§285a–13 Scientific Framework for Recalcitrant Cancers

Summary

The Institute director must create a clear scientific plan for each “recalcitrant cancer” the law names. Each plan must say what we know now about preventing, finding, and treating the cancer, how the cancer works biologically, and how common it is. The plan must point out new scientific ideas, say whether enough trained researchers exist, list useful research tools (like patient registries and tissue banks), and name the big research partnerships needed. It must list the unanswered research questions and give recommendations and measurable steps to fix them, such as training researchers, building partnerships, and improving research resources. The director must finish each plan within 18 months after January 2, 2013, update it within 5 years, may update it sooner if needed, and post it within 30 days to the House Energy and Commerce and Appropriations committees and the Senate HELP and Appropriations committees and on the HHS website. Not later than 6 months after January 2, 2013, the director had to pick two or more recalcitrant cancers that each have a 5-year relative survival under 20 percent and cause at least 30,000 U.S. deaths a year; more cancers can be added later using other measures. For each named cancer the director must form a working group with federal and nonfederal experts and take part in meetings. Every two years, NIH reports must describe grants, progress on outcomes (including survival), and related activities. Within 6 years after a plan’s first version, the director must report to Congress on how well the plan worked. The director must use these plans when recommending exception funding. “Recalcitrant cancer” here means a cancer with a five-year relative survival below 50 percent.