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[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 3566 Reported in Senate (RS)]

                                                       Calendar No. 521
112th CONGRESS
  2d Session
                                S. 3566

   To provide for scientific frameworks with respect to recalcitrant 
                                cancers.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 19, 2012

    Mr. Harkin, from the Committee on Health, Education, Labor, and 
 Pensions, reported the following original bill; which was read twice 
                       and placed on the calendar

_______________________________________________________________________

                                 A BILL

 
   To provide for scientific frameworks with respect to recalcitrant 
                                cancers.

    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 ``Recalcitrant Cancer Research Act of 
2012''.

SEC. 2. SCIENTIFIC FRAMEWORK FOR RECALCITRANT CANCERS.

    Subpart 1 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285 et seq.) is amended by adding at the end the following:

``SEC. 417G. SCIENTIFIC FRAMEWORK FOR RECALCITRANT CANCERS.

    ``(a) Development of Scientific Framework.--
            ``(1) In general.--For each recalcitrant cancer identified 
        under subsection (b), the Director of the Institute shall 
        develop (in accordance with subsection (c)) a scientific 
        framework for the conduct or support of research on such 
        cancer.
            ``(2) Contents.--The scientific framework with respect to a 
        recalcitrant cancer shall include the following:
                    ``(A) Current status.--
                            ``(i) Review of literature.--A summary of 
                        findings from the current literature in the 
                        areas of--
                                    ``(I) the prevention, diagnosis, 
                                and treatment of such cancer;
                                    ``(II) the fundamental biologic 
                                processes that regulate such cancer 
                                (including similarities and differences 
                                of such processes from the biological 
                                processes that regulate other cancers); 
                                and
                                    ``(III) the epidemiology of such 
                                cancer.
                            ``(ii) Scientific advances.--The 
                        identification of relevant emerging scientific 
                        areas and promising scientific advances in 
                        basic, translational, and clinical science 
                        relating to the areas described in subclauses 
                        (I) and (II) of clause (i).
                            ``(iii) Researchers.--A description of the 
                        availability of qualified individuals to 
                        conduct scientific research in the areas 
                        described in clause (i).
                            ``(iv) Coordinated research initiatives.--
                        The identification of the types of initiatives 
                        and partnerships for the coordination of 
                        intramural and extramural research of the 
                        Institute in the areas described in clause (i) 
                        with research of the relevant national research 
                        institutes, Federal agencies, and non-Federal 
                        public and private entities in such areas.
                            ``(v) Research resources.--The 
                        identification of public and private resources, 
                        such as patient registries and tissue banks, 
                        that are available to facilitate research 
                        relating to each of the areas described in 
                        clause (i).
                    ``(B) Identification of research questions.--The 
                identification of research questions relating to basic, 
                translational, and clinical science in the areas 
                described in subclauses (I) and (II) of subparagraph 
                (A)(i) that have not been adequately addressed with 
                respect to such recalcitrant cancer.
                    ``(C) Recommendations.--Recommendations for 
                appropriate actions that should be taken to advance 
                research in the areas described in subparagraph (A)(i) 
                and to address the research questions identified in 
                subparagraph (B), as well as for appropriate benchmarks 
                to measure progress on achieving such actions, 
                including the following:
                            ``(i) Researchers.--Ensuring adequate 
                        availability of qualified individuals described 
                        in subparagraph (A)(iii).
                            ``(ii) Coordinated research initiatives.--
                        Promoting and developing initiatives and 
                        partnerships described in subparagraph (A)(iv).
                            ``(iii) Research resources.--Developing 
                        additional public and private resources 
                        described in subparagraph (A)(v) and 
                        strengthening existing resources.
            ``(3) Timing.--
                    ``(A) Initial development and subsequent update.--
                For each recalcitrant cancer identified under 
                subsection (b)(1), the Director of the Institute 
                shall--
                            ``(i) develop a scientific framework under 
                        this subsection not later than 18 months after 
                        the date of the enactment of this section; and
                            ``(ii) review and update the scientific 
                        framework not later than 5 years after its 
                        initial development.
                    ``(B) Other updates.--The Director of the Institute 
                may review and update each scientific framework 
                developed under this subsection as necessary.
            ``(4) Public notice.--With respect to each scientific 
        framework developed under subsection (a), not later than 30 
        days after the date of completion of the framework, the 
        Director of the Institute shall--
                    ``(A) submit such framework to the Committee on 
                Energy and Commerce and Committee on Appropriations of 
                the House of Representatives, and the Committee on 
                Health, Education, Labor, and Pensions and Committee on 
                Appropriations of the Senate; and
                    ``(B) make such framework publically available on 
                the Internet website of the Department of Health and 
                Human Services.
    ``(b) Identification of Recalcitrant Cancer.--
            ``(1) In general.--Not later than 6 months after the date 
        of the enactment of this section, the Director of the Institute 
        shall identify two or more recalcitrant cancers that each--
                    ``(A) have a 5-year relative survival rate of less 
                than 20 percent; and
                    ``(B) are estimated to cause the death of at least 
                30,000 individuals in the United States per year.
            ``(2) Additional cancers.--The Director of the Institute 
        may, at any time, identify other recalcitrant cancers for 
        purposes of this section. In identifying a recalcitrant cancer 
        pursuant to the previous sentence, the Director may consider 
        additional metrics of progress (such as incidence and mortality 
        rates) against such type of cancer.
    ``(c) Working Groups.--For each recalcitrant cancer identified 
under subsection (b), the Director of the Institute shall convene a 
working group comprised of representatives of appropriate Federal 
agencies and other non-Federal entities to provide expertise on, and 
assist in developing, a scientific framework under subsection (a). The 
Director of the Institute (or the Director's designee) shall 
participate in the meetings of each such working group.
    ``(d) Reporting.--
            ``(1) Biennial reports.--The Director of NIH shall ensure 
        that each biennial report under section 403 includes 
        information on actions undertaken to carry out each scientific 
        framework developed under subsection (a) with respect to a 
        recalcitrant cancer, including the following:
                    ``(A) Information on research grants awarded by the 
                National Institutes of Health for research relating to 
                such cancer.
                    ``(B) An assessment of the progress made in 
                improving outcomes (including relative survival rates) 
                for individuals diagnosed with such cancer.
                    ``(C) An update on activities pertaining to such 
                cancer under the authority of section 413(b)(7).
            ``(2) Additional one-time report for certain frameworks.--
        For each recalcitrant cancer identified under subsection 
        (b)(1), the Director of the Institute shall, not later than 6 
        years after the initial development of a scientific framework 
        under subsection (a), submit a report to the Congress on the 
        effectiveness of the framework (including the update required 
        by subsection (a)(3)(A)(ii)) in improving the prevention, 
        detection, diagnosis, and treatment of such cancer.
    ``(e) Recommendations for Exception Funding.--The Director of the 
Institute shall consider each relevant scientific framework developed 
under subsection (a) when making recommendations for exception funding 
for grant applications.
    ``(f) Definition.--In this section, the term `recalcitrant cancer' 
means a cancer for which the five-year relative survival rate is below 
50 percent.''.
                                                       Calendar No. 521

112th CONGRESS

  2d Session

                                S. 3566

_______________________________________________________________________

                                 A BILL

   To provide for scientific frameworks with respect to recalcitrant 
                                cancers.

_______________________________________________________________________

                           September 19, 2012

                 Read twice and placed on the calendar
```