[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 4472 Introduced in Senate (IS)]
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119th CONGRESS
2d Session
S. 4472
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.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
April 30, 2026
Ms. Murkowski (for herself and Mr. Coons) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Accelerating Access to Critical
Therapies for ALS Reauthorization Act of 2026''.
SEC. 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
``2026'' and inserting ``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''.
SEC. 3. 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.''.
SEC. 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 by adding at the end the
following:
``(c) Report on ALS and Other Rare Neurodegenerative Disease Action
Plans.--Not later than one year after the date of enactment of the
Accelerating Access to Critical Therapies for ALS Reauthorization Act
of 2026, the Commissioner of Food and Drugs shall publish on the
website of the Food and Drug Administration a report that contains--
``(1) an updated action plan, including--
``(A) a description of the actions the Food and
Drug Administration intends to take during the 5-year
period following publication of the plan with respect
to the program enhancements, policy development,
regulatory science initiatives, and other appropriate
initiatives described in subsection (a);
``(B) a description of the resources necessary to
implement each section of the plan within such 5-year
period; and
``(C) specific approaches the Commissioner will
take to improve coordination of implementation of the
plan with rare neurodegenerative disease communities
that are not specifically ALS communities; and
``(2) with respect to the Action Plan for Rare
Neurodegenerative Diseases including Amyotrophic Lateral
Sclerosis (ALS) published by the Food and Drug Administration
on June 23, 2022 (referred to in this section as the `2022
Action Plan'), a description of--
``(A) the actions taken by the Food and Drug
Administration under the 2022 Action Plan;
``(B) the effect of the implementation of the 2022
Action Plan on the development of therapies and
regulatory consideration of therapies for ALS and other
rare neurodegenerative diseases;
``(C) any programs and initiatives that established
or carried out as part of the implementation of the
2022 Action Plan; and
``(D) the extent to which the 2022 Action Plan was
implemented with respect to rare neurodegenerative
diseases that are not amyotrophic lateral sclerosis.''.
SEC. 5. GAO REPORT.
Section 6 of the Accelerating Access to Critical Therapies for ALS
Act (Public Law 117-79) is amended, in the matter preceding paragraph
(1)--
(1) by striking ``4 years after the date of the enactment
of this Act'' and inserting ``5 years after the date of
enactment of the Accelerating Access to Critical Therapies for
ALS Reauthorization Act of 2026''; and
(2) by inserting ``, with respect to the 10-year period
starting on the date of enactment of this Act'' after
``containing''.
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