deficiency disease and only have Medicare 
     coverage. These limitations in service are caused by health 
     care providers--
       (A) not being able to acquire IVIG at prices at or below 
     the Medicare part B reimbursement level; and
       (B) not being reimbursed for the infusion services provided 
     by a nurse.
       (13) Access to home infusion of IVIG for patients with 
     primary immune deficiency disease, who have a genetic or 
     intrinsic defect in their human immune system, will reduce 
     their exposure to infections at a time when their antibodies 
     are compromised and will improve the quality of care and 
     health of the patient.

     SEC. 3. MEDICARE PAYMENT FOR INTRAVENOUS IMMUNE GLOBULINS.

       (a) In General.--Section 1842(o) of the Social Security Act 
     (42 U.S.C. 1395u(o)) is amended--
       (1) in paragraph (1)(E)(ii), by inserting ``, plus an 
     additional amount (if applicable) under paragraph (7)'' 
     before the period at the end;
       (2) by redesignating paragraph (7) as paragraph (8); and
       (3) by inserting after paragraph (6) the following new 
     paragraph:
       ``(7)(A) Not later than 6 months after the date of 
     enactment of the Medicare IVIG Access Act of 2008, the 
     Secretary shall--
       ``(i) collect data on the differences, if any, between 
     payments to physicians for intravenous immune globulin under 
     paragraph (1)(E)(ii) and costs incurred by physicians for 
     furnishing such products; and
       ``(ii) review available data, including survey and pricing 
     data collected by the Federal Government and data presented 
     by members of the intravenous immune globulin community on 
     the access of individuals eligible for services under this 
     part to intravenous immune globulin and the differences 
     described in clause (i).
       ``(B) Subject to subparagraph (C), in the case of 
     intravenous immune globulin furnished on or after the date of 
     enactment of this paragraph, the Secretary shall continue the 
     IVIG preadministration-related services payment established 
     under the final rule promulgated by the Secretary in the 
     Federal Register on November 27, 2007 (72 Fed. Reg. 66254), 
     until such time as the Secretary determines that payment for 
     intravenous immune globulin is adequate.
       ``(C) Upon collection of data and completion of the review 
     under subparagraph (A), the Secretary shall, during a 2-year 
     period beginning not later than 7 months after such date of 
     enactment, provide, if appropriate, to physicians furnishing 
     intravenous immune globulins, a payment, in addition to the 
     payment under paragraph (1)(E)(ii) and instead of the IVIG 
     preadministration-related services payment under subparagraph 
     (B), for all items related to the furnishing of intravenous 
     immune globulin, in an amount the Secretary determines to be 
     appropriate.''.
       (b) As Part of Hospital Outpatient Services.--Section 
     1833(t)(14) of such Act (42 U.S.C. 1395l(t)(14)) is amended--
       (1) in subparagraph (A)(iii), by striking ``subparagraph 
     (E)'' and inserting ``subparagraphs (E) and (I)''; and
       (2) by adding at the end the following new subparagraph:
       ``(I) Additional payment for intravenous immune globulin.--
       ``(i) Data collection and review.--Not later than 6 months 
     after the date of enactment of the Medicare IVIG Access Act 
     of 2008, the Secretary shall--

       ``(I) collect data on the differences, if any, between 
     payments of intravenous immune globulin under subparagraph 
     (A)(iii) and costs incurred by a hospital for furnishing such 
     products; and
       ``(II) review available data, including survey and pricing 
     data collected by the Federal Government and data presented 
     by members of the intravenous immune globulin community on 
     the access of individuals eligible for services under this 
     part to intravenous immune globulin and the differences 
     described in subclause (I).

       ``(ii) Continuation of special payment rule.--Subject to 
     clause (iii), in the case of intravenous immune globulin 
     furnished on or after the date of enactment of this 
     subparagraph, the Secretary shall continue the IVIG 
     preadministration-related services payment established under 
     the final rule promulgated by the Secretary in the Federal 
     Register on November 27, 2007 (72 Fed. Reg. 66697), until 
     such time as the Secretary determines that payment for 
     intravenous immune globulin is adequate.
       ``(iii) Additional payment authority.--Upon collection of 
     data and completion of the review under clause (i), the 
     Secretary shall, during a 2-year period beginning not later 
     than 7 months after such date of enactment, provide, if 
     appropriate, to hospitals furnishing intravenous immune 
     globulin as part of a covered OPD service, in addition to the 
     payment under subparagraph (A)(iii) and instead of the IVIG 
     preadministration-related services payment under clause (ii), 
     for all items related to the furnishing of intravenous immune 
     globulin, in an amount the Secretary determines to be 
     appropriate.''.

     SEC. 4. COVERAGE AND PAYMENT OF INTRAVENOUS IMMUNE GLOBULIN 
                   IN THE HOME.

       (a) In General.--Section 1861 of the Social Security Act 
     (42 U.S.C. 1395x) is amended--
       (1) in subsection (s)(2)(Z), by inserting ``and items and 
     services related to the administration of intravenous immune 
     globulin'' after ``globulin''; and
       (2) in subsection (zz), by striking ``but not including 
     items or services related to the administration of the 
     derivative,''.
       (b) Payment for Intravenous Immune Globulin Administration 
     in the Home.--Section 1842(o) of the Social Security Act (42 
     U.S.C. 1395u(o), as amended by section 3, is amended--
       (1) in paragraph (1)(E)(ii), by striking ``paragraph (7)'' 
     and inserting ``paragraph (7) or (8)'';
       (2) by redesignating paragraph ``(8)'' as paragraph 
     ``(9)''; and
       (3) by inserting after paragraph (7) the following new 
     paragraph:
       ``(8)(A) Subject to subparagraph (B), in the case of 
     intravenous immune globulins described in section 
     1861(s)(2)(Z) that are furnished on or after January 1, 2008, 
     the Secretary shall provide for a separate payment for items 
     and services related to the administration of such 
     intravenous immune globulins in an amount that the Secretary 
     determines to be appropriate based on a review of available 
     published and unpublished data and information, including the 
     Study of Intravenous Immune Globulin Administration Options: 
     Safety, Access, and Cost Issues conducted by the Secretary 
     (CMS Contract #500-95-0059). Such payment amount may take 
     into account the following:
       ``(i) Pharmacy overhead and related expenses.
       ``(ii) Patient service costs.
       ``(iii) Supply costs.
       ``(B) The separate payment amount provided under this 
     paragraph for intravenous immune globulins furnished in 2009 
     or a subsequent year shall be equal to the separate payment 
     amount determined under this paragraph for the previous year 
     increased by the percentage increase in the medical care 
     component of the consumer price index for all urban consumers 
     (United States city average) for the 12-month period ending 
     with June of the previous year.''.

     SEC. 5. REPORTS.

       (a) Report by the Secretary.--Not later than 7 months after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services (in this section referred to as the 
     ``Secretary'') shall submit a report to Congress on the 
     following:
       (1) The results of the data collection and review conducted 
     by the Secretary under subparagraph (A) of section 1842(o)(7) 
     of the Social Security Act, as added by section 3(a), and 
     clause (i) of section 1833(t)(14)(I) of such Act, as added by 
     section 3(b).
       (2) Whether the Secretary plans to use the authority under 
     subparagraph (C) of such section 1842(o)(7) and clause (iii) 
     of such section 1833(t)(14)(I) to provide an additional 
     payment to physicians furnishing intravenous immune 
     globulins.
       (b) MedPAC Report.--Not later than 2 years after the date 
     of enactment of this Act, the Medicare Payment Advisory 
     Commission shall submit a report to the Secretary and to 
     Congress that contains the following:
       (1) In the case where the Secretary has used the authority 
     under sections 1842(o)(7)(C) and 1833(t)(14)(I)(iii) of the 
     Social Security Act, as added by subsections (a) and (b), 
     respectively, of section 3 to provide an additional payment 
     to physicians furnishing intravenous immune globulins during 
     the preceding year, an analysis of whether beneficiary access 
     to intravenous immune globulins under the Medicare program 
     under title XVIII of the Social Security Act has improved as 
     a result of the Secretary's use of such authority.
       (2) An analysis of the appropriateness of implementing a 
     new methodology for payment for intravenous immune globulins 
     under part B of title XVIII of the Social Security Act (42 
     U.S.C. 1395k et seq.).
       (3) An analysis of the feasibility of reducing the lag time 
     with respect to data used to determine average sales price 
     under section 1847A of the Social Security Act (42 U.S.C. 
     1395w-3a).
       (4) Recommendations for such legislation and administrative 
     action as the Medicare Payment Advisory Commission determines 
     appropriate, including recommendations for such legislation 
     and administrative action as the Commission determines is 
     necessary to implement any methodology analyzed under 
     paragraph (2).

[[Page 7961]]



     SEC. 6. OFFSET.

       Section 1861(n) of the Social Security Act (42 U.S.C. 
     1395x(n)) is amended by adding at the end the following: 
     ``Such term includes disposable drug delivery systems, 
     including elastomeric infusion pumps, for the treatment of 
     colorectal cancer.''.
                                 ______
                                 
      By Mr. REID (for himself, Mr. Schumer, Mr. Levin, Mr. Wyden, Mr. 
        Inouye, Mr. Cardin, Ms. Stabenow, Mr. Brown, Mr. Whitehouse, 
        Mrs. Feinstein, Mr. Johnson, Mr. Kennedy, Ms. Klobuchar, Mr. 
        Lautenberg, Mr. Leahy, Ms. Mikulski, Mrs. Murray, Mr. Reed, 
        Mrs. McCaskill, and Mr. Durbin):
  S. 2991. A bill to provide energy price relief and hold oil companies 
and other entities accountable for their actions with regard to high 
energy prices, and for other purposes; read the first time.
  Mr. REID. Mr. President, I ask unanimous consent that the text of the 
bill be printed in the Record.
  There being no objection, the text of the bill was ordered to be 
placed in the Record, as follows:

                                S. 2991

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

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

       (a) Short Title.--This Act may be cited as the ``Consumer-
     First Energy Act of 2008''.
       (b) Table of Contents.--The table of contents of this Act 
     is as follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.

             TITLE I--TAX PROVISIONS RELATED TO OIL AND GAS

Sec. 101. Denial of deduction for major integrated oil companies for 
              income attributable to domestic production of oil, gas, 
              or primary products thereof.
Sec. 102. Elimination of the different treatment of foreign oil and gas 
              extraction income and foreign oil related income for 
              purposes of the foreign tax credit.
Sec. 103. Windfall profits tax.
Sec. 104. Energy Independence and Security Trust Fund.

                        TITLE II--PRICE GOUGING

Sec. 201. Short title.
Sec. 202. Definitions.
Sec. 203. Energy emergency and additional price gouging enforcement.
Sec. 204. Presidential declaration of energy emergency.
Sec. 205. Enforcement by the Federal Trade Commission.
Sec. 206. Enforcement by State attorneys general.
Sec. 207. Penalties.
Sec. 208. Effect on other laws.

                 TITLE III--STRATEGIC PETROLEUM RESERVE

Sec. 301. Suspension of petroleum acquisition for Strategic Petroleum 
              Reserve.

            TITLE IV--NO OIL PRODUCING AND EXPORTING CARTELS

Sec. 401. No Oil Producing and Exporting Cartels Act of 2008.

                      TITLE V--MARKET SPECULATION

Sec. 501. Speculative limits and transparency for off-shore oil 
              trading.
Sec. 502. Margin level for crude oil.

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) excessive prices for petroleum products have created, 
     or imminently threaten to create, severe economic 
     dislocations and hardships, including the loss of jobs, 
     business failures, disruption of economic activity, 
     curtailment of vital public services, and price increases 
     throughout the economy;
       (2) those hardships and dislocations jeopardize the normal 
     flow of commerce and constitute a national energy and 
     economic crisis that is a threat to the public health, 
     safety, and welfare of the United States;
       (3) consumers, workers, small businesses, and large 
     businesses of the United States are particularly vulnerable 
     to those price increase due to the failure of the President 
     to aggressively develop alternatives to petroleum and 
     petroleum products and to promote efficiency and 
     conservation;
       (4) reliable and affordable supplies of crude oil and 
     products refined from crude oil (including gasoline, diesel 
     fuel, heating oil, and jet fuel) are vital to the economic 
     and national security of the United States given current 
     energy infrastructure and technology;
       (5) the price of crude oil and products refined from crude 
     oil (including gasoline, diesel fuel, heating oil, and jet 
     fuel) have skyrocketed to record levels and are continuing to 
     rise;
       (6) since 2001, oil prices have increased from $29 per 
     barrel to levels near $120 per barrel and gasoline prices 
     have more than doubled from $1.47 per gallon to more than 
     $3.50 per gallon;
       (7) the record prices for crude oil and products refined 
     from crude oil (including gasoline, diesel fuel, heating oil, 
     and jet fuel)--
       (A) are hurting millions of consumers, workers, small 
     businesses, and large businesses of the United States, and 
     threaten long-term damage to the economy and security of the 
     United States;
       (B) are partially due to--
       (i) the declining value of the dollar and a widespread lack 
     of confidence in the management of economic and foreign 
     policy by the President;
       (ii) the accumulation of national debt and growing budget 
     deficits under the failed economic policies of the President; 
     and
       (iii) high levels of military expenditures under the failed 
     policies of the President in Iraq; and
       (C) are no longer justified by traditional forces of supply 
     and demand;
       (8) rampant speculation in the markets for crude oil and 
     products refined from crude oil has magnified the price 
     increases and market volatility resulting from those 
     underlying causes of price increases; and
       (9) Congress must take urgent action to protect consumers, 
     workers, and businesses of the United States from rampant 
     speculation in the energy markets and the price increases 
     resulting from the failed domestic and foreign policies of 
     the President.

             TITLE I--TAX PROVISIONS RELATED TO OIL AND GAS

     SEC. 101. DENIAL OF DEDUCTION FOR MAJOR INTEGRATED OIL 
                   COMPANIES FOR INCOME ATTRIBUTABLE TO DOMESTIC 
                   PRODUCTION OF OIL, GAS, OR PRIMARY PRODUCTS 
                   THEREOF.

       (a) In General.--Subparagraph (B) of section 199(c)(4) 
     (relating to exceptions) is amended by striking ``or'' at the 
     end of clause (ii), by striking the period at the end of 
     clause (iii) and inserting ``, or'', and by inserting after 
     clause (iii) the following new clause:
       ``(iv) in the case of any major integrated oil company (as 
     defined in section 167(h)(5)(B)), the production, refining, 
     processing, transportation, or distribution of oil, gas, or 
     any primary product thereof during any taxable year described 
     in section 167(h)(5)(B).''.
       (b) Primary Product.--Section 199(c)(4)(B) is amended by 
     adding at the end the following flush sentence:

     ``For purposes of clause (iv), the term `primary product' has 
     the same meaning as when used in section 927(a)(2)(C), as in 
     effect before its repeal.''.
       (c) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2008.

     SEC. 102. ELIMINATION OF THE DIFFERENT TREATMENT OF FOREIGN 
                   OIL AND GAS EXTRACTION INCOME AND FOREIGN OIL 
                   RELATED INCOME FOR PURPOSES OF THE FOREIGN TAX 
                   CREDIT.

       (a) In General.--Subsections (a) and (b) of section 907 of 
     the Internal Revenue Code of 1986 (relating to special rules 
     in case of foreign oil and gas income) are amended to read as 
     follows:
       ``(a) Reduction in Amount Allowed as Foreign Tax Under 
     Section 901.--In applying section 901, the amount of any 
     foreign oil and gas taxes paid or accrued (or deemed to have 
     been paid) during the taxable year which would (but for this 
     subsection) be taken into account for purposes of section 901 
     shall be reduced by the amount (if any) by which the amount 
     of such taxes exceeds the product of--
       ``(1) the amount of the combined foreign oil and gas income 
     for the taxable year,
       ``(2) multiplied by--
       ``(A) in the case of a corporation, the percentage which is 
     equal to the highest rate of tax specified under section 
     11(b), or
       ``(B) in the case of an individual, a fraction the 
     numerator of which is the tax against which the credit under 
     section 901(a) is taken and the denominator of which is the 
     taxpayer's entire taxable income.
       ``(b) Combined Foreign Oil and Gas Income; Foreign Oil and 
     Gas Taxes.--For purposes of this section--
       ``(1) Combined foreign oil and gas income.--The term 
     `combined foreign oil and gas income' means, with respect to 
     any taxable year, the sum of--
       ``(A) foreign oil and gas extraction income, and
       ``(B) foreign oil related income.
       ``(2) Foreign oil and gas taxes.--The term `foreign oil and 
     gas taxes' means, with respect to any taxable year, the sum 
     of--
       ``(A) oil and gas extraction taxes, and
       ``(B) any income, war profits, and excess profits taxes 
     paid or accrued (or deemed to have been paid or accrued under 
     section 902 or 960) during the taxable year with respect to 
     foreign oil related income (determined without regard to 
     subsection (c)(4)) or loss which would be taken into account 
     for purposes of section 901 without regard to this 
     section.''.
       (b) Recapture of Foreign Oil and Gas Losses.--Paragraph (4) 
     of section 907(c) of the Internal Revenue Code of 1986 
     (relating to recapture of foreign oil and gas extraction 
     losses by recharacterizing later extraction income) is 
     amended to read as follows:
       ``(4) Recapture of foreign oil and gas losses by 
     recharacterizing later combined foreign oil and gas income.--

[[Page 7962]]

       ``(A) In general.--The combined foreign oil and gas income 
     of a taxpayer for a taxable year (determined without regard 
     to this paragraph) shall be reduced--
       ``(i) first by the amount determined under subparagraph 
     (B), and
       ``(ii) then by the amount determined under subparagraph 
     (C).

     The aggregate amount of such reductions shall be treated as 
     income (from sources without the United States) which is not 
     combined foreign oil and gas income.
       ``(B) Reduction for pre-2008 foreign oil extraction 
     losses.--The reduction under this paragraph shall be equal to 
     the lesser of--
       ``(i) the foreign oil and gas extraction income of the 
     taxpayer for the taxable year (determined without regard to 
     this paragraph), or
       ``(ii) the excess of--

       ``(I) the aggregate amount of foreign oil extraction losses 
     for preceding taxable years beginning after December 31, 
     1982, and before January 1, 2008, over
       ``(II) so much of such aggregate amount as was 
     recharacterized under this paragraph (as in effect before and 
     after the date of the enactment of the Consumer-First Energy 
     Act of 2008) for preceding taxable years beginning after 
     December 31, 1982.

       ``(C) Reduction for post-2008 foreign oil and gas losses.--
     The reduction under this paragraph shall be equal to the 
     lesser of--
       ``(i) the combined foreign oil and gas income of the 
     taxpayer for the taxable year (determined without regard to 
     this paragraph), reduced by an amount equal to the reduction 
     under subparagraph (A) for the taxable year, or
       ``(ii) the excess of--

       ``(I) the aggregate amount of foreign oil and gas losses 
     for preceding taxable years beginning after December 31, 
     2008, over
       ``(II) so much of such aggregate amount as was 
     recharacterized under this paragraph for preceding taxable 
     years beginning after December 31, 2008.

       ``(D) Foreign oil and gas loss defined.--
       ``(i) In general.--For purposes of this paragraph, the term 
     `foreign oil and gas loss' means the amount by which--

       ``(I) the gross income for the taxable year from sources 
     without the United States and its possessions (whether or not 
     the taxpayer chooses the benefits of this subpart for such 
     taxable year) taken into account in determining the combined 
     foreign oil and gas income for such year, is exceeded by
       ``(II) the sum of the deductions properly apportioned or 
     allocated thereto.

       ``(ii) Net operating loss deduction not taken into 
     account.--For purposes of clause (i), the net operating loss 
     deduction allowable for the taxable year under section 172(a) 
     shall not be taken into account.
       ``(iii) Expropriation and casualty losses not taken into 
     account.--For purposes of clause (i), there shall not be 
     taken into account--

       ``(I) any foreign expropriation loss (as defined in section 
     172(h) (as in effect on the day before the date of the 
     enactment of the Revenue Reconciliation Act of 1990)) for the 
     taxable year, or
       ``(II) any loss for the taxable year which arises from 
     fire, storm, shipwreck, or other casualty, or from theft,

     to the extent such loss is not compensated for by insurance 
     or otherwise.
       ``(iv) Foreign oil extraction loss.--For purposes of 
     subparagraph (B)(ii)(I), foreign oil extraction losses shall 
     be determined under this paragraph as in effect on the day 
     before the date of the enactment of the Consumer-First Energy 
     Act of 2008.''.
       (c) Carryback and Carryover of Disallowed Credits.--Section 
     907(f) of the Internal Revenue Code of 1986 (relating to 
     carryback and carryover of disallowed credits) is amended--
       (1) by striking ``oil and gas extraction taxes'' each place 
     it appears and inserting ``foreign oil and gas taxes'', and
       (2) by adding at the end the following new paragraph:
       ``(4) Transition rules for pre-2009 and 2009 disallowed 
     credits.--
       ``(A) Pre-2009 credits.--In the case of any unused credit 
     year beginning before January 1, 2009, this subsection shall 
     be applied to any unused oil and gas extraction taxes carried 
     from such unused credit year to a year beginning after 
     December 31, 2008--
       ``(i) by substituting `oil and gas extraction taxes' for 
     `foreign oil and gas taxes' each place it appears in 
     paragraphs (1), (2), and (3), and
       ``(ii) by computing, for purposes of paragraph (2)(A), the 
     limitation under subparagraph (A) for the year to which such 
     taxes are carried by substituting `foreign oil and gas 
     extraction income' for `foreign oil and gas income' in 
     subsection (a).
       ``(B) 2009 credits.--In the case of any unused credit year 
     beginning in 2009, the amendments made to this subsection by 
     the Consumer-First Energy Act of 2008 shall be treated as 
     being in effect for any preceding year beginning before 
     January 1, 2009, solely for purposes of determining how much 
     of the unused foreign oil and gas taxes for such unused 
     credit year may be deemed paid or accrued in such preceding 
     year.''.
       (d) Conforming Amendment.--Section 6501(i) of the Internal 
     Revenue Code of 1986 is amended by striking ``oil and gas 
     extraction taxes'' and inserting ``foreign oil and gas 
     taxes''.
       (e) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2008.

     SEC. 103. WINDFALL PROFITS TAX.

       (a) In General.--Subtitle E of the Internal Revenue Code of 
     1986 (relating to alcohol, tobacco, and certain other excise 
     taxes) is amended by adding at the end thereof the following 
     new chapter:

              ``CHAPTER 56--WINDFALL PROFITS ON CRUDE OIL

``Sec. 5896. Imposition of tax.
``Sec. 5897. Windfall profit; qualified investment.
``Sec. 5898. Special rules and definitions.

     ``SEC. 5896. IMPOSITION OF TAX.

       ``(a) In General.--In addition to any other tax imposed 
     under this title, there is hereby imposed on any applicable 
     taxpayer an excise tax in an amount equal to 25 percent of 
     the excess of--
       ``(1) the windfall profit of such taxpayer, over
       ``(2) the amount of the qualified investment of such 
     applicable taxpayer.
       ``(b) Applicable Taxpayer.--For purposes of this chapter, 
     the term `applicable taxpayer' means any major integrated oil 
     company (as defined in section 167(h)(5)(B)).

     ``SEC. 5897. WINDFALL PROFIT; QUALIFIED INVESTMENT.

       ``(a) General Rule.--For purposes of this chapter, the term 
     `windfall profit' means the excess of the adjusted taxable 
     income of the applicable taxpayer for the taxable year over 
     the reasonably inflated average profit for such taxable year.
       ``(b) Adjusted Taxable Income.--For purposes of this 
     chapter, with respect to any applicable taxpayer, the 
     adjusted taxable income for any taxable year is equal to the 
     taxable income for such taxable year (within the meaning of 
     section 63 and determined without regard to this 
     subsection)--
       ``(1) increased by any interest expense deduction, 
     charitable contribution deduction, and any net operating loss 
     deduction carried forward from any prior taxable year, and
       ``(2) reduced by any interest income, dividend income, and 
     net operating losses to the extent such losses exceed taxable 
     income for the taxable year.

     In the case of any applicable taxpayer which is a foreign 
     corporation, the adjusted taxable income shall be determined 
     with respect to such income which is effectively connected 
     with the conduct of a trade or business in the United States.
       ``(c) Reasonably Inflated Average Profit.--For purposes of 
     this chapter, with respect to any applicable taxpayer, the 
     reasonably inflated average profit for any taxable year is an 
     amount equal to the average of the adjusted taxable income of 
     such taxpayer for taxable years beginning during the 2001-
     2005 taxable year period (determined without regard to the 
     taxable year with the highest adjusted taxable income in such 
     period) plus 10 percent of such average.
       ``(d) Qualified Investment.--For purposes of this chapter--
       ``(1) In general.--The term `qualified investment' means, 
     with respect to any applicable taxpayer, means any amount 
     paid or incurred with respect to--
       ``(A) section 263(c) costs,
       ``(B) qualified refinery property (as defined in section 
     179C(c) and determined without regard to any termination 
     date),
       ``(C) any qualified facility described in paragraph (1), 
     (2), (3), or (4) of section 45(d) (determined without regard 
     to any placed in service date), or
       ``(D) any facility for the production renewable fuel or 
     advanced biofuel (as defined in section 211(o) of the Clean 
     Air Act 942 U.S.C. 7545).
       ``(2) Section 263(c) costs.--For purposes of this 
     subsection, the term `section 263(c) costs' means intangible 
     drilling and development costs incurred by the taxpayer which 
     (by reason of an election under section 263(c)) may be 
     deducted as expenses for purposes of this title (other than 
     this paragraph). Such term shall not include costs incurred 
     in drilling a nonproductive well.

     ``SEC. 5898. SPECIAL RULES AND DEFINITIONS.

       ``(a) Withholding and Deposit of Tax.--The Secretary shall 
     provide such rules as are necessary for the withholding and 
     deposit of the tax imposed under section 5896.
       ``(b) Records and Information.--Each taxpayer liable for 
     tax under section 5896 shall keep such records, make such 
     returns, and furnish such information as the Secretary may by 
     regulations prescribe.
       ``(c) Return of Windfall Profit Tax.--The Secretary shall 
     provide for the filing and the time of such filing of the 
     return of the tax imposed under section 5896.
       ``(d) Crude Oil.--The term `crude oil' includes crude oil 
     condensates and natural gasoline.
       ``(e) Businesses Under Common Control.--For purposes of 
     this chapter, all members of the same controlled group of 
     corporations (within the meaning of section 267(f)) and all 
     persons under common control (within the meaning of section 
     52(b) but determined by treating an interest of more than 50 
     percent as a controlling interest) shall be treated as 1 
     person.

[[Page 7963]]

       ``(f) Regulations.--The Secretary shall prescribe such 
     regulations as may be necessary or appropriate to carry out 
     the purposes of this chapter.''.
       (b) Clerical Amendment.--The table of chapters for subtitle 
     E of the Internal Revenue Code of 1986 is amended by adding 
     at the end the following new item:

             ``Chapter 56. Windfall Profit on Crude Oil.''.

       (c) Deductibility of Windfall Profit Tax.--The first 
     sentence of section 164(a) of the Internal Revenue Code of 
     1986 (relating to deduction for taxes) is amended by 
     inserting after paragraph (5) the following new paragraph:
       ``(6) The windfall profit tax imposed by section 5896.''.
       (d) Effective Date.--The amendments made by this section 
     shall apply to taxable years beginning after December 31, 
     2007.

     SEC. 104. ENERGY INDEPENDENCE AND SECURITY TRUST FUND.

       (a) Establishment.--Subchapter A of chapter 98 of the 
     Internal Revenue Code of 1986 (relating to trust fund code) 
     is amended by adding at the end the following new section:

     ``SEC. 9511. ENERGY INDEPENDENCE AND SECURITY TRUST FUND.

       ``(a) Creation of Trust Fund.--There is established in the 
     Treasury of the United States a trust fund to be known as 
     `Energy Independence and Security Trust Fund' (referred to in 
     this section as the `Trust Fund'), consisting of such amounts 
     as may be appropriated or credited to the Trust Fund as 
     provided in this section or section 9602(b).
       ``(b) Transfers to Trust Fund.--There is hereby 
     appropriated to the Trust Fund an amount equivalent to the 
     increase in the revenues received in the Treasury as the 
     result of the amendments made by sections 101, 102, and 103 
     of the Consumer-First Energy Act of 2008.
       ``(c) Distribution of Amounts in Trust Fund.--Amounts in 
     the Trust Fund shall be available, as provided by 
     appropriation Acts, for the purposes of reducing the 
     dependence of the United States on foreign and unsustainable 
     energy sources and reducing the risks of global warming 
     through programs and measures that--
       ``(1) reduce the burdens on consumers of rising energy 
     prices;
       ``(2) diversify and expand the use of secure, efficient, 
     and environmentally-friendly energy supplies and 
     technologies;
       ``(3) result in net reductions in emissions of greenhouse 
     gases; and
       ``(4) prevent energy price gouging, profiteering, and 
     market manipulation.''.
       (b) Clerical Amendment.--The table of sections for 
     subchapter A of chapter 98 of such Code is amended by adding 
     at the end the following new item:

``Sec. 9511. Energy Independence and Security Trust Fund.''.

       (c) Effective Date.--The amendments made by this section 
     shall take effect on the date of the enactment of this Act.

                        TITLE II--PRICE GOUGING

     SEC. 201. SHORT TITLE.

       This title may be cited as the ``Petroleum Consumer Price 
     Gouging Protection Act''.

     SEC. 202. DEFINITIONS.

       In this title:
       (1) Affected area.--The term ``affected area'' means an 
     area covered by a Presidential declaration of energy 
     emergency.
       (2) Supplier.--The term ``supplier'' means any person 
     engaged in the trade or business of selling or reselling, at 
     retail or wholesale, or distributing crude oil, gasoline, 
     petroleum distillates, or biofuel.
       (3) Price gouging.--The term ``price gouging'' means the 
     charging of an unconscionably excessive price by a supplier 
     in an affected area.
       (4) Unconscionably excessive price.--The term 
     ``unconscionably excessive price'' means an average price 
     charged during an energy emergency declared by the President 
     in an area and for a product subject to the declaration, 
     that--
       (A)(i)(I) constitutes a gross disparity from the average 
     price at which it was offered for sale in the usual course of 
     the supplier's business during the 30 days prior to the 
     President's declaration of an energy emergency; and
       (II) grossly exceeds the prices at which the same or 
     similar crude oil, gasoline, petroleum distillates, or 
     biofuel was readily obtainable by purchasers from other 
     suppliers in the same relevant geographic market within the 
     affected area; or
       (ii) represents an exercise of unfair leverage or 
     unconscionable means on the part of the supplier, during a 
     period of declared energy emergency; and
       (B) is not attributable to increased wholesale or 
     operational costs, including replacement costs, outside the 
     control of the supplier, incurred in connection with the sale 
     of crude oil, gasoline, petroleum distillates, or biofuel, 
     and is not attributable to local, regional, national, or 
     international market conditions.
       (5) Commission.--The term ``Commission'' means the Federal 
     Trade Commission.

     SEC. 203. ENERGY EMERGENCY AND ADDITIONAL PRICE GOUGING 
                   ENFORCEMENT.

       (a) In General.--During any energy emergency declared by 
     the President under section 204 of this title, it is unlawful 
     for any supplier to sell, or offer to sell crude oil, 
     gasoline, petroleum distillates, or biofuel subject to that 
     declaration in, or for use in, the area to which that 
     declaration applies at an unconscionably excessive price.
       (b) Factors Considered.--In determining whether a violation 
     of subsection (a) has occurred, there shall be taken into 
     account, among other factors, whether--
       (1) the price charged was a price that would reasonably 
     exist in a competitive and freely functioning market; and
       (2) the amount of gasoline, other petroleum distillates, or 
     biofuel the seller produced, distributed, or sold during the 
     period the Proclamation was in effect increased over the 
     average amount during the preceding 30 days.

     SEC. 204. PRESIDENTIAL DECLARATION OF ENERGY EMERGENCY.

       (a) In General.--If the President finds that the health, 
     safety, welfare, or economic well-being of the citizens of 
     the United States is at risk because of a shortage or 
     imminent shortage of adequate supplies of crude oil, 
     gasoline, petroleum distillates, or biofuel due to a 
     disruption in the national distribution system for crude oil, 
     gasoline, petroleum distillates, or biofuel (including such a 
     shortage related to a major disaster (as defined in section 
     102(2) of the Robert T. Stafford Disaster Relief and 
     Emergency Assistance Act (42 U.S.C. 5122(2))), or significant 
     pricing anomalies in national energy markets for crude oil, 
     gasoline, petroleum distillates, or biofuel the President may 
     declare that a Federal energy emergency exists.
       (b) Scope and Duration.--The emergency declaration shall 
     specify--
       (1) the period, not to exceed 30 days, for which the 
     declaration applies;
       (2) the circumstance or condition necessitating the 
     declaration; and
       (3) the area or region to which it applies which may not be 
     limited to a single State; and
       (4) the product or products to which it applies.
       (c) Extensions.--The President may--
       (1) extend a declaration under subsection (a) for a period 
     of not more than 30 days;
       (2) extend such a declaration more than once; and
       (3) discontinue such a declaration before its expiration.

     SEC. 205. ENFORCEMENT BY THE FEDERAL TRADE COMMISSION.

       (a) Enforcement.--This title shall be enforced by the 
     Federal Trade Commission in the same manner, by the same 
     means, and with the same jurisdiction as though all 
     applicable terms of the Federal Trade Commission Act were 
     incorporated into and made a part of this title. In enforcing 
     section 203 of this title, the Commission shall give priority 
     to enforcement actions concerning companies with total United 
     States wholesale or retail sales of crude oil, gasoline, 
     petroleum distillates, and biofuel in excess of $500,000,000 
     per year but shall not exclude enforcement actions against 
     companies with total United States wholesale sales of 
     $500,000,000 or less per year.
       (b) Violation Is Treated as Unfair or Deceptive Act or 
     Practice.--The violation of any provision of this title shall 
     be treated as an unfair or deceptive act or practice 
     proscribed under a rule issued under section 18(a)(1)(B) of 
     the Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).
       (c) Commission Actions.--Following the declaration of an 
     energy emergency by the President under section 204 of this 
     title, the Commission shall--
       (1) maintain within the Commission--
       (A) a toll-free hotline that a consumer may call to report 
     an incident of price gouging in the affected area; and
       (B) a program to develop and distribute to the public 
     informational materials to assist residents of the affected 
     area in detecting, avoiding, and reporting price gouging;
       (2) consult with the Attorney General, the United States 
     Attorney for the districts in which a disaster occurred (if 
     the declaration is related to a major disaster), and State 
     and local law enforcement officials to determine whether any 
     supplier in the affected area is charging or has charged an 
     unconscionably excessive price for crude oil, gasoline, 
     petroleum distillates, or biofuel in the affected area; and
       (3) conduct investigations as appropriate to determine 
     whether any supplier in the affected area has violated 
     section 203 of this title, and upon such finding, take any 
     action the Commission determines to be appropriate to remedy 
     the violation.

     SEC. 206. ENFORCEMENT BY STATE ATTORNEYS GENERAL.

       (a) In General.--A State, as parens patriae, may bring a 
     civil action on behalf of its residents in an appropriate 
     district court of the United States to enforce the provisions 
     of section 203 of this title, or to impose the civil 
     penalties authorized by section 207 for violations of section 
     203, whenever the attorney general of the State has reason to 
     believe that the interests of the residents of the State have 
     been or are being threatened or adversely affected by a 
     supplier engaged in the sale or resale, at retail or 
     wholesale,

[[Page 7964]]

     or distribution of crude oil, gasoline, petroleum 
     distillates, or biofuel in violation of section 203 of this 
     title.
       (b) Notice.--The State shall serve written notice to the 
     Commission of any civil action under subsection (a) prior to 
     initiating the action. The notice shall include a copy of the 
     complaint to be filed to initiate the civil action, except 
     that if it is not feasible for the State to provide such 
     prior notice, the State shall provide such notice immediately 
     upon instituting the civil action.
       (c) Authority to Intervene.--Upon receiving the notice 
     required by subsection (b), the Commission may intervene in 
     the civil action and, upon intervening--
       (1) may be heard on all matters arising in such civil 
     action; and
       (2) may file petitions for appeal of a decision in such 
     civil action.
       (d) Construction.--For purposes of bringing any civil 
     action under subsection (a), nothing in this section shall 
     prevent the attorney general of a State from exercising the 
     powers conferred on the Attorney General by the laws of such 
     State to conduct investigations or to administer oaths or 
     affirmations or to compel the attendance of witnesses or the 
     production of documentary and other evidence.
       (e) Venue; Service of Process.--In a civil action brought 
     under subsection (a)--
       (1) the venue shall be a judicial district in which--
       (A) the defendant operates;
       (B) the defendant was authorized to do business; or
       (C) where the defendant in the civil action is found;
       (2) process may be served without regard to the territorial 
     limits of the district or of the State in which the civil 
     action is instituted; and
       (3) a person who participated with the defendant in an 
     alleged violation that is being litigated in the civil action 
     may be joined in the civil action without regard to the 
     residence of the person.
       (f) Limitation on State Action While Federal Action Is 
     Pending.--If the Commission has instituted a civil action or 
     an administrative action for violation of this title, a State 
     attorney general, or official or agency of a State, may not 
     bring an action under this section during the pendency of 
     that action against any defendant named in the complaint of 
     the Commission or the other agency for any violation of this 
     title alleged in the Commission's civil or administrative 
     action.
       (g) No Preemption.--Nothing contained in this section shall 
     prohibit an authorized State official from proceeding in 
     State court to enforce a civil or criminal statute of that 
     State.

     SEC. 207. PENALTIES.

       (a) Civil Penalty.--
       (1) In general.--In addition to any penalty applicable 
     under the Federal Trade Commission Act, any supplier--
       (A) that violates section 203 of this title is punishable 
     by a civil penalty of not more than $1,000,000; and
       (B) that violates section 203 of this title is punishable 
     by a civil penalty of--
       (i) not more than $500,000, in the case of an independent 
     small business marketer of gasoline (within the meaning of 
     section 324(c) of the Clean Air Act (42 U.S.C. 7625(c))); and
       (ii) not more than $5,000,000 in the case of any other 
     supplier.
       (2) Method.--The penalties provided by paragraph (1) shall 
     be obtained in the same manner as civil penalties imposed 
     under section 5 of the Federal Trade Commission Act (15 
     U.S.C. 45).
       (3) Multiple offenses; mitigating factors.--In assessing 
     the penalty provided by subsection (a)--
       (A) each day of a continuing violation shall be considered 
     a separate violation; and
       (B) the court shall take into consideration, among other 
     factors, the seriousness of the violation and the efforts of 
     the person committing the violation to remedy the harm caused 
     by the violation in a timely manner.
       (b) Criminal Penalty.--Violation of section 203 of this 
     title is punishable by a fine of not more than $5,000,000, 
     imprisonment for not more than 5 years, or both.

     SEC. 208. EFFECT ON OTHER LAWS.

       (a) Other Authority of the Commission.--Nothing in this 
     title shall be construed to limit or affect in any way the 
     Commission's authority to bring enforcement actions or take 
     any other measure under the Federal Trade Commission Act (15 
     U.S.C. 41 et seq.) or any other provision of law.
       (b) State Law.--Nothing in this title preempts any State 
     law.

                 TITLE III--STRATEGIC PETROLEUM RESERVE

     SEC. 301. SUSPENSION OF PETROLEUM ACQUISITION FOR STRATEGIC 
                   PETROLEUM RESERVE.

       (a) In General.--Except as provided in subsection (b) and 
     notwithstanding any other provision of law, during the period 
     beginning on the date of enactment of this Act and ending on 
     December 31, 2008--
       (1) the Secretary of the Interior shall suspend acquisition 
     of petroleum for the Strategic Petroleum Reserve through the 
     royalty-in-kind program; and
       (2) the Secretary of Energy shall suspend acquisition of 
     petroleum for the Strategic Petroleum Reserve through any 
     other acquisition method.
       (b) Resumption.--Not earlier than 30 days after the date on 
     which the President notifies Congress that the President has 
     determined that the weighted average price of petroleum in 
     the United States for the most recent 90-day period is $75 or 
     less per barrel--
       (1) the Secretary of the Interior may resume acquisition of 
     petroleum for the Strategic Petroleum Reserve through the 
     royalty-in-kind program; and
       (2) the Secretary of Energy may resume acquisition of 
     petroleum for the Strategic Petroleum Reserve through any 
     other acquisition method.
       (c) Existing Contracts.--In the case of any oil scheduled 
     to be delivered to the Strategic Petroleum Reserve pursuant 
     to a contract entered into by the Secretary of Energy prior 
     to, and in effect on, the date of enactment of this Act, the 
     Secretary shall, to the maximum extent practicable, negotiate 
     a deferral of the delivery of the oil for a period of not 
     less than 1 year, in accordance with procedures of the 
     Department of Energy in effect on the date of enactment of 
     this Act for deferrals of oil.

            TITLE IV--NO OIL PRODUCING AND EXPORTING CARTELS

     SEC. 401. NO OIL PRODUCING AND EXPORTING CARTELS ACT OF 2008.

       (a) Short Title.--This section may be cited as the ``No Oil 
     Producing and Exporting Cartels Act of 2008'' or ``NOPEC''.
       (b) Sherman Act.--The Sherman Act (15 U.S.C. 1 et seq.) is 
     amended by adding after section 7 the following:

     ``SEC. 7A. OIL PRODUCING CARTELS.

       ``(a) In General.--It shall be illegal and a violation of 
     this Act for any foreign state, or any instrumentality or 
     agent of any foreign state, to act collectively or in 
     combination with any other foreign state, any instrumentality 
     or agent of any other foreign state, or any other person, 
     whether by cartel or any other association or form of 
     cooperation or joint action--
       ``(1) to limit the production or distribution of oil, 
     natural gas, or any other petroleum product;
       ``(2) to set or maintain the price of oil, natural gas, or 
     any petroleum product; or
       ``(3) to otherwise take any action in restraint of trade 
     for oil, natural gas, or any petroleum product;

     when such action, combination, or collective action has a 
     direct, substantial, and reasonably foreseeable effect on the 
     market, supply, price, or distribution of oil, natural gas, 
     or other petroleum product in the United States.
       ``(b) Sovereign Immunity.--A foreign state engaged in 
     conduct in violation of subsection (a) shall not be immune 
     under the doctrine of sovereign immunity from the 
     jurisdiction or judgments of the courts of the United States 
     in any action brought to enforce this section.
       ``(c) Inapplicability of Act of State Doctrine.--No court 
     of the United States shall decline, based on the act of state 
     doctrine, to make a determination on the merits in an action 
     brought under this section.
       ``(d) Enforcement.--The Attorney General of the United 
     States may bring an action to enforce this section in any 
     district court of the United States as provided under the 
     antitrust laws.''.
       (c) Sovereign Immunity.--Section 1605(a) of title 28, 
     United States Code, is amended--
       (1) in paragraph (6), by striking ``or'' after the 
     semicolon;
       (2) in paragraph (7), by striking the period and inserting 
     ``; or''; and
       (3) by adding at the end the following:
       ``(8) in which the action is brought under section 7A of 
     the Sherman Act.''.

                      TITLE V--MARKET SPECULATION

     SEC. 501. SPECULATIVE LIMITS AND TRANSPARENCY FOR OFF-SHORE 
                   OIL TRADING.

       Section 4 of the Commodity Exchange Act (7 U.S.C. 6) is 
     amended by adding at the end the following:
       ``(e) Foreign Boards of Trade.--
       ``(1) In general.--In the case of any foreign board of 
     trade for which the Commission has granted or is considering 
     an application to grant a board of trade located outside of 
     the United States relief from the requirement of subsection 
     (a) to become a designated contract market, derivatives 
     transaction execution facility, or other registered entity, 
     with respect to an energy commodity that is physically 
     delivered in the United States, prior to continuing to or 
     initially granting the relief, the Commission shall determine 
     that the foreign board of trade--
       ``(A) applies comparable principles or requirements 
     regarding the daily publication of trading information and 
     position limits or accountability levels for speculators as 
     apply to a designated contract market, derivatives 
     transaction execution facility, or other registered entity 
     trading energy commodities physically delivered in the United 
     States; and
       ``(B) provides such information to the Commission regarding 
     the extent of speculative and nonspeculative trading in the 
     energy commodity that is comparable to the information the 
     Commission determines necessary to publish a Commitment of 
     Traders report for a designated contract market, derivatives 
     transaction execution facility, or

[[Page 7965]]

     other registered entity trading energy commodities physically 
     delivered in the United States.
       ``(2) Existing foreign boards of trade.--During the period 
     beginning 1 year after the date of enactment of this 
     subsection and ending 18 months after the date of enactment 
     of this subsection, the Commission shall determine whether to 
     continue to grant relief in accordance with paragraph (1) to 
     any foreign board of trade for which the Commission granted 
     relief prior to the date of enactment of this subsection.''.

     SEC. 502. MARGIN LEVEL FOR CRUDE OIL.

       (a) In General.--Section 2(a)(1) of the Commodity Exchange 
     Act (7 U.S.C. 2(a)(1)) is amended by adding at the end the 
     following:
       ``(G) Margin level for crude oil.--Not later than 90 days 
     after the date of enactment of this subparagraph, the 
     Commission shall promulgate regulations to set a substantial 
     increase in margin levels for crude oil traded on any trading 
     facility or as part of any agreement, contract, or 
     transaction covered by this Act in order to reduce excessive 
     speculation and protect consumers.''.
       (b) Studies.--
       (1) Study relating to effect of certain regulations.--Not 
     later than 1 year after the date of enactment of this Act, 
     the Commodity Futures Trading Commission shall submit to the 
     appropriate committees of Congress a report describing the 
     effect of the amendment made by subsection (a) on any trading 
     facilities and agreements, contracts, and transactions 
     covered by the Commodity Exchange Act (7 U.S.C. 1 et seq.).
       (2) Study relating to effects of changes in margin 
     levels.--Not later than 180 days after the date of enactment 
     of this Act, the Comptroller General of the United States 
     shall submit to the appropriate committees of Congress a 
     report describing the effect (including any effect relating 
     to trade volume or volatility) of any change of a margin 
     level that occurred during the 10-year period ending on the 
     date of enactment of this Act.

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