Sec. 6. GAO REPORT
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## SEC. 6 GAO REPORT Not later than 4 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report containing— ####
(1)with respect to grants awarded under the program established under section 2— #####
(A)an analysis of what is known about the impact of such grants on research or development related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis; and #####
(B)data concerning such grants, including— ######
(i)the number of grants awarded; ######
(ii)the participating entities to whom grants were awarded; ######
(iii)the value of each such grant; ######
(iv)a description of the research each such grant was used to further; ######
(v)the number of patients who received expanded access to an investigational drug to prevent, diagnose, mitigate, treat, or cure amyotrophic lateral sclerosis under each grant; ######
(vi)whether the investigational drug that was the subject of such a grant was approved by the Food and Drug Administration; and ######
(vii)the average number of days between when a grant application is submitted and when a grant is awarded; and ####
(2)with respect to grants awarded under the program established under section 5— #####
(A)an analysis of what is known about the impact of such grants on research or development related to the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis; #####
(B)an analysis of what is known about how such grants increased efficiency and productivity of the clinical development of therapies, including through the use of clinical trials that operated with common master protocols, or had adaptive or add-on clinical trial designs; and #####
(C)data concerning such grants, including— ######
(i)the number of grants awarded; ######
(ii)the participating entities to whom grants were awarded; ######
(iii)the value of each such grant; ######
(iv)a description of the research each such grant was used to further; and ######
(v)whether the investigational drug that was the subject of such a grant received approval by the Food and Drug Administration.