42 U.S.C. § 285a: Scientific framework for recalcitrant cancers

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. the prevention, diagnosis, and treatment of such cancer; the fundamental biologic processes that regulate such cancer (including similarities and differences of such processes from the biological processes that regulate other cancers); and the epidemiology of such cancer. 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). A description of the availability of qualified individuals to conduct scientific research in the areas described in clause (i). 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. 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). 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. Ensuring adequate availability of qualified individuals described in subparagraph (A)(iii). Promoting and developing initiatives and partnerships described in subparagraph (A)(iv). Developing additional public and private resources described in subparagraph (A)(v) and strengthening existing resources. develop a scientific framework under this subsection not later than 18 months after January 2, 2013 ; and review and update the scientific framework not later than 5 years after its initial development. The Director of the Institute may review and update each scientific framework developed under this subsection as necessary. 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 make such framework publically available on the Internet website of the Department of Health and Human Services. have a 5-year relative survival rate of less than 20 percent; and are estimated to cause the death of at least 30,000 individuals in the United States per year. 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. 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. Information on research grants awarded by the National Institutes of Health for research relating to such cancer. An assessment of the progress made in improving outcomes (including relative survival rates) for individuals diagnosed with such cancer. An update on activities pertaining to such cancer under the authority of section 285a–2(b)(7) of this title . 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. The Director of the Institute shall consider each relevant scientific framework developed under subsection (a) when making recommendations for exception funding for grant applications. In this section, the term “recalcitrant cancer” means a cancer for which the five-year relative survival rate is below 50 percent.