[Congressional Record Volume 154, Number 75 (Wednesday, May 7, 2008)]
[Senate]
[Pages S3893-S3906]
From the Congressional Record Online through the 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,
[[Page S3894]]
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.
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
[[Page S3895]]
the $2,300,000,000,000 spent annually on healthcare in the
United States, and for 16 percent of gross domestic product;
(C) to research and development vacuums in the private for-
profit market, such as in the fields of vaccine and
antibiotic production, drugs for Third World diseases, orphan
drugs, and medical tools for pediatric populations; and
(D) to facilitate the process of converting medical
innovations into commercial products.
(5) Key components of the translational research process
include research prioritization, a strengthening and
maintenance of an expert workforce, multidisciplinary
collaborative work, strategic risk taking, support of small
innovative businesses caught along common pathways in the
research and development Valley of Death, simplification and
promotion of the clinical research endeavor, and early
involvement of private entities that are skilled in the
manufacturing and marketing process in the translational
research endeavor.
(6) A National Academy of Sciences/Institute of Medicine
report made recommendations for reorganizing NIH to meet new
challenges facing the biomedical research endeavor. The
committee report contained specific recommendations aimed at
strengthening clinical and translational research including:
increasing trans-NIH research, promoting innovation and risk
taking in intramural research, creating a ``special
projects'' program, and increasing funding for research
management and support.
(7) The Government Accountability Office reported that
although the pharmaceutical industry has increased its
research and development investment by 147 percent from 1993
to 2004, new drug applications to the Food and Drug
Administration have only increased by 39 percent; thus, the
productivity of the industry's research and development
expenditures is declining. The report cited that a limited
scientific understanding of how to translate research
discoveries into safe and effective drugs is contributing to
the problem and recommended that training researchers who can
translate drug discoveries into effective medicines is
necessary.
(8) It is estimated to take 17 years for a science
discovery to be translated from the point of proof of concept
to clinical application. The percent of physicians engaged in
research has declined steadily from a peak of 4.6 percent in
1985 to 1.8 percent in 2003.
(9) A report by the Infectious Disease Society of America
cited concerns with the lack of new antibiotics to treat
infectious diseases. The report commended the NIH Roadmap,
but also recommended that NIH aggressively expand the
translational research components of the Roadmap, increase
grants to small businesses, universities, and nonprofits
working in antibiotics research and development, and seek
more opportunities to partner with pharmaceutical and biotech
companies.
(10) Clinical effectiveness results provide patients,
payers, and clinicians with tools to evaluate the benefits
versus risks of the ever evolving number of prevention,
diagnosis, and treatment strategies available.
(11) The Common Fund is an annual set aside account created
from an agreed upon percentage of the annual budget that
supports innovative and trans-NIH initiatives to improve and
accelerate research to impact health.
(12) The ``Valley of Death'' is a stage in biomedical
development between research and commercialization where the
success of a product is dependent on its profitability.
(b) Purpose.--The purpose of this Act is to create a new
pathway to curing disease by enhancing public and private
research to translate new discoveries from bench to bedside.
SEC. 4. ACCELERATING CURES ACT OF 2008.
Title IV of the Public Health Service Act (42 U.S.C. 281 et
seq.) is amended by adding at the end the following:
``PART J--ACCELERATING CURES
``Subpart 1--Pathways to Cures Subcommittee
``SEC. 499A. PATHWAYS TO CURES SUBCOMMITTEE.
``(a) Definition of Translational Research.--In this
section, the term `translational research' means research
that transforms scientific discoveries arising from
laboratory, clinical, or population studies into clinical
application to reduce disease incidence, morbidity, and
mortality.
``(b) Establishment of Pathways to Cures Subcommittee.--
There is established a Pathways to Cures Subcommittee within
the Council of Councils of the Office of Portfolio Analysis
and Strategic Initiatives of the National Institutes of
Health that shall convene not less frequently than twice a
year to help advise and direct the translational research
priorities of the Office of Portfolio Analysis and Strategic
Initiatives (referred to in this part as the `OPASI').
``(c) Membership.--
``(1) In general.--The subcommittee established under
subsection (b) may be composed of the following members:
``(A) The Director of NIH and the Director of OPASI who
shall be subcommittee co-chairs.
``(B) The heads of the institutes and centers of the
National Institutes of Health.
``(C) Heads from Federal agencies, including--
``(i) the Administrator for the Substance Abuse and Mental
Health Services Administration;
``(ii) the Under Secretary for Science and Technology of
the Department of Homeland Security;
``(iii) the Commanding General for the United States Army
Medical Research and Materiel Command;
``(iv) the Director of the Centers for Disease Control and
Prevention;
``(v) the Commissioner of Food and Drugs;
``(vi) the Director of the Office of Science of the
Department of Energy;
``(vii) the President of the Institute of Medicine;
``(viii) the Director of the Agency for Healthcare Research
and Quality; and
``(ix) the Director of the Defense Advanced Research
Projects Agency.
``(2) Other members.--The subcommittee established under
subsection (b) shall also include not fewer than 3 leaders
from the small business medical research community, 3 leaders
from large pharmaceutical or biotechnology companies, and 3
leaders from academia and patient advocacy organizations, all
of whom shall be appointed by the Director of NIH.
``(d) Recommendations; Coordination; Funding.--
``(1) Setting priorities.--The subcommittee established
under subsection (b) shall make recommendations to assist the
Director of OPASI in setting translational research
priorities.
``(2) Recommendations.--In making recommendations, the
subcommittee shall--
``(A) consider risk and burden of disease as well as lines
of research uniquely poised to deliver effective diagnostics
and therapies; and
``(B) be mission-driven and identify research that shows
specific promise for a new treatment or cure for a disease.
``(3) Coordination.--The subcommittee shall ensure sharing
of research agendas among the institutes and centers of the
National Institutes of Health for the purpose of coordinating
translational research priorities, where appropriate, across
such institutes and centers.
``(4) Funding.--The subcommittee and the Director of
OPASI--
``(A) shall identify research with application or
commercialization potential; and
``(B) may fund such research.
``(e) Report.--The subcommittee established under
subsection (b) shall submit an annual report to Congress on
progress towards finding new treatments and cures.
``Subpart 2--Clinical Effectiveness; FFRDC
``SEC. 499B. FEDERALLY FUNDED RESEARCH AND DEVELOPMENT
CENTER.
``(a) Establishment of Center.--
``(1) In general.--The Director of NIH, in conjunction with
the Director of the Agency for Healthcare Research and
Quality (referred to in this subpart as the `AHRQ'), shall
establish a Federally Funded Research and Development Center
(referred to in this subpart as the `FFRDC') on clinical
effectiveness research.
``(2) Definition of clinical effectiveness research.--In
this section, the term `clinical effectiveness research'
means research that--
``(A) provides information for health care decision makers,
including patients, providers, and public and private payers,
to make evidence-based decisions about the delivery of health
care; and
``(B) considers specific subpopulations.
``(3) Director of the ffrdc.--The Director of NIH, in
conjunction with the Director of the AHRQ, shall appoint a
Director of the FFRDC.
``(b) Duties of the Director of the FFRDC.--The Director of
the FFRDC shall--
``(1) review, synthesize, and disseminate clinical
effectiveness research;
``(2) set priorities for, and fund, trials, such as
randomized controlled trials, adaptive trials, and practical
trials, observational studies, secondary data analysis in
areas of clinical effectiveness research where evidence is
lacking, systematic reviews of existing research, as
necessary, and cost-effectiveness studies;
``(3) make recommendations regarding the findings of
paragraphs (1) and (2);
``(4) study the differential outcomes of interventions on
subpopulations within diseases;
``(5) use competitive award processes, including, but not
solely, competitive peer review, and examine methods of rapid
review cycles to reduce delays in funding decisions;
``(6) encourage the development and use of electronic
health data to conduct clinical effectiveness research for
the goal of improving clinical care delivery;
``(7) support the development of methodological standards
to be used when conducting studies of clinical effectiveness
and value in order to help ensure accurate and effective
comparisons and update such standards not less frequently
than annually;
``(8) include, and collaborate and consult with, as
necessary, the Food and Drug Administration, the Centers for
Medicare & Medicaid Services, the Centers for Disease Control
and Prevention, the Department of Defense, the Department of
Veterans Affairs, and other Federal agencies, and the
Institute of Medicine, as well as private payers, insurers,
pharmaceutical and device companies, patient advocacy and
public interest groups, professional societies, hospitals,
academic institutions, and health foundations;
``(9) establish a public review or hearing process, which
includes the Food and Drug Administration, to examine
findings of studies;
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``(10) determine the best approach to make available the
findings resulting from subparagraphs (A) and (B) to relevant
Federal agencies, private and public stakeholders in the
health care system, and consumers;
``(11) provide a public forum for addressing conflicting
guidelines and recommendations; and
``(12) submit annual reports to Congress on the research
activities and findings of the FFRDC.
``(c) Clinical Effectiveness Advisory Board.--
``(1) Establishment and function.--The Director of the
FFRDC shall establish, in conjunction with the Director of
NIH and the Director of the AHRQ, an independent Clinical
Effectiveness Advisory Board (referred to in this section as
the `Advisory Board'), to include not more than 20 appointed
members, in order to provide expert advice and guidance on
the research priorities of the FFRDC.
``(2) Membership.--
``(A) In general.--Membership on the Advisory Board shall
be comprised of--
``(i) representatives of the National Institutes of Health,
the AHRQ, the Food and Drug Administration, the Centers for
Medicare & Medicaid Services, the Centers for Disease Control
and Prevention, the Department of Defense, the Department of
Veterans Affairs, and other Federal agencies, and the
Institute of Medicine; and
``(ii) private payers, insurers, pharmaceutical and device
companies, patient advocacy and public interest groups,
professional societies, hospitals, academic institutions, and
health foundations.
``(B) Experts.--Membership on the Advisory Board shall
consist of leading experts from diverse disciplinary areas,
including physicians, social scientists, statisticians,
health services researchers, economists, and other health
care professionals.
``(C) Terms.--Terms for members of the Advisory Board shall
be fixed, multiyear, and staggered.
``(D) Appointment.--The members of the Advisory Board who
are described in subparagraph (A)(ii) shall be appointed by
the Director of the FFRDC, the Director of NIH, and the
Director of the AHRQ.
``(E) Chair.--The Director of the AHRQ shall be chair of
the Advisory Board.
``(3) Conflicts of interest.--Members of the Advisory Board
shall disclose any financial, political, or organizational
conflicts of interest in conducting the work of the Advisory
Board.
``(4) Duties.--The Advisory Board shall--
``(A) recommend priorities for clinical effectiveness
research to be undertaken by the FFRDC, taking into
consideration significant gaps in clinical effectiveness
research, including research needs for information on
subpopulations and diverse populations, including women,
children, and racial and ethnic minorities, and on
individuals with comorbid diseases;
``(B) identify existing and novel research designs and
methods that may be considered by the FFRDC in conducting
clinical effectiveness research;
``(C) review clinical effectiveness research methods;
``(D) review the FFRDC processes to determine whether the
research conducted is objective, credible, developed through
a transparent process that includes consultations with
appropriate stakeholders, including consumers, patient
organizations, and the public, and is clinically relevant;
``(E) make recommendations to the AHRQ and the National
Institutes of Health for the effective dissemination of the
findings of the FFRDC supported research to clinicians,
payers, and consumers, and patient organizations; and
``(F) following the first year, review current and previous
research agendas and make recommendations regarding research
agendas.
``(5) Initial meeting.--The initial meeting of the Advisory
Board shall be no later than 6 months after the date of
enactment of the Accelerating Cures Act of 2008.
``(6) Advisory nature of board.--The recommendations of the
Advisory Board shall not be binding, but shall be considered
by the Director of the FFRDC when developing the clinical
effectiveness research agenda.
``(d) Research Agenda.--The Director of the FFRDC shall
establish the research agenda of the FFRDC, based on the
priorities established by the Advisory Board, and shall
update such agenda not less frequently than annually, and
shall--
``(1) focus on--
``(A) identifying gaps in clinical effectiveness research
relating to medical procedures, medical technologies,
pharmaceuticals, health information technologies, and other
relevant services and products that significantly contribute
to health care outcomes and expenditures;
``(B) funding trials, studies, and reviews, and
coordinating these efforts with ongoing research efforts in
the Federal Government, academic institutions, and private
entities to fill gaps identified under subparagraph (A);
``(C) synthesizing and reviewing clinical effectiveness
research to fill gaps identified under subparagraph (A); and
``(D) supporting the development of an evidence base for
the development of clinical care guidelines based on the
results of clinical effectiveness research;
``(2) convene such working groups on clinical effectiveness
research as the Director of the FFRDC determines necessary;
``(3) meet with members representing the National
Institutes of Health, the AHRQ, the Food and Drug
Administration, the Centers for Medicare & Medicaid Services,
the Centers for Disease Control and Prevention, the
Department of Defense, the Department of Veterans Affairs,
and other Federal agencies, and the Institute of Medicine, as
well as private payers, insurers, pharmaceutical and device
companies, patient advocacy and public interest groups,
professional societies, hospitals, academic institutions,
practice based research networks health foundations, and the
general public to promote communication and transparency; and
``(4) notify the public well in advance of any public
meetings.
``(e) Reports.--
``(1) Guidance or recommendations.--The Director of the
FFRDC, in conjunction with the Director of NIH and the
Director of the AHRQ, shall provide, not less frequently than
annually, guidance or recommendations to health care
providers, payers, and consumers, and Congressional
committees of jurisdiction on the comparative effectiveness
of health care services.
``(2) Status reports.--The Director of the FFRDC shall
provide annual status reports on the work of the FFRDC to
Congressional committees of jurisdiction.
``(f) Availability of Research Findings.--The Director of
the FFRDC shall develop and identify efficient and effective
methods of disseminating the findings of the clinical
effectiveness assessments of medical procedures,
technologies, and therapeutics, including by making these
available on the Internet. Any relevant reports (including
interim progress reports, draft final clinical effectiveness
reviews, and final progress reports on new research submitted
for publication) on the results of clinical effectiveness
research supported by the FFRDC shall be made available on
the Internet, not later than 90 days after the report is
completed.
``(g) Evaluations and Reports of FFRDC.--The Director of
NIH, in conjunction with the Director of the AHRQ, shall
enter into regular agreements with entities, such as the
Institute of Medicine, to--
``(1) evaluate the FFRDC and its functioning; and
``(2) produce reports on priority setting for the FFRDC,
and on research methods developed and employed by the FFRDC,
among other purposes.
``Subpart 3--Health Advanced Research Projects Program
``SEC. 499C. HEALTH ADVANCED RESEARCH PROJECTS PROGRAM.
``(a) Establishment.--There is established within the
OPASI, a Health Advanced Research Projects Program (referred
to in this section as the `Research Projects Program') that
shall be headed by a Director of the Research Projects
Program who is appointed by the Director of NIH.
``(b) Composition.--The Research Projects Program shall be
composed of portfolio managers in key health areas, which are
determined by the Director of the Research Projects Program
in conjunction with the Director of OPASI, the Director of
NIH, and the Pathways to Cures Subcommittee established under
section 499A.
``(c) Guidance.--The Research Projects Program shall be
guided by and shall undertake grand challenges that encourage
innovative, multidisciplinary, and collaborative research
across institutes and centers of the National Institutes of
Health, across Federal agencies, and between public and
private partners of the National Institutes of Health.
``(d) Management Guidance.--The Research Projects Program
shall be guided by the following management and organizing
principles in directing the Research Projects Program:
``(1) Keep the Research Projects Program small, flexible,
entrepreneurial, and non-hierarchical, and empower portfolio
managers with substantial autonomy to foster research
opportunities with freedom from bureaucratic impediments in
administering the manager's portfolios.
``(2) Seek to employ the strongest scientific and technical
talent in the Nation in research fields in which the Research
Projects Program is working.
``(3) Rotate a significant portion of the staff after 3 to
5 years of experience to ensure continuous entry of new
talent into the Research Projects Program.
``(4) Use, whenever possible, research and development
investments by the Research Projects Program to leverage
comparable matching investment and coordinated research from
other institutes and centers of the National Institutes of
Health, from other Federal agencies, and from the private and
nonprofit research sectors.
``(5) Utilize supporting technical, contracting, and
administrative personnel from other institutes and centers of
the National Institutes of Health in administering and
implementing research efforts to encourage participation,
collaboration, and cross-fertilization of ideas across the
National Institutes of Health.
``(6) Utilize a challenge model in Research Projects
Program research efforts, creating a translational research
model that supports fundamental research breakthroughs, early
and late stage applied development, prototyping, knowledge
diffusion, and technology deployment.
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``(7) Establish metrics to evaluate research success and
periodically revisit ongoing research efforts to carefully
weigh new research opportunities against ongoing research.
``(8) Support risk-taking in research pursuits and tolerate
productive failure.
``(9) Ensure that revolutionary and breakthrough technology
research dominates the Research Projects Program's research
agenda and portfolio.
``(e) Activities.--Using the funds and authorities provided
to the Director of NIH, the Research Projects Program shall
carry out the following activities:
``(1) The Research Projects Program shall support basic and
applied health research to promote revolutionary technology
changes that promote health.
``(2) The Research Projects Program shall advance the
development, testing, evaluation, prototyping, and deployment
of critical health products.
``(3) The Research Projects Program, consistent with
recommendations of the Pathways to Cures Subcommittee
established under section 499A, with the priorities of OPASI,
and with the grand challenges that encourage innovative,
multidisciplinary, and collaborative research, shall
emphasize--
``(A) translational research efforts, including efforts
conducted through collaboration with the private sector, that
pursue--
``(i) innovative health products that could address acute
health threats such as a flu pandemic, spread of antibiotic
resistant hospital acquired infections, or other comparable
problems;
``(ii) remedies for diseases afflicting lesser developed
countries;
``(iii) remedies for orphan diseases for which the for-
profit sector is not finding new treatments;
``(iv) alternative technologies with significant health
promise that are not well-supported in the system of health
research, such as adjuvant technology or technologies for
vaccines based on the innate immunological response; and
``(v) fast track development, including development through
accelerated completion of animal and human clinical trials,
for emerging remedies for significant public health problems;
and
``(B) other appropriate translational research efforts for
critical health issues.
``(4) The Research Projects Program shall utilize funds to
provide support to outstanding research performers in all
sectors and encourage cross-disciplinary research
collaborations that will allow scientists from fields such as
information and computer sciences, nanotechnology, chemistry,
physics, and engineering to work alongside top researchers
with more traditional biomedical backgrounds.
``(5) The Research Projects Program shall provide selected
research projects with single-year or multiyear funding and
require researchers for such projects to provide interim
progress reports, including milestones on progress, to the
Research Projects Program on not less frequently than a
biannual basis.
``(6) The Research Projects Program shall award
competitive, merit-reviewed grants, cooperative agreements,
or contracts to public or private entities, including
businesses, federally-funded research and development
centers, and universities.
``(7) The Research Projects Program shall provide advice to
the Director of OPASI concerning funding priorities.
``(8) The Research Projects Program may solicit proposals
for competitions to address specific health vulnerabilities
identified by the Director of NIH and the Director of OPASI
and award prizes for successful outcomes.
``(9) The Research Projects Program shall periodically hold
health research and technology demonstrations to improve
contact among researchers, technology developers, vendors,
and acquisition personnel.
``(10) The Research Projects Program shall carry out other
activities determined appropriate by the Director of NIH.
``(f) Employees.--
``(1) Hiring.--The Director of the Research Projects
Program, in hiring employees for positions with the Research
Projects Program, shall have the same hiring and management
authorities as described in section 1101 of the Strom
Thurmond National Defense Authorization Act for Fiscal Year
1999 (5 U.S.C. 3104 note).
``(2) Term.--
``(A) In general.--Except as provided in subparagraph (B),
the term of such appointments for employees of the Research
Projects Program may not exceed 5 years.
``(B) Extension.--The Director of the Research Projects
Program may, in the case of a particular employee of the
Research Projects Program, extend the term to which
employment is limited under subparagraph (A) by not more than
2 years if the Director of the Research Projects Program
determines that such action is necessary to promote the
efficiency of the Research Projects Program.
``(g) Flexibility.--The Director of the Research Projects
Program shall have the authority to flexibly fund projects,
including the prompt awarding, releasing, enhancing, or
withdrawal of monies in accordance with the assessment of the
Research Projects Program and project manager.
``Subpart 4--Clinical Trials
``SEC. 499D. GRANTS FOR QUALITY CLINICAL TRIAL DESIGN AND
EXECUTION.
``The Director of OPASI--
``(1) shall award grants for clinical trial design and
execution to academic centers and practice-based research
networks to fund multidisciplinary clinical research teams,
which clinical research teams may be composed of members who
include project managers, clinicians, epidemiologists, social
scientists, and clinical research coordinators; and
``(2) may award grants for clinical trial design and
execution to researchers.
``SEC. 499D-1. STREAMLINING THE REGULATORY PROCESS GOVERNING
CLINICAL RESEARCH.
``(a) Establishment of Centralized Institutional Review
Boards.--
``(1) In general.--
``(A) Establishment and oversight.--The Director of OPASI
shall appoint a Director of Centralized Institutional Review
Boards (referred to in this part as the `Director of CIRBs')
who shall establish and oversee the functioning and progress
of a series of Centralized Institutional Review Boards
(referred to in this part as `CIRBs') to serve as human
subject safety and well-being custodians for multi-
institutional clinical trials that are funded partially or in
full by public research dollars.
``(B) Work with fda.--The Director of CIRBs shall work with
the Commissioner of Food and Drugs to make regulations
governing multi-site clinical trials and the regulatory
requirements of the Food and Drug Administration more
consistent in order to reduce barriers to commercialization
of new treatments.
``(2) Existing guidelines and best practices.--CIRBs shall
be established in accordance with professional best practices
and Good Clinical Practice (GCP) guidelines so that
institutions involved in multi-institutional studies may--
``(A) use joint review;
``(B) rely upon the review of another qualified
institutional review board; or
``(C) use similar arrangements to avoid duplication of
effort and to assure a high-quality of expert oversight.
``(b) Housed.--Each CIRB shall be housed--
``(1) at the institute or center of the National Institutes
of Health with expertise on the subject of the clinical
trial; or
``(2) at a public or private institution with comparable
organizational capacity, such as the Department of Veterans
Affairs.
``(c) Service.--The use of CIRBs shall be available, as
appropriate, at the request of public or private institutions
and shall be funded through user fees of the CIRBs or the
National Institutes of Health's funds.
``(d) Review Process.--
``(1) In general.--Each CIRB shall review research
protocols and subject informed consent forms to ensure the
protection of safety and well-being of research participants
enrolled in multi-institutional clinical trials.
``(2) Process.--The CIRB review process shall consist of
contractual agreements between the CIRB and the study sites
of multi-institutional clinical trials. The CIRB shall act on
behalf, in whole or in part, of the bodies ordinarily
responsible for the safety of research subjects in a
locality. In the case in which a locality does not have such
a body, the locality shall depend solely on the CIRB to
oversee the protection of human subjects and the CIRB shall
assume responsibility for ensuring adequate assessment of the
local research context.
``(e) Research Applications.--
``(1) In general.--Each CIRB shall review and package
research applications for facilitated electronic review by
local institutional review boards participating in a multi-
institutional clinical trial.
``(2) CIRB review.--A local institutional review board may
accept or reject a CIRB review. In the case in which a local
institutional review board accepts a CIRB review, the CIRB
shall assume responsibility for annual, amendment, and
adverse event reviews. If a local institutional review board
elects to decline participation in the CIRB, the local
institutional review board shall appoint a liaison to the
CIRB.
``(f) Work in Concert.--In the case in which a local
institutional review board works in concert with a CIRB, the
local institutional review board shall be responsible for
taking into consideration local characteristics (including
ethnicity, educational level, and other demographic
characteristics) of the population from which research
subjects will be drawn, which influence, among other things,
whether there is sound selection of research subjects or
whether adequate provision is made to minimize risks to
vulnerable populations.
``(g) Communication of Important Information.--Each CIRB
shall regularly communicate important information in
electronic form to the local institutional review boards or,
in cases where a local institutional review board does not
exist, to the principal investigator, including regular
safety updates or requirements to change a research protocol
in order to improve safety.
``(h) Coordination.--Each CIRB shall fully coordinate with
the institute or center of the National Institutes of Health
that has specialized knowledge of the research area of the
clinical trial. Other Federal agencies and private entities
undertaking clinical trials may contract with the National
Institutes of Health to use a CIRB.
``SEC. 499D-2. CLINICAL RESEARCH STUDY AND CLINICAL TRIAL.
``(a) In General.--The Director of NIH shall--
``(1) commission the Institute of Medicine to study the
rules that protect patient safety
[[Page S3898]]
and anonymity so that in a contemporary clinical research
context, a better balance can be achieved between clinical
research promotion and regulatory requirements governing
research subject safety and privacy;
``(2) examine informed consent processes; and
``(3) request that the Institute of Medicine issue a
written report not later than 18 months after the date of
enactment of the Accelerating Cures Act of 2008 that shall--
``(A) consider changes to the Health Insurance Portability
and Accountability Act of 1996 (Public Law 104-191) and the
amendments made by such Act that further promote the clinical
research endeavor; and
``(B) include recommendations for changes that shall not be
limited to legislation but shall include changes to
healthcare systems, including health information technology,
and to researcher practice that facilitate the clinical
research endeavor.
``Subpart 5--Training Clinical and Translational Researchers of the
Future
``SEC. 499E. TRAINING TRANSLATIONAL AND CLINICAL RESEARCHERS
OF THE FUTURE.
``(a) In General.--
``(1) Establishment of program.--The Director of OPASI
shall establish training programs to increase the number of,
and maintain existing, translational and clinical
researchers, including researchers trained in community-based
research.
``(2) Purpose.--The purpose of the training programs
described in paragraph (1) shall be to train a cadre of
researchers in core competencies in the translational and
clinical sciences for the ultimate goal of improving
healthcare delivery, healthcare options to the public, the
use of healthcare by patients, and healthcare outcomes.
``(b) Grants.--
``(1) In general.--The Director of OPASI shall award grants
to, and enter into contracts with, public and nonprofit
educational entities to establish, strengthen, or expand
training programs for researchers to be trained in the
translational and clinical sciences.
``(2) Awarding of grants.--The Director of OPASI shall
award grants to, and enter into contracts with, applicants
that--
``(A) support multidisciplinary approaches in training;
``(B) utilize collaborative strategies for conducting
research across various disciplines to translate basic
science discoveries; and
``(C) train researchers focused on improving care and
patient outcomes.
``(3) Required use of funds.--The Director of OPASI shall
award grants to, and enter into contracts with, entities for
the following purposes:
``(A) To establish training programs for M.D. and Ph.D.
researchers in translational or clinical research.
``(B) To establish training programs for individuals at
predoctoral levels, including those in medical school, and
for allied health professionals, in translational or clinical
research.
``(C) To establish training programs for nurses in
translational and clinical research.
``(D) To strengthen or expand existing training programs
for translational or clinical researchers.
``(E) To establish a wide range of training programs,
including one-year training programs, summer programs, pre-
and postdoctoral clinical or translational research
fellowships, and advanced research training programs for mid-
career researchers and clinicians.
``(F) To provide stipends and allowances, including for
travel and subsistence expenses, in amounts the Director of
OPASI determines appropriate, to support the training of
translational or clinical researchers.
``(G) To provide financial assistance to public and
nonprofit educational entities for the purpose of supporting
the training of translational or clinical researchers,
through clinical education, curricula, and technological
support, and other measures.
``(H) To measure the impact of the translational and
clinical research training programs on the biomedical
sciences and on clinical practice.
``(c) Funds Available.--The Director of OPASI may make
funds available to support training programs for
translational or clinical researchers at the National
Institutes of Health for entities awarded grants or contracts
under subsection (b).
``(d) Novel and Best Practices.--The Director of OPASI
shall convene, on not less frequently than a biannual basis,
members of training institutions to share novel and best
practices in training translational or clinical researchers.
``(e) Training.--A trainee of a program funded under a
grant or contract awarded under this section may conduct part
of the trainee's training at the Health Advanced Research
Projects Program.
``(f) Consistent Definitions and Methodologies.--For the
purposes of funding training programs for clinical
researchers, the Director of NIH shall develop consistent
definitions and methodologies to classify and report clinical
research.
``SEC. 499E-1. TRANSLATIONAL RESEARCH TRAINING PROGRAM.
``The Director of NIH shall ensure that each institute and
center of the National Institutes of Health has established,
or contracted for the establishment of, a translational
research training program at the institute or center.
``Subpart 6--The `Valley of Death'
``SEC. 499F. SMALL BUSINESS PARTNERSHIPS.
``(a) In General.--An independent advisory board shall be
established at the National Academy of Sciences to conduct
periodic evaluations of the Small Business Innovation
Research program (referred to in this subpart as the `SBIR
program') and the Small Business Technology Transfer program
(referred to in this subpart as the `STTR program') of the
Office of Extramural Research in the Office of the Director
of the National Institutes of Health for the purpose of
improving management of the programs through data-driven
assessment. The advisory board shall consist of the Director
of NIH, the Director of the SBIR program, senior National
Institutes of Health agency managers, university and industry
experts, and program stakeholders.
``(b) Sbir and Sttr Grants and Contracts.--
``(1) In general.--
``(A) Program managers with sufficient expertise.--Not less
than 25 percent of the grants and contracts awarded by each
of the SBIR and STTR programs shall be awarded on a
competitive basis by an SBIR or STTR program manager who has
sufficient managerial, technical, and translational research
expertise to expertly assess the quality of a SBIR or STTR
proposal.
``(B) Experience of program managers.--In hiring new SBIR
or STTR program managers, the Director of NIH shall consider
experience in commercialization or industry.
``(C) Emphasis on grant and contract awards.--In awarding
grants and contracts under the SBIR program and the STTR
program--
``(i) each SBIR and STTR program manager shall place an
emphasis on applications that identify from the onset
products with commercial potential to prevent, diagnose, and
treat diseases, as well as promote health and well-being; and
``(ii) risk-taking shall be supported and productive
failure shall be tolerated.
``(2) Examination of commercialization and other metrics.--
The independent advisory board described in subsection (a)
shall evaluate the success of the requirement under paragraph
(1)(A) by examining increased commercialization and other
metrics, to be determined and collected by SBIR and STTR
programs.
``(3) Success.--Each recipient of a SBIR or STTR grant or
contract, as a condition of receiving such grant or contract,
shall report to the SBIR or STTR program--
``(A) whether there was eventual commercial success of the
product developed with the assistance of the grant or
contract; and
``(B) on other metrics as determined by the SBIR or STTR
program to capture broader measures of success.
``(c) Potential Purchasers or Investors.--The SBIR and STTR
programs shall administer nonpeer review grants and contracts
pursuant to this section through program managers who shall
place special emphasis on partnering grantees and entities
awarded contracts from the very beginning of the research and
development process with potential purchasers or investors of
the product, including large pharmaceutical or biotechnology
companies, venture capital firms, and Federal agencies
(including the National Institutes of Health).
``(d) Phase I and II.--The SBIR and STTR programs shall
reduce the time period between Phase I and Phase II funding
of grants and contracts under the SBIR and STTR programs to--
``(1) 6 months; or
``(2) less than 6 months if the grantee or entity awarded a
contract demonstrates that the grantee or entity awarded a
contract has interest from third parties to buy or fund the
product development with the grant or contract.
``(e) Phase III.--A SBIR or STTR program manager may
petition the Director of NIH for Phase III funding of a grant
or contract for a project that requires a boost to finalize
procurement of a product. The maximum funding for Phase III
funding shall be $2,000,000 for each of a maximum of 2 years.
Such Phase III funding may come from the Common Fund of the
NIH.
``(f) Evaluation and Reporting Requirements.--In order to
enhance the evidence base guiding SBIR and STTR program
decisions and changes, the SBIR and STTR programs shall--
``(1) conduct regular internal and external evaluations of
the program;
``(2) review current data collection methods for the
purpose of identifying gaps and deficiencies, and develop a
formal plan for evaluation and assessment of program success,
including operational benchmarks for success; and
``(3) conduct a review on the number of SBIR and STTR
awards made to women and minorities and develop outreach and
review strategies to increase the number of awards to women
and minorities.
``(g) Pilot Programs.--
``(1) In general.--The SBIR and STTR programs may initiate
pilot programs, based on the development of a formal
mechanism for designing, implementing, and evaluating pilot
programs, to spur innovation and to test new strategies that
may enhance the effectiveness of the program.
``(2) Considerations.--The SBIR and STTR programs shall
consider, among other issues, conducting pilot programs on
including individuals with commercialization experience
[[Page S3899]]
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 199 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 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
[[Page S3900]]
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.
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
[[Page S3901]]
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 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:
[[Page S3902]]
``(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).
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.
[[Page S3903]]
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.--
``(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
[[Page S3904]]
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.
``(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:
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(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, 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
[[Page S3906]]
(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 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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