[Congressional Record Volume 172, Number 106 (Wednesday, June 24, 2026)]
[Senate]
[Pages S3383-S3384]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
SA 6206. Ms. MURKOWSKI (for herself and Mr. Coons) submitted an
amendment intended to be proposed by her to the bill S. 4784, to
authorize appropriations for fiscal year 2027 for military activities
of the Department of Defense, for military construction, and for
defense activities of the Department of Energy, to prescribe military
personnel strengths for such fiscal year, and for other purposes; which
was ordered to lie on the table; as follows:
At the end of subtitle G of title X, add the following:
SEC. 10___. ACCELERATING ACCESS TO CRITICAL THERAPIES FOR
ALS.
(a) Short Title.--This section may be cited as the
``Accelerating Access to Critical Therapies for ALS
Reauthorization Act of 2026''.
(b) Reauthorization of Accelerating Access to Critical
Therapies for ALS Act.--
(1) 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''.
(2) 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''.
(c) 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.''.
(d) 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)--
[[Page S3384]]
(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.''.
(e) 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.''.
(f) 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''.
______