Accelerating Access to Critical Therapies for ALS Act (Public Law 117-79)

The ACT for ALS is a US federal law signed on 2021-12-23 as Public Law 117-79. It sets up grants, a public-private partnership, an FDA action plan and an FDA grant program for ALS and "other rare neurodegenerative diseases". Sections 3, 4 and 5 are written for the wider group, so they are the ones that could matter to prion disease; Section 2 is ALS only. The statute never defines the wider term, so prion eligibility is not settled by the text.

Key facts

  • Section 2 lets HHS give grants for research that uses data from expanded access to investigational ALS drugs; the grantee must be a clinical trial site sponsored by a small business with an ALS drug in phase 3.
  • Section 2 grants may not be awarded on or after 2026-09-30. Whether this was extended is not known from the sources read.
  • Section 3 requires HHS to set up, within one year, a public-private partnership among NIH, FDA and eligible universities or 501(c)(3) bodies for ALS and other rare neurodegenerative diseases, covering regulatory science, research and drug development.
  • Section 4 requires the FDA Commissioner to publish within six months a five-year action plan on drug development and access to investigational drugs for ALS and other rare neurodegenerative diseases. FDA runs public docket FDA-2022-N-1279 for it.
  • Section 5 directs FDA grants and contracts for adults and children with ALS and other rare neurodegenerative diseases; eligible work includes disease characterization, molecular target identification and trial efficiency such as master protocols and clinical trial networks.
  • Section 6 requires a GAO report within four years on the Section 2 and Section 5 grants.
  • Section 7 authorizes 100 million USD for each of fiscal years 2022 to 2026.
  • FDA runs the Section 5 program through its Office of Orphan Products Development and announced over 16.9 million USD over four years on 2023-09-29, with ALS, Niemann-Pick C and myotonic dystrophy type 1 named as examples; no prion disease is named.
  • FDA and NIH launched CP-RND, the Section 3 partnership, on 2022-09-14 with the Critical Path Institute as convener.
  • A search excerpt, not verified, reports a GAO report of February 2026 putting FDA grants at about 10 percent of spending under the Act.

Timeline

  1. 2021Act signed as Public Law 117-79.
  2. 2022FDA and NIH stakeholder engagement meeting on the Act.
  3. 2022CP-RND partnership launched.
  4. 2023FDA announces over 16.9 million USD in rare neurodegenerative disease grants.
  5. 2024to 2024-03-01 Application window for the FDA START pilot.
  6. 2025Deadline for the clinical trial funding opportunity announced in August 2024.
  7. 2026End of fiscal year 2026 authorization and Section 2 grant cutoff.

Last checked 1 November 2026

Sources for this page