42 U.S.C. § 287 — National Center for Advancing Translational Sciences

(a) Purpose The purpose of the National Center for Advancing Translational Sciences ("the Center") is to advance translational science by: (1) coordinating and developing resources that use basic research to support translational science; and (2) building partnerships and working together in ways that create synergy — without duplicating, competing with, or crowding out industry activities. (b) Clinical trial activities (1) In general. The Center may develop and provide infrastructure and resources for all phases of clinical trials research. Except as provided in paragraph (2), the Center can only support clinical trials through the end of phase IIB. (2) Exception. The Center may support clinical trial activities through the end of phase III for a treatment for a rare disease or condition, but only if: (A) the Center gives at least 120 days' public notice of its plan to support that phase III work; (B) no public or private organization gives the Center credible written notice that it has timely plans to continue that work, or run similar trials, beyond phase IIB; and (C) the Center makes sure that supporting the phase III work won't raise the federal government's liability beyond the value of the Center's award. (c) Biennial report Every two years, the Center must publish a report covering all research it supports, listing: (1) the molecules being studied; (2) clinical trial activities being conducted; (3) methods and tools in development; (4) ongoing partnerships — including (A) the reason for each one, (B) its status, (C) how much funding the Center gave to other entities through it, and (D) what activities have been transferred to industry through it; (5) known research by other entities that is or will build on the Center's research; (6) any methods and tools developed since the last biennial report; and (7) any methods and tools the Food and Drug Administration has developed and is using, with the Center's support, for medical product reviews. (d) Inclusion of list The first biennial report submitted after December 13, 2016 must include a complete list of every method and tool developed through research the Center has supported. (e) Rule of construction Nothing in this section lets the Secretary disclose any trade secret or other privileged or confidential information protected under 5 U.S.C. § 552(b)(4) or 18 U.S.C. § 1905.