Enrolled Bill

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8205 Enrolled Bill (ENR)]

        H.R.8205

                     One Hundred Nineteenth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Saturday,
          the third day of January, two thousand and twenty-six


                                 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).''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.