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 amended— (1) in the section heading, by adding at the end the following: (c) Report on striking ALS and other rare neurodegenerative disease action plans Not and inserting FDA; (2) in subsection (a), in the matter preceding paragraph (1)— (A) by inserting and not later than one 1 year after the date of enactment of the Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026, 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 Commissioner matter preceding paragraph (1), by striking initial; (B) in paragraph (2)— (i) in subparagraph (A), by inserting of Food 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 Drugs shall publish on (iii) in subparagraph (D), by striking; and and inserting a semicolon; (C) in paragraph (3), by striking the website 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 Food and Drug Administration a report that contains— (1) an updated action plan, including— (A) a description Accelerating Access to Critical Therapies for ALS Reauthorization Act 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), 2026, include a description of— (A) the previous actions taken by the Food and Drug Administration to implement the previous action plan published under the 2022 Action Plan; subsection (a); (B) the effect of the implementation of the 2022 Action Plan on the development of therapies any other planned actions to implement such action plan; and regulatory consideration of therapies for ALS and other rare neurodegenerative diseases; (C) any programs barriers to implementing such action plan and initiatives that established or carried out as part related recommendations, which may include an estimate of the implementation of the 2022 Action Plan; and (D) the extent resources necessary to which the 2022 Action Plan was implemented with respect to rare neurodegenerative diseases that are not amyotrophic lateral sclerosis..address such barriers..