Accelerating Access to Critical Therapies for ALS Act

Bill: 117-hr-3537
Sponsor: Rep. Quigley, Mike [D-IL-5]
Introduced: 2021-05-25 in the House
Policy area: Health
Subjects: Drug safety, medical device, and laboratory regulation
Drug therapy
Government information and archives
Health care coverage and access
Health programs administration and funding
Health promotion and preventive care
Higher education
Medical research
Medical tests and diagnostic methods
Neurological disorders
Prescription drugs
Public-private cooperation
Research administration and funding
Research and development
Social work, volunteer service, charitable organizations

Summary:
action_date: 2021-05-25
text: 

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.

action_date: 2021-12-08
text: 

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. 

action_date: 2021-12-16
text: 

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. 

action_date: 2021-12-23
text: 

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. 


Legislative actions:
action_date: 2021-12-23
text: Became Public Law No: 117-79.
action_date: 2021-12-23
text: Became Public Law No: 117-79.
action_date: 2021-12-23
text: Signed by President.
action_date: 2021-12-23
text: Signed by President.
action_date: 2021-12-23
text: Presented to President.
action_date: 2021-12-23
text: Presented to President.
action_date: 2021-12-17
text: Message on Senate action sent to the House.
action_date: 2021-12-16
text: Passed Senate without amendment by Voice Vote. (consideration: CR S9242)
action_date: 2021-12-16
text: Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.(consideration: CR S9242)
action_date: 2021-12-09
text: Received in the Senate, read twice.
action_date: 2021-12-08
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2021-12-08
text: 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)
action_date: 2021-12-08
text: 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)
action_date: 2021-12-08
text: Considered as unfinished business. (consideration: CR H7535-7536)
action_date: 2021-12-08
text: 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.
action_date: 2021-12-08
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 3537.
action_date: 2021-12-08
text: Considered under suspension of the rules. (consideration: CR H7509-7514)
action_date: 2021-12-08
text: Mr. Pallone moved to suspend the rules and pass the bill, as amended.
action_date: 2021-12-08
text: Placed on the Union Calendar, Calendar No. 148.
action_date: 2021-12-08
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-207.
action_date: 2021-12-08
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 117-207.
action_date: 2021-11-17
text: Ordered to be Reported (Amended) by Voice Vote.
action_date: 2021-11-17
text: Committee Consideration and Mark-up Session Held.
action_date: 2021-11-04
text: Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
action_date: 2021-11-04
text: Subcommittee Consideration and Mark-up Session Held.
action_date: 2021-05-26
text: Referred to the Subcommittee on Health.
action_date: 2021-05-25
text: Referred to the House Committee on Energy and Commerce.
action_date: 2021-05-25
text: Introduced in House
action_date: 2021-05-25
text: Introduced in House

Enacted as: number: 117-79