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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 3320 Introduced in Senate (IS)]

111th CONGRESS
  2d Session
                                S. 3320

  To amend the Public Health Service Act to provide for a Pancreatic 
               Cancer Initiative, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                              May 6, 2010

Mr. Whitehouse introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
  To amend the Public Health Service Act to provide for a Pancreatic 
               Cancer Initiative, and for other purposes.

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

SECTION 1. SHORT TITLE; FINDINGS.

    (a) Short Title.--This Act may be cited as the ``Pancreatic Cancer 
Research and Education Act''.
    (b) Findings.--The Congress finds the following:
            (1) Nearly 42,500 Americans were expected to be diagnosed 
        with pancreatic cancer in 2009 and nearly 35,250 were expected 
        to die from the disease. The incidence among African-Americans 
        is 40 to 50 percent higher than other ethnic groups.
            (2) Pancreatic cancer is one of the few cancers for which 
        survival has not improved substantially over the past 40 years. 
        As a result, in 2003, pancreatic cancer surpassed prostate 
        cancer as the 4th leading cause of cancer-related death in the 
        United States.
            (3) Seventy-six percent of pancreatic cancer patients die 
        within the first 12 months of the diagnosis. The 5-year 
        survival rate is 5 percent.
            (4) Scientific understanding of pancreatic cancer--its 
        etiology, pathogenesis, detection, and treatment--lags far 
        behind that of most other forms of cancer. In fact, pancreatic 
        cancer research is where breast cancer research was in the 
        1930s--little understanding of the causes, no early detection, 
        few effective treatments, and single-digit survival rates.
            (5) In 2001, the National Cancer Institute developed 
        ``Pancreatic Cancer: An Agenda for Action''. Nine years later, 
        only five of the report's 39 recommendations have been 
        implemented because of a lack of funding, focus, and 
        commitment. In the meantime, pancreatic cancer death rates have 
        continued to increase. Further, according to the Cancer Trends 
        Progress Report--2009/2010 Update, death rates for pancreatic 
        cancer are increasing while death rates for all cancers 
        combined, including the four most common cancers (prostate, 
        breast, lung, and colorectal), continue to decline.
            (6) Pancreatic cancer research constitutes less than 2 
        percent of the National Cancer Institute's Federal research 
        funding, a figure far too low given the severity of the 
        disease, its mortality rate, and how little is known about how 
        to arrest the disease.
            (7) Of the more than 5,000 research grants awarded annually 
        by the Nations Cancer Institute in 2006, only 134 
        (approximately 3 percent) were categorized by the Institute as 
        at least 50 percent relevant to pancreatic cancer research.
            (8) The future supply of scientists entering this field of 
        study is in serious jeopardy. Out of the researchers who 
        received National Cancer Institute funding specifically for 
        pancreatic cancer research in 2008, only 38 received funding 
        totaling $500,000 or more, a level appropriate for senior 
        scientists. By comparison, this level of funding was awarded to 
        273 breast cancer researchers, 129 prostate cancer researchers, 
        and 121 colorectal cancer researchers. Further, in the last 3 
        years, the National Cancer Institute has awarded only 5 grants 
        for training and supporting new principal investigators in 
        pancreatic cancer.
            (9) In 2007, the Scientific Advisory Board of the 
        Pancreatic Cancer Action Network reviewed the current state of 
        the science and the Federal Government's efforts on pancreatic 
        cancer research and prepared ``The National Plan to Advance 
        Pancreatic Cancer Research'' to identify the highest research 
        priorities, scientific infrastructure needs, and workforce 
        training requirements that are needed to provide the answers 
        that pancreatic cancer patients and their families and loved 
        ones so desperately need.

SEC. 2. PANCREATIC CANCER INITIATIVE.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by adding at the end the following:

``SEC. 320B. PANCREATIC CANCER INITIATIVE.

    ``(a) Pancreatic Cancer Initiative.--
            ``(1) Establishment.--The Secretary shall establish and 
        implement a Pancreatic Cancer Initiative to assist in 
        coordinating activities to address the high mortality rate 
        associated with pancreatic cancer. Such Initiative shall focus 
        on--
                    ``(A) advancing research on the causes, diagnosis, 
                and treatment of pancreatic cancer with the goal of 
                increasing the 5-year survival rate;
                    ``(B) promoting a cadre of new investigators in the 
                field of pancreatic cancer research; and
                    ``(C) increasing physician and public awareness of 
                pancreatic cancer.
            ``(2) Consultation.--In carrying out this subsection, the 
        Secretary shall consult with the Director of the National 
        Institutes of Health, the Director of the National Cancer 
        Institute, the Director of the Centers of Disease Control and 
        Prevention, and the Interdisciplinary Pancreatic Cancer 
        Coordinating Committee established under subsection (b).
    ``(b) Interdisciplinary Pancreatic Cancer Coordinating Committee.--
            ``(1) Establishment.--Not later than 60 days after the date 
        of the enactment of this section, the Secretary, in 
        consultation with the Director of the National Institutes of 
        Health, shall establish a committee to be known as the 
        Interdisciplinary Pancreatic Cancer Coordinating Committee (in 
        this subsection referred to as the `Committee').
            ``(2) Membership.--
                    ``(A) In general.--The members of the Committee 
                shall be appointed by the Secretary, in consultation 
                with the Director of the National Institutes of Health, 
                and shall consist of 13 individuals as follows:
                            ``(i) Nine experts in pancreatic cancer 
                        research, who are each a full professor at a 
                        major academic research institution and who 
                        have each received multiple grants from the 
                        National Cancer Institute or other entities of 
                        the National Institutes of Health with a 
                        primary focus on pancreatic cancer research.
                            ``(ii) Two young principal investigators in 
                        pancreatic cancer, who are each an assistant-
                        level professor in a major academic research 
                        institution and who have each received at least 
                        one grant from the National Cancer Institute or 
                        another entity of the National Institutes of 
                        Health with a primary focus in pancreatic 
                        cancer research.
                            ``(iii) One pancreatic cancer advocate.
                            ``(iv) The Director of the National Cancer 
                        Institute (or the Director's designee).
                    ``(B) Chair.--The Secretary shall designate the 
                Chair of the Committee from among its members.
                    ``(C) Publication of names.--Not later than 30 days 
                after the establishment of the Committee, the Secretary 
                shall publish the names of the Chair and members of the 
                Committee on the Website of the Department of Health 
                and Human Services.
                    ``(D) Terms.--The members of the Committee shall 
                each be appointed for a 3-year term and, at the end of 
                each such term, may be reappointed.
                    ``(E) Vacancies.--A vacancy on the Committee shall 
                be filled by the Secretary in the same manner in which 
                the original appointment was made.
            ``(3) Responsibilities.--The Committee shall--
                    ``(A) provide advice on overall research objectives 
                and benchmarks for pancreatic cancer research;
                    ``(B) develop and annually update a strategic plan 
                in accordance with paragraph (4) for the conduct and 
                support of pancreatic cancer research awareness during 
                the upcoming year; and
                    ``(C) conduct evaluations and make recommendations 
                to the Secretary, the Director of the National 
                Institutes of Health, and the Director of the National 
                Cancer Institute in accordance with paragraph (5) 
                regarding the prioritization and award of National 
                Institutes of Health research grants relating to 
                pancreatic cancer.
            ``(4) Strategic plan.--
                    ``(A) Development.--The Committee shall develop and 
                annually update a strategic plan for the conduct and 
                support of pancreatic cancer research and awareness 
                during the upcoming fiscal year.
                    ``(B) Submission.--The Committee shall--
                            ``(i) submit to the Secretary each 
                        strategic plan developed under subparagraph (A) 
                        for the upcoming fiscal year; and
                            ``(ii) publish each such plan on the 
                        Website of the Department of Health and Human 
                        Services within 30 days after the earlier of--
                                    ``(I) the date of submission of the 
                                plan to the Secretary under clause (i); 
                                or
                                    ``(II) June 1.
                    ``(C) Contents.--Each strategic plan developed 
                under subparagraph (A) shall include--
                            ``(i) recommended budgetary requirements 
                        for pancreatic cancer research, including 
                        research grants awarded through the National 
                        Cancer Institute, funding for Specialized 
                        Programs of Research Excellence (SPORE) that 
                        are focused on pancreatic cancer, and funding 
                        for the portion of the cancer research 
                        incubator pilot project established by section 
                        409J(a) that is focused on pancreatic cancer;
                            ``(ii) recommendations on the coordination 
                        of extramural and intramural pancreatic cancer 
                        research initiatives and possibilities for 
                        partnerships among the national research 
                        institutes, including the National Cancer 
                        Institute, the National Institute of Diabetes 
                        and Digestive and Kidney Diseases, the National 
                        Institute of Environmental Health Sciences, the 
                        National Center for Complementary and 
                        Alternative Medicine, and the National Center 
                        on Minority Health and Health Disparities;
                            ``(iii) recommendations for improving 
                        physician and public education about pancreatic 
                        cancer;
                            ``(iv) recommendations for increasing the 
                        number of scientists with doctorate degrees and 
                        clinician-scientists specializing in pancreatic 
                        cancer research; and
                            ``(v) guidelines for information gathered 
                        by pancreatic cancer patient registries and 
                        tissue banks to ensure uniformity and 
                        accessibility to the research community.
            ``(5) Prioritization and award of nih research grants.--
                    ``(A) In general.--The Committee shall conduct 
                evaluations and make recommendations to the Secretary, 
                the Director of the National Institutes of Health, and 
                the Director of the National Cancer Institute regarding 
                the prioritization and award of National Institutes of 
                Health research grants relating to pancreatic cancer.
                    ``(B) Peer review committee.--In carrying out 
                subparagraph (A), the Committee may appoint a peer 
                review committee to assist in the evaluation of 
                pancreatic cancer grant applications to ensure that 
                such applications are reviewed by individuals with the 
                appropriate expertise.
                    ``(C) Evaluation.--In evaluating pancreatic cancer 
                grant applications under subparagraph (A), the 
                Committee shall emphasize grants that achieve at least 
                one of the following goals:
                            ``(i) The grant is determined to be at 
                        least 75 percent relevant to pancreatic cancer 
                        research and has a primary focus on at least 
                        one of the following areas:
                                    ``(I) Basic research to advance the 
                                understanding of the biology of 
                                pancreatic cancer, its natural history, 
                                and the genetic and environmental 
                                factors that contribute to its 
                                development.
                                    ``(II) Research on more precise 
                                diagnostic methods and screening to 
                                detect pancreatic cancer in earlier 
                                stages.
                                    ``(III) Advanced innovative 
                                clinical trials testing targeted 
                                therapeutics and novel agents that will 
                                extend the survival of pancreatic 
                                cancer patients and improve their 
                                quality of life.
                            ``(ii) The grant will increase the number 
                        of young pancreatic cancer investigators.
                            ``(iii) The grant will meet identified 
                        needs, criteria, or specific research goals set 
                        forth in the strategic plan developed under 
                        paragraph (3)(B).
                    ``(D) Recommendations.--The Committee shall make 
                recommendations for exception funding for grant 
                applications that--
                            ``(i) have 75 percent or greater relevance 
                        to pancreatic cancer; and
                            ``(ii) score within 10 points of the 
                        payline.
    ``(c) Physician Awareness.--
            ``(1) Program.--The Secretary, in consultation with the 
        Director of the National Institutes of Health, the Director of 
        the Centers for Disease Control and Prevention, and relevant 
        patient advocate and physician organizations, shall develop a 
        primary care provider education program on pancreatic cancer. 
        The Secretary may include in such program accredited continuing 
        medical education and such other activities as the Secretary 
        determines appropriate.
            ``(2) Definition.--The term `relevant patient advocate and 
        physician organization' means a nationwide organization that--
                    ``(A) provides evidence-based disease information 
                to the public in a case management style;
                    ``(B) directly funds research in an unbiased manner 
                by working collaboratively with health professionals at 
                a variety of institutions and using a peer-reviewed 
                grant mechanism;
                    ``(C) advocates public policy outcomes that reflect 
                the needs of patients; and
                    ``(D) provides information to patients, families, 
                and health professionals at the community level.
    ``(d) Communication Tool Kit.--The Director of the National 
Institutes of Health and the Director of the Centers for Disease 
Control and Prevention, working collaboratively with patient advocate 
organizations, shall develop a communication tool kit for patients and 
their families that focuses on specific pancreatic cancer issues 
related to patient choices and patient care.
    ``(e) Report to Congress.--Not later than 1 year after the date of 
the enactment of this section, and annually thereafter, the Secretary 
shall submit a report to the Congress identifying the steps taken to 
implement the Pancreatic Cancer Initiative under subsection (a). The 
report shall include--
            ``(1) an assessment of the progress in improving outcomes 
        and reducing mortality rates for those diagnosed with 
        pancreatic cancer;
            ``(2) an explanation of how recommendations of the 
        Interdisciplinary Pancreatic Cancer Coordinating Committee in 
        the strategic plan developed under subsection (b)(3)(B) for the 
        preceding year have been implemented;
            ``(3) a summary of the recommendations that were made by 
        the Interdisciplinary Pancreatic Cancer Coordinating Committee 
        for grant funding, including exception funding, the number of 
        such recommendations that were met, and the reasons why any 
        recommendations were not met;
            ``(4) a breakdown of research grant award amounts by the 
        National Institutes of Health during the past year that are 
        deemed relevant to pancreatic cancer research along with a 
        quantifiable measure as to the relevancy of the grants to 
        pancreatic cancer;
            ``(5) the number of such grants awarded to young principal 
        investigators in pancreatic cancer described in subsection 
        (b)(2)(A)(ii); and
            ``(6) a summary of progress and deficiencies that were made 
        in pancreatic cancer research during the preceding year.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated--
            ``(1) to carry out subsection (a), $140,000,000 for fiscal 
        year 2011 and such sums as may be necessary for fiscal years 
        2012 through 2015;
            ``(2) to carry out subsection (c), $2,000,000 for fiscal 
        year 2011 and such sums as may be necessary for fiscal years 
        2012 through 2015; and
            ``(3) to carry out subsection (d), $2,000,000 for fiscal 
        year 2011 and such sums as may be necessary for fiscal years 
        2012 through 2015.''.

SEC. 3. NATIONAL INSTITUTES OF HEALTH RESEARCH.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``SEC. 409J. CANCER RESEARCH.

    ``(a) Cancer Research Incubator Pilot Project.--
            ``(1) Grants.--
                    ``(A) In general.--The Secretary may award grants 
                to research institutions for use in developing 
                innovative compounds or technologies for the 
                prevention, early detection, or treatment of those 
                cancers with 5-year survival rates of less than 50 
                percent.
                    ``(B) Relation to other nih grants.--Subject to 
                subparagraph (A), the Secretary shall encourage each 
                recipient of a grant under this section to use the 
                grant for research activities that may serve as a 
                springboard for the receipt of other grants, including 
                Specialized Programs of Research Excellence (SPORE) 
                grants, from the National Institutes of Health and its 
                national research institutes.
            ``(2) Grant period.--The period of a grant under this 
        section shall be 5 years.
            ``(3) Focus.--During the initial 5 fiscal years of carrying 
        out this section, the Secretary shall focus on awarding grants 
        for use in developing innovative compounds or technologies for 
        the prevention, early detection, or treatment of pancreatic 
        cancer.
            ``(4) Report.--Not later than 5 years after the date of the 
        enactment of this section, the Secretary shall submit a report 
        to the Congress evaluating the program under this section and 
        making recommendations for expansion of the program to other 
        cancers.
            ``(5) Authorization of appropriations.--To carry out this 
        subsection, there are authorized to be appropriated $5,000,000 
        for fiscal year 2011 and such sums as may be necessary for 
        fiscal years 2012 through 2015.
    ``(b) Centers of Excellence.--
            ``(1) Designation.--The Secretary may designate two 
        additional Specialized Programs of Research Excellence (SPOREs) 
        focusing solely on pancreatic cancer research. In carrying out 
        this paragraph, the Secretary may choose to designate one or 
        more satellite centers that augment the work of a previously 
        designated Specialized Program of Research Excellence.
            ``(2) Authorization of appropriations.--To carry out this 
        subsection, there are authorized to be appropriated $20,000,000 
        for fiscal year 2011 and such sums as may be necessary for 
        fiscal years 2012 through 2015.''.
                                 <all>
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