Report on ALS and other rare neurodegenerative disease action plans

Section 4 of the Accelerating Access to Critical Therapies for ALS Act (21 U.S.C. 360aa note) is amended by adding at the end the following: (c) Report on ALS and other rare neurodegenerative disease action plans Not later than one year 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 contains— (1) an updated action plan, including— (A) a description of the actions the Food and Drug Administration intends to take during the 5-year period following publication of the plan with respect to the program enhancements, policy development, regulatory science initiatives, and other appropriate initiatives described in subsection (a); (B) a description of the resources necessary to implement each section of the plan within such 5-year period; and (C) specific approaches the Commissioner will take to improve coordination of implementation of the plan with rare neurodegenerative disease communities that are not specifically ALS communities; and (2) with respect to the Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) published by the Food and Drug Administration on June 23, 2022 (referred to in this section as the 2022 Action Plan), a description of— (A) the actions taken by the Food and Drug Administration under the 2022 Action Plan; (B) the effect of the implementation of the 2022 Action Plan on the development of therapies and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases; (C) any programs and initiatives that established or carried out as part of the implementation of the 2022 Action Plan; and (D) the extent to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis..

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 and inserting FDA; (2) in subsection (a), in the matter preceding paragraph (1)— (A) by inserting and not later than 1 year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 and every 5 years thereafter, after this Act,; and (B) by inserting develop, or update, as applicable, and before publish on; (3) in subsection (b)— (A) in the matter preceding paragraph (1), by striking initial; (B) in paragraph (2)— (i) in subparagraph (A), by inserting of relevant investigational new drug applications after sponsors; (ii) in subparagraph (C) by inserting for the prevention, diagnosis, mitigation, treatment, or cure of rare neurodegenerative diseases before the semicolon; and (iii) in subparagraph (D), by striking; and and inserting a semicolon; (C) in paragraph (3), by striking the period at the end and inserting; and; and (D) by adding at the end the following: (4) for each action plan published after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, include a description of— (A) previous actions taken by the Food and Drug Administration to implement the previous action plan published under subsection (a); (B) any other planned actions to implement such action plan; and (C) any barriers to implementing such action plan and related recommendations, which may include an estimate of resources necessary to address such barriers..