42 U.S.C. § 285a–13 — 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 must build a scientific framework for researching that cancer, following the process in subsection (c). (2) Contents: Each framework must include: (A) Current status — (i) a summary of current research literature on preventing, diagnosing, and treating the cancer, on the basic biological processes that drive it (including how those differ from processes in other cancers), and on its epidemiology; (ii) identification of promising new scientific areas and advances in basic, translational, and clinical science related to those same topics; (iii) a description of how many qualified researchers are available to work in these areas; (iv) identification of ways the Institute's own research (both inside and outside NIH) could be coordinated with research from other national research institutes, federal agencies, and outside public and private groups; and (v) identification of public and private resources — like patient registries and tissue banks — available to support this research. (B) Identification of research questions that these current-status reviews show have not been adequately answered. (C) Recommendations for actions to advance research and answer those questions, plus benchmarks for measuring progress, covering: (i) making sure enough qualified researchers are available; (ii) promoting the coordinated research initiatives and partnerships described above; and (iii) developing new public and private research resources and strengthening existing ones. (3) Timing: (A) For each recalcitrant cancer identified under subsection (b)(1), the Director must create its scientific framework within 18 months of January 2, 2013, and must review and update it within 5 years after that. (B) The Director may also review and update any framework at other times as needed. (4) Public notice: Within 30 days of finishing each framework, the Director must (A) send it to the House Energy and Commerce and Appropriations Committees and the Senate HELP and Appropriations Committees, and (B) post it publicly on the HHS website. (b) Identification of recalcitrant cancer. (1) Within 6 months of January 2, 2013, the Director had to identify at least two recalcitrant cancers, each of which (A) has a five-year relative survival rate under 20 percent, and (B) is estimated to kill at least 30,000 people in the United States per year. (2) The Director may identify more recalcitrant cancers at any time, and may use other measures of progress, like how often the cancer occurs and how many people it kills, when doing so. (c) Working groups. For each recalcitrant cancer identified under subsection (b), the Director must convene a working group of representatives from relevant federal agencies and outside groups to give expert input and help build the scientific framework. The Director (or a designee) must take part in that working group's meetings. (d) Reporting. (1) The Director of NIH must make sure every other biennial report under section 283 includes, for each recalcitrant cancer with a framework, information on: (A) research grants NIH has awarded for that cancer; (B) an assessment of progress made in improving outcomes, including survival rates, for people with that cancer; and (C) an update on activities carried out under section 285a–2(b)(7). (2) For each recalcitrant cancer identified under subsection (b)(1), the Director must, within 6 years of that cancer's framework being created, send Congress a one-time report on how well the framework (including its required 5-year update) has improved prevention, detection, diagnosis, and treatment of that cancer. (e) Recommendations for exception funding. The Director must consider each relevant scientific framework when recommending exception funding for grant applications. (f) Definition. In this section, a "recalcitrant cancer" is a cancer with a five-year relative survival rate below 50 percent.