{"format":1,"id":"117-hr-3537","congress":117,"number":"H.R. 3537","kind":"bill","group":"bills","title":"Accelerating Access to Critical Therapies for ALS Act","title_source":"Short Titles as Enacted","official_title":"To direct the Secretary of Health and Human Services to support research on, and expanded access to, investigational drugs for amyotrophic lateral sclerosis, and for other purposes.","titles":[{"type":"Official Title as Introduced","title":"To direct the Secretary of Health and Human Services to support research on, and expanded access to, investigational drugs for amyotrophic lateral sclerosis, and for other purposes."},{"type":"Short Titles from ENR (Enrolled) bill text","title":"Accelerating Access to Critical Therapies for ALS Act"},{"type":"Display Title","title":"Accelerating Access to Critical Therapies for ALS Act"},{"type":"Short Title(s) as Passed House","title":"Accelerating Access to Critical Therapies for ALS Act"},{"type":"Short Title(s) as Introduced","title":"Accelerating Access to Critical Therapies for ALS Act"},{"type":"Short Titles as Enacted","title":"Accelerating Access to Critical Therapies for ALS Act"},{"type":"Short Titles as Passed Senate","title":"Accelerating Access to Critical Therapies for ALS Act"},{"type":"Short Title(s) as Reported to House","title":"Accelerating Access to Critical Therapies for ALS Act"}],"outcome":"became_law","law_number":"Public Law 117-79","introduced":"2021-05-25","chambers":{"house":{"status":"roll_call","date":"2021-12-08","vote":{"id":"117-2021-h415","question":"On Motion to Suspend the Rules and Pass, as Amended","title":"Accelerating Access to Critical Therapies for ALS Act","result":"Passed","yea":423,"nay":3,"present":0,"not_voting":7,"source":"https://clerk.house.gov/evs/2021/roll415.xml"}},"senate":{"status":"voice","date":"2021-12-16","vote":null,"how":"voice_vote","words":"Passed/agreed to in Senate: Passed Senate without amendment by Voice Vote.(consideration: CR S9242)"}},"president":{"status":"signed","date":"2021-12-23"},"vice_president_tie_breaker":null,"latest_action":{"text":"Became Public Law No: 117-79.","date":"2021-12-23"},"nominees":null,"amendments":[],"other_votes":[],"crs_summary":{"date":"2021-12-23","stage":"Public Law","blocks":[{"k":"h","t":"Accelerating Access to Critical Therapies for ALS Act"},{"k":"p","t":"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."},{"k":"p","t":"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."},{"k":"p","t":"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."},{"k":"p","t":"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."},{"k":"p","t":"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."},{"k":"p","t":"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."}],"words":220},"summary":{"main_subject":{"text":"Directs the Secretary of Health and Human Services to fund research on, and expanded access to, investigational drugs for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases through grants, a public-private partnership, and an FDA action plan.","cites":[{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H9C4D984F36ED4E6086808955D94EB0AF:~:text=2.%20Grants%20for%20research%20on%20therapies%20for"},{"label":"Sec. 3","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#HCB1009B07FC94C4FB3D0CE2F51D2D19C:~:text=3.%20HHS%20public"},{"label":"Sec. 4","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H322B7188499044BCB531749E9403DE58:~:text=4.%20ALS%20and%20other%20rare%20neurodegenerative%20disease"},{"label":"Sec. 5","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H4C3F7FC7744D4207BAD2F6E0F6049FFB:~:text=5.%20FDA%20rare%20neurodegenerative%20disease%20grant%20program"}]},"core_areas":["Grants for research using expanded access data for ALS investigational drugs","Public-Private Partnership for Neurodegenerative Diseases","FDA action plan for rare neurodegenerative diseases","FDA grants for rare neurodegenerative disease research and drug development","GAO reporting on the grant programs"],"what_it_does":[{"text":"Requires the Secretary of Health and Human Services to award grants to participating entities for research using data from expanded access to investigational drugs for ALS patients who are not otherwise eligible for clinical trials.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H9C4D984F36ED4E6086808955D94EB0AF:~:text=2.%20Grants%20for%20research%20on%20therapies%20for"}},{"text":"Bars the Secretary from awarding the Sec. 2 grants on or after September 30, 2026.","cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H9C4D984F36ED4E6086808955D94EB0AF:~:text=2.%20Grants%20for%20research%20on%20therapies%20for"}},{"text":"Requires the Secretary to establish a Public-Private Partnership for Neurodegenerative Diseases between the National Institutes of Health, the Food and Drug Administration, and one or more eligible entities within one year of enactment.","cite":{"label":"Sec. 3","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#HCB1009B07FC94C4FB3D0CE2F51D2D19C:~:text=3.%20HHS%20public"}},{"text":"Requires the Commissioner of Food and Drugs to publish on the FDA website, within 6 months of enactment, an action plan covering the following 5 years to foster development of, and facilitate access to, drugs for ALS and other rare neurodegenerative diseases.","cite":{"label":"Sec. 4","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H322B7188499044BCB531749E9403DE58:~:text=4.%20ALS%20and%20other%20rare%20neurodegenerative%20disease"}},{"text":"Requires the Secretary, acting through the Commissioner of Food and Drugs, to award grants and contracts to public and private entities to cover costs of research on, and development of interventions for, ALS and other rare neurodegenerative diseases in adults and children.","cite":{"label":"Sec. 5","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H4C3F7FC7744D4207BAD2F6E0F6049FFB:~:text=5.%20FDA%20rare%20neurodegenerative%20disease%20grant%20program"}},{"text":"Authorizes $100,000,000 to be appropriated for each of fiscal years 2022 through 2026 to carry out the Act.","cite":{"label":"Sec. 7","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H03096D3C7BA9436FB3C194F41F5E06CD:~:text=7.%20Authorization%20of%20appropriations"}}],"unexpected":[{"category":"narrow_beneficiary","items":[{"cite":{"label":"Sec. 2","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr#H9C4D984F36ED4E6086808955D94EB0AF:~:text=2.%20Grants%20for%20research%20on%20therapies%20for"},"heading":"Grants for research on therapies for ALS","effect":"Grants for ALS research using expanded access data go only to a 'participating entity,' defined as trial sites sponsored by a small business concern that sponsors a drug under an investigational new drug application for ALS.","amount":null,"quote":"means a participating clinical trial site or sites sponsored by a small business concern (as defined in section 3(a) of the Small Business Act (15 U.S.C. 632(a))) that is the sponsor of a drug"}]}],"version":{"type":"Enrolled Bill","date":null,"rule":"enrolled","href":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text/enr"},"current":true,"model":"claude-sonnet-5-5","approved":"2026-10-15","approved_by":"checks"},"sources":{"congress_gov":"https://www.congress.gov/bill/117th-congress/house-bill/3537","text":"https://www.congress.gov/bill/117th-congress/house-bill/3537/text"},"card":{"image":"card/item/117-hr-3537.png","v":"27943b1ad042","alt":"Votes on Record. H.R. 3537, 117th Congress: Accelerating Access to Critical Therapies for ALS Act. House: 423 Yea, 3 Nay. Senate: voice vote. Outcome: Became law, 23 Dec 2021."}}