#aaith ,,congress #b;d ,session ,s4 #ddgb ,,an ,,act ,to amend the ,accelerating ,access to ,critical ,therapies for ,,als ,act to reauthorize the provisions of such ,act through fiscal year #bjca1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,accelerating ,access to ,critical ,therapies for ,,als ,reauthorization ,act of #bjbf4 #b4 ,reauthorization of ,accelerating ,access to ,critical ,therapies for ,,als ,act 7a7 ,in general ,section #g of the ,accelerating ,access to ,critical ,therapies for ,,als ,act 7,public ,law #aag-gi7 is amended by striking #bjbb through #bjbf and inserting #bjbg through #bjca4 7b7 ,grants for ,,als research ,section #b7;f7 of the ,accelerating ,access to ,critical ,therapies for ,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 is amended by striking #bjbf and inserting #bjca4 #c4 ,improvements to program for grants for research on therapies for ,,als ,section #b of the ,accelerating ,access to ,critical ,therapies for ,,als ,act 7#ba ,u4,s4,c4 #cfj;ee note7 is amended-- 7#a7 in subsection 7a71 by inserting 7referred to in this section as expanded access grants7 before the period at the end of the first sentence2 7#b7 in subsection 7b7-- 7,a7 by striking 7b7 ,application-- and all that follows through ,a participating in paragraph 7#a7 and inserting the following3 7b7 ,application ,a participating 2 7,b7 by redesignating paragraphs 7#b7 and 7#c7 as paragraphs 7#a7 and 7#b7 respectively2 7,c7 in the matter preceding paragraph 7#a71 as so redesignated1 by striking the period at the end and inserting including--2 7,d7 by amending paragraph 7#a71 as so redesignated1 to read as follows3 7#a7 a description of how data generated through the proposed expanded access grant will be used to support research or development related to the prevention1 diagnosis1 mitigation1 treatment1 or cure of amyotrophic lateral sclerosis2 2 7,e7 in paragraph 7#b71 as so redesignated-- 7i7 by striking ,noninterference with clinical trials-- and all that follows through shall include2 7ii7 by striking program and inserting grant2 and 7iii7 by striking the period at the end and inserting 2 and2 and 7,f7 by adding at the end the following3 7#c7 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 grant4 2 7#c7 in subsection 7c7-- 7,a7 by redesignating subparagraphs 7,a7 and 7,b7 of paragraph 7#b7 as clauses 7i7 and 7ii71 respectively1 and adjusting the margins accordingly2 7,b7 by redesignating paragraphs 7#a7 through 7#c7 as subparagraphs 7,a7 through 7,c71 respectively1 and adjusting the margins accordingly2 7,c7 in subparagraph 7,c71 as so redesignated1 by striking the period at the end and inserting 2 and2 7,d7 in the matter preceding subparagraph 7,a71 as so redesignated1 by striking this section1 confirm that-- and inserting the following3 8this section-- 7#a7 confirm that-- 2 and 7,e7 by adding at the end the following3 7#b7 in the case of a renewal of such a grant1 request from the sponsor of the investigational new drug application involved1 and assess1 the enrollment1 safety1 and any available efficacy data of the drug related to the prevention1 diagnosis1 mitigation1 treatment1 or cure of amyotrophic lateral sclerosis4 2 7#d7 in subsection 7d77#a71 by striking request described in subsection 7a7 and inserting grant2 and 7#e7 in subsection 7e7-- 7,a7 in paragraph 7#b71 by inserting 1 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 end2 and 7,b7 by adding at the end the following3 7#d7 ,the term phase #c clinical trial includes a phase #b_/c combined trial and a planned phase #c clinical trial that is not yet enrolling participants4 4 #d4 ,report on ,,als and other rare neurodegenerative disease action plans ,section #d of the ,accelerating ,access to ,critical ,therapies for ,,als ,act 7#ba ,u4,s4,c4 #cfj;aa note7 is amended-- 7#a7 in the section heading1 by striking ,,als and other and inserting ,,fda2 7#b7 in subsection 7a71 in the matter preceding paragraph 7#a7-- 7,a7 by inserting and not later than #a year after the date of enactment of the ,accelerating ,access to ,critical ,therapies for ,,als ,reauthorization ,act of #bjbf and every #e years thereafter1 after this ,act12 and 7,b7 by inserting develop1 or update1 as applicable1 and before publish on2 7#c7 in subsection 7b7-- 7,a7 in the matter preceding paragraph 7#a71 by striking initial2 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting of relevant investigational new drug applications after sponsors2 7ii7 in subparagraph 7,c7 by inserting for the prevention1 diagnosis1 mitigation1 treatment1 or cure of rare neurodegenerative diseases before the semicolon2 and 7iii7 in subparagraph 7,d71 by striking 2 and and inserting a semicolon2 7,c7 in paragraph 7#c71 by striking the period at the end and inserting 2 and2 and 7,d7 by adding at the end the following3 7#d7 for each action plan published after the date of enactment of the ,accelerating ,access to ,critical ,therapies for ,,als ,reauthorization ,act of #bjbf1 include a description of-- 7,a7 previous actions taken by the ,food and ,drug ,administration to implement the previous action plan published under subsection 7a72 7,b7 any other planned actions to implement such action plan2 and 7,c7 any barriers to implementing such action plan and related recommendations1 which may include an estimate of resources necessary to address such barriers4 4 #e4 ,reports ,section #f of the ,accelerating ,access to ,critical ,therapies for ,,als ,act 7,public ,law #aag-gi7 is amended-- 7#a7 in the heading1 by striking ,,gao ,report and inserting ,reports2 7#b7 by striking ,not later than and inserting the following3 7a7 ,,gao report ,not later than 2 7#c7 in the matter preceding paragraph 7#a7 of subsection 7a71 as so designated1 by striking this ,act and inserting the ,accelerating ,access to ,critical ,therapies for ,,als ,reauthorization ,act of #bjbf2 and 7#d7 by adding at the end the following3 7b7 ,,hhs report ,not later than #d years after the date of enactment of the ,accelerating ,access to ,critical ,therapies for ,,als ,reauthorization ,act of #bjbf1 the ,secretary of ,health and ,human ,services shall1 in a manner that does not duplicate the information described in the action plan published pursuant to section #d1 submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report assessing the effectiveness of the activities carried out under sections #b1 #c1 and #e and making recommendations to improve such activities4 4 #f4 ,technical amendments ,section #c of the ,accelerating ,access to ,critical ,therapies for ,,als ,act 7#db ,u4,s4,c4 #bhj;g-#g;b7 is amended-- 7#a7 in subsection 7a71 in the matter preceding paragraph 7#a71 by striking amytrophic and inserting amyotrophic2 and 7#b7 in subsection 7b77#c77;,a77iii71 by striking rational4 ,passed the ,senate ,august #d1 #bjbf4,secretary