S. 4472

117 S4472 ES: Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026
 U.S. Senate
 text/xml
 EN
 Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
 119th CONGRESS  2d Session  S. 4472  IN THE SENATE OF THE UNITED STATES  AN ACT
To amend the Accelerating Access to Critical Therapies for ALS Act to reauthorize the provisions of such Act through fiscal year 2031, and for other purposes.
1.
Short title
This Act may be cited as the   Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026  .
2.
Reauthorization of Accelerating Access to Critical Therapies for ALS Act
(a)
In general
Section 7 of the Accelerating Access to Critical Therapies for ALS Act ( Public Law 117–79 ) is amended by striking  2022 through 2026  and inserting  2027 through 2031 .
(b)
Grants for ALS research
Section 2(f) of the Accelerating Access to Critical Therapies for ALS Act ( 21 U.S.C. 360ee  note) is amended by striking  2026  and inserting  2031 .
3.
Improvements to program for grants for research on therapies for ALS
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.
 .
4.
Report on ALS and other rare neurodegenerative disease action plans
Section 4 of the Accelerating Access to Critical Therapies for ALS Act ( 21 U.S.C. 360aa  note) is amended—
(1)
in the section heading, by striking
ALS and other   and inserting
FDA  ;
(2)
in subsection (a), in the matter preceding paragraph (1)—
(A)
by inserting  and not later than 1 year after the date of enactment of the  Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026  and every 5 years thereafter,  after  this Act, ; and
(B)
by inserting  develop, or update, as applicable, and  before  publish on ;
(3)
in subsection (b)—
(A)
in the matter preceding paragraph (1), by striking  initial ;
(B)
in paragraph (2)—
(i)
in subparagraph (A), by inserting  of relevant investigational new drug applications  after  sponsors ;
(ii)
in subparagraph (C) by inserting  for the prevention, diagnosis, mitigation, treatment, or cure of rare neurodegenerative diseases  before the semicolon; and
(iii)
in subparagraph (D), by striking  ; and  and inserting a semicolon;
(C)
in paragraph (3), by striking the period at the end and inserting  ; and ; and
(D)
by adding at the end the following:
(4)
for each action plan published after the date of enactment of the  Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 , include a description of—
(A)
previous actions taken by the Food and Drug Administration to implement the previous action plan published under subsection (a);
(B)
any other planned actions to implement such action plan; and
(C)
any barriers to implementing such action plan and related recommendations, which may include an estimate of resources necessary to address such barriers.
 .
5.
Reports
Section 6 of the Accelerating Access to Critical Therapies for ALS Act ( Public Law 117–79 ) is amended—
(1)
in the heading, by striking
GAO Report   and inserting
Reports  ;
(2)
by striking  Not later than  and inserting the following:
(a)
GAO report
Not later than
 ;
(3)
in the matter preceding paragraph (1) of subsection (a), as so designated, by striking  this Act  and inserting  the  Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026  ; and
(4)
by adding at the end the following:
(b)
HHS report
Not later than 4 years after the date of enactment of the  Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 , the Secretary of Health and Human Services shall, in a manner that does not duplicate the information described in the action plan published pursuant to section 4, submit to the Committee on Health, Education, Labor, 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 2, 3, and 5 and making recommendations to improve such activities.
 .
6.
Technical amendments
Section 3 of the Accelerating Access to Critical Therapies for ALS Act ( 42 U.S.C. 280g–7b ) is amended—
(1)
in subsection (a), in the matter preceding paragraph (1), by striking  amytrophic  and inserting  amyotrophic ; and
(2)
in subsection (b)(3)(A)(iii), by striking  rational .
    Passed the Senate August 4, 2026.    Secretary