H.R. 8205

[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