Improvements to program for grants for research on therapies for ALS

(a) Clinical trial status 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 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 the status of a clinical trial carried out for such drug with respect to data on enrollment of patients in such clinical trial. (B) Interim clinical trial data To enable the Secretary 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 with the Secretary.. (b) 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 and a planned phase 3 clinical trial that is not yet enrolling participants..

Section 2 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended— (1) in subsection (a), by inserting (referred to in this section as expanded access grants) before the period at the end of the first sentence; (2) in subsection (b)— (A) by striking (b) Application— and all that follows through A participating in paragraph (1) and inserting the following: (b) Application A participating; (B) by redesignating paragraphs (2) and (3) as paragraphs (1) and (2) respectively; (C) in the matter preceding paragraph (1), as so redesignated, by striking the period at the end and inserting including—; (D) by amending paragraph (1), as so redesignated, to read as follows: (1) a description of how data generated through the proposed expanded access grant will be used to support research or development related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis;; (E) in paragraph (2), as so redesignated— (i) by striking Noninterference with clinical trials— and all that follows through shall include; (ii) by striking program and inserting grant; and (iii) by striking the period at the end and inserting; and; and (F) by adding at the end the following: (3) an assurance that such entity will promptly report to the Secretary available safety data from any ongoing clinical trial of the investigational drug as set forth in the terms and conditions of the grant.; (3) in subsection (c)— (A) by redesignating subparagraphs (A) and (B) of paragraph (2) as clauses (i) and (ii), respectively, and adjusting the margins accordingly; (B) by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively, and adjusting the margins accordingly; (C) in subparagraph (C), as so redesignated, by striking the period at the end and inserting; and; (D) in the matter preceding subparagraph (A), as so redesignated, by striking this section, confirm that— and inserting the following: “this section— (1) confirm that—; and (E) by adding at the end the following: (2) in the case of a renewal of such a grant, request from the sponsor of the investigational new drug application involved, and assess, the enrollment, safety, and any available efficacy data of the drug related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis.; (4) in subsection (d)(1), by striking request described in subsection (a) and inserting grant; and (5) in subsection (e)— (A) in paragraph (2), by inserting, and that begins enrollment within a timeframe as determined by the Secretary through the terms and conditions of the grant before the period at the end; and (B) by adding at the end the following: (4) The term phase 3 clinical trial includes a phase 2/3 combined trial and a planned phase 3 clinical trial that is not yet enrolling participants..