[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8205 Engrossed in House (EH)]

<DOC>
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
119th CONGRESS
  2d Session
                                H. R. 8205

_______________________________________________________________________

                                 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.

    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).''.

            Passed the House of Representatives July 22, 2026.

            Attest:

                                                                 Clerk.
119th CONGRESS

  2d Session

                               H. R. 8205

_______________________________________________________________________

                                 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.