Improvements to program for grants for research on therapies for ALS

(a) Renewal of grants for research on therapies for ALS review Section 2(b) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: (4) Renewal of grants for research on therapies for ALS review In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall request from the manufacturer or sponsor, and assess, the enrollment, safety, and any available efficacy data relating to the investigational drug in the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.. (b) Reporting safety data Section 2(c) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended— (1) in paragraph (2)(B), by striking and at the end; (2) in paragraph (3), by striking the period at the end and inserting; and; and (3) by adding at the end the following: (4) the entity seeking such grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to the phase 3 trial to the grant-making institution, in addition to complying with the safety reporting requirements under section 312.32 of title 21, Code of Federal Regulations (or any successor regulations).. (c) Clarifying participating clinical trial definition Section 2(e) of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended by adding at the end the following: (4) The term phase 3, with respect to a clinical trial, includes a phase 2/3 combined trial that begins enrollment within a timeframe, determined by the Secretary through the terms and conditions of the grant awarded under this section..