[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8205 Reported in House (RH)]
<DOC>
Union Calendar No. 637
119th CONGRESS
2d Session
H. R. 8205
[Report No. 119-733]
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 HOUSE OF REPRESENTATIVES
April 6, 2026
Mr. Quigley (for himself and Mr. Calvert) introduced the following
bill; which was referred to the Committee on Energy and Commerce
July 9, 2026
Additional sponsors: Mr. Fitzpatrick, Ms. Schakowsky, Mr. McCaul, Mr.
Auchincloss, Mr. DesJarlais, Ms. Craig, Mr. Valadao, Mr. Crow, Mr.
Thompson of Pennsylvania, Ms. Moore of Wisconsin, Mr. Hurd of Colorado,
Mr. Schneider, Mr. Joyce of Ohio, Mr. Veasey, Ms. Salazar, Ms.
Bonamici, Mr. Bilirakis, Mr. Sherman, Mr. Garbarino, Mr. Lynch, Mr.
Bacon, Mr. Cohen, Mr. Sessions, Mr. Smith of Washington, Mr. Obernolte,
Ms. Dean of Pennsylvania, Mr. Cole, Mrs. Foushee, Mr. Rutherford, Ms.
Sewell, Mr. Wilson of South Carolina, Mr. Davis of Illinois, Mr.
Aderholt, Mr. Torres of New York, Mr. Mann, Ms. Norton, Mr. Van Drew,
Mr. Krishnamoorthi, Mr. Alford, Ms. Underwood, Mr. LaLota, Ms. Schrier,
Mrs. Kim, Ms. Matsui, Mr. Edwards, Mrs. Dingell, Mr. Walberg, Ms.
Tlaib, Mr. Weber of Texas, Mr. Thompson of California, Mr. Bost, Mr.
Tonko, Mrs. Bice, Ms. DelBene, Mr. Diaz-Balart, Mr. Correa, Mr. LaHood,
Mr. Kennedy of New York, Mr. Womack, Mr. Whitesides, Mr. Rouzer, Mr.
Bishop, Ms. Letlow, Ms. Kelly of Illinois, Mr. Amodei of Nevada, Mr.
Gottheimer, Mr. Moore of North Carolina, Mr. Cleaver, Mr. Carter of
Texas, Mr. Stanton, Mr. Wittman, Mr. Vindman, Mr. Guest, Ms. Bynum,
Mrs. Miller of West Virginia, Mrs. Hayes, Mr. Latimer, Mr. Davis of
North Carolina, Ms. McBride, Mr. Riley of New York, Mr. Conaway, Ms.
Stansbury, Ms. Ross, Ms. Pingree, Mr. Himes, Mrs. Watson Coleman, Mr.
Casten, Mr. Landsman, Mrs. Grijalva, Ms. Mejia, Mr. Larson of
Connecticut, Mr. Sorensen, Mr. Peters, Mr. Jackson of Illinois, Ms.
Adams, Ms. Budzinski, Mrs. Beatty, Mr. Magaziner, Ms. Kaptur, Mr.
Carter of Louisiana, Mr. Suozzi, and Ms. Scanlon
July 9, 2026
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on April
6, 2026]
_______________________________________________________________________
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) Renewal of Grants for Research on Therapies for ALS 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) Renewal of grants for research on therapies for als
review.--In reviewing applications for renewals of a grant
awarded under this section with respect to an investigational
drug, the Secretary shall request from the manufacturer or
sponsor, and assess, the enrollment, safety, and any available
efficacy data relating to the investigational drug in the
prevention, diagnosis, mitigation, treatment, or cure of
amyotrophic lateral sclerosis.''.
(b) Reporting Safety Data.--Section 2(c) of the Accelerating Access
to Critical Therapies for ALS Act (21 U.S.C. 360ee note) is amended--
(1) in paragraph (2)(B), by striking ``and'' at the end;
(2) in paragraph (3), by striking the period at the end and
inserting ``; and''; and
(3) by adding at the end the following:
``(4) the entity seeking such grant will promptly report
any new and serious adverse events and safety information that
is considered to be unexpected with respect to the phase 3
trial to the grant-making institution, in addition to complying
with the safety reporting requirements under section 312.32 of
title 21, Code of Federal Regulations (or any successor
regulations).''.
(c) 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 that begins enrollment
within a timeframe, determined by the Secretary through the
terms and conditions of the grant awarded under this
section.''.
SEC. 4. FDA RARE NEURODEGENERATIVE DISEASE ACTION PLAN.
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
rare neurodegenerative disease action plan'' and inserting
``fda rare neurodegenerative disease action plan''; and
(2) by adding at the end the following:
``(c) FDA Rare Neurodegenerative Disease Action Plan.--
``(1) In general.--Not later than 18 months 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 an action plan that includes a description of
the actions that the Food and Drug Administration intends to
take during the 5-year period following publication of the
action plan with respect to the program enhancements, policy
development, regulatory science initiatives, and other
appropriate initiatives described in subsection (a).
``(2) Report.--Not later than 5 years 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 describes the actions taken by the
Food and Drug Administration under the action plan published
under paragraph (1) and the extent to which such action plan
meets the requirements specified in paragraph (1).''.
Union Calendar No. 637
119th CONGRESS
2d Session
H. R. 8205
[Report No. 119-733]
_______________________________________________________________________
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.
_______________________________________________________________________
July 9, 2026
Reported with an amendment, committed to the Committee of the Whole
House on the State of the Union, and ordered to be printed