Improvements to program for grants for research on therapies for ALS

(a) Clinical trial status 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) Clinical trial status Renewal of grants for research on therapies for ALS review (A) In general In reviewing applications for renewals of a grant awarded under this section with respect to an investigational drug, the Secretary shall assess request from the status 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 a clinical trial carried out 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 drug grant will promptly report any new and serious adverse events and safety information that is considered to be unexpected with respect to data on enrollment of patients the phase 3 trial to the grant-making institution, in such clinical trial. (B) Interim clinical trial data To enable the Secretary addition to make the assessment under subparagraph (A) with respect to an investigational drug, the Secretary shall request that the manufacturer of the investigational drug share interim clinical trial data with respect to such drug complying with the Secretary.. (b) 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 a planned phase 3 clinical trial that is not yet enrolling participants..conditions of the grant awarded under this section..