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Public Law117th CongressHealth
H.R. 3537Became Law

Accelerating Access to Critical Therapies for ALS Act

This bill became law

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What it doesSummary public law (Dec 23, 2021)

Accelerating Access to Critical Therapies for ALS Act

This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions.

The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials. 

The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases.

HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases.

The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

What just happenedDec 23, 2021

Became Public Law No: 117-79.

Who’s behind it

Rep. Quigley, Mike [D-IL-5](D-IL)Sponsor
331 cosponsors186 D145 R
Read on Congress.gov
331cosponsors1committees29actions1related bills15subjects
  • Enrolled Bill
  • Received in SenateDec 9, 2021
  • Reported in HouseDec 8, 2021
  • Engrossed in HouseDec 8, 2021
  • Introduced in HouseMay 25, 2021
  • Public LawDec 24, 2021
  1. Dec 23, 2021President

    Became Public Law No: 117-79.

  2. Dec 23, 2021BecameLaw36000

    Became Public Law No: 117-79.

  3. Dec 23, 2021President

    Signed by President.

  4. Dec 23, 2021BecameLaw36000

    Signed by President.

  5. Dec 23, 2021Floor

    Presented to President.

  6. Dec 23, 2021President28000

    Presented to President.

  7. Dec 17, 2021Floor

    Message on Senate action sent to the House.

  8. Dec 16, 2021Floor

    Passed Senate without amendment by Voice Vote. (consideration: CR S9242)

  9. Dec 16, 2021Floor17000

    Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.(consideration: CR S9242)

  10. Dec 9, 2021IntroReferral

    Received in the Senate, read twice.

  11. Dec 8, 2021FloorH38310

    Motion to reconsider laid on the table Agreed to without objection.

  12. Dec 8, 2021FloorH37300

    On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 423 - 3 (Roll no. 415). (text: CR H7509-7511)

  13. Dec 8, 2021Floor8000

    Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 423 - 3 (Roll no. 415).(text: CR H7509-7511)

  14. Dec 8, 2021FloorH30000

    Considered as unfinished business. (consideration: CR H7535-7536)

  15. Dec 8, 2021FloorH37220

    At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.

  16. Dec 8, 2021FloorH8D000

    DEBATE - The House proceeded with forty minutes of debate on H.R. 3537.

  17. Dec 8, 2021FloorH30000

    Considered under suspension of the rules. (consideration: CR H7509-7514)

  18. Dec 8, 2021FloorH30300

    Mr. Pallone moved to suspend the rules and pass the bill, as amended.

  19. Dec 8, 2021CalendarsH12410

    Placed on the Union Calendar, Calendar No. 148.

  20. Dec 8, 2021CommitteeH12200

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-207.

  21. Dec 8, 2021Committee5000

    Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-207.

  22. Nov 17, 2021Committee

    Ordered to be Reported (Amended) by Voice Vote.

  23. Nov 17, 2021Committee

    Committee Consideration and Mark-up Session Held.

  24. Nov 4, 2021Committee

    Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .

  25. Nov 4, 2021Committee

    Subcommittee Consideration and Mark-up Session Held.

  26. May 26, 2021Committee

    Referred to the Subcommittee on Health.

  27. May 25, 2021IntroReferralH11100

    Referred to the House Committee on Energy and Commerce.

  28. May 25, 2021IntroReferralIntro-H

    Introduced in House

  29. May 25, 2021IntroReferral1000

    Introduced in House

Public LawDec 23, 202149

Accelerating Access to Critical Therapies for ALS Act

This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions.

The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials. 

The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases.

HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases.

The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

Passed SenateDec 16, 202155

Accelerating Access to Critical Therapies for ALS Act

This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions.

The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials. 

The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases.

HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases.

The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

Passed HouseDec 8, 202153

Accelerating Access to Critical Therapies for ALS Act

This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions.

The Department of Health and Human Services (HHS) shall award grants to eligible entities for scientific research utilizing data from expanded access to investigational ALS treatments for individuals who are not otherwise eligible for clinical trials. 

The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other rare neurodegenerative diseases.

HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases.

The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

The Government Accountability Office must report to Congress about the grants provided under this bill, including an analysis of the impact of such grants on research and development of treatments for ALS.

Introduced in HouseMay 25, 2021

Accelerating Access to Critical Therapies for ALS Act

This bill establishes grant programs to address neurodegenerative diseases, such as amyotrophic lateral sclerosis (also known as ALS or Lou Gehrig's disease), and contains other related provisions.

The Department of Health and Human Services (HHS) shall award grants to eligible entities to facilitate patients' access to investigational drugs that diagnose or treat ALS. The Food and Drug Administration (FDA) shall award grants to public and private entities to cover the costs of research and development of drugs that diagnose or treat ALS and other severely debilitating neurodegenerative diseases.

HHS shall also establish the Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the FDA, and at least one eligible entity (generally, an institution of higher education or a nonprofit organization). The partnership shall support the development and regulatory review of drugs that address ALS and other rare neurodegenerative diseases.

The FDA shall publish on its website a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

Accelerating Access to Critical Therapies for ALS Act — Informed